2. Why are you here?
• To acquire knowledge of the core of medical
device regulations
• To develop a consistent understanding of the
regulations
• To have reinforced how the regulations affects
your role
• To have an opportunity to have any uncertainties
regarding medical device regulations clarified
3. Modules
• Medical Device Regulation Basics
• Medical Device Standards
• Quality Management System Audits
• Product Approvals and management of changes
• Postmarket surveillance
4. An Overview of the Landscape:
Who are the Regulatory
Agencies
6. Regulations
Regulation is
"controlling human or societal behavior by rules or
restrictions.“
Regulation mandated by a state attempts to
• produce outcomes which might not otherwise occur,
• produce or prevent outcomes in different places to
what might otherwise occur, or
• produce or prevent outcomes in different timescales
than would otherwise occur .
7. Regulators’ perspectives - TGA
Vision:
• We aim to be recognised as a world leader in
advancing and protecting public health and the
environment through scientific and regulatory
excellence.
Mission:
• We will develop and implement appropriate national
regulatory policies and controls for medicines, medical
devices, blood, blood products, tissues, chemicals and
gene technology.
8. Regulators’ perspectives - FDA
Mission:
• CDRH promotes and protects the
health of the public by ensuring the
safety and effectiveness of
medical devices and the safety of
radiological products.
Vision:
• Ensuring the health of the public
throughout the "Total Product Life
Cycle - it's everyone's business."
9. Regulators’ perspectives:
PMDA, Japan
PMDA continues to improve the public health
and safety of our nation by reviewing
applications for marketing approval of
pharmaceuticals and medical devices,
conducting safety measures, and providing
relief to people who have suffered from
adverse drug reactions.
10. Regulators’ perspectives:
EU
“Providing access to the best medical
technology and devices, that meet the highest
standards of safety and improve the quality
of life, is a key objective of the Commission
policy towards European citizens”.
Commissioner Erkki Liikanen
15. Classification determines extent of
regulatory control
Assessment
Quality Management
System
Technical
Class A Class B Class C Class D
No Audit Audit Audit Audit
Not Not usually
Documentation
Declaration of
Conformity &
Essential Principles
Checklist
Required
Normally
not
requested
required Reviewed in depth
Review for Review for Review for
compliancecompliancecompliance
Devices are typically assigned to four risk classes
(eg, EU I, IIa, IIb, III + AIMD)
16. Cochlear Implant System
FDA EU Canada Australia Japan China GHTF
III AIMD IV AIMD IV III D
III III
II IIb III IIb III II C
510(k),
510(k) IIa II IIa II B
exempt
I I I I I I A
510(k),
510(k)
exempt
Implant
Speech Processor
Programming System
Software
Accessories
Surgical tools
20. Key Regulations for Cochlear
Regulations
1. Therapeutic Goods (Medical Devices) Regulations 2002 (Statutory Rules 2002 No. 236), Therapeutic Goods
Administration, Australia
2. Uniform Recall Procedure for Therapeutic Goods 2004 edition (Australia)
3. Food and Drug Administration, USA Title 21, Code of Federal Regulations
Part 820: Quality System Regulation.
Part 11 Electronic Records, Electronic Signatures
Part 806 Medical Devices, Reports of Corrections and Removals
Part 803 Medical Device Reporting
Part 812 Investigational Device Exemptions
Part 814 Premarket Approval of Medical Devices
4. MHLW (Ministry of Health, Labour, and Welfare, Japan) Ordinance no. 169 (revised GMP, Japan) based on
PAL (Pharmaceutical Affairs Law, Japan) [Law No. 145, as of August 10, 1960; Law No. 87 as of July 26,
2005]
5. Active Implantable Medical Device Directive (AIMD) 90/385/EEC (including 2007 rev), Europe
6. Medical Device Directive (MDD) 93/42/EEC (including 2007 rev), Europe
7. Medical Device Regulations (SOR/98-282) 1998, Department of Justice, Canada
8. Regulations for the Supervision and Administration of Medical Devices, State Food and Drug Administration
(SFDA), China
9. Medical Devices Regulation, KFDA. Korea Food and Drug Administration, Korea
10. Medical Devices Regulation, Taiwan Department of Health DoH, Taiwan
