EAST AFRICAN COMMUNITY
DRAFT 7: JANUARY, 2015
EAST AFRICAN COMMUNITY REGIONAL PROJECT PROPOSAL ON
STRENGTHENING AND HARMONIZATION OF THE REGULATION OF
MEDICAL DEVICES AND DIAGNOSTICS IN THE EAST AFRICAN
COMMUNITY PARTNER STATES
EAC Secretariat,
EAC Close
P.O. BOX 1096, Arusha, Tanzania
Tel: +255-27-2162100/14
Fax: Fax: +255-27-2162190
E-Mail: eac@eachq.org; health@eachq.org
Website: www.eac.int
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Table of Contents
1.0 EXECUTIVE SUMMARY ............................................................................................................ 3
2.0 DEFINITIONS .............................................................................................................................. 4
3.0 BACKGROUND AND RATIONALE ......................................................................................... 6
3.1 Republic of Burundi ........................................................................................................................... 7
3.2 Republic of Kenya ............................................................................................................................... 7
3.3 United Republic of Tanzania (Mainland) ................................................................................... 8
3.4 United Republic of Tanzania (Zanzibar)..................................................................................... 8
3.5 Republic of Rwanda............................................................................................................................ 8
3.6 Republic of Uganda ............................................................................................................................. 8
4.0 REGIONAL AND INTERNATIONAL REGULATORY HARMONIZATION LANDSCAPE
............................................................................................................................................................. 12
4.1 EAC Medicines Regulatory Harmonization .............................................................................. 12
4.2 Regulation of medical devices and IVDs ................................................................................... 12
4.3 The Global Harmonization Task Force...................................................................................... 13
4.4 Asian Harmonization Working Party (AHWP) ....................................................................... 13
4.6 International Organisation for Standardisation.................................................................... 14
5.0 GOAL, PURPOSE AND OBJECTIVES ................................................................................... 15
5.1 GOAL ...................................................................................................................................................... 15
5.2 PURPOSE .............................................................................................................................................. 15
5.3 OBJECTIVES ......................................................................................................................................... 16
5.3.1 Specific objectives..................................................................................................................................... 16
5.3.2 Attributable benefits ............................................................................................................................... 16
5.4 Project Framework Narrative ...................................................................................................... 17
5.4.1 Objective 1: .................................................................................................................................................. 17
5.4.2 Objective 2: .................................................................................................................................................. 18
5.4.3 Objective 3: .................................................................................................................................................. 19
5.4.4 Objective 4: .................................................................................................................................................. 21
5.4.5 Objective 5: .................................................................................................................................................. 21
6.0 PROJECT DESIGN AND IMPLEMENTATION .................................................................... 22
6.1 Management and Staffing Plan for this Project ...................................................................... 25
7.0 MONITORING AND EVALUATION ...................................................................................... 27
8.0 SUSTAINABILITY .................................................................................................................... 28
9.0 CITATIONS ................................................................................................................................ 29
10.0 PROJECT FRAMEWORK AND BUDGET .......................................................................... 30
APPENDIX I Elements of regulation of medical devices and diagnostics .................. 39
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EAST AFRICAN COMMUNITY REGIONAL PROJECT PROPOSAL ON THE
STRENGTHENING AND HARMONIZATION OF THE REGULATION OF MEDICAL
DEVICES AND DIAGNOSTICS
1.0 EXECUTIVE SUMMARY
East African Community (EAC) is a regional inter-governmental organization of the five Partner
States, namely the Republic of Burundi, the Republic of Kenya, the Republic of Rwanda, the United
Republic of Tanzania and the Republic of Uganda, with its headquarters located in Arusha, Tanzania.
Access to medical devices and diagnostics for health in the EAC is limited by their availability and
cost, and there is uncertainty as to the safety and effectiveness of some products. Regulatory control
of medical devices and diagnostics is weak across the EAC with efforts to control the quality of
imported products largely confined to national disease programs for pathogens such as Human
Immunodeficiency Virus (HIV) and malaria. Weak regulation allows poor quality products to be
marketed. Inefficient regulation delays access to beneficial new products and increases costs to
manufacturers, inflating prices for consumers. Streamlining and harmonizing regulatory processes in
EAC Partners States can reduce delay and unnecessary expense, and improve access to new
products.
The primary aim of the East African Community Regional Project Proposal on Strengthening and
Harmonization of the Regulation of Medical Devices and Diagnostics is to enhance the health of the
population by improving access to diagnosis and treatment of communicable and noncommunicable diseases by ensuring access to safe and effective medical devices and diagnostics
though the enhancement of regulatory capacity and supporting the use of collaborative mechanisms
for regulatory approval in the region in accordance with the mandate provided by Article 118 of the
Treaty on the establishment of the EAC.
The project will be implemented by EAC Secretariat’s Health Department together with the National
Medicines Regulatory Authorities (NMRAs). In undertaking this project a Project Coordination team
operating within the EAC Secretariat will be responsible for the overall management and
implementation at regional level while national level activities will be undertaken by the technical
staff of the NMRAs’.
It is envisaged that the project will run for five years with the following objectives:
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i.
To develop and implement regional harmonized regulatory and mutual recognition
framework for regulation of medical devices and in vitro diagnostics
ii.
To develop and implement Quality Management System in EAC Partner States NMRA’s for
regulation of medical devices and in vitro diagnostics
iii.
To build and improve human resource and infrastructural capacity for the regulation of
medical devices and diagnostics in the EAC region
iv.
To develop and implement a regional integrated Information Management System (IMS) for
regulation of medical devices and in vitro diagnostics linked to all EAC Partner States and
EAC Secretariat
v.
To establish and strengthen platforms for sharing developments in research and innovations
on medical devices and in-vitro diagnostics
The EAC harmonized regional medical devices and diagnostics regulation system will be sustained
through the existing organisational and institutional framework of the EAC Secretariat and Partner
States’ NMRAs. Financial resources to be mobilized will be used to support the project for the five
years of its duration. Subsequently, the cost of maintaining on-going project activities and personnel
will be borne by the EAC Secretariat and the Partner States’ NMRAs. The project staff at EAC
Secretariat and at the NMRAs will be absorbed and retained as regular staff in order to
institutionalize the harmonized regulatory systems.
This proposal was developed in consultation with the World Health Organization (WHO), London
School of Hygiene and Tropical Medicine (LSHTM), African Society for Laboratory Medicine (ASLM),
Deutsche Gesellschaft für Internationale Zusammenarbeit (GIZ) and African Union New Partnership
for Africa’s Development (AU-NEPAD).
2.0 DEFINITIONS
The following definitions have been adopted from the IMDRF.
‘Medical device’ means any instrument, apparatus, implement, machine, appliance, implant,
reagent for in vitro use, software, material or other similar or related article, intended by the
manufacturer to be used, alone or in combination, for human beings, for one or more of the specific
medical purpose(s) of:

diagnosis, prevention, monitoring, treatment or alleviation of disease,

diagnosis, monitoring, treatment, alleviation of or compensation for an injury,
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
investigation, replacement, modification, or support of the anatomy or of a physiological process,

supporting or sustaining life,

control of conception,

disinfection of medical devices,

providing information by means of in vitro examination of specimens derived from
the human body;
and does not achieve its primary intended action by pharmacological, immunological or metabolic
means, in or on the human body, but which may be assisted in its intended function by such means.
Note: Products which may be considered to be medical devices in some jurisdictions but not in
others include:

disinfection substances,

aids for persons with disabilities,

devices incorporating animal and/or human tissues,

devices for in-vitro fertilization or assisted reproduction technologies.
Medical devices vary greatly in complexity and application. Examples range from simple devices such
as tongue depressors, medical thermometers, and disposable gloves to advanced devices such as
computers which assist in the conduct of medical testing, implants including those used for
contraception and prostheses. The design of medical devices constitutes a major segment of the
field of biomedical engineering.
Medical devices are assigned to one of four regulatory classes on the basis of its risk and the
evaluation necessary to demonstrate safety and effectiveness. Most class I devices (e.g.,
stethoscopes) are low-risk and subject only to “general controls,” such as tests of sterility. Class II
devices (e.g., computed tomographic scanners) meet general controls as well as “special controls,”
such as additional labeling requirements. Class III products (e.g., deepbrain stimulators and
implantable cardioverter–defibrillators) require clinical studies evaluating the safety and
effectiveness of the device. Class IV are of high risk and require design/clinical trial reviews, product
certification, and an assessed quality system involving clinical trials.
‘In-Vitro Diagnostic (IVD) medical device’ means a medical device, whether used alone or in
combination, intended by the manufacturer for the in-vitro examination of specimens derived from
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the human body solely or principally to provide information for diagnostic, monitoring or
compatibility purposes.
Note 1: In-vitro Diagnostic (IVD) medical devices include reagents, calibrators, control materials,
specimen receptacles, software, and related instruments or apparatus or other articles and are used,
for example, for the following test purposes: diagnosis, aid to diagnosis, screening, monitoring,
predisposition, prognosis, prediction, determination of physiological status.
Note 2: In some jurisdictions, certain In-vitro Diagnostic (IVD) medical devices may be covered by
other regulations.
Note 3: Because In-vitro Diagnostics (IVDs) are a subset of medical devices, the internationally
acknowledged regulatory framework for IVDs is very similar to that of medical devices. Jurisdictions
therefore chose to establish one regulation for medical devices that encompasses IVDs (for example
United States Food and Drug Administration, Therapeutic Goods Administration of Australia), with
specific requirements for IVDs identified within, or as a separate but aligned regulation (for example,
the European directives for medical devices and IVDs).
In vivo diagnostics are used to make test within the body, such as imaging equipment
(UltraSonography and Manometry) as opposed to vitro diagnostics test a sample of tissue or
bodily fluids.
3.0 BACKGROUND AND RATIONALE
East African Community is a regional inter-governmental organization of the five Partner States,
namely the Republic of Burundi, the Republic of Kenya, the Republic of Rwanda, the United Republic
of Tanzania and the Republic of Uganda, with its headquarters located in Arusha, Tanzania
(www.eac.int). The region covers an area of approximately 2.0 million square kilometres, has a
combined gross domestic product of US$110 billion and an estimated population of over 143.5
million people who share a common history, language, culture and infrastructurea. These advantages
provide the Partner States with a unique framework for regional co-operation and integration in
various political, economic, social and cultural areas of common interest. These include joint action
in prevention, control and management of communicable and non-communicable diseases of public
health concern; harmonization of health policies and regulation; and promotion of information
exchange on health issues which are explicitly detailed in Chapter 21 (Article 118) of the EAC Treatyb.
a
b
EAC Facts and Figures Report 2014
EAC Treaty available at www.eac.int
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EAC
[The map should be placed to the left of the text above it]
The five EAC Partner States have six (6) National Medicines Regulatory Authorities (NMRAs) namely
Department of Pharmacy and Medical Laboratories (DPML) of Burundi, Pharmacy Task Force (PTF) of
Rwanda, Pharmacy and Poisons Board (PPB) of Kenya, Tanzania Food and Drugs Authority (TFDA),
Zanzibar Food and Drugs Board (ZFDB) and National Drug Authority (NDA) of Uganda. The current
status of the regulation of medical devices and in-vitro diagnostics in the EAC is as follows:
3.1 Republic of Burundi
In the Republic of Burundi, the regulation of medicines, medical devices and diagnostics falls under
the Department of Pharmacy, Medicines and Laboratories (DPML) in the Ministry of Public Health
and Fight Against AIDS. However, there are advanced institutional arrangements towards the
establishment of the proposed Burundi Medicines Regulatory Authority (ABREMA), once the draft
law is approved and enacted by the Senate of Burundi.
3.2 Republic of Kenya
The Pharmacy and Poisons Board (PPB) was established in 1957 under the Pharmacy and Poisons Act
(Chapter 244), with the legal mandate to control the trade in medicines and poisons and to regulate
the practice of pharmacy. PPB’s Registration of Drugs Rules, Legal Notices on 147/1981, 142/1991
and 192/2010 allowed it to start regulating medical devices in Kenya. The Pharmaceutical Sector
Regulation 4.1.3 is paving way for the establishment of a national Food and Drug Authority (FDA),
responsible for protecting the public health by assuring the safety, efficacy, quality and security of
human and veterinary drugs, biological products, medical devices, cosmetics, tobacco products,
complementary/alternative and herbal medicines and products that emit radiation.
The Pharmaceutical Sector Regulation 4.1.4 will transform the National Quality Control Laboratory
into a state corporation with expansion of its mandate and capacity to include testing of medical
devices, food products, cosmetics. There is currently a requirement to register and pay importation
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fees for all medical devices and diagnostics to the Kenya Medical Technicians and Technologists’
Board.
3.3 United Republic of Tanzania (Mainland)
Tanzania Food and Drugs Authority (TFDA) is responsible for ensuring that all medicines, cosmetics
and medical devices are correctly evaluated for quality, safety and effectiveness before being
approved for use. TFDA is also responsible for inspection and enforcement of medicines, cosmetics
and medical devices. Control of clinical trials and adverse drug reactions monitoring and evaluation
are also regulated by TFDA. Private Health Laboratories Board is currently mandated to regulate in
vitro diagnostic devices. However, processes are underway to confer the mandate to TFDA.
3.4 United Republic of Tanzania (Zanzibar)
The Zanzibar Food and Drugs Board is a semi-autonomous agency responsible for the regulation of
medicines, medical devices, diagnostics and food established by the Zanzibar Food, Drugs and
Cosmetics Act of 2006
3.5 Republic of Rwanda
All matters pertaining to the control of pharmaceuticals including drugs, devices and diagnostics are
handled by the Pharmacy Task Force (PTF) under the Ministry of Health of Rwanda. An act of
parliament (No. 74/2013 of 11/09/2013) has been passed to establish the Rwanda Food and
Medicines Regulatory Authority (RFMRA).
3.6 Republic of Uganda
The National Drug Authority (NDA) was established by the National Drug Policy and Authority Act
Cap 206 of the Laws of Uganda. It is mandated to regulate the quality, safety and efficacy of drugs.
NDA is also involved to some extent in the regulation of medical devices and diagnostics though not
explicitly mandated by the law. Specifically NDA performs physical inspection of imported medical
devices at the ports of entry. For the locally manufactured medical diagnostics NDA performs quality
audits annually. The National Drug Quality Control Laboratory (NDQCL) tests all batches of medical
gloves, male latex condoms and insecticide treated mosquito nets before they are released for use
by the population.
A baseline survey on regulatory activities for medical diagnostics in EAC and other selected African
countries undertaken in 2012 found that the capacity to regulate medical devices and diagnostics
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was limited in terms of skills and human resource. The survey noted that in some countries the
regulation of medical devices and diagnostics had been delegated to the NMRAs while in other
countries Ministry of Health departments were involved. Control of medical devices and diagnostics
was largely confined to those used by national disease programs such as Human Immunodeficiency
Virus (HIV) and malaria. In addition, some activities to evaluate medical devices and diagnostics were
performed in research laboratories but post market surveillance was rarely done.
Table 1: Summary of regulatory activities for medical diagnostics in East Africa and other selected
African countries.
Generally, the regulatory landscape for medical devices and diagnostics in EAC was found to be weak
and inefficient. While much effort and resources have been placed in strengthening regulation of
medicines, the area of medical devices including in vitro diagnostics has been forgotten or very little
effort has been made towards their regulation. Weak regulation allows defective or substandard
products to be marketed. Inefficiency in regulation causes unnecessary delay and increases costs to
manufacturers and consumers. Wrong diagnosis resulting from a defective or substandard device
may result in a complete failure of the whole treatment cycle including wrong medication and may
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result into death. Therefore, the issue of safety and performance of medical devices and diagnostics
cannot be underestimated.
In almost all five countries in East Africa with the exception of Tanzania, nothing much has been done
in terms of regulation of medical devices and in vitro diagnostics. EAC is bordered by seven countries
which do not have any system yet to regulate devices. Therefore, the region is prone to influx of
substandard or counterfeit medical devices from the bordering countries through the multiple porous
borders. The other concern is the fact that in all the five EAC countries there are few or no
manufacturing facilities for devices and therefore at least 80-90% of these products are imported. A
report by Mori M, Ravinetto R & Jacobs J et al (2011); Quality of Medical Devices and In Vitro
Diagnostics in Resource Limited Settingsc showed that there were limited reports and evidence with
regards to poor quality medical devices and this was mainly due to:
(i) the poor regulatory oversight of medical devices and in vitro diagnostics in resource-limited
settings;
(ii) a general lack of awareness of the problem of poor-quality medical devices and in vitro
diagnostics amongst the scientific community and decision-makers; and
(iii) poor quality assurance in diagnostic laboratories in resource-poor settings, precluding
tracing quality problems of IVDs from the other potential causes of diagnostic inaccuracy.
The report went further to cite examples of reported substandard and defective products found in
different parts of the world including Africa. This proves that poor quality products can easily find
ways into the market especially those that are poorly regulated. Some of the examples are Syphilis
Rapid Plasma regain (RPR) purchased in Tete, Mozambique in January 2007; malaria rapid tests in
Benin in May 2007; malaria rapid tests in the Republic of South Africa in June 2010 and HIV
diagnostic test in Kinshasa, March 2011.
In order to address the challenges, the East African Community has developed a Regional Project on
Strengthening and Harmonization of the Regulation of Medical Devices Including In Vitro Diagnostics
to enhance the regulatory capacity of NMRAs and supporting the use of collaborative mechanisms
for regulatory approval in the region. The project will focus on the coordination, capacity
strengthening and harmonization of regional policies, regulations, standards, guidelines and
procedures for the regulation and post-market surveillance of medical devices and diagnostics
through the organizational and institutional strengthening of the existing EAC Partner States’
c
Quality of Medical Devices and In Vitro Diagnostics in Resource Limited Settings
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National Medicines Regulatory Authorities (NRAs) and the establishment of the proposed East
African Community Medicines and Food Safety Commission (EACMFSC).
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4.0
REGIONAL
AND
INTERNATIONAL
REGULATORY
HARMONIZATION
LANDSCAPE
4.1 EAC Medicines Regulatory Harmonization
As part of collaboration on matters of health generally and in particular harmonization of regulation
of health products, the Partner States through their NMRAs are currently implementing the EAC
Medicines Regulatory Harmonization Project (EAC-MRH). The goal of EAC-MRH is to have
harmonized and functioning medicines regulatory systems within the EAC in accordance with
national and internationally recognized standards. So far, the EAC-MRH has been able to develop
harmonized standards for medicines evaluation and registration, Good Manufacturing Practices,
Quality Management Systems and is in the process of establishing common information
management systems in all NMRAs. Collaborative mechanisms for drug regulatory systems and
processes at the regional level should translate into improved regulatory approval processes and
operational efficiencies at the national level. In this regard, the project will increase the capacity of
the national medicines regulatory authorities and specifically strengthen the administrative,
structural and technical elements of medicine regulation. In doing so, the project will help countries
to enhance and facilitate their decision-making processes regarding the registration of medicines, as
well as exercise more control over medicines circulating on the market. The long term vision of EACMRH is to expand the scope of regulation to cover other product streams such as medical devices
including in-vitro diagnostics, biological products and other regulatory functions including clinical
trials and post marketing surveillance (PMS).
4.2 Regulation of medical devices and IVDs
The World Health Organization (WHO) Prequalification of Diagnostics Programme which aims to
promote and facilitate access to safe, appropriate and affordable diagnostics of good quality in an
equitable manner has evaluated and prequalified a selection of diagnostic products for malaria and
HIV. They have published guiding principles on the regulation of medical devices based on
International Medical Devices Regulators Forum (IMDRF) regulatory model. Documents have also
been developed to assist with evaluation of diagnostics for persons living with HIV and for reporting
post market complaints of WHO prequalified products. The Programme has previously assisted the
Tanzania Food and Drugs Authority to prepare for their forthcoming role as regulators of IVDs,
including developing a strategy for post market surveillance. Currently, Tanzania is the only EAC
Partner State that has adopted a regulatory system based on IMDRF/GHTF recommendations.
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4.3 The Global Harmonization Task Force
The Global Harmonization Task Force (GHFT) was conceived in 1992 in response to the growing need
for international harmonization in the regulation of medical devices to ensure the safety,
effectiveness and quality of medical devices. Harmonization can promote technological innovation
and facilitate international trade. GHTF was a voluntary group of representatives from national
medical device regulatory authorities and the medical device industry. Its Founding Members are
Australia, Canada, Japan, USA and the European Union. Chairmanship of the GHTF rotated among
the representatives of the five Founding Members. The GHTF published and disseminated
harmonized documents on basic regulatory practices and served as an information exchange forumd.
In 2012, GHTF transitioned to a purely regulatory body called the International Medical Devices
Regulatory Forum (IMDRF) which will continue to promote the principles of harmonization.
4.4 Asian Harmonization Working Party (AHWP)
Convergence in Asia is being facilitated by the work of the Asian Harmonization Working Party
(AHWP)e, a voluntary organisation of regulators and manufacturers from 23 member economies
(Abu Dhabi, Brunei Darussalam, Cambodia, Chile, Chinese Taipei, Hong Kong SAR, China, India,
Indonesia, Jordan, Kingdom of Saudi Arabia, Korea, Laos PDR, Malaysia, Myanmar, Pakistan,
People's Republic of China, Philippines, People's Republic of China, Singapore, South Africa, Thailand,
Vietnam and Yemen). AHWP aims to promote harmonization among its member economies through
the adoption and application of GHTF guidance documents in collaboration with APEC and the
Association of East Asian Nations (ASEAN) and other related international organizations. AHPW
provides a platform for the harmonization of medical device regulations among member economies
to ensure safety, quality, and effectiveness of medical devices marketed in its member economies.
Seven AHWP working groups have been established to develop practical guidance on
implementation of GHTF recommendations.
d
e
www.imdrf.org
http://www.ahwp.info/
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4.5 Pan-African Harmonization Working Party
The Pan-African Harmonization Working Party on Medical Devices and Diagnostics (PAHWP)fwas
conceived in 2012. It is a voluntary body whose mission is to improve access to safe and affordable
medical devices and diagnostics in Africa though harmonized regulation and forums such as the
African Regulatory Forum on Medical Diagnostics. PAHWP aims to study and recommend ways to
ensure tests are safe and effective while minimizing costs and delays, allowing faster access to
cheaper products. The work of PAHWP was facilitated by the London School of Hygiene and Tropical
Medicine (LSHTM) with grant funding from Grand Challenges Canada (GCC). The PAHWP is housed
under the African Union-New Partnership for Africa's Development (AU-NEPAD) Planning and
Coordinating Agency. Founding members include the East African Community Health Secretariat
(EAC) and the EAC Partner States, Ethiopia, Nigeria and South Africa and LSHTM. Partners include
German International Co-operation (EAC-GIZ), the African Society for Laboratory Medicine (ASLM)
and the WHO. The priority areas for PAHWP are:
i.
Common risk classification system
ii.
Common registration file
iii.
Reduction in duplication of clinical performance studies by joint review of data
iv.
Reduction in duplication of manufacturing audits through adoption of the single audit
programme similar to the MD-SAP initiative
v.
Post-marketing surveillance
4.6 International Organisation for Standardisation
The International Organisation for Standardisation (ISO) is a federation of national standards bodies
that works with the International Electro technical Commission (IEC) on standards and terminology
in the areas of electrical, electronic and related technologies. Kenya, Rwanda, Tanzania and Uganda
have Membership to ISO through their national standards bodies and Burundi has correspondent
Membership status. The adoption of different standards by individual countries creates technical
barriers which may hinder the flow of goods between countries. To overcome this EAC NMRA will
apply common standards for regulation of medical devices and in vitro diagnostics.
4.7 African Organization for Standardisation
f
http://www.pahwp.org/
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The African Organization for Standardisation (ARSO)g is an intergovernmental body that works under
the auspices of the African Union, with the principal mandate to harmonise African Standards and
conformity assessment procedures in order to reduce technical barriers and promote trade. ARSO
have not published standards specific for medical devices or IVDs but have adopted some general
ISO standards for quality systems.
The proposed EAC project will utilize the experience of the above harmonization initiatives and
expertise, in particular those of IMDRF and WHO.
5.0 GOAL, PURPOSE AND OBJECTIVES
5.1 GOAL
The goal is to enhance the health of the population by improving access to quality medical devices
and in vitro diagnostics for management of diseases and other health conditions.
5.2 PURPOSE
The purpose is to enhance the health of the population in Partner States by improving access to
diagnosis and treatment of communicable and non-communicable diseases by ensuring access to
safe and effective medical devices and diagnostics though the enhancement of regulatory capacity
and supporting the use of collaborative mechanisms for regulatory approval in the region in
accordance with the mandate provided by Article 118 of the Treaty on the establishment of the EAC.
The implementation of this project will focus on the coordination, capacity strengthening and
harmonization of regional policies, regulations, standards, guidelines and procedures for the
regulation and post-market surveillance of medical devices and diagnostics through the
organizational and institutional strengthening of the existing EAC Partner States’ National Medicines
Regulatory Authorities (NRAs) and the establishment of the proposed East African Community
Medicines and Food Safety Commission (EACMFSC).
Setting international standards and streamlining the regulatory process for medical devices and
diagnostics will diminish the regulatory burden, lower costs, reduce delays and provide a basis for
mutual recognition of regulatory decisions among Partner States’ NMRAs. Ultimately, a product
http://www.arso-oran.org/
g
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registered under the harmonized rules in one EAC Partner States shall be accepted for registration in
all EAC Partner States without further review, other than to check that the documentation
submitted to the regulatory body is complete.
5.3 OBJECTIVES
The overall objective of the project is to establish a harmonised framework for regulation of medical
devices and in vitro diagnostics in EAC Partner States based on internationally accepted principles
and standards.
5.3.1 Specific objectives
i.
To develop and implement regional harmonized regulatory and mutual recognition
framework for regulation of medical devices and in vitro diagnostics
ii.
To develop and implement Quality Management System in EAC Partner States NMRA’s for
regulation of medical devices and in vitro diagnostics
iii.
To build and improve human resource and infrastructural capacity for the regulation of
medical devices and in vitro diagnostics in the EAC region
iv.
To develop and implement a regional integrated Information Management System (IMS) for
regulation of medical devices and in vitro diagnostics linked to all EAC Partner States and
EAC Secretariat
v.
To establish and strengthen platforms for sharing developments in research and innovations
on medical devices and in-vitro diagnostics
5.3.2 Attributable benefits
The project will address the problems associated with weak and inefficient regulation of medical
devices and diagnostics and contribute the following benefits:
i.
Communities/patients: The population of EAC will enjoy better health outcomes due to
improved access to safe and effective medical devices and in vitro diagnostics for diagnosis
and management of diseases. Collaborative approaches will facilitate introduction of new
products into the market and lower cost recovery by manufacturers will make products
more affordable.
ii.
National Medicines Regulatory Authorities: Streamlined approval processes will reduce
duplication of efforts by the NMRAs and they will be better equipped to assess devices and
diagnostics in a timely and efficient manner through collaborative mechanisms.
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iii.
Development Partners: There will be more efficient use of resources from development
partners to address the challenges in regulation and procurement of medical devices and in
vitro diagnostics.
iv.
Industry: The streamlined processes will facilitate compilation and submission of technical
files to NMRAs medical devices and diagnostics regulatory authorities. Reduction in
duplication of clinical evaluation and manufacturing audits as well as faster approval times
will translate into cost savings and boost investment potential of the East African market.
5.4 Project Framework Narrative
5.4.1 Objective 1:
To develop and implement regional harmonized regulatory and mutual recognition framework for
regulation of medical devices and in vitro diagnostics.
Milestone: Harmonized Legal and Mutual Recognition for regulation of medical devices and in vitro
diagnostics in the EAC region developed and implemented by end of year five (5)
Activities:
i.
Review existing national policies and legal frameworks using WHO National Regulatory
Authorities (NRAs) assessment guidelines and IMDRF/GHTF requirements as a benchmark.
ii.
Development of EAC regional harmonized policy for regulation of medical devices and in
vitro diagnostics.
iii.
Development of EAC regional legal framework for regulation of medical devices and in vitro
diagnostics.
iv.
Development of regional mutual recognition framework (MRF) for regulation of medical
devices and in vitro diagnostics.
v.
Conduct sensitization meetings with national and regional stakeholders including
parliamentarians.
vi.
Develop and adopt EAC harmonized guidelines and SOP’s for pre market registration, market
and post-market control based on GHTF and IMDRF
vii.
To adopt international harmonized guidelines for quality audits of medical devices and in
vitro diagnostics manufacturers.
Description (Activities):
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The strategic objective focuses on development and implementation of regional harmonized
policies, legal and regulatory framework for regulation of medical devices and in vitro diagnostics in
EAC Partner States.
In order to achieve this, the EWG on Pharmaceutical Policy, Legal and
Regulatory Reform as well as the EWG on Medical Devices and In Vitro Diagnostics will spearhead
the review of the existing policies and laws. In addition the EWG on Medical Devices and In Vitro
Diagnostics will formulate harmonized guidelines and procedures for:
i.
Premarket controls: definition of medical devices, common nomenclature, risk-based
classification, clinical evaluation, dossier submission template (CDST), quality audits and
standards.
ii.
Market controls: import and export, advertising and labelling.
iii.
Post market controls: adverse events monitoring, sample collection and testing and recalls.
The development of the harmonized regulatory framework will be done with the involvement of
stakeholders.
5.4.2 Objective 2:
To develop and implement Quality Management System in EAC Partner States NMRA’s for regulation
of medical devices and in vitro diagnostics.
Milestone:
Quality Management System for regulation of medical devices and in vitro diagnostics established at
the end of year five (5).
Activities:
i.
Develop and implement QMS requirements for medical devices and in vitro diagnostics for
NMRAs and quality control laboratories in line with internationally recognized standards
ii.
Dissemination and capacity building on the developed guidelines and SOPs in Partner States
iii.
Piloting joint audit using the developed QA tools
iv.
Conduct audits of the NMRAs and quality control laboratories to facilitate certification
Description:
Currently, all Partner States have no QMS for medical devices and in vitro diagnostics. Development
of QMS for regulating medical devices is of paramount importance in order to ensure consistency in
quality and safety of medical devices within the Region. The strengthening of quality management
18
systems in NMRAs and quality control laboratories will facilitate uniformity of procedures and
decision making processes as well as mutual recognition hence improving the quality of medical
devices and in vitro diagnostics available in the region.
In implementing this objective manuals, guidelines and standard operating procedures will be
developed in consultation within the partner states and reference will be made to existing processes
in the region as well as those of WHO and well resourced NMRAs.
5.4.3 Objective 3:
To build and improve human resource and infrastructural capacity for the regulation of medical
devices and in vitro diagnostics in the EAC region
Milestones:
i.
A pool of well trained and motivated regional experts to regulate medical devices and
diagnostics in the EAC market established by year five (5)
ii.
A regional centre of excellence in training of regulation of health products by year five (5)
Activities:
i.
Strengthen infrastructure capacity of NMRAs and Laboratories for regulation of medical
devices and diagnostics
ii.
Recruit national and regional staff to implement the project
iii.
Conduct regional trainings to NMRAs and laboratory technologists on assessment of quality
and safety of medical devices and in vitro diagnostics.
iv.
Identify and utilize opportunities for e-learning
v.
Facilitate regional and international staff exchange and/or twinning programmes on
regulation of medical devices and diagnostics
vi.
Conduct joint assessment of dossiers for registration of medical devices and in vitro
diagnostics.
vii.
Conduct joint quality audits of manufacturer’s of medical devices and in vitro diagnostics
viii.
Conduct joint laboratory evaluation
ix.
Establish regional centres of excellences to provide continuous training programme on
regulation of medical devices
Description:
19
Human resource capacity at both NMRAs and EAC Secretariat is of paramount importance to
successfully establish functional and harmonized medical devices and in vitro diagnostics regulatory
systems. It is for this reason that the following persons will be recruited:
EAC Secretariat
i.
Senior Health Officer (Medical Devices and Diagnostics Regulation) – Pathologist (P2)
ii.
Health Officer (Medical Devices) – Biomedical Engineer (P1)
iii.
Health Officer (Diagnostics) – Laboratory Technologist (P1)
National Medicines Regulatory Authorities
i.
Health Officer (Medical Devices) – Biomedical Engineer (P1)
ii.
Health Officer (Diagnostics) – Laboratory Technologist (P1)
iii.
e-Health Information Systems Expert (P1)
The above staff will work within the existing structure of the EAC Secretariat’s Health Department
and together with the following existing staff:

Senior Health Officer (Medicines Regulation) (EAC P2),

National Medicines Regulation Officers (EAC P1)

e-Health and Informatics Expert (EAC P1),

Accountant (EAC P1)

Pharmaceutical Programme Assistant (EAC G5) at the regional level
To facilitate the work of the recruited staff as well as implementation of other objectives office
equipment will be procured and installed in all Partner States and at the EAC Secretariat. There will
also be a series of trainings conducted on project management, pre market, market and post market
controls. To institutionalize these trainings in the existing regional and national programmes,
regional centres of excellence will be identified. Staff exchange will be organized between EAC
NMRAs and well-resourced NMRAs. Joint laboratory evaluation, assessment of dossiers for
registration, quality audits of manufacturer’s of medical devices and in vitro diagnostics will be
conducted regularly as part of capacity building.
20
5.4.4 Objective 4:
To develop and implement a regional integrated Information Management System (IMS) for
regulation of medical devices and in vitro diagnostics linked to all EAC Partner States and EAC
Secretariat.
Milestone: Regional integrated information management system established and linked to all
Partner States by end of year three (3).
Activities:
i.
Mapping of regulatory processes for medical devices and in vitro diagnostics.
ii.
Procure, install and maintain Information Management System (IMS) equipment for all EAC
Partner States and EAC Secretariat
iii.
Training of staff on the use of IMS for regulation of medical devices and in vitro diagnostics.
iv.
Package and disseminate regulatory information and best practices on medical devices and
in vitro diagnostics.
Description:
The integrated information management system will be installed and linked in all EAC partner states
by end of year three (3). In the first year, EAC will facilitate the regional mapping of medical devices
and in vitro diagnostics regulatory processes. The exercise will help to identify the gaps in different
NMRAs. In addition, in year one, experts from the Partner States will develop systems requirement
for the IMS solutions. All the regulatory processes will be covered.
In year two and three, installation, training and maintenance of the IMS will be done. The system
will continue to be used through years four and five.
5.4.5 Objective 5:
To establish and strengthen platforms for sharing developments in research and innovations on
medical devices and in-vitro diagnostics
Milestone:
Increase visibility for regulation of medical devices and in vitro diagnostics within broad range of
stakeholders throughout the five (5) years of the project’s duration.
21
Activities:
i.
Enhancing NMRAs participation in national, regional and international fora to share
information and best practices on regulation of medical devices and in vitro diagnostics.
ii.
Organise and participate in symposia on medical devices and in vitro diagnostics within the
margin of existing regional and continental health research scientific conferences.
Description:
Under this objective, the EAC Secretariat will support collaboration between NMRAs and partners so
as to ensure that the region keeps pace with advances in technology. Specifically, the NMRAs will
participate in regional and international meetings, such as meetings of the Pan African
Harmonization Working Party (PAHWP), African Society for Laboratory Medicine (ASLM),
International Medical Devices Regulators Forum (IMDRF), Asian Harmonization Working Party
(AHWP), Latin American Alliance for the Development of In Vitro Diagnostics (ALADDIV) and London
School of Hygiene and Tropical Medicine (LSHTM).
The NMRAs will endeavour to inform the public and interested parties, including manufacturers and
distributors of medical products, of the harmonised regulation of medical device and diagnostics in
EAC Partner States through website and advocacy materials, articles in the media, articles in
newsletters and presentation of papers at international symposia including the East African Health
and Scientific Conference.
6.0 PROJECT DESIGN AND IMPLEMENTATION
At regional level the EAC medical devices and diagnostics regulation harmonization will be
implemented within the existing EAC Secretariat organizational and institutional structures and
financial management systems and procedures, which among others include; EAC Organizational
and Staffing Structure (2007), EAC Staff Rules and Regulations (2006), EAC Financial Rules and
Regulations (2006), EAC Procurement Manual and Procedures, EAC Policy and Budget Approval
Process through the EAC Council of Ministers, and EAC Audit Commission composed of EAC Partner
States’ National Audit Commissions.
The Project Coordination Team based at the EAC Secretariat will operate under the overall
supervision of the EAC Principal Health Officer (as indicated in Fig 2) and will focus on the overall
project management and implementation. The Project Coordination Team will also play the Secretariat role
22
to the Project Steering Committee comprised of heads of Partner States’ NMRAs for medical devices and
diagnostics. National level coordination will be through focal points at the respective NMRAs supported by
this project.
All technical matters including drafting of technical guidelines and procedures shall be done by EWG
on medical device and in vitro diagnostics which shall be constituted by members drawn from all the
six (6) NMRAs. The EWG shall meet regularly at least twice a year to develop the Annual Work Plans
and Budgets and draft technical documents. The Annual Work Plans and Budgets (AWPBs) and draft
technical documents developed by the EWG will be presented to the Project Steering Committee for
review and adoption and thereafter onward submission to the EAC Sectoral Committee on Health
for consideration in accordance with existing EAC Governing Structures.
The areas of focus shall be;
iv.
Premarket controls: definition of medical devices, common nomenclature, risk-based
classification, clinical evaluation, dossier submission template (CDST), quality audits and
standards.
v.
Market controls: import and export, advertising and labelling.
vi.
Post market controls: adverse events monitoring, sample collection and testing and recalls.
Members EWG will regularly carry out their tasks within the individual regulatory body according to
the assigned tasks and thereafter meet at least twice a year to jointly review and approve their
reports before presentation to the Project Steering Committee. Both the Project Team and National
MRH Focal Points will participate in EWG meetings to provide both technical and secretariat support.
The EWG may when required invite to their meetings experts from other institutions with relevant
knowledge and experience.
Under the proposed project technical assistance will be required to support the implementation of
the project. Particularly knowledge and skills transfer and guidance in development of the medical
devices and in vitro diagnostics regulatory system for the EAC. The following institution may be
requested for technical assistance: WHO, ASLM, LSHTM, NRAs or any other technical expert groups
23
EAC Council of Ministers
EAC Sectoral Council of
Ministers of Health
••
Advocacy
NEPAD
Agenc
EAC Sectoral Committee on
Health
WHO, LSHTM,FDA, ASLM
•
• Regional Annual Wor
• Consolidated Budget &
procurement plan
• Interim Finance Repor
• Annual Audit
Project Steering Committee
•• Policy & Guidelines
harmonization
for
TA
EAC Project Coordination
(EAC SECRETARIAT)
Expert Working Group
• Nomination of experts
• Participation in
consultations
NMRA 1
NMRA 2
• NMRA Annual Work Plans
• Annual Budgets
• Procurement Plans
• Quarterly performance Reports
NMRA 3
NMRA 4
Implementation Arrangements for EAC Medical Devices & Diagnostics Project
Organizational and institutional structures and financial management systems exist in each of the
Partner States though with varying capacities. In this respect, training to the staff of the regulatory
authorities has been incorporated in this project.
EAC has previously developed, implemented and managed various health projects including:
1. SIDA/Norway/IrishAID– “EAC Regional Integrated Multisectoral HIV and AIDS Programme:
2008 - 2013”– USD $ 6,842,128.00over five years (FY 2009 -2013)
2. Rockefeller Foundation (RF) – “East African Integrated Disease Surveillance Network
Regional Project to Strengthen Cross-Border Human and Animal Disease Prevention and
Control in the East African Community Partner States: 2004 - 2012” – 1st Grant worth USD
24
NMRA 5
$ USD $ 406,760.00 over four years from 1st October 2004 to 30th September 2008 and 2nd
Grant worth USD $500,000.00 over three years(1st October 2008 to 30th September 2011).
3. Federal Government of Germany (BMZ) through the German Technical Cooperation
Agency (GTZ) – “Regional Project to Strengthen the East African Community Partner States
in the area of WTO/TRIPS and Pharmaceutical Production: 2009 - 2011”–€800,000.00 over
three years (FY 2009 – 2011).
4. European Commission (EC) – “The East African Community Regional Sexual and
Reproductive Health and Rights Programme (Invest in Adolescents: Building Advocacy
Capacity in East Africa ): 2010 - 2013” – (EURO 1.497.959.00)
5. European Commission (EC) – “EAC Regional Programme for the Prevention and Control of
Human and Animal Trans-boundary Diseases in East Africa: 2007 – 2012” – USD
3,000,000.00 over three years (FY 2008 – 2012)
6. EC/ACP/WHO Partnership on Pharmaceutical Policies – “Regional Harmonization of
Medicines Policy and Regulation in the East African Community Partner States Project:
March 2004 – September 2010” – USD $421,478.00 was earmarked for EAC Countries
through WHO-AFRO and the regional activities of the project were coordinated by the
Principal Health Officer (PHO) of the EAC Secretariat in collaboration with the EAC Partner
States’ National Medicines Regulatory Authorities (NRAs) and the WHO Country Offices in
each of the respective EAC Partner States.
Management and Staffing Plan for this Project
Human resource capacity at both NMRAs and EAC Secretariat is of paramount importance to
successfully establish functional and harmonized medical devices and in vitro diagnostics regulatory
systems. It is for this reason that the following new project staff will be recruited under the EAC
Secretariat Health Department in accordance with the existing EAC Staff Rules and Regulations.
EAC Secretariat
iv.
Senior Health Officer (Medical Devices and In Vitro Diagnostics Regulation) – Pathologist (P2)
v.
Health Officer (Medical Devices) – Biomedical Engineer (P1)
vi.
Health Officer (In Vitro Diagnostics) – Laboratory Technologist (P1)
National Medicines Regulatory Authorities
vii.
Health Officer (Medical Devices) – Biomedical Engineer (P1)
viii.
Health Officer (In Vitro Diagnostics) – Laboratory Technologist (P1)
25
ix.
e-Health Information Systems Expert (P1)
The above staff will work within the existing structure of the EAC Secretariat’s Health Department
together with the following existing staff:

Principal Health Officer – Health Department (P3)

Senior Health Officer (Medicines and Food Safety Unit) (P2)

Senior Health Officer (Medicines Regulation) (P2)

National Medicines Regulation Officers (P1)

e-Health and Informatics Expert (P1),

Accountant (P1)

Pharmaceutical Programme Assistant (G5) at the regional level
The Senior Health Officer (Medical Devices and In Vitro Diagnostics Regulation) will be responsible
for the technical coordination and implementation of the EAC Regional Medical Devices and
Diagnostics Regulation Harmonization Program on full time basis under the supervision of the Senior
Health Officer in charge of Medicines and Food Safety. In addition, the other staff will jointly and
individually support the implementation of the approved regulatory activities for medical devices
and diagnostics at both EAC regional level and at country level.
The project will run for five years and will focus on the coordination, capacity strengthening, quality
assurance and harmonization of regional policies, regulations, standards, guidelines and procedures
for the regulation of medical devices and diagnostics through the organizational and institutional
strengthening of the existing EAC Partner States’ National Medicines Regulatory Authorities (NRAs)
and the establishment of the proposed East African Community Medicines and Food Safety
Commission (EACMFSC).
In the first year, the EAC will facilitate a region wide assessment of the existing policies and laws on
regulation of medical devices and diagnostics. The assessment will compare the regulatory situation
in each country to the internationally accepted regulatory model of GHTF/IMDRF. The legal,
institutional and human resource gaps required for effective regulation will be identified. The
findings and recommendations of the assessment will guide the review and development of national
and regional policies and laws including the EAC mutual recognition framework. The laws will be
developed through consultative processes involving stakeholders from legislature, NMRAs, industry,
academia, professional associations, consumer associations and patient advocacy groups. It is
26
expected that by year three the new laws will be effective. This will pave way for the establishment
of infrastructure for regulation of medical devices and diagnostics. As the legal framework is being
reviewed or developed, NMRAs will continue to use their existing mandates to implement the
project.
In years one and two regional and international experts will develop harmonized framework for
premarket, market and post-market controls.
In year three regional experts with the support of international experts will initiate collaborative premarket assessments, quality audits of manufacturers, import controls, control of promotion, post
market surveillance activities, adverse events monitoring and information management. The joint
activities will continue through years four and five. These joint activities as opposed to national level
activities will pave the way for mutual recognition of regulatory decisions and reduce duplication of
effort. Collaboration will also translate to improved efficiency in regulation and expertise through
information sharing.
7.0 MONITORING AND EVALUATION
Monitoring and evaluation (M&E) will play a key role in ensuring that the project implementation is
in line with the set project objectives. It will generate information and provide lessons during
implementation that will be essential for improving strategy and ensuring that the project has an
impact on the health of the people of the EAC region. Within the project, M&E will serve three main
purposes including:
i.
provide the project office, focal points and other relevant stakeholders with relevant
information and feedback as implementation of project unfolds;
ii. synthesize the lessons learned during implementation and using them for improving the project
delivery process;
iii. assess the progress of NMRAs in the harmonization process and proposing next steps.
The Senior Health Officer (Medical Devices and In Vitro Diagnostics) will be responsible for M&E
activities within the project at all levels. They will be assisted by all the project staff at EAC
Secretariat and NMRAs.
27
A situational analysis studies will be commissioned by EAC during project development with the aim
of establishing the situation on regulation of medical devices and diagnostics within the EAC region.
This study will be used to provide baseline information on the set indicators in the project
framework. A monitoring and evaluation system will be developed based on the project framework
and the milestones table that will enable the project management team collect relevant information
for improving action and documenting lessons learnt. The main focus in M&E system will be:
i.
Process monitoring which will mainly centre on continuous tracking of activities and
milestones. This will be key for project management with timely information on the
performance of the project for facilitating improvement of action where necessary
ii. Output monitoring and evaluation which will mainly focus on tracking progress in the
achievement of project outputs. The information regarding outputs will be collected during
both continuous monitoring processes and the midterm evaluation. The midterm evaluation
will also be the main reflection point on the progress being made and the likelihood of the
project to achieve its set targets.
iii. Outcome and impact monitoring which will mainly focus on assessing if the project has
achieved its set immediate and intermediate outcomes. The end of project evaluation will
that will be conducted at the end of the project will be a key for providing this assessment
data.
In order to ensure that learning is internalized in the project implementation process, there will be
key learning activities that will be organized. These activities will provide a forum through which
project management team will be briefed on the progress being made in the implementation of
activities and achievement of outputs and outcomes. The bi-annual Project Steering Committee
meetings will be organized with the aim of providing feedback on the progress made in
implementation and to provide a way forward for improving action. The Project Coordinator in
collaboration with the national focal points through the heads of the NRAs will produce project
quarterly, biannual and annual reports that will be presented to the Project Steering Committee
during their meetings. Lessons learnt will also be documented for providing lessons and improving
actions.
8.0 SUSTAINABILITY
The EAC harmonized regional medical devices and diagnostics regulation system will be sustained
through the existing organisational and institutional framework of the EAC Secretariat and Partner
States’ NMRAs. Financial resources to be mobilized will be used to support the project for the five
28
years of its duration. Subsequently, the cost of maintaining on-going project activities and personnel
will be borne by the EAC Secretariat and the Partner States’ NMRAs. The project staff at EAC
Secretariat and at the NMRAs will be absorbed and retained as regular staff in order to
institutionalize the harmonized regulatory systems.
9.0 CITATIONS
1. Rugera SP, McNerney R, Poon AK, et al. Regulation of Medical Diagnostics and Medical Devices in
the East African Community Partner States. . Under review.
2. McNerney R, Sollis K, Peeling R. Improving access to new diagnostics through harmonised
regulation: priorities for action. Afr J Lab Med 2104;3(1).
3. Peeling R, McNerney R. Increasing access to diagnostics through technology transfer and local
production. Geneva: WHO, 2011.
4. Ecclestone R. A model regulatory program for medical devices: an international guide. In:
Hernández A, ed. Washington, D.C.: World Health Organization and United States Food and
Drug Administration, 2001.
29
10.0 PROJECT FRAMEWORK AND BUDGET
30
Objective
Year 1
Responsible
1
To
establish
and
i.
Assessment
report
the existing policy and
and policy framework
legal framework
on regulation of (i)
ii.
Policy framework
medical devices and (ii)
iii.
Legal framework
in
iv.
For each Partner State
diagnostics
Q2
of
strengthen the legal
vitro
Q1
within each of the
an
Partner States
regulatory body, or a
established
business
plan
and
timelines
for
establishment of a NRA,
with
capacity
harmonized
for
regulation
of medical devices and
in vitro diagnostics.
2
To build and improve
i.
human resource and
infrastructural capacity
Equipped and furnished
offices
ii.
for the regulation of (i)
IT
support
and
iii.
Recruited staff
in
iv.
Strategy
vitro
diagnostics
amongst the Partner
web
pages established
medical devices and (ii)
for
31
human
resource retention and
Year 2
Q3
Q4
Q5
Year 3
Q6
Q7
Q8
Q9
Q10
Q11
Q12
States
career development
v.
Report of training needs
and
identification
partners
to
of
conduct
training
vi.
Number of staff trained,
level
and
scope
of
criteria
for
training.
3
To establish criteria for
laboratories
i.
Published
to
laboratories to perform
undertake post market
post-market evaluation
surveillance
of IVD for selected major
activities
for in vitro diagnostics.
diseases
The criteria to include
malaria)
(e.g.
HIV,
indicators of quality
and good practice, and
timely
access
to
appropriate samples.
4
To establish an EAC
i.
Register of laboratories
network
ii.
A common information
of
laboratories accredited
management
for
for
post
market
post
systems
market
surveillance of in vitro
surveillance, to include
diagnostics for major
web based platforms in
32
diseases
and
implement
each Partner State
common
information
management systems
for
post
market
surveillance in each of
the EAC Partner States’
NRAs and the East
African
Community
Medicines and Food
Safety
Commission
(EACMFSC).
5
To implement regional
i.
Published
documents,
harmonized regulatory
and
framework and mutual
dissemination
recognition
for
classification rules and
(i)
common definitions for
regulation
of
medical devices and (ii)
in
vitro
based
diagnostics
on
web-based
of
risk
medical devices and IVD
ii.
risk
A strategy to determine
risk
classification
classification
for
novel
technologies/products
seeking market entry.
iii.
List
of
EAC
Partner
33
States priority IVDs and
medical devices, by type
and disease and risk
classification
iv.
Model
regulations,
guidelines and standard
operating procedures for
regulation
of
medical
devices and IVDs
v.
Recommendations
recognizing
for
regulatory
decisions of stringent
NRAs
or
WHO
Prequalification Program
and
process
expedited
for
review,
if
appropriate.
vi.
Common post market
surveillance strategy
vii.
Mechanism
for
correction and recall
viii.
Report
towards
on
ISO
progress
90001
certification of National
34
Regulatory
Authorities
of Partner States
ix.
6
To
implement
common
a
i.
information
management systems
ii.
of
common
A
platform
for
information sharing
iii.
Guidelines and standard
in vitro diagnostics in
operating procedures for
each
analysing and sharing
of
the
EAC
Partner States’ NRAs
7
List
elements to be captured
for registration of (i)
medical devices and (ii)
Roadmap
To
work
collaboration
information
in
i.
with
Attendance at IMDRF
meetings
and
other
IMDRF, PAHWP, AHWP
international
and other international
including meetings of
organisations
the PAHWP.
to
fora,
promote access to safe
and affordable medical
devices and diagnostics
though
harmonized
regulation.
8
To
work
in
collaboration
with
the London School of
i.
To establish a forum
for
collaboration,
technical
exchanges
35
Hygiene and Tropical
on new science and
Medicine and other
technologies
partners to establish
regulators, healthcare
mechanisms
professional
to
ensure
that
are based on strong
and
clear
groups,
academia
regulatory decisions
among
and
consumers.
ii.
To foster mechanisms
science
for
harmonized
and that regulatory
assessment of new
science keeps pace
technologies
with
develop
technological
innovation
regulatory
science
with
and
in
keeping
technological
innovation
9
To inform the public
i.
and interested parties,
including
manufacturers
and
distributors of medical
products,
of
Website
and
advocacy materials
ii.
Articles in the media
iii.
Articles
in
newsletters
the
harmonised regulation
of medical device and
36
diagnostics
in
EAC
Partner States.
37
38
APPENDIX I Elements of regulation of medical devices and diagnostics
The table below contains a summary of internationally recognized elements of regulation of medical
devices and diagnostics.
Premarket controls
Policy and Legal Framework
A legal framework allows national regulatory control authorities to
administer and enforce the regulations. Regulations may pertain to
safety, performance, quality, good manufacturing practices, labelling,
advertising and other such matters deemed in the interest of public
health protection. For a regulatory system to be effective it must be
enforceable in both the public and private healthcare sector.
Definitions,
nomenclature Clear definition of terms and nomenclature is required to inform the
and Unique device identifier regulations. Adherence to internationally accepted definitions, such as
(UDI)
those proposed by IMDRF/GHTF, and Global Medical Device
Nomenclature (GMDN) advances harmonisation efforts and reduces
barriers to trade.
Risk Based classification
Activities undertaken by or on behalf of the regulator should be
proportional to the product under consideration where products are
stratified according to the risk (or hazard) they pose to public or
personal health according to the intended use. References:
GHTF/SG1/N77:2012;GHTF/SG1/N045:2008
Premarket
conformity To assess quality, safety, performance, benefits and risks. The
assessment
conformity assessment activity will be determined by the risk class of
the medical device or diagnostic. References: GHTF/SG1/N78:2012;
GHTF/SG1/N046:2008; GHTF/SG1/N063:2011; GHTF/SG1/N011:2008
Manufacturing controls
To verify conformance with manufacturing standards and validate
quality assurance. Auditing of manufacturing processes may include site
inspection. The IMDRF single audit program (MD-SAP) will provide for a
single audit to be undertaken by a recognised competent organisation
using agreed standards of inspection.
Standards
International standards are tools to assure the safety, quality and
performance of products or services.
Regulatory Authorities (RA)
should establish a mechanism for recognizing international standards to
39
provide manufacturers with a method of demonstrating conformity
with the Essential Principles. Refer GHTF/SG1/N044:2008
Registration and Listing
Registration provides information on the parties that are or will be,
supplying medical devices and diagnostics to the market that is within
the NRA’s jurisdiction. Refer GHTF/SG1/N065:2010
Provisions for access under This may include provisions for wavering of fees or specific regulatory
exceptional circumstances.
requirements, based on exceptional needs such as response to a novel
disease with high public impact. The provisions may be of a permanent
nature (e.g. lower fees where the product is needed for a limited
number of patients) or time limited, as is the case of needing a novel
device during an emergency.
Marketing Controls
Advertising control
To avoid inappropriate marketing of a device, or propagation of
misleading claims regarding product effectiveness.
Labelling Controls (also can Provisions to avoiding misbranding, which includes but is not limited to,
be considered in premarket information that is misleading, insufficient or false. Also providing for
controls)
clear and unambiguous instruction for use.
Market entry controls
Conditions under which devices can be offered for sale, and intended
use.
Post-marketing Controls
Medical
Devices
diagnostics
post
surveillance
and Active and/or passive system to maintain vigilance over marketed
market products to ensure their continued safety, quality and performance, as
well as on going regulatory compliance by manufacturers or suppliers
after
obtaining
market
clearance.
References:
GHTF/SG2/N79R11:2009;GHTF
SG2/N47R4:2005;GHTF/SG2/N61R4:2004;GHTF/SG2/N33R11:2002
Device
reporting
adverse
event A method for information sharing among users and national health
authorities of similar devices is vital to preventing additional adverse
incidents and their unwanted health effects. References:
SG2
N87:2012;
GHTFSG2/N68R3:2005;GHTF/SG2/N31R8:2003;
40
GHTF/SG2/N54R8:2006;
GHTF/SG2/N32R5:2002; GHTF/SG2/N36R7:2003; GHTF-SG2-N008R4;
GHTF/FD: 99-7
Corrections/Recall
A means by which corrections can be made and where there is a risk to
public health substandard products can be removed from the market.
Reference: GHTF SG2/N57R8:2006
Information Exchange
Establishment of systems to ensure timely exchange in confidence, of
adverse events and other aspects associated with quality, safety and
performance of a medical device or diagnostic. References: GHTF/SG2/
N38R19:2009; GHTF/SG2/N9R11:2003; GHTF/SG2/N20R10:2002
Post market inspections
Mechanism to inspect as required in response to a concern regarding
the quality, safety and performance of a medical device or diagnostic.
See references from premarket controls.
Penalties
Legislation should include relevant and appropriate penalties to ensure
that manufacturers and suppliers comply with the regulation.
Premarket controls
Policy and Legal Framework
A legal framework allows national regulatory control authorities to
administer and enforce the regulations. Regulations may pertain to
safety, performance, quality, good manufacturing practices, labelling,
advertising and other such matters deemed in the interest of public
health protection. For a regulatory system to be effective it must be
enforceable in both the public and private healthcare sector.
Definitions,
nomenclature Clear definition of terms and nomenclature is required to inform the
and Unique device identifier regulations. Adherence to internationally accepted definitions, such as
(UDI)
those proposed by IMDRF/GHTF, and Global Medical Device
Nomenclature (GMDN) advances harmonisation efforts and reduces
barriers to trade.
Risk Based classification
Activities undertaken by or on behalf of the regulator should be
proportional to the product under consideration where products are
stratified according to the risk (or hazard) they pose to public or
personal health according to the intended use. References:
GHTF/SG1/N77:2012;GHTF/SG1/N045:2008
Premarket
assessment
conformity To assess quality, safety, performance, benefits and risks. The
conformity assessment activity will be determined by the risk class of
the medical device or diagnostic. References: GHTF/SG1/N78:2012;
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GHTF/SG1/N046:2008; GHTF/SG1/N063:2011; GHTF/SG1/N011:2008
Manufacturing controls
To verify conformance with manufacturing standards and validate
quality assurance. Auditing of manufacturing processes may include site
inspection. The IMDRF single audit program (MD-SAP) will provide for a
single audit to be undertaken by a recognised competent organisation
using agreed standards of inspection.
Standards
International standards are tools to assure the safety, quality and
performance of products or services.
Regulatory Authorities (RA)
should establish a mechanism for recognizing international standards to
provide manufacturers with a method of demonstrating conformity
with the Essential Principles. Refer GHTF/SG1/N044:2008
Registration and Listing
Registration provides information on the parties that are or will be,
supplying medical devices and diagnostics to the market that is within
the NRA’s jurisdiction. Refer GHTF/SG1/N065:2010
Provisions for access under This may include provisions for wavering of fees or specific regulatory
exceptional circumstances.
requirements, based on exceptional needs such as response to a novel
disease with high public impact. The provisions may be of a permanent
nature (e.g. lower fees where the product is needed for a limited
number of patients) or time limited, as is the case of needing a novel
device during an emergency.
Marketing Controls
Advertising control
To avoid inappropriate marketing of a device, or propagation of
misleading claims regarding product effectiveness.
Labelling Controls (also can Provisions to avoiding misbranding, which includes but is not limited to,
be considered in premarket information that is misleading, insufficient or false. Also providing for
controls)
clear and unambiguous instruction for use.
Market entry controls
Conditions under which devices can be offered for sale, and intended
use.
Post-marketing Controls
Medical
diagnostics
Devices
post
and Active and/or passive system to maintain vigilance over marketed
market products to ensure their continued safety, quality and performance, as
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surveillance
well as on going regulatory compliance by manufacturers or suppliers
after
obtaining
market
clearance.
References:
GHTF/SG2/N79R11:2009;GHTF
SG2/N47R4:2005;GHTF/SG2/N61R4:2004;GHTF/SG2/N33R11:2002
Device
adverse
event A method for information sharing among users and national health
reporting
authorities of similar devices is vital to preventing additional adverse
incidents and their unwanted health effects. References:
SG2
N87:2012;
GHTF/SG2/N54R8:2006;
GHTFSG2/N68R3:2005;GHTF/SG2/N31R8:2003;
GHTF/SG2/N32R5:2002; GHTF/SG2/N36R7:2003; GHTF-SG2-N008R4;
GHTF/FD: 99-7
Corrections/Recall
A means by which corrections can be made and where there is a risk to
public health substandard products can be removed from the market.
Reference: GHTF SG2/N57R8:2006
Information Exchange
Establishment of systems to ensure timely exchange in confidence, of
adverse events and other aspects associated with quality, safety and
performance of a medical device or diagnostic. References: GHTF/SG2/
N38R19:2009; GHTF/SG2/N9R11:2003; GHTF/SG2/N20R10:2002
Post market inspections
Mechanism to inspect as required in response to a concern regarding
the quality, safety and performance of a medical device or diagnostic.
See references from premarket controls.
Penalties
Legislation should include relevant and appropriate penalties to ensure
that manufacturers and suppliers comply with the regulation.
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ANVISA:
1. Good Distribution Practice and Good Storage Practice for both Medical Devices and IVDs in
Portuguese.
2. Post-marketing surveillance documents – active technical surveillance implemented by a
network of 195 hospital/labs
Pilots in PAHWP:

New WHO Classification for IVDs

WHO PQ dossier for CD4

Joint review of CD data

Post-marketing surveillance –WHO Global Fund and ASLM involved
Meetings in 2014:
1. PAHWP joint data review workshop: July 3-4 in Arusha, Tanzania
2. AHWP: Sept 2-3 in Taiwan ; Annual AHWP meeting Nov 18-21 in Korea
3. ALADDIV: Week of Oct 27 in Brasilia
4. PAHWP: 3rd African Regulatory Forum Nov 29-30 in Cape Town (preceding ASLM Congress)
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