Look out! The Working Procedures including Procedure for Re-issuance of Medical Device Registration Certificate will be changed

On Sep.25, 2015, CFDA issued Notification of Exposure Drafts about Related Working Procedures for Registration of Medical Devices.
In order to further standardize the related registration procedure and service items handling procedure of imported class II and Class III medical device, CFDA is cleaning and collating the original files such as Six Working Procedures including Procedure for Re-issuance of Medical Device Registration Certificate (SFDA No.169 2007), Procedure for Applying for Cancellation of Medical Device Registration Certificate (SFDA No. 634 2007), and so on. CFDA plans to abolish the three working procedures such as Procedure to Delay Registration Test of Medical Device, Procedure to Postpone the Handling of Medical Device Registration Certificate, and Procedure for Handling Customs Certificates of Medical Device, and revise the procedures such as Procedure for Re-issuance of Medical Device Registration Certificate, Procedure to Correct Mistakes in Medical Device Registration Certificate, and so on. At the same time, CFDA formulate the working procedure for record change of medical device instruction.

CIRS will continue concern the relevant information about the working procedures change.

If you want more information, please feel free to contact us.

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