CFDA Updates: Priorities of CFDA 2017 Reform Related to Medical Device, MedTech, IVD

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CFDA Updates: Priorities of CFDA 2017 Reform Related to Medical Device, MedTech, IVD

 

 

In a press conference held earlier this year by CFDA, the agency declared that it would be pursuing its reform of the drug and medical device approval system in 2017 with these priorities, related to medical device, medtech and IVD areas:

 

  1. Drug and Device Approval System. The CFDA will increase resources for technical review and inspections to establish an approval system for drugs and medical devices that is not only focused on technical review, but also supported by on-site inspection and product testing.

 

  1. On-site Inspections. The CFDA will strengthen its data integrity assessment of regulatory dossiers, continue its on-site inspections on clinical trials and manufacturing processes for both drugs and medical devices, and clarify the legal responsibilities of its inspectors.

 

The CFDA has started an unprecedented reform of its approval systems for drugs and medical devices, coupled with increased good clinical practice and good manufacturing practice enforcement in and outside China.


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