The Medical Device regulatory regime in South Africa is still in its infancy, having only been partially implemented since August 2017. During this first phase, wholesalers, manufacturers, importers or distributors are require to apply for a Medical Device Establishment License.
The next phase of Medical Device Regulation may start as early as 2020. This will involve the registration of medical devices, on a call up basis.
Recognizing the challenge of international manufacturers and suppliers of Medical Devices to South Africa not having a registered place of business in South Africa but wish to market their products directly or through distributors, while retaining control over its products, we offer an alternative which addresses these challenges.
Authorized Representative services are provided to these international companies include:
- Listing the clients products in Sections 4.3 or 4.4 as applicable with corresponding activities in Section 18.4;
- Conformity Assessment Procedures;
- Post Market Surveillance;
- Complaints, incidents and reports on corrective actions or preventive actions in alignment with the clients Quality Management System
- Maintenance of Summary Technical Documentation for Class C and Class D;
- Adverse Event Reporting to SAHPRA;
- Recall and Field Safety Notice management compliance;
- Clinical Trial or Performance Evaluation registration with SAHPRA;
- To keep international manufacturers and suppliers fully informed regarding the South African regulatory environment and requirements for Medical Devices and IVDs.
- Product Registration on behalf of the international manufacturer or supplier;
- Retaining a register of other importer/distributors of the clients products in South Africa and to coordinate activities between these economic operators with regard to Medical Device and IVD regulatory compliance.
Unlike the European Union, there is no specific provision in South African law for Authorized Representatives as third parties to importers/distributors of medical devices or IVDs. The definition of Authorized Representative in South Africa indicates that the AR is a natural person, resident in South Africa employed in the economic operator business and responsible for that organizations regulatory compliance obligations.
Afrihealth is a licensed importer/distributor of medical devices. Clients products are listed under that license and all regulatory compliance obligations are provided under that license.
At present multiple local importer/distributors are permitted to list the same imported medical devices and IVDs on their establishment license. However, when products are called up for Registration, only one of these companies will be able to successfully Register a called up product. Other former importers of the product will have to convert to wholesalers the Holder of the Product Registration.
By using Afrihealth as an alternative or additional licensed importer/distributor, for the company’s product, the international company retains flexibility and control over its products in the South African market as Afrihealth is not an economic operator and not have a commercial in the product.
Contact us
Belinda Banfield – 0836304388