What are the standards for medical devices in African countries?

Hello, I'm glad to answer your question. The effective supervision and policy of medical devices in South Africa controls the quality of medical devices produced and used in the market, ensuring that they will not pose a threat to public safety and health, which also makes the local manufacturing industry in line with international standards and gain a strong competitive foundation. Supporting regulation and appropriate industrial policies are essential to encourage and reward innovation and local investment. It is equally important to encourage the innovation and development of the private sector, which will contribute to the success of the medical device industry in South Africa and greatly accelerate the pace of entering the international market. In order to improve the inefficiency of MMC, the Parliament is currently considering the bill on drugs and related substances, transforming MMC into "SAHPRA" and expanding its functions to medical devices and in-vitro diagnosis. Some legislative provisions of medical devices proposed by SAHPRA include licensing, equipment classification and labeling. Regulation and Regulation of Grape Plantation under Rainbow The existing regulatory agencies: Drug Administration Commission (MMC), South African National Certification System (SANAS), South African Bureau of Standards (SABS), National Compulsory Standards System (NRCS) and Drug Administration Commission (MCC) are a medical institution in South Africa, which is responsible for managing and regulating the production, circulation, retail and market of domestic drugs. The person in charge of product approval is not a full-time employee, which is one of the main reasons for the delay in product approval. South Africa's National Certification System (SANAS)SANAS is an independent government agency. Is responsible for the certification of all walks of life and institutions, and has the right to carry out specific business related to its industry. SANAS cannot directly certify medical equipment, production or service facilities, and only institutions authorized by SANAS are qualified to provide certification services for medical equipment, production or service facilities. As far as medical equipment is concerned, the role of SANAS is to recognize the accreditation services of South African Bureau of Standards (SABS) and other private certification bodies, and take ISO 13485 certification as the international standard of South African medical device companies.