Botswana medical device registration timeline

G01 s.4.15 publishes the screening target per route: 'Within 3 months' for the notification pathway, 'Within 1 month' for Class A and B, and 'Within 2 months' for Class C and 'Within 2 months' for Class D. The row publishes that published ladder as a range rather than picking one class.

Two query cycles are allowed. Once a query is raised the processing halts until the response is received, and if no response is received within the timeline specified in s.4.15 the application is deemed withdrawn by the applicant (G01 s.4.8(ii)).

Only after the screening step is approved does the applicant submit the evaluation application, and the s.4.15 evaluation clocks run from the accepted evaluation application with the evaluation fee paid.

G01 s.4.15 publishes the abridged target as Class A and B 'Within 4 months', Class C 'Within 6 months' and Class D 'Within 8 months', with 'NA' for the notification route; the row carries the published ladder as a range.

The abridged route is the one route where a foreign approval does work: G01 Table 3 marks 'Proof of Reference Regulatory Agency' and 'Proof of Marketing Reference Regulatory Agency' as required for the abridged dossier and not required for the full dossier, which makes those two documents the eligibility evidence for entering the shorter route.

A Reference Regulatory Authority is defined in G01 s.3.1.25 as an NRA recognised by BoMRA under its policy 'Recognition and-or Reliance on Information on Medical Devices including IVDs from Regional and International Regulatory Agencies' — a policy this review did not retrieve, so the list of recognised authorities is not asserted here.

G01 s.4.15 publishes the full-evaluation target for local manufacturers as Class A and B 'Within 6 months', Class C 'Within 8 months' and Class D 'Within 10 months'; the row carries that published ladder as a range.

The full dossier requires, among other items, the Declaration of Conformity, the Certificate of Compliance with Recognized Standards, medical-device quality-management-system evidence, a post-market surveillance plan, an executive summary, the Summary Technical Documentation and device labelling (G01 Table 3).

Registration is site specific (G01 s.4.9) and a quality-system audit of the manufacturing site may be conducted as part of the evaluation (G01 s.4.8(v)).

G01 s.4.15 publishes the full-evaluation target for a foreign manufacturer as Class A and B 'Within 8 months', Class C 'Within 10 months' and Class D 'Within 12 months'; the row carries that ladder as a range. This is the route a foreign device manufacturer uses unless it qualifies for the abridged route.

Where the applicant is not resident in Botswana it must appoint a Local Technical Representative (also called an Authorized Representative) that is a company residing or incorporated in Botswana, and the LTR is the applicant of record (G01 s.3.1.3).

Applications for renewal must be made six months before the existing registration expires (G01 s.4.14), so a registrant has to re-enter the dossier cycle well before the five-year term ends.

G01 s.4.15 publishes the expedited target as Class A and B 'Within 4 months', Class C 'Within 6 months' and Class D 'Within 8 months'. The expedited clock is the same as, or close to, the abridged clock, so expediting buys little over a supported abridged filing.

G01 does not publish the criteria for granting expedited evaluation, and no expedited fee head exists in the in-force schedule, so the route is described here only as the guideline states it.

G01 s.4.15 publishes a single 'WHO CRP — Within 3 months' row with no class columns, which is why this row carries a route-wide exemption rather than a class link. It is the shortest published route in Botswana.

The guideline adds a filing condition rather than only a clock: for WHO PQ medical devices the manufacturer has to submit a filled form 2 and form 3 along with the application (G01 s.4.8(vi)).

G01 s.4.15's periods are target assessment times; the clock stops while a query is outstanding (G01 s.4.8(ii)).

G01 s.4.15 publishes 'Major Variations — Within 3 months', 'Minor Variations — Within 3 months' and 'Notification variations — Within 1 Month'; the variation ladder is by variation type, not by device risk class, which is why the row carries a route-wide exemption.

The registered holder must inform the Authority of any significant change that could reasonably be expected to affect safety or effectiveness, and certain fundamental changes cannot be handled as a variation at all — a new dossier must be submitted (G01 s.4.13).