A company that supplies only non-sterile, non-measuring Class A medical devices is exempt from requiring a medical device establishment license from SAHPRA. The individual products may still be subject to other requirements from other bodies such as the NRCS.
Related Knowledge Base Posts
- We have Section 21 approval by SAHPRA to begin trading a COVID-19 antigen test. Does our wholesalers selling the device also need to get approval from SAHPRA?
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- What are the turnaround times for COVID-19 product applications?
- If I want to bring in a serological/rapid test kit or PCR test kit for Research Use Only (RUO), what must I do?
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- Do you require a medical device establishment license from SAHPRA in order to supply a surgical gloves?
- Are local manufacturers of masks required to comply to the standards set out by NRCS?
