Registering a Medical Device in South Africa

Learn how to register a medical device in South Africa. Follow our step by step guide below to register a medical device in South Africa.

1. Identify the risk class (categories based on their potential risk to patients, users, or public health) of the medical device. For example, Class A, Class B, Class C, Class D (from low to high risk).
2. Choose and assign a resident of South Africa to be an authorized representative (‘local agent’) that abides with The South African Medicines and Related Substances Act, 1965 (Act 101 of 1965) which plays a role in regulating medical devices.
3. Verify that the medical device has evidence of registration from at least one of the six jurisdictions recognized by South African Health Products Regulatory Authority (SAHPRA) which are Australia, Brazil, Canada, Europe, Japan, and United States of America. Approval by the World Health Organization is also an option. 
4. Secure ISO 13485 certification (ensures that medical devices consistently meet customer and regulatory requirements) for manufacturer.
5. Navigate to the SAHPRA website and download the appropriate application under the “Health Products” tab.
6. Once the application is completed in MS Excel or MS Word format and the necessary documents are gathered, submit all and required fee receipt via email to mdadmin@sahpra.org.za for regular business applications. 
7. The application will be processed within an estimated timeframe of 2 months.

FAQ – Transpara AI Software

Q1: What are the risk classes for medical devices?

Medical devices are categorized into four classes based on risk: Class A (low risk), Class B (moderate risk), Class C (high risk), and Class D (very high risk).

Q2: How do I appoint an authorized representative in South Africa?

Assign a South African resident as an authorized representative who complies with The South African Medicines and Related Substances Act, 1965.

Q3: What jurisdictions are recognized by SAHPRA for device registration?

SAHPRA recognizes registrations from Australia, Brazil, Canada, Europe, Japan, and the United States. Approval by the World Health Organization is also acceptable.

Q4: What certification must the manufacturer secure?

Manufacturers must secure ISO 13485 certification to ensure medical devices meet customer and regulatory requirements consistently.

Q5: Where can I find the application form for medical device registration?

Navigate to the SAHPRA website, go to the “Health Products” tab, and download the appropriate application form.

Q6: How do I submit the application and what is the processing time?

Complete the application in MS Excel or MS Word, gather necessary documents, and email them with the fee receipt to mdadmin@sahpra.org.za. Processing takes about 2 months.

Legal Disclaimer

Information is provided on a ‘best endeavours’ basis. Always speak to a local agent to verify regulatory intelligence provided.