NDA market accessResearch NDA registration records, classification, regulations, timelines, fees, and market updates — the stable entrance to every Uganda medical device resource.
Describe your device and get a preliminary NDA risk class with an explanation and source links.
Check whether product features may trigger separate radio, electrical, metrology, radiation, import, or other Uganda requirements.
Review current NDA application, review, and renewal fees.
Browse Uganda's official medical-device instrument — the NDA guideline on registration of surgical instruments and appliances — with citeable English passages.
Compare official and realistic NDA approval times by device class and pathway.
Common questions about changing a registered medical device in Uganda. Each question separates published rules from details still awaiting verification.
21 of 25 research dimensions currently covered · 14 official sources · latest verification 2026-09-18
No source-verified answer is published for this dimension yet.
No source-verified answer is published for this dimension yet.
NDA registration fees in USD · reviewed 2026-09-16
| Fee line | Amount | Provenance |
|---|---|---|
| Application for registration of imported surgical instruments and appliances | USD 1500 | Verified |
| Application for registration of locally manufactured surgical instruments and appliances | USD 200 | Verified |
| Retention of imported surgical instruments and appliances on the Register | USD 200 | Verified |
| Retention of locally manufactured surgical instruments and appliances on the Register | USD 100 | Verified |
National Drug Authority (NDA) (NDA) review clocks and planning ranges · 4-class (A, B, C, D) — NDA's own risk axis from Class A (low risk) to Class D (high risk, where the risk relates to the patient or to public health), applied from the classification rules in DAR/GDL/028 Rev 0 (Appendix VII and Table 1); every device must be registered before importation or supply regardless of class classification
| Class / pathway | Review clock | Planning total | Provenance |
|---|---|---|---|
| Surgical instruments and appliances — registration by the Authority(Application to the National Drug Authority for registration of a surgical instrument before manufacture, importation or exportation, on Form 7 of Schedule 6 to S.I. 2014 No. 29 (reg. 27(1)-(2)), filed by the patent holder, a licensed person, the manufacturer, or an agent authorised by the manufacturer or patent holder (reg. 27(3)); registration is a precondition of sale or distribution (reg. 25(1))) Reg. 38(1) of the National Drug Policy and Authority (Registration) Regulations, 2014 (S.I. 2014 No. 29), Part IV: 'The Authority shall determine an application for registration under these Regulations, within sixty days from the date of receipt of the application.' It is the only clock in the instrument that runs against the Authority, and reg. 38(2)-(4) name the three decisions it governs — approve and register, require further information, or refuse with reasons. The device scope is established by reg. 2(c), which applies the Regulations to 'surgical instruments', and by Part III (regs. 24-35, Registration of Surgical Instruments), reg. 25(1) of which requires all surgical instruments to be registered by the Authority before sale or distribution. The unit is calendar days: the regulation says 'within sixty days', not working days or business days. THE SIXTY DAYS IS NOT A WALL-CLOCK PROMISE, and the reasons are recorded rather than smoothed over. Reg. 37 lets the Authority require further information and samples in the course of examining an application without any time limit and contains no clock-stop rule; NDA's registration guideline then supplies the stop rule the statute lacks — 'Once a query or a request has been raised, the processing shall halt until after the response to the query has been received' — and adds that an application may be cancelled or rejected if no response is received 'within six months from the written query notification date'; and the licence applications that must be lodged alongside registration at NDA carry no period at all. The realistic range covers those unclocked steps around the statutory 60 days. Registered surgical instruments are recorded in the register kept under reg. 26 in the format of Schedule 5; the certificate of registration is Form 8 under reg. 30(2) (Schedule 7), and a first registration certificate is valid for five years under reg. 40(1). The instrument read in full is the gazetted text of S.I. 2014 No. 29 (https://www.nda.or.ug/wp-content/uploads/2022/03/Drug-Registration-Regulation.pdf — NDA's own 'NDPA Act & Regulations' page links it under the title 'Drug Registration Regulation', the only registration regulation the Authority publishes). NDA's medical-devices page cites a later device instrument, 'statutory Instrument no 77 of the Surgical Instruments and appliances Regulation 2019', which could not be retrieved on any transport and is not listed on the Authority's own legislation page, so whether it amends or replaces this clock is unresolved and is recorded as such in the entry's other rows. | 60 days | 2-6 months | Verified |
Official NDA rules and guidance · 1 of 1 documents linked to official sources
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Connect the NDA route, evidence, labels, local role, timing, and dependencies to a wider launch plan.
Compare an existing authorization and evidence set against NDA administrative, testing, labeling, and dossier needs.
Map a product or manufacturing change to NDA evidence, notification, timing, and implementation questions.
Assess a current NDA 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 Uganda (NDA).
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