Gas Regulator Levies Act, 2002
R 385
Regulations relating to Medical Devices and In Vitro Diagnostic Medical Devices (IVDs) |
2. Manner and conditions for allowing international tendering
3. Importation of medical devices and IVDs into the Republic
4. Transmission of medical devices or IVDs through the Republic
6. Period of validity of licence and renewal of licence
7. Appeal against decision of Council
8. Application for registration of a medical device or IVD
9. Information that must appear in the register for medical devices or IVDs
10. Amendment to the medical device and IVD register
11. Classification of medical devices and IVDs
14. Destruction of medical devices or IVDs
16. Conduct of clinical trial and clinical investigation
17. Adverse event reporting and vigilance for medical devices or IVDs
20. Compliance with requirements
21. Advertising of medical devices or IVDs
22. Labelling of medical device or IVD
23. Instructions for use of medical device
24. Instructions for use of IVD
25. Custom made medical device
26. Record of implantable medical device and custom made medical device
27. Transitional arrangements regarding unlicensed manufacturer, distributor and wholesaler
28. Transitional arrangements regarding unregistered medical devices and IVDs
