SFDA MDS-REQ9MDS-REQ9
MDS-REQ9 is the official SFDA identifier for “Requirements for Licensing of Medical Devices Establishments”. MDS-REQ9 is the official identifier SFDA uses for this instrument.
- Instrument
- MDS-REQ9
- Full name
- MDS-REQ9
- Category
- Registration
- Authority source
- English
- Readable HTML
- 0 articles · 1 language version
- Published
- 11 June 2024
- Effective
- 2024
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Requirements for Licensing of Medical Devices Establishments
MDS-REQ9 (running code MDS-REQ-002 V5, English version 2, version date 11 June 2024; resolved from the SFDA [regulations publication page](https://sfda.gov.sa/en/regulations/87126) to its direct official PDF): requirements for licensing medical device establishments — SFDA responsibilities and authorities, general requirements, and specific obligations for ten establishment categories (local manufacturers, authorized representatives, importers and distributors, warehouses, and six service-provider types incl. clinical-trial verification, testing laboratories, conformity assessment, radiation quality assurance, technical consultation, and medical maintenance), plus Annex 2 license periods and fees (5,000 SAR / 5 years for manufacturers). MDEL is required before device registration.
MDS-REQ9 is the official identifier SFDA uses for this instrument. Always confirm the current consolidated text and transition provisions with the official source before filing.