Regulation of medical devices in South Africa is currently in transition from a regime in which only certain electronic medical devices and devices containing a pharmaceutical substance are regulated to newly released medical device regulations, which more closely align with those in other markets.
Under the preceding regime, licensing from the Directorate of Radiation Control is required in order to import certain electronic medical devices into the country, and devices incorporating a pharmaceutical substance must be registered as a pharmaceutical with the Medicines Control Council. Market authorization for regulated electronic devices in South Africa requires prior EU approval.
Also, the Medicines Control Council is in the process of implementing the new medical device and IVD regulations under the Medicines and Related Substances Act, 1965. These regulations establish a formalized regulatory system similar to that of other markets, including a four-tier classification system, Authorized Representation requirements, device registration, etc. Thus, many previously unregulated devices will face new requirements in South Africa moving forward.
Let Emergo assist you in evaluating the south african medical device registration process as it applies to your device(s).
Emergo's worldwide network, including Emergo South Africa's office, in-house consultants, industry contacts, and regulatory sources allows us to provide in-depth and accurate analysis of medical device markets, including South Africa. Our Regulatory Pathway report service covers the following issues regarding the South African market and can help you learn how to register a medical device in South Africa:
- Regulatory Background for the Directorate of Radiation Control and Medicines Control Council
- Product Assessment and Classification
- In-Country Representation in South Africa
- License Requirements
- Labeling and Language Requirements
- Costs and Timeframes
- Regulatory Roadmap for South Africa
- Post-Market Obligations