Medtech Regulatory Framework
South Africa (SA)
The Medicines and Related Substances Amendment Act 14 (2015) introduced a four-tier, risk-based licensing and registration system, which applies to South Africa-based companies that manufacture, sell, import, export, distribute and wholesale medical devices in the country. The Act also regulates procedures for device registration and requirements relating to advertising and labelling, and the restriction of sampling for the sale of medical devices.
South Africa (SA)
- No medical device may be manufactured, distributed, imported, exported or sold without a valid SAHPRA medical device establishment license.
- This is especially important for eligibility to bid for National and Provincial tenders. An exemption has been introduced for manufacturers, distributors and wholesalers of non-sterile, non-measuring Class A medical devices (SAHPRA, 2021b).
- No medical device may be manufactured, distributed, imported, exported or sold without a valid SAHPRA medical device establishment license.
- This is especially important for eligibility to bid for National and Provincial tenders. An exemption has been introduced for manufacturers, distributors and wholesalers of non-sterile, non-measuring Class A medical devices (SAHPRA, 2021b).
As part of the application for a SAHPRA medical device establishment license, a company must appoint an Authorised Representative based in South Africa who is responsible for adherence to the law, regulations and guidelines, and must list all the medical devices that it manufactures, distributes or wholesales.
The application must also include a declaration on the quality management system in place in the company, which, upon renewal of the SAHPRA license, must include ISO 13485 certification (SAHPRA, 2021b).
South Africa (SA)
Aside from statutory regulation of medical devices, in 2011,The South African Medical Technology Industry Association (SAMED) became a member of the Marketing Code Authority (MCA), making it a signatory to a single Code of Marketing Practice, adopted by various health product associations in South Africa (Who Owns Whom, 2019). (Kiara MedTech is a member of SAMED).
The Medical Device Code of Ethical Marketing and Business Practice was published in 2018. The intention is to facilitate ethical behaviour in the industry. Healthcare practitioners, customers and patients may lodge a complaint with the MCA regarding marketing and advertising of healthcare products