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China Regulation Update from the month of January

1. Notice from NMPA on the second batch of medical devices and IVD products exempted from clinical trials.

On the date of 14th January 2021, NMPA published a 2nd batch of medical devices and IVD products exempted from clinical trials.  The 1st batch of clinical exemption catalogue was released in December 2019, which consolidated all the products exempted from clinical trial requirements and updated the category coding numbers. The 2nd batches included 37 additional devices into the clinical exemption catalogue, in which all the products under the ophthalmic related products 16-04-21 are exempted from clinical trials. 7 IVD products are added into the catalogue too. In addition, 16 products are removed from the catalogue due to the downgrading from class II to class I. 

2. Notice on the management specifications for the supplementary documents required during medical device registration review (No.1, 2020).

The notice re-emphasize that the technical reviewer shall inform all the contents that need to be supplemented and/or clarified at one time in the deficiency letter, and the applicant shall provide supplementary documents once within one year time frame.  The scope covers the initial registration of medical devices (including in vitro diagnostic reagents), the product change/amendment with permission, the registration renewal, the approval of clinical trials that involved deficiency letter issuance and response.  The reviewer shall issue the deficiency letter according to the ERPS guidance and list questions by order of the ERPS structures and secondary categories.  The questions shall be clear and directional.  When the applicant / registrant submits the supplementary information, it shall also submit the "description of the supplementary information" and the specific supplementary documents.

If the reviewers must be changed in the middle of the review process, the requirement shall keep continuity and consistency.

3. NMPA issues several guidance for IVD products and active equivalence devices.

Notice from NMPA on Issuing the guiding principles for the examination of three registration technologies including Mycoplasma pneumoniae IgM / IgG antibody detection reagents (No. 4 of 2021).  Guidelines for the technical review of the registration of detection reagents for hereditary deafness related gene mutation (No.4 of 2021). Guidelines for technical examination of cryptococcal capsular polysaccharide antigen test reagent registration (No.4 of 2021). Guidelines for technical review of the registration of Mycoplasma pneumoniae IgM / IgG antibody test reagents (No.4 of 2021) Guidelines for technical review of clinical evaluation of the equivalence device of X-ray computed tomography equipment (No.2 of 2021).  Guidelines for technical review of clinical evaluation of the equivalence of imaging ultrasound diagnostic equipment (No.2 of 2021).  Notice of Issuing two guiding principles for registration technology review, including the guiding principles for clinical evaluation of the equivalence of imaging ultrasonic diagnostic equipment (No. 2 of 2021).   A copy of detailed guidance could be available by request.

Should you have more questions regarding China regulations, please feel free to contact Qserve at info@qservegroup.com.

Stephanie (Xing) Huang
Post date: March 09, 2021
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