Statistics Act, 1999
R 385
Medicines and Related Substances Control Act, 1965 (Act No. 101 of 1965)RegulationsRegulations relating to Medical Devices and In Vitro Diagnostic Medical Devices (IVDs)12. Registration certificate |
The Registrar must, after a medical device or IVD has been registered, issue a registration certificate substantially in the form shown below:
MEDICINES AND RELATED SUBSTANCES ACT 1965, (ACT NO. 101 OF 1965)
MEDICAL DEVICE OR IVD REGISTRATION CERTIFICATE
It is hereby certified that registration of the medical device or IVD described below has been approved by the Council subject to the conditions is indicated.
| 1. | Name ............................................................................................................................... |
| 2. | Registration number ........................................................................................................ |
| 3. | Class of medical device or IVD .......................................................................................... |
| 4. | In the case of combination medical devices the name and quantity of the scheduled substance(s), or biological substance(s) |
| 5. | Nomenclature system or code .......................................................................................... |
| 6. | Conditions under which the medical device or IVD is registered ....................................... |
| 7. | Registered in the name of (holder of certificate of registration) ....................................... |
| 8. | Name and physical address of the original manufacturer .................................................. |
| 9. | Date of registration .......................................................................................................... |
Registrar
Issued at ...................................... on ...................................................................20 ..........
