CE2012 Medical Device Regulatory
Revision
Austin Court, Birmingham
20th September 2012
Sponsored
by
THE REGULATION OF MEDICAL
DEVICES
- GLOBAL TRENDS
Alan Kent
CE2012 - 20th September 2012
THEMES

Why regulate?

The Global Harmonization Task Force
(GHTF).

The International Medical Device
Regulators Forum (IMDRF).

Developing regulations.

EU, USA, Japan, Canada update.

Challenges for industry.
WHY REGULATE?

To safeguard public health.

As an indicator of improved prosperity.

Prevent ‘dumping’ of non-conforming
devices.

Reduce the uncontrolled importation of
products of dubious benefit or
provenance.

Encourage the development of a local
medical devices industry.

In the EU …… to enable the single market.
MATURE REGULATIONS

EU / EFTA

USA

Japan

Canada

Australia
GHTF FOUNDING MEMBERS
EMERGING REGULATIONS

Hong Kong

Saudi Arabia

Singapore

Brazil

South Africa

Etc.
MEMBERS OF AHWP
GHTF FORCE STRUCTURE

Conceived in September 1992.

Purpose: to encourage convergence of
existing medical device regulations, and
publish regulatory guidance documents for
use by ‘new-entrants’.

A self-funding organisation with equal
participation from regulators and industry of
the Founding Member jurisdictions
(eventually included AHWP).

Five Study Groups to undertake the work
under the direction of a Steering Committee.
SGs meet face-to-face about 3 times per
GHTF OBJECTIVES

Improve public health, globally.

Remove unnecessary regulatory differences
and duplicative controls to simplify trade and
reduce regulatory costs.

Encourage the introduction of beneficial new
technology.

Encourage RAs to exchange information on
adverse events / incidents.
continued …..
GHTF OBJECTIVES

Share the experience of GHTF Founding
Members with other countries introducing
or modifying regulations.

Secure the universal recognition of
regulatory decisions, certificates and
inspections.

Rotating Secretariat with an informative
website @ www.ghtf.org.
OVERARCHING DOCUMENTS

GHTF Medical Device Regulatory Model.

Definition and Glossary of Terms Used in
GHTF Documents.

Unique Device Identification (UDI) System
for Medical Devices.

GHTF Retrospective Assessment - Key
Findings and Recommendations (January
2008).
STUDY GROUP THEMES

SG1: premarket procedures.

SG2: reporting adverse incidents and
post-market surveillance.

SG3: quality systems for manufacturers
and inspectors of medical devices.

SG4: quality system auditing
practices.

SG5: clinical safety and performance.
SO WHY CHANGE?

Major items of work are ‘completed’.

Remaining issues are ‘difficult to harmonize’
e.g. combination products / devices
incorporating viable animal or human tissues
/ nanomaterials.

Pressure on RA budgets. Why should a
government devote resource to global rather
than national priorities?
continued …..
REASONS FOR CHANGE

Public / media / political criticisms of the
effectiveness of Founding Member’s
regulations (e.g. breast implants /
orthopaedic implants etc.).

RAs seen as being too close to the regulated
industry.

While the ‘legal manufacturer’ is located in
Founding Member jurisdictions, most
medical devices are made in China, Mexico,
Brazil and the developing World. This affects
the regulatory task.
THE GHTF IS DEAD ……. LONG
LIVE THE IMDRF

International Medical Device Regulators
Forum first met in May 2011 (Australia Chair).

The forum is for RAs - Industry is not a
member.

Industry invited to participate in some
Working Groups but otherwise are limited to
providing comments on draft documents.

China, Brazil, India, Russia have been invited
to join (AHWP?).

GHTF documents will be maintained – HOW?.
FIRST 5 IMDRF WORK ITEMS

Improvement of GHTF National Competent
Authority Reporting (NCAR) system and
exchange of PMS information. RA only WG - I.
Demade (EU Commission) to lead.

Roadmap for implementation of UDI system.
Joint WG - L. Selles (EU Commission) to lead.
Report by Dec. 2012.

Single QMS audit programme accreditation
requirements. Closed WG - K. Trautmann (US
FDA) to lead. Initial focus on guidance on
qualifications/certification/accreditation of
auditors for regulatory purposes. Report 12-18
months
continued …..
FIRST 5 WORK ITEMS

List of standards recognised by IMDRF
regulators as basis for demonstrating
conformity. RA only WG - M. Neumann
(Germany BfArM). Report end-2013.

Regulated Product Submission (RPS) in
electronic format standard. Part open / part
closed WG - M. Ward (Health Canada). Preand post-marketing submissions; assess
fitness for purpose for medical devices; start
with ‘table of contents’ based on GHTF STED.
EU UPDATE
The subject of this
Conference.
continued …..
USA UPDATE

Proposed User Fee 5-year Renewal request is
with US Congress.

Ten potential bills impacting FDA/Medical
Devices under discussion by US Congress.

FDA continues to address the preamendments, Class III devices 515(i) calls for
information that include two classification
involving metal-on-metal total hip
replacements (cemented and un-cemented
versions).
continued …..
USA UPDATE

FDA continues to assess the safety and
effectiveness of urogynaecologic surgical
mesh devices, through review and analysis
of published literature, adverse event
reports, and post-approval surveillance
studies. FDA is considering the
recommendation that urogynaecologic
surgical mesh used for trans-vaginal repair
of pelvic organ prolapse (POP) be
reclassified from Class II to Class III.
CANADA UPDATE

A document on what information should
appear in a QMS audit report has been
published (based on SG4 guidance).

Will now accept premarket submissions in the
STED format for medical devices other than
IVDS.

Working on guidance for reprocessing of
single-use devices, and on refurbishing.

About to publish a notice on the transition to
the revised version of IEC 601 standard (i.e.
Edition 3), and its collateral standards.
JAPAN UPDATE

Proposed revision of Pharmaceutical
Affairs Law to take account of the unique
characteristics of medical devices was
published in January 2012.

Due to on-going reform to social security
system etc., submission of legislation
related to the revision of Pharmaceutical
Affairs Law is likely to be deferred to the
next session of the National Diet of Japan
in the latter part of this year.
CHALLENGES FOR INDUSTRY

Keep abreast of changes to national medical
device regulations – and a host of others.

Influencing the IMDRF – especially SMEs.

Promote the benefits of medical devices to
MEPs, MPs, the public, and the media thereby increasing confidence and trust in
the industry.

Persuading senior management to support its
regulatory and QMS departments and
maintain a robust and continually improving
continued …..
QMS.
CHALLENGES FOR INDUSTRY

Building bridges to RAs in target markets –
all with the active participation of senior
management.

Strengthen product liability defence
strategies since many countries are
becoming more litigious.

Adopt a life-cycle management approach to
the design and support of devices, including
a strategy for addressing disposal and
environmental issues. Regulations are
placing an increasing emphasis on postmarketing activities/controls.
THANK YOU
CE2012 Medical Device Regulatory
Revision
Austin Court, Birmingham
20th September 2012
Sponsored
by