SFDA Regulations

29 Dec 20

SFDA’s Guidance on Importation Requirements of Medical Devices Intended for Demonstration or Training Purpose only.

25 Nov 20

SFDA’s Guidance on Import and Clearance Requirements for Particle Accelerators

22 Nov 20

SFDA’s Guidance on Requirements of Shipments Clearance at Ports of Entry

22 Nov 20

SFDA’s Guidance on Requirements for Medical Masks and Particulate Respirators

22 Nov 20

SFDA’s Products Classification Guidance

19 Nov 20

SFDA’s Quality Management System Auditing Organizations

SFDA has published a new implementing rule on how Quality Management Auditing Organizations can comply with SFDA’s requirements; Click here to read the official document. Highlights from this Document Article four: Quality Management System Auditing SFDA will perform (if needed) auditing for QMS of the establishment…