Only companies who solely supply Class A non-sterile, non-measuring device are exempt from exempt from requiring a medical device establishment license from SAHAPRA. As both these products are classified as Class B devices, the supplier of such devices would need to have a medical device establishment license from SAHPRA.
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 is the involvement of the SABS and is there an additional registration that is required for Medical Devices and IVD’s?
- 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?
