For COVID-19 related products, there are additional measures in place, to ensure the quality of product used by the healthcare professionals. In terms of rapid tests and PCR test kits for use in COVID-19, guidance has been published by SAHPRA. In terms of ventilators, SAHPRA has published additional guidance. In terms of PPE, all products must include compliance to applicable SANS or global standards, on amendment to the license application and meet applicable NRCS specifications.
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?
- Covid 19 Testing Kits
- 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?
- What are the limitations on the sale of serological/rapid test kits?
- What is the classification on serological/rapid test kits?
- If a supplier sells different masks, do they require a compliance certificate for each mask type?
- 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?
