Please prepare top 3-5 concerns of each Provision followed by suggestions /recommendations for the discussion. We’ll consolidate the information and then submit to CFDA for their reference.

·         No. 4- Provisions for Medical Device Registration

·         No. 5- Provisions for IVD Registration

·         No. 6- Provisions on the Management of Instructions and Labels of Medical Devices

·         No. 7- Provisions for Supervision of Medical Device Manufacture

·         No. 8- Provisions for the Supervision and Management of Medical Device Operation

·         No. 143-Announcement of Relevant Issues on Implementing Provisions for MD Manufacture and Distribution

·         No. 144-Announcement of Relevant Issues on Implementing Provisions for Registration of MD and IVD

Contact