1. INTERNATIONAL MODELS ON A MEDICAL
DEVICE REGULATORY QUALIFICATION
What could work for South
Africa?

2. IMPLEMENTING GENERAL PRINCIPLES
 Clear definition of the roles and responsibilities of the
different stake-holders:
manufacturers, dealers, importers, distributors,
authorized representatives, …)
 Balance regulatory stringency & MD availability
 Risk-based approach
 MD classification

3. PRE-REQUISITES OF EFFECTIVE
INTERNATIONAL MEDICAL DEVICES (MD)
REGULATORY MODELS
► Regulatory Framework to include all key features.
► Regulatory Auhorities to set up clear policy principles
and priorities.
► Priorities to be matched by adequate financial and human
resources.

4. KEY FEATURES OF MD REGULATORY MODELS
Regulatory framework to cover the whole product life cycle
PREMARKET ----------------> PLACING ON THE MARKET
QMS, Performance, Registration, Technical dossier, Labelling, IFU,...
---------------> POST MARKET -------------> END OF LIFE,
Adverse Event(AE) reporting, Device modification
Lab. controls
MD modification, disposal, …..

5. GENERAL PRINCIPLES
OF MD REGULATORY MODELS
 Protection of public health
 Political accountability
 Transparency and fairness- predictability
 Administrative efficiency

6. BASIC REQUIREMENTS
OF MD REGULATORY MODELS
KNOW YOUR MARKET !
 Registration of all stakeholders:
(MFRs, dealers, importers, distributors, official rep.,..)
 Registration of all medical devices
 Product Registry (name, intended use, legal MFR, local rep.)
AND ▫ Good record keeping,
▫ Adequate IT Tool

7. STEP-WISE IMPLEMENTATION
OF KEY REGULATORY FEATURES.
Good definition of all stakeholders
 who does what, contact point, ….
 Robust definitions of medical devices
 exclude all products outside the scope

8. STEPWISE IMPLEMENTATION (cont.)
Premarket investigation:
establish requirements for human subjects protection
& ethical frame-work.
 Registration/ Placing in the market:
review claims & advertising.
 Post Market:
clear requirements for Adverse Event reporting,
adoption of FSCAs, incl. recalls

9. STEPWISE IMPLEMENTATION (cont)
+/- Outsourcing parts of regulatory process
 Third Party (Conformity Assessment Body, Notified
Body) review of:
□ MFR QMS,
□ Product certification,
□ MFRs/Distrib., PMS system….

10. GRADUAL EXPANSION
OF REGULATORY OVERSIGHT
Depending of NATIONAL PRIORITIES AND IN-HOUSE
EXPERTISE, review:
o High risk class devices:
review device certification/compliance to essential
principles.
o Accredited Third Parties (CABs, NBs)
o MFR’s QMS & MFRs/distributors PMS system
o Clinical investigations, performance tests.

11. INTERNATIONAL COOPERATION
Transitional measures:
accept certification from respected national agencies for
certain risk class products
Possible partnering with other national agencies:
create synergies /pool expertise with national/regional
Authorities
 Develop Mutual Recognition Agreements.

12. INTERNATIONAL MEDICAL DEVICES (MD)
REGULATORY MODELS
UNDERLYING ASSUMPTIONS
►Regulatory Authorities:
held accountable for patients safety in their jurisdictions.
 TRANSPARENCY AND PREDICTABILTY of the Regulatory
Framework.
► Manufacturers:
considered responsible for their products

13. MEDICAL DEVICE LIFECYCLE
Conception and
development
Manufacture
Packaging and
Labelling, DoC
Registration
Advertising
& Sale
Use Disposal
Phases
DoC (Declaration of Conformity) includes completion of a technical documentation/dossier.

14. STAKEHOLDERS & NRA CONTROL STAGES
Conception and
development
Manufacture
Packaging and
Labelling, DoC
Registration
Advertising
& Sale
Use Disposal
MANUFACTURER VENDOR USER
Phases
STAKEHOLDERS
Stages of regulatory control
Pre-Market Placing On-Market PMS/Vigilance

15. A COMMON FRAMEWORK FOR MEDICAL DEVICE
REGULATIONS (WHO. MEDICAL DEVICE REGULATIONS, 2003)
STAGE PRE-MARKET PLACING ON-MARKET POST-MARKET
CONTROL/MONITOR PRODUCT SALE AFTER-SALE/USE
PERSON MANUFACTURER VENDOR VENDOR/USER
Items or activities
regulated
Device attributes
• Quality, Safety &
Performance
Establishment registration
• List products available or in
use
• Requires vendor to fulfil
after-sale obligations
Surveillance/vigilance
• After-sale obligations
• Complaints handling
• Reporting adverse
events
• Monitoring of device’s
clinical performance
• Problem identification
and alerts
Manufacturing
• Quality systems
Labelling
• Accurate description of
product
• Instruction for use
Product registration
• Essential requirements
Advertising
• Prohibits misleading or
fraudulent advertisement

16. CONFORMITY ASSESSMENT (CA) SYSTEM
(GHTF/SG1/N78:2012)
CA Element Manufacturer Responsibility Nat. Reg. Authority / CAB Responsibility
CA of the QMS QMS Establish and maintain a full QMS Have confidence that a current and appropriate
QMS is in place or conduct a QMS audit prior to
marketing authorization
PMS Establish and maintain an
adverse event reporting
procedure
Be satisfied that a current and appropriate
adverse event reporting procedure is in place as
part of the QMS.
CA of device
safety &
performance
Technical
Documentation
Establish and keep up to date,
technical documentation, prepare,
submit a technical documentation
for review.
In-depth review of the technical documentation to
determine conformity to Essential Principles, prior
to the device being placed on the market
DoC Prepare, sign, and submit Review, verify compliance with requirements.
Registration Registration of
Mft. & devices
Perform accord. to regulatory
requirements
Maintain, verify as appropriate.

17. CONFORMITY ASSESSMENT SYSTEM
Conformity Assessment Element Assessment of the Elements
Conformity assessment of the QMS Quality Management System NRA/CAB
Post-market Surveillance NRA/CAB
Conformity assessment of device
safety & performance
Technical Documentation NRA/CAB
Declaration of Conformity NRA/CAB
Registration Registration of manufacturers and
their devices
NRA
NRA =National regulatory authority, CAB = Conformity Assessment Body

18. CONFORMITY ASSESSMENT SYSTEM
Conformity Assessment
Element
Quality Management System NRA NRA/CAB NRA/CAB CAB CAB
Post-market Surveillance NRA NRA NRA NRA CAB/NRA
Technical Documentation NRA NRA NRA NRA CAB
Declaration of Conformity NRA NRA NRA NRA CAB
Registration of manufacturers
and their devices
NRA NRA NRA NRA NRA

19. CONFORMITY ASSESSMENT SYSTEM
Conformity Assessment Element Goverment Third Party
Quality Management System USA, but also MDSAP (MD
Single Audit Program)
Most countries
Post-market Surveillance Most countries EU: PMS process at manufacturers
Technical Documentation Usually high risk devices
Low risk sometimes exempt
EU all
Other countries: Low to moderate risk devices
Declaration of Conformity Most countries EU
Registration of manufacturers and
their devices
All countries N/A

20. DEVICE CLASSIFICATION
Class Risk Level General Device Examples IVD Devices Examples
A Low Surgical retractors, tongue depressors Clinical chemistry analyzer, prepared
selective culture media
B Low–moderate Hypodermic needles, suction equipment Vitamin B12, Pregnancy self-testing, Anti-
Nuclear antibody, urine test strips
C Moderate–high Lung ventilator, bone fixation plate Blood glucose self-testing HLA typing,
PSA screening, Rubella
D High Heart valves, implantable defibrillator HIV blood donor screening, HIV blood
diagnostic

21. WHAT COULD WORK FOR SOUTH AFRICA?
Conformity Assessment Element Assessment of the Elements
Conformity assessment of the QMS Quality Management System MDSAP
Post-market Surveillance Government, MDSAP
Conformity assessment of device
safety & performance
Technical Documentation Class A-C: Notified Body (EU)
Class D: Government
Declaration of Conformity Class A-C: NB
Class D: Government
Registration Registration of manufacturers and
their devices
Government

22. WHAT COULD WORK FOR SOUTH AFRICA?
Conception and
development
Manufacture
Packaging and
Labelling, DoC
Registration
Advertising
& Sale
Use Disposal
Pre-Market Placing On-Market PMS/Vigilance
STED/DoC
Class D
Registration
STED/DoC
Class A–C
Surveillance of
CAB
Adverse Event Rep.,
Surv. PMS & FSCA

23. WHAT COULD WORK FOR SOUTH AFRICA?
• MDSAP is on its way. Pilot will end Q4 2016
• MDSAP Auditing Organizations have technical competence for product assessment
• Less personnel for product assessment. Only high risk devices.
• NRA can concentrate on core competencies

24. THANK YOU FOR YOUR ATTENTION!
More information:
Dr Isabelle Demade: i.demade@outlook.com
Dr. Peter Drechsler: peter.drechsler@qtec-group.com