NDA DARDAR/GDL/028 Revision No. 0
DAR/GDL/028 Revision No. 0 is the official NDA identifier for “Guidelines on Registration of Surgical Instruments and Appliances (DAR/GDL/028, Revision No. 0)”. DAR/GDL/028 Revision No. 0 is the official identifier NDA uses for this instrument.
- Instrument
- DAR
- Full name
- DAR/GDL/028 Revision No. 0
- Category
- Registration
- Authority source
- English
- Readable HTML
- 25 articles · 1 language version
- Published
- —
- Effective
- 2020-08-14
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Each version has stable article anchors for direct citations and highlighting. The readable text is generated from an authority source and does not replace the legally controlling publication.
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a review due date of 14 August 2023 recorded on the copy: that review date has passed and the document has not been superseded on the Authority's site, which is recorded in `currentnessVerifiedOn` rather than corrected.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.
DAR/GDL/028 Revision No. 0 is the official identifier NDA uses for this instrument. Always confirm the current consolidated text and transition provisions with the official source before filing.