Kenya medical device regulatory resources

PPB publishes its clocks by pathway, not by device class: Fig. 3 gives screening 90 days, scientific review 24 months, approval by the Board 14 days and issue of the registration certificate 7 days

Two steps inside the same chart are expressly unbounded — assessor review time carries "No timeline" and review of the applicant's response carries "No target time" — so the 24 months is the review target rather than a guaranteed decision date

The applicant's own reply is capped at not more than 6 months

Fig. 3: screening 30 days instead of 90, and the reliance review is 90 days instead of the FIFO 24 months, with the same 14-day Board approval and 7-day certificate issue

The chart publishes no review clock for the fast-track full-assessment route; this row is the reliance clock

Eligibility is set by the PPB reliance guidelines and the guidelines for fast-track review, not by risk class

Fig. 2: screening for completeness 3 days, review 30 days on the full assessment pathway or 7 days for abridged and WHO-listed products, and a final decision in 15 days

The low end of the range is the abridged and WHO-listed route (3 + 7 + 15); the high end is full assessment (3 + 30 + 15)