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
- 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
- GMDN code/descriptor for a product I wish to manufacture/import
- Storage or warehouse facility/site for medical devices require a SAHPRA medical device establishment license
- ISO13485 is a requirement for renewing my company SAHPRA medical device establishment license
- ISO13485 is a mandatory requirement for medical devices manufactured in South Africa
