Yes, in the case of all three the above scenarios, you will need to apply for a full amendment with associated fees (visit the website for the fee schedule).
Related Knowledge Base Posts
- Does South Africa recognizes certification of medical devices approved in Australia?
- There is a local arm of a multinational that wants to know if their European principal’s QMS covers them or if they would need their own QMS as a subsidiary of the multinational. I enquired if they are subject to the principal’s QMS and they indicated that they are not as they are only the importer and do not manufacture locally but the international principal holds the ISAO13485 accreditation across its entire range of products (which makes sense because the company is ISO accredited and not the products themselves). Does the local subsidiary need to be listed on the international principal’s ISO accreditation or have its own?
- What are the regulatory requirements for importing IVD products?
- What are the ISO 13485 and conformity assessment bodies criteria for licence renewal?
- Who must I contact at SAHPRA if I have port health issues?
- Who must I contact at SAHPRA to report an adverse event?
- Who must I contact at SAHPRA to report poor quality or counterfeit medical devices?
- Who must I contact at SAHPRA regarding new licence applications
- Does SAHPRA allow re-sterilisation of a medical device?
- 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?