NMPA medical device standards modifications announced in September 2022

NMPA medical device standards modifications were announced on September 7, 2022, and came into effect immediately. Eighty-six (86) NMPA medical device standards have been modified following evaluation work on the optimization of mandatory medical device standards in China. These 86 mandatory standards have been transformed into recommended standards along with another 6 mandatory industry standard research projects which have also been transformed into recommended ones.

From the date of publication, the above-mentioned standard code is changed from YY to YY/T, however, each standard’s serial number and year code remain unchanged.

Standard list

Implications for NMPA medical device registration

Both mandatory standards and recommended standards have guiding significance for writing the performance indicators of the Product Technical Requirements (PTR) which is an integral part of medical device registrations in China.

The transformation of the standards has a guiding significance for the process of writing the Product Technical Requirements (PTR) which is an integral part of medical device registrations in China.  

A declared product must meet mandatory standards, whereas the applicability of recommended standards will be determined according to the declared product.

The impact of the transformation of mandatory standards to recommended standards on registrants is as follows:

• Mandatory standard: The declared product must refer to the mandatory standard, and it shall meet the requirements of the clauses, and explain any inapplicable clauses.
• Mandatory standards transformed into recommended standards: The declared product may refer to the recommended standard, the applicable clauses should be quoted and meet the requirements, and the non-cited clauses do not need to be explained.
• For products in the registration process, if the tests are not yet completed, and the mandatory standard cited by the registered product has been converted into a recommended standard, the applicable terms can be adjusted according to the technical performance indicators of the product.
• For products in the registration process where the product has already completed testing, but no registration application has been submitted yet, performance indicators in the technical requirements can be adjusted appropriately.
• The transformation of the above-mentioned six medical device projects from mandatory industry standards to recommended industry standards has no impact on existing registered projects.

Further information

Please refer to the links below for the full list of NMPA medical device standards modifications:

Appendix 1：List of 86 mandatory industry standards for medical devices transformed into recommended industry standards

Appendix 2：List of 6 medical device mandatory industry standards under research into recommended industry standards under research

If you would like to know how the NMPA medical device standards modifications affect your medical device or our registration and CRO services for pharmaceuticals, medical devices, IVDs, cosmetics, health foods, and industrial or consumer goods please contact us.

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