SFDA MDS-REQ-005MDS-REQ-005
MDS-REQ-005 is the official SFDA identifier for “Requirements on Importation and Shipments Clearance of Medical Devices and Supplies”. MDS-REQ-005 is the official identifier SFDA uses for this instrument.
- Instrument
- MDS-REQ-005
- Full name
- MDS-REQ-005
- Category
- Registration
- Authority source
- English
- Readable HTML
- 0 articles · 1 language version
- Published
- 19 July 2023
- Effective
- 2023
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Requirements on Importation and Shipments Clearance of Medical Devices and Supplies
MDS-REQ-005 Version 6.0 (19 July 2023): requirements on importation and shipment clearance of medical devices and supplies — ten importation purposes (circulation, used devices, local manufacturing, clinical studies, research and education, GHAD system, demonstration, national emergency, humanitarian, personal importation, free sale certificates), the required-documents matrix, and Annexes 1-10 (declarations and attestation forms, the free-sale application form, and definitions). Title corrected to the official cover: the previous metadata title described MDS-REQ1, not this document.
MDS-REQ-005 is the official identifier SFDA uses for this instrument. Always confirm the current consolidated text and transition provisions with the official source before filing.