Snapshot

The SAHPRA Fast Track Licensing for Medical Devices and In Vitro Diagnostics (IVDs) pathway has been developed by the of South Africa.

This pathway can be used where Covers Class B (low-moderate risk), Class C (moderate-high risk), and Class D (high risk) medical devices including IVDs such as reagents, test kits, instruments, and accessories. Licensing includes manufacture, importation, distribution, exportation, and wholesale. SAHPRA’s framework allows for accelerated review pathways by accepting prior approval from recognized authorities including WHO Prequalification, US FDA, EU CE marking, TGA Australia, and others as originating approvals. Applicants must provide comprehensive technical documentation, proof of QMS (like ISO 13485), and demonstrate conformity assessment. The process includes postmarket surveillance commitments and rapid submission of adverse event and modification notifications to ensure safety and compliance. Licenses are typically valid for five years with renewal options. .

This pathway accelerates the regulatory review process.

It is an abridged review (a reliance pathway).

Target time assessment is .