ZAMRA · Middle East & AfricaEvery Zambia dataset, comparison, and AI workpaper we maintain — one entry point for the whole market.
Describe your device and get a preliminary ZAMRA risk class with an explanation and source links.
Check whether product features may trigger separate radio, electrical, metrology, radiation, import, or other Zambia requirements.
Review current ZAMRA application, review, and renewal fees.
Compare official and realistic approval times by device class and pathway.
Browse Zambia's official medical-device instruments — the Medicines and Allied Substances Act, ZAMRA's marketing-authorisation, classification, labelling and essential-principles guidelines, and the recall guideline — with citeable English passages.
23 of 25 research dimensions currently covered · 13 official sources · latest verification 2026-09-16
ZAMRA registration fees in USD · reviewed 2026-09-16
| Fee line | Amount | Provenance |
|---|---|---|
| Application for marketing authorisation — allied substances imported as finished products | US$ 500.00 | Verified |
| Annual retention fee — allied substances imported as finished products | US$ 200.00 | Verified |
| Renewal of marketing authorisation — allied substances imported as finished products | US$ 350.00 | Verified |
| Late submission of an application for renewal of marketing authorisation | US$ 5.00 | Verified |
Zambia Medicines Regulatory Authority (ZAMRA) review clocks and planning ranges · 4-class (A, B, C and D) — GHTF/IMDRF-derived rules in ZAMRA/MA/GUD/0002 for non-IVDs and a parallel four-class individual/public-health-risk table for IVDs in ZAMRA/MA/GUD/0003 classification
| Class / pathway | Review clock | Planning total | Provenance |
|---|---|---|---|
| Class A to D in-vitro diagnostic device — marketing authorisation(Marketing authorisation application to ZAMRA under s.39 of the Medicines and Allied Substances Act No. 3 of 2013, filed physically in duplicate with one hard and one soft copy of the full product dossier under ZAMRA/MA/GUD/0003) | 180 working days | 9-14 months | Verified |
| Class A to D non-IVD medical device — expedited evaluation (fast track)(Expedited evaluation authorised by the Authority, charged at double the applicable marketing authorisation fee) | 90 days | 4-8 months | Verified |
| Condoms — marketing authorisation under the dedicated condom guideline(Application to ZAMRA for marketing authorisation of a condom under s.39 of the Medicines and Allied Substances Act No. 3 of 2013, evaluated against the condom guideline's dossier requirements with laboratory analysis by the National Drug Quality Control Laboratory against ISO 4074:2015 (male) or ISO 25841:2014 (female), and tabled before the Technical Committee for approval) | 365 days | 1-1.5 years | Verified |
Official ZAMRA rules and guidance · 8 of 8 documents linked to official sources
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Connect the ZAMRA route, evidence, labels, local role, timing, and dependencies to a wider launch plan.
Compare an existing authorization and evidence set against ZAMRA administrative, testing, labeling, and dossier needs.
Map a product or manufacturing change to ZAMRA evidence, notification, timing, and implementation questions.
Assess a current ZAMRA update against one product and turn it into an owner-ready action workpaper.
Review connected-device architecture, risks, SBOM, testing, lifecycle controls, and market-specific questions for Zambia (ZAMRA).
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