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Uganda medical device regulations

Official sources linked

NDA rules and guidance for medical device market access, registration, and lifecycle compliance. Each code opens a metadata page with the official source and readable HTML when available.

1 documents1 categories100% linked to official sourcesauthority NDA1 readable HTML
CodeRegulationCategoryEffectiveProvenance
DAR/GDL/028 Revision No. 0
Guidelines on Registration of Surgical Instruments and Appliances (DAR/GDL/028, Revision No. 0)
The Authority's guideline for registering surgical instruments and appliances: introduction and mandate, definitions, the classification of surgical instruments and appliances into four risk classes (A, B, C and D), and then the registration procedure itself — general rules for applications, application processing, the registration dossier, labelling requirements, the registration certificate, the register, validity and termination, appeals, variations, regulatory approval certificates, registration tracks, the submission checklist and maintenance of registration — followed by seven appendices that carry the Authority's own forms (Form 7 application, Form 8 certificate, the register format, the variation/alteration form, the submission checklist) and its classification rules. Revision 0, effective 14 August 2020, revision date 6 August 2020, with a review due date of 14 August 2023 recorded on the copy: that review date has passed and the document has not been superseded on the Authority's site, which is recorded in `currentnessVerifiedOn` rather than corrected. Its own heading for section 4 is misspelled "INSRUMENTS" in the copy; the extract keeps the document's spelling.
Registration2020-08-14Official
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Each row above represents one regulatory instrument. Its code is the authority’s identifier. A regulation page collects the metadata and official source; when readable HTML is available, article links can open and highlight the exact cited passage.

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Tracked from official NDA publications · row IDs are stable — cite as regulations:uganda:dar-gdl-028-surgical-instruments