Snapshot

The Reliance Review Process - Abridged Review pathway has been developed by the of South Africa.

This pathway can be used where SAHPRA has adopted the reliance review process as a pathway for routine listing of medical devices, including IVDs, pre-marketing, post-marketing, as well as demonstration (imported), appraisal, personal use, and donation. This approach allows the authority to leverage evaluation efforts done by a recognized regulatory authority (RRA) that SAHPRA aligns with to make evaluation process more efficient and enhance market access. Reliance can facilitate/support regulatory preparedness and response, particularly during public health emergencies. .

This pathway accelerates the regulatory review process.

It is an abridged review (a reliance pathway).

Target time assessment is .