Snapshot

The Abridged Registration Assessment Pathway pathway has been developed by the of Botswana.

This pathway can be used where In Vitro Diagnostic (IVD) Medical Devices (class B, C and D IVD medical devices)..

This pathway accelerates the regulatory review process.

It is an abridged review (a reliance pathway).

Target time assessment is 1. SCREENING: - Class B: 1 month - Class C: 2 months - Class D: 2 months. 2. ABRIDGED & EXPEDITED REVIEW: - Class B: 4 months - Class C: 6 months - Class D: 8 months. 3. WHO CRP: 3 months for Classes B-D. .