Currently limited banks of panels for validation available hence the length of the validation process. Kits must receive SAHPRA approval first and then can progress to the validation by an accredited facility.
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?
- 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?
