Issuance of Announcement on Standardization of Medical Device Product Classification
ISSUING AUTHORITY:
National Medical Products Administration
DATE OF ISSUANCE:
May 10, 2024
EFFECTIVE DATE:
September 1, 2024
In order to further standardize the classification of medical device products, the National Medical Products Administration (NMPA) has revised the Notice on Relevant Work Regarding the Standardization of Medical Device Product Classification (Notice No. 127) which was issued by the former China Food and Drug Administration Office (now renamed as the NMPA) based on the actual situation of medical device product classification in China. The NMPA has now issued the Announcement on the Standardization of Medical Device Product Classification (the “Announcement”), which will take effect from September 1, 2024.
The Announcement consists of three parts:
1.The first part clarifies the positioning of classification work, the purpose and basis for conducting classification, and the responsibilities of various parties involved in classification.
2.The second part specifies the principles and requirements related to classification determination in various scenarios, including product filing, product registration application acceptance, technical evaluation, regulatory inspections, emergency needs during public health incidents, combination products, and innovative medical devices.
3. The third part outlines principles for the digitalization of classification information, provides guidance to provincial-level drug supervision and management departments on classification determination, and details principles for dynamic adjustments to the classification catalog.
Compared to Notice No. 127, the Announcement mainly adjusts the following aspects:
1.Further clarifies the positioning and responsibilities of classification determination work.
2.Enhances the application channels and procedures for classification determination.
3.Standardizes the requirements of classification determination application materials.
4.Strengthens the supervision of the classification implementation.
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