Revised Measures for Assessing Medical Device Standards Issued

The China Food and Drug Administration (CFDA) has recently issue revised guidelines with regard to the Administrative Measures for Medical Device Standards (Trial Implementation).

The three primary amendments are summarised below:

1. With regard to medical device standards, clarification has been provided as to the classification basis and the types of standards, including the mandatory and recommended standards for medical devices. The standards have also been further divided into basic standards, methodology standards, management standards and product standards.

2. The correct procedure for revising medical device standards has also been clarified.

3. In terms of establishing a system for the review of standards, it has been announced that the Medical Device Standardisation Technical Committee will review the medical device standards already in use, before issuing revised guidance.

These revised measures come into effect as of 1 July 2017.

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

Administrative Measures for Medical Device Standards