Medical Device Regulatory Requirements in South Africa
| Regulatory Authority |
South African Health Products Regulatory Authority (SAHPRA) |
| Regulatory Authority Website Link |
Click Here
|
| Device Classification |
A,B,C,D |
| Medical Device Regulations |
Medical Devices And In Vitro Diagnostics Guidelines (Same Regulations for IVD)
| Click Here
|
| IVD Classification |
A,B,C,D |
| In Vitro Diagnostics Regulations |
Medical Devices And In Vitro Diagnostics Guidelines |
| Registration Process |
Licensing of Medical Device Establishments
| Click Here
|
| Registration Timeline |
2 months |
| Requirement of Authorized Representative |
Yes |
| Language Requirement |
Documentation and labelling must be provided in English. |
| Additional Information |
There are 2 different screening processes that take place for a medical device establishment license application- that is the administrative and technical screening. |
Disclaimer: This website sources information from regulatory authorities and aims for accuracy, but regulations may change without notice. Users are advised to verify details with relevant authorities before making compliance decisions. We are not responsible for errors, omissions, or outdated content.
The above information is last updated on 09/Apr/2025