Zambia medical device registration timeline

Planning steps and estimates; these are not regulator deadlines.

• An applicant not resident in Zambia must appoint a local responsible person with a power of attorney, defined as a natural or legal person resident in Zambia appointed by a foreign-based marketing authorisation holder to be responsible for all regulatory matters in respect of products granted marketing authorisation; the Annex I form separately requires the authorised local distributor's details and letter of appointment.
• An original Free Sale Certificate addressed specifically to Zambia from the manufacturer's home authority (notarized copies acceptable), the manufacturer's manufacturing licence, documentary proof of ISO 13485 compliance and documentary proof of registration in other countries, specifically those in the SADC region.
• The dossier follows the guideline's Chapters 1-6 table of contents for Classes B to D, or the shorter Annex II package for Class A, with a dedicated Chapter 4 on Clinical Evidence and a Chapter 2 that must include global market history with incident and recall rates.
• A complete application on filing: the guideline states an application is not accepted where any one of the six listed items is missing — cover letter, completed and signed Annex I form, proof of payment of the prescribed fee, at least two samples in the smallest commercial pack size labelled primarily in English, the completed Annex II checklist, and the product dossier.
• Applications and supporting documents must be in English, in 12-point Times New Roman or Arial at 1.5 line spacing with sequentially numbered pages; the non-IVD dossier is submitted as an electronic text-selectable PDF via the Authority's online portal, while IVD applications are physically delivered to the Authority.
• Samples may be analysed by the National Drug Quality Control Laboratory against the manufacturer's claimed specifications and against available local or internationally recognised standards, and the marketing authorisation fees exclude laboratory testing and site audit fees, which are charged separately.
• An applicant must facilitate site audits of its manufacturing site to demonstrate ISO 13485 compliance; where the Authority cannot inspect it shall (IVDs) or may (non-IVDs) consider previous satisfactory inspection reports from ZAMRA or other recognised competent authorities, provided the inspection was conducted within 24 months preceding receipt of the application.
• A marketing authorisation is valid for five years from the date of grant subject to terms and conditions the Authority may specify, with an annual retention fee payable by the marketing authorisation holder; suspension or revocation may follow non-payment or an unforeseen high public or personal health risk.
• Changes are made by amendment application, with the fee schedule distinguishing a minor amendment (US$ 100) from a major amendment (US$ 500) for an imported allied substance; the applicant remains responsible for the product information supporting the application and its variations.
• Pre-market disclosure obligations: the Annex I form requires the applicant to state whether the device has had previous recalls, reportable adverse incidents, banning in other countries or post-market surveillance studies, and to attach the relevant documentation.

Reviewed 2026-09-16. End-to-end totals remain planning estimates.