SAHPRA Regulatory
- If a product has the same manufacturer but multiple distributors, does each distributor require a Medical Device Establishment License?
- Apply for an amendment to my Medical Device Establishment License if I am removing products from my listing
- Can my management representative or quality manager also be my Authorized Representative?
- Submit an amendment to my Medical Device Establishment License if my Authorized Representative changes
- Requiring a local authorized representative for imported medical device
- Storage or warehouse facility/site for medical devices require a SAHPRA medical device establishment license
- ISO13485 is a mandatory requirement for medical devices manufactured in South Africa
- Are there any specific requirements for Materiovigilance in terms of an Materiovigilance-officer residing in South Africa, or having a nominated person who’s contact details are submitted to SAHPRA, like there is with PV? Would it be “legally” allowed for someone in the Global Company Headquarters or Regional Office to perform this function, or does it have to be a local person?
- If I want to bring in a Class A device (which currently is exempted from licensing) then I only need to provide an updated product list to the current license (which has been approved for Class B/C/D) that is in place?
- When will my SAHPRA annual retention fee be due?
- We have submitted 3 amendments to one of our Medical Device Establishment license, but only received an acknowledgement on the final amendment. The final amendment included the previous two amendment changes, as well as the final addition of some products to our portfolio. How do we go about ensuring that a license is only issued based on the latest amendment?
- I have listed all our products with the Item Code as a prefix, is this necessary, or can the Item Code be removed?
- We have listed all our imported products in Section 4.3 and 4.4. Which Company Name should be in column B, is it our Company, or the Name of the Company from which we are importing?
- We have offices in Johannesburg and Cape Town where Technical repairs take place, therefore we have applied for licenses to Manufacture for both these sites. Does the Authorized Representative have to be based at the office for which a license is obtained, or can the Authorized Representative of the Head Office in Johannesburg also serve as the Authorized Representative for the Cape Town office?
- What are the rules and procedures around a healthcare practitioner purchasing a product from us in South Africa, but then taking it with them to work on an international project?
- What is the process for obtaining a Free Sales Certificate for export countries?
- We currently export to all African countries. Do we need to list each country individually for each export product? The spreadsheet only has space for 9 countries per row.
