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China Sets End of Year Deadline for Adoption of 99 New/Updated Medical Device Standards

A total of 99 “mandatory” or “recommended” industry standards relating to medical devices are to be adopted or updated before the end of the year, according to a recently issued circular on the part of the China Drug Administration (CDA).

As part of its submission, the CDA urged the Medical Device Standard Administration Centre of the China Food and Drug Administration, as well as all other relevant bodies, to finalise work on the required standards, all of which will need to be in compliance with the Measures for the Administration of Medical Device Standards and the Administrative Guidelines on the Formulation and Revision of Standards for Medical Devices.

For further details (in Chinese), please visit the following link:

Circular of the General Office of the China Drug Administration on Issuing the List of Medical Device Industry Standards to be Formulated or Revised in 2018 (Yao Jian Ban No. 26 [2018])

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