Explore the medical device requirements currently available for South Africa, organized by topic and linked to official sources.
What expires, what is retained periodically, and when must renewal start?
Establishment Licence Only Or Transitional
Current broad control is establishment licensing rather than a universal mature product-registration certificate; establishment licences are valid 5 years.
Structured from the R183 official-source atlas. Confirm the exact article or page before treating this as fact-level legal advice.
After expiry, a new licence is required and trading must stop.
Structured from the R183 official-source atlas. Confirm the exact article or page before treating this as fact-level legal advice.
Apply for establishment-licence renewal at least 90 days before expiry.
Structured from the R183 official-source atlas. Confirm the exact article or page before treating this as fact-level legal advice.
Does the event require internal documentation, notice, prior approval, transfer, or a new application?
Responsible person/licence-holder changes are establishment-licence amendments; product list updates are separate notifications.
Structured from the R183 official-source atlas. Confirm the exact article or page before treating this as fact-level legal advice.
Which manufacturer, representative, holder, applicant, importer, and distributor roles apply?
Responsible Natural Person Within Licensed Establishment
South African Authorized Representative/responsible person within licence holder
Yes As Local Establishment Responsibility
Responsible Person For Licensed Establishment Not Generic Product Holder
manufacturer/importer/distributor establishment roles licensed
Licensed Distribution Role
Roles Can Coexist In Establishment If Licensed
Structured from the R183 official-source atlas. Confirm the exact article or page before treating this as fact-level legal advice.
Establishment Licence Amendment
New Product Registration Not Applicable Currently
This AR is a responsible natural person, not the EU AR archetype.
Structured from the R183 official-source atlas. Confirm the exact article or page before treating this as fact-level legal advice.
