Registering a Medical Device in South Africa: Compliance Steps with SAHPRA Regulations
To register a medical device in South Africa, apply for a license from SAHPRA. Appoint an Authorised Representative in South Africa. Complete the registration form for Class A devices. The license lasts five years and requires an initial fee of $1,010 and an annual fee of $282. After submission, SAHPRA evaluates the application for compliance … Read more