Each mask type is subject to the specifications set out by the National Regulator for Compulsory Specifications (NRCS) for that type of mask. It is therefore essential that the supplier ensure compliance for each type. Different manufacturers may have applied different standards and so it is also essential to check that the devices from each manufacturer (even if they are the same product) meet the required specification.
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?
- What are the limitations on the sale of serological/rapid test kits?
- What is the classification on serological/rapid test kits?
- 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?
