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South Africa's (SAPHRA): Questions And Answers Licensing Of Medical Device Establishments

Last Friday (17 November 2023) the South African Health Products Regulatory Authority (SAPHRA) released updated guidance on "Guideline On Questions And Answers Licensing Of Medical Device Establishments".

SAPHRA, as the regulatory authority in South Africa, establishes and enforces guidelines to ensure that medical devices entering the market meet stringent standards.


Licensing of medical device establishments is a critical component of this process, encompassing manufacturers, importers, and distributors.


The intent of this guideline is to clarify licensing guidelines and applications for medical device establishments. In order to minimize delays in the application evaluation and processing, applicants are strongly advised to comply with the administrative requirements in order to avoid delays in the application evaluation and processing.


There are three different types of medical device establishment licences that applicants may apply for:

a) Manufacturer license

b) Distributor license

c) Wholesaler license


All applications should be submitted with a Cover letter that has been prepared on a company letterhead, signed by the authorised representative and it should be dated.


The Cover letter must include a list of annexures that are submitted with the application, for example:

• Annex 1: Licence Application

• Annex 2: Proof of Payment

• Annex 3: Curriculum Vitae of the Authorised Representative

• Annex 4: Quality Manual (Manufacturers/Distributors) or Site Master File (Wholesalers)


To know more about the requirements, click this LINK.

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