ISO13485 is a mandatory requirement for medical devices manufactured in South Africa

ISO13485 is a standard which medical device manufacturers in South Africa (and the world) use to ensure that they have stringent quality, monitoring and recall processes in place to ensure the safety and efficacy of the medical devices produced.

The device itself will not be ISO13484 accredited, but rather the company which is manufacturing the device.

It is also a requirement from SAHPRA that any company with an existing medical device establishment license will require ISO 13485 accreditation by the time their license is up for renewal (5 years from issue).

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