1. 23 March 2011 Madeleine Pearce Chair: SAMED Regulatory Committee
Medical Devices and Regulations: Feedback from SAMED’s Meeting with Benguela EOH 27 February 2012
23 March 2011
Madeleine Pearce
Chair: SAMED Regulatory Committee

2. POSITION ON MEDICAL DEVICE REGULATION
SAMED strongly supports a legislative and regulatory framework to control the manufacture, distribution and marketing of medical devices and in-vitro diagnostics (IVDs) to ensure that South African patients have access to products that are safe, effective and of good quality. 2

4. Previously…….

5. Act 72 of 2008
Amended the Medicines and Related Substances Control Act 101 of 1965
Introduced SAHPRA (the South African Health Products Regulatory Authority)
Made provisions for the registration of medical devices and in-vitro diagnostics
…….. was never brought into law

6. Implementation of SAHPRA
SAHPRA is not likely to be implemented in 2012
Cabinet decision Dec 2011:
SAHPRA will be a Schedule 3A Public Entity
Medicines and Related Substances Amendment Act (Act 72 of 2008) will be returned to Parliament for an amendment to remove the definition of health product (“product”).
Changing legislation takes time (>12 months)
With no enabling legislation, implementation of SAHPRA cannot go ahead

7. Benguela Health
Was brought in to handle the medicines backlog and design SAHPRA
SAMED/SALDA worked on medical device regulations with BH in several workshops Jan-June 2011
Project was put on hold – priorities such as NHI

8. Benguela EOH Project Team
Benguela Health joined EOH
Continuation of work done with industry in 2011 and previous years
Project secured renewed funding to complete SAHPRA project
In 2012, reports to Registrar of Medicines, Mandisa Hela, who is in charge of delivering SAHPRA
Legislation update means that the Project Team will not facilitate implementation of SAHPRA but will prepare everything needed to establish and run entity
Target of end June 2012 to have all outstanding work completed and packaged for the Minister

9. Health Technology Department NDOH
Sam Bakhane appointed as DDG
Terry Downes collating comments from regulations pertaining to Act 101 published in July 2011
Not likely to go any further
MAC _HT
Advisory Panel for regulation

10. Meeting Benguela/Industry 27 Feb 2012
PART A (All)
General feedback
Act and amendments
Public Entity
Structure
Food
CAMS
New Project Team
Medicines
EDMS
eCTD
Fees
PART B (With core group of device industry players to pick up on the Act 72 device regulations)
Devices
Regulations

11. Prepare all required to establish and run SAHPRA
Deliverable:
Prepare all required to establish and run SAHPRA
new establishment must improve situation, must not be ambiguous, must not be subject to corruption -
medicines, medical devices, diagnostics, food, complimentary medicine, cosmetics, African traditional medicines, disinfectants
Create an Operating Manual for SAHPRA

12. A regulations document – general principles
To support the coming amendment to the Act
Attempt to fix gaps in regulation before amended law is enacted
Attempt to adapt medicines regulations and guidelines for medical devices/IVDs
Cannot refer to international standards
Tighter regulation and in detail
to prevent too many changes as DOH changes policy (politicians come and go)
Offences and penalties are required

13. Discussion Points 27 Feb 2012 SAHPRA Fees
no cross subsidisation from other regulated health products categories
estimated 35 line items per product group for registration/per fee payable

14. Discussion Points 27 Feb 2012 Labelling
no special labelling for South Africa
international guidelines for device/IVD labelling
impact of supply if medicines labelling regime is followed
medical device/IVD supply chain is different –to whom are you directing labelling

15. Discussion Points 27 Feb 2012 Authorised Representative
Manufacturer
Legal Manufacturer
Distributor
Agent
Consider Medical Device supply chain
Multiple agents, retail

16. Discussion Points 27 Feb 2012 Recalls Field Safety Corrective Action
Considerations
Role of the Regulator
Role of Applicant
Time frames

17. Discussion Points 27 Feb 2012 Combination products guideline
Medicines Control Council approach vs International approach

18. Discussion Points 27 Feb 2012 User Defined in the National Health Act
Patient?
Health care practitioner?
Operator?
Defined in the National Health Act
“user” means the person receiving treatment in a health establishment, including receiving blood or blood products, or using a health service

19. Documents provided by SAMED
Guidelines on:
Establishment Licence
Product Registration
Medical Device Classification
Medical Device Labelling
Lodging a complaint for a Medical Device/IVD
Recalls and Adverse Events

20. Documents provided by SAMED
International references provided information on:
Changes to Registration
Clinical Trials
Vigilance Reporting Requirements
Terminology differences for MDs (PIL, PI, IFU, User Manual)
Product evaluations
Differentiating handling of capital equipment vs other MDs
Implants
Custom made devices
Conformance Marking
Handling of Transition Period, Grandfathering
Quality Management Systems
Establishment vs device licence

21. Next Steps Meeting with core group 12 April
Regulations document review
Discussion on proposed fees vs service level agreements vs capacity
Comments on GWP guideline due 30 March
Comments on amendment to Act 101 due 15 June 2012

22. Questions