South Africa: Medtech regulations to kick off
South Africa’s medical device regulatory system has taken a big step forward with the setting of a deadline for manufacturers, importers and distributors to license their establishments locally.
Medical device and IVD manufacturers, importers and distributors are required to license their companies with the Medicines Control Council (MCC) before February 28, 2017. Moreover, the new agency SAHPRA – South African Health Products Regulatory Agency, is going to start in spring 2017.
SAHPRA will take over the role of a device regulator from the MCC and handle the registration of medical device products. The registration will be based on the new risk classification. Products will be classified into four categories: Class A (low-risk), Class B (low- to moderate-risk), Class C (moderate- to high-risk) and Class D (high-risk).
When applying for a license for their establishment, medical device and IVD companies are required to also include a listing of all products and a classification of them. There are to be two types of license: a license to manufacture, allowing importations, manufacture, distribution and exporting; and a license to distribute, allowing importations, distribution and exporting.
SANAS, the South African National Accreditation System, which carries out accreditations in respect of conformity assessment, will do the accreditation of conformity assessment bodies (similar to EU notified bodies) for auditing companies to local ISO 13485 on quality management systems (QMS). In the meantime, however, local companies are urged to use the international ISO 13485:2016 as their QMS guide.
Additionally, the MCC has published several new guidelines on its website on licencing, principles of safety &performance and classification of medical devices and IVDs:
• Licencing of Medical Devices and IVDs Manufacturers, Importers and Distributors;
• Medical Device and IVD Essential Principles of Safety & Performance; and
• Classification of Medical Devices and IVDs.
You can find them under MCC Publications.