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
- Where can I find a Medical Device Establishment License application form?
- How do I report companies trading without a Medical Device Establishment License?
- Do I need to apply for an amendment to my Medical Device Establishment License if the product is repacked and registered under another jurisdiction?
- 14. Do I need to apply for an amendment to my Medical Device Establishment License if I am changing the size of the kit, if I am changing or adding products to a kit or if the product is repackaged?
- Is a medical device establishment which provides repairs considered the same as a manufacturer in terms of licensing?
- 12. Can a supplier who is a distributor, a wholesaler and a pharmaceutical representative combine their quality management system into one document?
- If a product has the same manufacturer but multiple distributors, does each distributor require a Medical Device Establishment License?
- 10. Do I need to apply for an amendment to my Medical Device Establishment License if I am adding a product which adds a new Class to my license?
- Apply for an amendment to my Medical Device Establishment License if I am removing products from my listing
- Do I need to submit an amendment when I add a new product to my license listing?
