ZAMRA current fee schedule, reviewed for 2026, in USD.
7 fee lines100% exact amountscurrency USDFX rates 2026-09-17reviewed 2026-09-16
| Fee line | Official amount | USD equivalent | Frequency | Provenance |
|---|---|---|---|---|
| Application for marketing authorisation — allied substances imported as finished products Fee schedule item 3(a), imported-products table. Medical devices are 'allied substances' under the Medicines and Allied Substances Act No. 3 of 2013, so this allied-substance head is the operative device application fee; ZAMRA publishes no separate medical-device fee head. The fee covers evaluation of the initial submission only — laboratory testing and site audits are charged separately. | US$ 500.00 | $500 | Per product application | Verified |
| Annual retention fee — allied substances imported as finished products Fee schedule item 5(e). Retention is payable annually even though the marketing authorisation runs five years; non-payment is a ground on which the Authority may suspend or revoke the authorisation and remove the device from the register. | US$ 200.00 | $200 | Annually, for the life of the marketing authorisation | Verified |
| Renewal of marketing authorisation — allied substances imported as finished products Fee schedule item 6(e). | US$ 350.00 | $350 | Every five years | Verified |
| Late submission of an application for renewal of marketing authorisation Fee schedule item 6(f), imported-products table. | US$ 5.00 | $5.00 | For each day the application is late | Verified |
| Evaluating additional information for an application — inadequate technical information (quality, safety or efficacy) Fee schedule item 4(a), imported-products table. | US$ 400.00 | $400 | Per occurrence | Verified |
| Minor amendment to a marketing authorisation Fee schedule item 7(a), imported-products table. The criteria distinguishing a minor from a major amendment sit in ZAMRA's separate amendment guideline, which was not retrieved. | US$ 100.00 | $100 | Per amendment | Verified |
| Major amendment to a marketing authorisation Fee schedule item 7(b), imported-products table. | US$ 500.00 | $500 | Per amendment | Verified |
Government fees only — service and testing costs are separate- Medical devices are regulated as 'allied substances' under the Medicines and Allied Substances Act No. 3 of 2013, so the allied-substance lines in ZAMRA's fee schedule are the device fee lines. ZAMRA publishes no separate medical-device fee head, and no class-differentiated fee: the application fee is the same for Class A and Class D.
- The schedule runs two tables. Locally manufactured or packaged allied substances pay in Zambian Kwacha (ZMW 1,500 marketing authorisation, ZMW 1,000 annual retention, ZMW 1,200 renewal, ZMW 400 minor amendment, ZMW 1,950 major amendment, all expressed as fee units at 30 Ngwee per unit). Imported finished products — the table that applies to a foreign device manufacturer — are charged in United States dollars. This record publishes the imported-products table, so its currency is USD; the two tables cannot be mixed inside one record and the importer requires one currency throughout.
- Fast tracking is charged at double the applicable marketing authorisation fee (fee schedule 'Other fees', item l). That is a published formula rather than a fixed head, so no exact row is asserted here: for an imported allied substance it resolves to US$ 1,000.00. The non-IVD guideline defines 'expedited evaluation' as express evaluation within a 90-day period and the Authority authorises it without published criteria.
- Good-manufacturing-practice inspection fees for foreign-based manufacturers are set by region and are charged on top of the marketing authorisation fee: full site in Southern Africa US$ 3,500.00, rest of Africa US$ 5,000.00, Far East/Asia US$ 6,500.00, Europe/America/Australia US$ 7,500.00, each additional production line US$ 1,500.00, and GMP document evaluation (desk audit) US$ 3,500.00 per manufacturing site.
- The 2016 instrument (S.I. No. 38 of 2016) was read by OCR from a scanned gazette PDF in the spine round and its US-dollar amounts were cross-checked against this current published schedule, where they agree unchanged.
- Advertising and promotion of allied substances carries separate heads in the Kwacha table (ZMW 5,000 advertising to the general public, ZMW 1,000 promotion to health-care professionals, ZMW 2,000 exhibition at a public event). They are worded for medicines and are not published in the imported-products USD table, so they are not asserted as USD amounts here.
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Exact amounts verified against the ZAMRA fee schedule · full review 2026-09-16 · row IDs are stable — cite as government-fees:zambia:marketing-authorisation-application