Roberto Carlos Latini
COUNTRIES THAT HAVE STRUCTURED
REGULATORY AFFAIRS SYSTEM
(FOR IVD AND MEDICAL DEVICES)
↘
↘
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↘
↘
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↘
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ARGENTINA
BOLIVIA
BRAZIL
CHILE
COLOMBIA
MEXICO
PARAGUAY
URUGUAY
VENEZUELA
GETTING STARTED
WAYS TO GET INTO THE LATIN AMERICA MARKET
COMPANY
LOCAL COMPANY
(SUBSIDIARY)
LOCAL
DISTRIBUTOR
AUTHORIZED
REPRESENTATIVE
WAYS TO GET INTO THE LATIN AMERICA MARKET

Establishment of a Subsidiary in Brazil:
•
Advantages: the company will own the registrations under its
name. This way, the company will be free to choose and
change distributors any time that may find convenient.
•
Disadvantage: this process is more time consuming, once the
company has to get the state (or city) regulatory license and
the federal regulatory authorization, before submit the
registration of the products. The time to get the said licenses is
about 10 to12 months. The average time to register products
varies, as follows:
•
•
Medical Devices / IVD: 4~6 months.
Medical Consumables and Disposables: 4~9 months
WAYS TO GET INTO THE LATIN AMERICA MARKET

Registration on behalf of Distributor’s name:
•
Advantages: this option is faster than the establishment of a
subsidiary, once the distributor already has the regulatory licenses.
The timing of this operation will be only that described below for the
registration, considering that all documents were sent to the
distributor by the manufacturer:
•
•
•
Medical Devices / IVD: 4~6 months.
Medical consumables and disposables: 4~9 months.
Disadvantage: the main disadvantage is that the distributor will hold
the registrations, which (generally) are not transferable, unless in case
of incorporation, fusion or separation of companies. If the company
decides to change the distributor, then the registrations will need to
be re-make by the new distributor. However, various distributors can
hold the registration of the same product. In this case, each one will
have its own registration number.
WAYS TO GET INTO THE LATIN AMERICA MARKET

Registration Using an Authorized Representative
(Non Commercial Holder):
•
Advantages: the two basic advantages of this option are that it is faster than
•
Disadvantage: the holder of the registrations will not be the mother
company, but another one with a legal agreement to represent it in
LATAM, regarding the registration of the products only.
•
the establishment of a local subsidiary, once the Authorized Representative (AR)
company already has the regulatory licenses and the timing of this operation will
be only that considered to register the products in the Local Regulatory Agencies.
The other important advantage is that the mother company can change the
distributor any time, once the holder (AR) of the registrations will allow the
distributor to import the products using the AR’s registration number.
Important: the holder of the product’s registration can authorize another
company (local distributors) or final consumer (as Hospitals, Labs and Clinics) to
import the products under the registration number of the holder. This is
perfectly legal, once the holder continues to be technically and legally
responsible for the product itself.
COMPANIES APPROVAL
SOCIAL CONTRACT
COMPANIES APPROVAL
IN LATIN AMERICA
TAX ID CARD
BUILDING
CONSTRUCTION
OR OFFICE RENTAL
HIRE TECHNICAL
AND LEGAL
RESPONSIBLE
 BLUE PRINTS 1:100
 DESCRIPTION OF THE
ACTIVITIES
 BASIC LIST OF PRODUCTS
TO BE SOLD
PREPARATION &
SUBMISSION OF
THE BLUE PRINTS +
DOSSIER
PREPARATION &
SUBMISSION OF
THE LOCAL LICENSE
INSPECTION
PREPARATION &
SUBMISSION OF
THE FEDERAL
AUTHORIZATION
FINAL APPROVAL
 ALL NEEDED
LOCAL LICENSES
. DOCUMENTS REFERENCE
MEDICAL DEVICES COMPANIES
MD - COMPANY
COUNTRY
BP 1:100
SC
OD/RD
IER
CTR
TRP
LWP
NML
LOP
QQA
MNE
MFC
GMP
EAL
FDL
IRC
Argentina
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
Bolívia
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
Brazil
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
Colombia
O
X
X
X
X
X
O
X
X
X
X
X
X
O
X
X
Mexico
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
Paraguay
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
Uruguay
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
Venezuela
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
BP
Blue Prints 1:100 Scale
SC
Social Contract
LOP
List Of Products to be Manufactured/ Imported with the
Proper Technical Description
QQA
Quality Controls During Manufacturing or Inspection of
Importer Goods
OD/RD
Ownership Document/ Rental Document
IER
Importer/ Exporter Registration
MNE
Equipments Used in the manufacturing Process (For
Manufacturing Only)
CTR
Certification of Technical Responsibility (Issued by the Professional
Association)
MFC
Manufacturing Flowchart
TRP
Technical Responsible Professional Required
GMP
Need of Good Manufacturing Practices System Developed
EAL
Environmental Agency License (When Applicable)
LWP
Local Working Permit Required (Issued by Local Health/ Regulatory
Authorities)
FDL
Fire Dpt License
NML
Nuclear Materials License (When Applicable)
IRC
Periodic Insects and Rodents Control is Required.
.
IVD COMPANY DOCUMENTS
REFERENCE
IVD - COMPANY
COUNTRY
BP
1:100
SC
OD/RD
IER
CTR
TRP
LWP
NHL
QCL
QCE
LOP
MOA
MNE
MFC
GMP
EAL
FDL
IRC
ARGENTINA
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
BOLÍVIA
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
BRAZIL
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
COLOMBIA
O
X
X
X
X
X
O
X
O
O
X
X
X
X
X
O
X
X
MEXICO
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
PARAGUAY
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
URUGUAY
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
VENEZUELA
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
BP
Blue Prints 1:100 Scale
SC
Social Contract
OD/RD
Quality Control of Equipments (For Own QC Lab Only)
LOP
List Of Products to be Manufactured/ Imported with the Proper Techinical
Description
MOA
Methodology of Analysis used during the Manufacturing Process and for
Finished Products
MNE
Equipment's Used in the manufacturing Process (For Manufacturing Only)
MFC
Manufacturing Flowchart
Ownership Document/ Rental Document
IER
Importer/ Exporter Registration
CTR
Certification of Technical Responsibility (Issued by the Professional
Association)
TR
QCE
Technical Responsible Professional Required
GMP
Need of Good Manufacturing Practices System Developed
LWP
Local Working Permit Required (Issued by Local Health/ Regulatory
Authorities)
EAL
Environmental Agency License (When Applicable)
NML
Nuclear Materials License (When Applicable)
FDL
Fire Dpt License
QCL
Quality Control Lab (Maybe a Third Party Lab in Case of Importers only)
IRC
Periodic Insects and Rodents Control is Required.
PRODUCT REGISTRATION
MEDICAL DEVICES REGISTRATION
BASIC DOCUMENTS TO REGISTER
MEDICAL DEVICES IN LATIN AMERICA
↗ COMPANY’S WORKING PERMIT (LATAM)
↗ FREE SALES CERTIFICATE* (WHEN APPLICABLE)
↗ LETTER OF DISTRIBUTION* (WHEN APPLICABLE)
 (*) CONSULARIZATION REQUIRED IN THE CLOSEST EMBASSY/CONSULATE OF THE
COUNTRIE WHERE THE PRODUCT WILL BE REGISTERED.
↗ GMP CERTIFICATE (WHEN APPLICABLE)
↗ CERTIFICATE OF CONFORMITY (FOR ELECTROMEDICAL DEVICES ONLY)
↗ INSTRUCTIONS OF USE / INSERTS / USER’S MANUAL
↗ SERVICE / INSTALATION MANUAL
↗ LABELING
↗ PACKING
↗ COMPOSITION OF THE MEDICAL DEVICE
↗ BASIC MANUFACTURING FLOWCHART WITH OPERATIONS MADE IN EACH PHASE
↗ VALIDATION OF STERILIZATION PROTOCOL (WHEN APPLICABLE)
↗ PROOFS OF SAFETY AND EFFECTIVENESS (PUBLISHED PAPERS IN SPECIALIZED MAGAZINES
OR POINTS SPECIFICALLY DESCRIBED IN LOCAL LEGISLATION)
EXTRA DOCUMENTS TO REGISTER
MEDICAL DEVICES IN LATIN AMERICA
For Electromedical Equipments:
 Manufacturing Plant Audit;
 Tests performed according to the IEC 60601.1 and IEC 60601.2.X;
 If the Brazilian Notified Body has a Memorandum of Understanding (MOU) with the
one the certified the product in the country of origin then test report can be
accepted instead of new tests performed in Brazil.
Condoms and Surgical Gloves:
 Require local tests and certification.
In Vitro Diagnostic kits:
 The following IVD Kits may require local tests and certification:
ABO / Rh), Hepatites (B / C), Sífilis (Treponema pallidum), HIV, Doença de Chagas
(Trypanosoma cruzi) and HTLV.
EXTRA DOCUMENTS TO REGISTER
MEDICAL DEVICES IN LATIN AMERICA
• For Orthopedic Prosthesis:

Risk Analysis of the Manufacturer according with ISO 14971, EN 93/42 EEC;

All tests made to approve the raw materials including the Certificate issued by
the supplier when applicable;


All mechanical tests made according to accepted international standards like
ASTM, ISO, etc.. For example: dynamic tests, fatigue, static tests, etc.
Critical analysis of the efficacy of the Orthopedic Prosthesis (made by the
Technical Responsible) comparing the nominal features with those obtained in
the tests and the biometrical parameters described in the scientific literature.
Everything must be compared with the parameters set up during the design
phase;
EXTRA DOCUMENTS TO REGISTER
MEDICAL DEVICES IN LATIN AMERICA






Technical drawings of all components with the physical dimensions and
tolerances;
Controls used by the manufacturer during the manufacturing phase.
All Quality Certificates obtained by the Manufacturer like ISO 9001, 13485, CE
Mark, 21 CFR FDA etc.;
All Quality Certificates obtained by the third party companies that work for
Manufacturer like ISO 9001, 13485, 21 CFR FDA, etc., when applicable;
Clinical studies performed with the product itself or similar products to prove the
efficacy and safety
If the prosthesis contain any material originated from cattle then Animal Health
Certificates issued by the Veterinary authority of the country of origin of the cattle
must be presented to prove that the animals were free from spongiform
encephalopathy (mad cow disease).
MEDICAL DEVICE REGISTRATION FLOWCHART
DOCUMENTATION
FROM
MANUFACTURER
30
UP
TO
150
DAYS
CRITICAL ANALISYS
PREPARATION OF
TECHNICAL DOSSIER
IN LOCAL LANGUAGE
PAYMENT OF TAXES
SUBMISSION IN
LOCAL REGULATORY
AUTHORITIES
ANALISYS BY LOCAL
REGULATORY
AUTHORITIES
FINAL APPROVAL
CERTIFICATION
or
REQUIRED
LOCAL TESTS
MEDICAL DEVICES
.
REGISTRATION DOCUMENTS REFERENCE TABLE
MD - PRODUCTS
WP
Basic Documents
COUNTRY
IMP
N
MF
REG
GMP
FSC
PKG
IU
LAB
WRS
MFC
POA
COM
LLG
BBR
ARGENTINA
x
x
x
x
x
x
x
x
x
x
x
x
x
x
x
x
x
BOLIVIA
x
x
x
x
x
x
x
x
x
x
x
x
x
x
x
x
x
BRAZIL
x
x
x
x
x
x
x
x
x
x
x
x
x
x
x
x
x
COLOMBIA
x
x
x
x
x
x
x
x
x
o
x
x
x
x
o
o
x
MEXICO
x
x
x
x
x
x
x
x
x
x
x
x
x
x
x
x
x
PARAGUAY
x
x
x
x
x
x
x
x
x
x
x
x
x
x
x
x
x
URUGUAY
x
x
x
x
x
x
x
x
x
x
x
x
x
x
x
x
x
VENEZUELA
x
x
x
x
x
x
x
x
x
x
x
x
x
x
x
x
x
USA
NML
WP
Working Permit
WRS
Warning/ Risks/ Special Care
IMP
Importer
MFC
Manufacturing Flowchart
MNF
Manufacturer
POA
Principle of Action
REG
Need of Registration
COM
Composition
GMP
Need of Good Manufacturing Practices
LLG
Local Language Required
FSC
Free Sales Certificate
BBR
Bibliographic References Requires
PKG
Packaging
USA
Use of Symbols Accepts in the Instructions of Use/ Labels
IU
Instructions of Use/ Inserts / User Manual
NML
Nuclear Materials, License Required (When applicable)
LAB
Labelling
VSP
Validation of the Sterilization Process (When applicable)
VSP
BASIC STRUCTURE OF MEDICAL DEVICES
REGISTRATION DOSSIER
1.
FORMS ACCORDING TO LOCAL LEGISLATION
2.
TAX PAID
3.
LABELLING ACCORDING TO LOCAL LEGISLATION
4.
INSTRUCTIONS OF USE / USER MANUAL ACCORDING TO LOCAL LEGISLATION
5.
TECHNICAL REPORT
6.
CERTIFICATE OF CONFORMITY (FOR ELECTROMEDICAL DEVICES ONLY)
7.
PROOFS OF EFFICACY AND SAFETY
8.
NOTARIZED COPY OF THE FREE SALES CERTIFICATE* (WHEN APPLICABLE)
9.
NOTARIZED COPY OF THE LETTER OF DISTRIBUTION* (WHEN APPLICABLE)
10.
LOCAL (LATAM) GMP CERTIFICATE
(*) DOCUMENTS MUST BE CONSULARIZED (IN THE COUNTRIE OF ORIGIN) IN THE CLOSEST CONSULATE OF THE
COUNTRIE WHERE THE PRODUCT WILL BE CONSULARIZED
IVD REGISTRATION
IVD REGISTRATION FLOWCHART
30
DOCUMENTATION
FROM
MANUFACTURER
CRITICAL ANALISYS
UP
TO
150
DAYS
PREPARATION OF
TECHNICAL DOSSIER
IN LOCAL LANGUAGE
PAYMENT OF TAXES
SUBMISSION IN
LOCAL REGULATORY
AUTHORITIES
ANALISYS BY LOCAL
REGULATORY
AUTHORITIES
FINAL APPROVAL
TEST IN
LOCAL
LAB
•
•
•
•
BASIC DOCUMENTS TO REGISTER
IN-VITRO DIAGNOSTIC (IVD) IN LATIN AMERICA
COMPANY’S WORKING PERMIT (LATAM)
TECHNICAL RESPONSIBILITY CERTIFICATE (LATAM)
FREE SALES CERTIFICATE*
LETTER OF DISTRIBUTION*
(*) CONSULARIZATION REQUIRED (IN THE COUNTRIE OF ORIGIN) IN THE CLOSEST EMBASSY/CONSULATE OF THE COUNTRIE WHERE THE
PRODUCT WILL BE REGISTERED.
•
•
•
•
•
•
•
INSTRUCTIONS OF USE / INSERTS
•
•
VALIDATION OF STERILIZATION PROTOCOL (WHEN APPLICABLE)
ADITIONAL MATERIALS REQUIRED
LABELLING
PACKING
COMPOSITION / QUALI-QUANTI (CENTESIMAL) FORMULA
BASIC MANUFACTURING FLOWCHART WITH OPERATIONS MADE IN EACH STEP
TEST REPORT FOR CRITICAL ITEMS AS SENSITIVITY, ACCURACY, CALIBRATION CURVES, ETC. (LOCAL TEST MAY BE
REQUIRED)
PROOFS OF SAFETY AND EFFECTIVENESS
.
IVD REGISTRATION DOCUMENTS
REFERENCE
IVD - PRODUCTS
Basic Documents
WP
COUNTRY
ARGENTINA
BOLIVIA
BRAZIL
COLOMBIA
MEXICO
PARAGUAY
URUGUAY
VENEZUELA
IMP MNF
x
x
x
x
x
x
x
x
x
x
x
x
x
x
x
x
REG
GMP
x
x
x
x
x
x
x
x
x
x
x
x
x
x
x
x
Working Permit
Importer
Manufacturer
Need of Registration
Need of Good Manufacturing Pratices
Free Sales Certificate
Packaging
Instructions of Use/ Inserts
Labeling
Warning/ Risks/ Special Care
Evaluation Method Including
o
Sensitivity
o
Specificity
o
Power/ Accurancy/ Range
o
Reference Values
FSC PKG
x
x
x
x
x
x
x
x
x
x
x
x
x
x
x
x
IU
x
x
x
x
x
x
x
x
MFC
POA
QQF
LLG
BBR
USA
NWL
VSP
LAB WR
S
x
x
x
x
x
x
x
x
x
x
x
x
x
x
x
x
EM
MFC
x
x
x
x
x
x
x
x
x
x
x
o
x
x
x
x
POA QQF LLG
x
x
x
x
x
x
x
x
x
x
x
x
x
x
x
x
x
x
x
x
x
x
x
x
BBR USA
x
x
x
x
x
x
x
x
x
x
x
o
x
x
x
x
NML
VSP
x
x
x
o
x
x
x
x
x
x
x
x
x
x
x
x
Manufacturing Flowchart
Principle of Action
Quali/ Quanty Formula Including
o
All Ingridientes
o
Exact Quantatity/ Concentration
Local Language Required
Bibliographic References Required
Use of Symbols Accepts in the Instructions of Use/ Labels
Nuclear Materials License Required (When applicable)
Validation of the Sterilization Process (When applicable)
BASIC STRUCTURE OF AN IVD REGISTRATION DOSSIER
1.
FORMS ACCORDING TO LOCAL LEGISLATION
2.
TAX PAID
3.
CERTIFICATE OF TECHNICAL RESPONSIBILITY
4.
LOCAL WORKING PERMIT
5.
FEDERAL WORKING PERMIT
6.
LABELLING ACCORDING TO LOCAL LEGISLATION
7.
INSTRUCTIONS OF USE / USER MANUAL ACCORDING TO LOCAL LEGISLATION
8.
TECHNICAL REPORT
9.
PROOFS OF EFFICACY AND SAFETY
10.
NOTARIZED COPY OF THE FREE SALES CERTIFICATE*
11.
NOTARIZED COPY OF THE LETTER OF DISTRIBUTION*
12.
QUALI/QUANTI FORMULA ISSUED BY THE MANUFACTURER* (JUST FOR IVD)
13.
LOCAL (LATAM) GMP CERTIFICATE
(*) DOCUMENTS MUST BE CONSULARIZED (IN THE COUNTRIE OF ORIGIN) IN THE CLOSEST CONSULATE OF THE COUNTRIE WHERE THE
PRODUCT WILL BE CONSULARIZED
Technical
Concepts
Q&A
Class of Risk
•
•
•
•
Class I (low risk)
Class II (medium risk)
Class III (medium/high risk)
Class IV (high risk)
DEFINITION OF MEDICAL DEVICE
• Product, equipment, device, material, article or system of
Medical, Odontological or Laboratorial (Clinical Lab) use or
application, used for prevention, diagnostic, therapeutic,
rehabilitation or anti-conception that does not use
pharmacological, immunological or metabolic methods to
perform its main function but may be helped in its functions
by these methods.
Softwares
• In general, softwares are classified as follows:
– If they are designed only for images or data filing then
they will be considered as Class I products - Low Risk;
– If they give to the operator the possibility to alter the
image or the collected data, then they will be considered
as Class II - Medium Risk.
Note: it is important to re-enforce that when a product is
to be used with another higher risk class product then the
first one has to be considered in the same class of risk of
the second one.
Softwares
•
Requires Registration, and the Good Manufacturing
Practices (GMP) Certificate issued by ANVISA:
 Medical Software, not pre-installed in medical
devices/equipments,
which
performs
image
processing, or suggests diagnostics, or is intended to be
used in surgical procedures or in ICU (intensive care
unit), or directly influences the functioning of medical
devices/equipments which require registration.
Used Equipment / Materials
• It is forbidden by LATAM legislation to sell used products. The
equipment must be refurbished by the manufacturer or by
some service company duly authorized by the manufacturer.
The product must have its registration valid.
• Some materials can be re-used if re-processed properly by the
hospitals.
Spare Parts
• Once one product is registered is LATAM all its parts and
components are automatically considered as registered also
but some accessories that can be sold separately like
disposables. It is not necessary to keep the registration alive
to import spare parts for servicing but the importer has to
prove that the said product was imported during the validity
of the registration.
Harmonization
• Many norms are already harmonized in Mercosur.
Nevertheless it was expected to harmonization to be
concluded and registrations accepted among the countries
since 2003. The harmonization is delayed because of the
economic situation of some partners and also because new
technologies were introduced in the LATAM market what
lead the countries to take he discussion to a totally new
different level.
After Sales Monitoring (Techno Vigilance)
• The LATAM market (specially Mercosur) already adopted the
Techno Vigilance system. All recalls and malfunction have to
be reported to the local authorities. The Regulatory
Authorities also monitor the global market looking for
problems with products that can be sold in LATAM countries.
What happen when I have these changes? (1)
• Change the Manufacturing Address: it is possible to update
the registration.
• Change of the Manufacturer: it is possible to update the
registration but it is strongly suggested that the company
applies for a new registration. It is faster and less
complicated.
• My company wants to add a new manufacturing site: no
problem. It is just a matter of updating the registration.
What happen when I have these changes? (2)
• When I have a major change in my product? The company
should report to the RA authorities or submit a new
registration.
• Can I add new products to the approved registration? Yes, if
the new product fits the criteria of registration per family of
products.
Family of Products
• What are the basic criteria for registration as Family of
Products?
 Same manufacturer;
 Same technology;
 Same composition;
 Same use;
 Same side effects, warnings and special care.
Is It possible to have more than one company
holding the registration of the same product?
• Yes, since the manufacturer authorizes each applicant. Then
each applicant will have its own registration number.
TAKE INTO CONSIDERATION…
•
•
REGULATORY SYSTEMS IN LATAM ARE NEW COMPARED TO EUROPE OR
FDA.
LOW EXPERIENCE OF THE REGULATORY AUTHORITIES IN SOME ISSUES
AND TECHNOLOGIES.
•
SYSTEM HIGHLY INFLUENCED BY POLITICAL FACTS / ENVIRONMENT.
•
UNEXPECTED CHANGES MAY OCCOUR IN THE LEGISLATION.
•
INFLUENCE OF OTHER AUTHORITIES THAN THE REGULATORY ONES
(METROLOGY, LABOR, ETC).
Technical Notes in the Brazilian Health
Surveillance Agency – ANVISA
•
N° 01/2012/GQUIP/GGTPS/ANVISA: for Fitness and Wellness Products;
•
N° 02/2012/GQUIP/GGTPS/ANVISA: for Electro-Medical Devices;
•
N° 03/2012/GQUIP/GGTPS/ANVISA: for Medical and Non Medical
Devices Definition List;
•
04/2012/GQUIP/GGTPS/ANVISA: Software for Medical Devices.
Latini & Associados
Av. Vereador José Diniz, 2270
São Paulo / SP / Brazil
Tel.: (011) 5090-5080.
Fax.: (011) 5090-5083.
E-mail: latini@latini.com.br
Website: www.latini.com.br
Offices: São Paulo / Brasília / Rib.Preto / Rio de Janeiro
Intel Partnerships: UK (Meddiquest) and 24 other countries.