Zambia medical device regulatory resources

The published clock is the IVD guideline's: 'All applications shall be evaluated within one hundred and eighty (180) working days from the date of receipt in the order of submission.' It is a queue-inclusive figure, not a pure assessment time, because it runs in order of submission.

The clock is not suspended quietly: where the Authority requests additional data the applicant must supply it within 90 working days of the request, and any extension must be requested in writing within 14 days of receipt of the request and be approved by the Authority. If the Technical Committee defers an application for unresolved safety or quality issues and the data is not provided within 90 days, the application is refused; if the applicant misses the response deadline the application is closed and must be refiled as a new application.

The realistic range adds the queue and the two-cycle query pattern to the 180 working days, which is roughly 8.3 working months of assessment on its own.

The non-IVD guideline defines 'expedited evaluation' as 'the express evaluation of a product application within a 90 - day period'. That definition is the published clock this row carries.

The Authority authorises expedited evaluation and the guideline states no criteria for granting it, so holding a WHO prequalification, an FDA approval, a CE mark or an approval in an IMDRF member state does not by itself trigger it — those are disclosure items on the Annex I form. The published commercial signal is the fee schedule's 'Fast track fees' head at double the applicable marketing authorisation fee.

The IVD guideline defines the equivalent as a 'Fast Track process' without a period of its own.

Section 1.12.2 (Time Frames — Evaluation of new applications) of the ZAMRA condom guideline: 'All applications shall be reviewed within 365 days from the date of receipt on a first come basis.' The period is queue-inclusive rather than pure assessment time, because it runs on a first-come basis; the same section separately commits the Authority to acknowledge receipt within 14 days (s.1.12.1), which also binds the Authority but is not the review clock.

The applicant-facing side of the same section is not part of the clock: 'The applicant shall be requested to provide additional data when required within 120 days of such a request. Should additional time be required, a formal request must be made and approved by the Authority.'

The instrument is a device instrument: condoms are an allied substance under the Medicines and Allied Substances Act No. 3 of 2013, and ZAMRA lists this guideline in the Medical Devices section of its guidelines page.

CAVEAT 1 — INSTRUMENT CURRENCY, stated rather than resolved: the guideline's own version table carries 'Version 1 draft March 2016', 'Version 1 released for comment April 2016' and 'Deadline for comment May 2016', then leaves both 'Version 2 published for implementation' and 'Date of implementation' blank, and the PDF's metadata Subject field reads 'DRAFT'; the file's embedded metadata gives CreationDate 6 September 2016 and ModDate 24 August 2023, and it is the version the Authority currently hosts in the Medical Devices section of its guidelines page.

CAVEAT 2 — INSTRUMENT CONFLICT, stated rather than resolved: the Authority's later general guideline, the Guidelines on Application for Grant of Marketing Authorisation of Non In-Vitro Diagnostic Medical Devices Version 2 published for implementation on 21 June 2024, governs non-IVD medical devices generally, states only that 'An application shall be evaluated on a first come first serve basis unless expedited evaluation has been authorised by the Authority', and fixes no period; condoms are a non-IVD device, so on one reading the 2024 general guideline governs and this 365-day clock is superseded, and on another reading the condom-specific guideline still governs because ZAMRA continues to publish it as the condom route and neither document says it replaces the other. The 365 days is published because it is a period the Authority fixed in a device instrument; the two readings are stated rather than reconciled.

The row is route-wide rather than class-specific because the condom guideline fixes one period for the product class it governs, and condoms do not sit on the A-D device axis.