Snapshot

The PPB Fast Track, Reliance and Emergency Use Pathways for IVDs Region: AFRICA pathway has been developed by the of Kenya.

This pathway can be used where PPB defines Fasttrack and emergency/compassionate use pathways that apply to “health products and medical devices,” a category that includes in vitro diagnostic devices.​ Fasttrack may be full assessment or reliance‑based, leveraging decisions of stringent or regional reference authorities to shorten timelines, while emergency/compassionate pathways provide accelerated access to diagnostics needed in public health emergencies.​ The reliance model includes unilateral reliance, unilateral recognition and joint inspections/work‑sharing within EAC and IGAD, allowing IVDs already assessed by trusted regulators or joint schemes to move faster through national authorization.​ .

This pathway accelerates the regulatory review process.

It is an abridged review (a reliance pathway).

Target time assessment is .