Announcement of the State Food and Drug Administration on Adjusting Some Contents of the “Medical Device Classification Catalog” (No. 30 [2022])

2022-03-28

In order to further deepen the reform of the medical device review and approval system, according to the actual development of the medical device industry and supervision work, and in accordance with the relevant requirements of the “Regulations on the Supervision and Administration of Medical Devices” and the “Working Procedures for Dynamic Adjustment of the Classification of Medical Devices”, the State Food and Drug Administration Part of the content of the “Device Classification Catalog” has been adjusted. The relevant matters are hereby announced as follows:

1. Adjustment content Adjustments

are made to the contents   of the “Medical Device Classification Catalog” for 27 types of medical devices. Please refer to the attachment for the specific adjustment contents.

2. Implementation requirements

(1) For the radio frequency therapeutic apparatus and radio frequency skin therapeutic apparatus among the radio frequency therapy (non-ablation) equipment in 09-07-02, which are involved in the adjustment in the annex, from the date of this announcement, it can be approved according to the “Medical Devices” Registration and filing management measures (Order No. 47 of the State Administration for Market Regulation) apply for registration. From April 1, 2024, products such as radio frequency therapeutic apparatus and radio frequency skin therapeutic apparatus shall not be produced, imported or sold without obtaining a medical device registration certificate in accordance with the law.

The relevant registrants and manufacturers of radio frequency therapeutic apparatus and radio frequency skin therapeutic apparatus products shall earnestly fulfill the main responsibility of product quality and safety, comprehensively strengthen the quality management of the whole product life cycle, and ensure the safety and effectiveness of the listed products. From the date of this announcement, the relevant registrants and manufacturers of radio frequency therapeutic devices and radio frequency skin therapeutic devices should take the initiative to report to the provincial drug regulatory department where the products are located (where the agent is located for imported products). , Applicable safety standard commitment, production quality management system and operation, customer complaint handling and adverse event system and implementation, etc. Provincial-level drug regulatory departments should establish enterprise credit files, strengthen inspections of registrants and manufacturers of such products, urge enterprises to implement their main responsibilities, speed up the completion of product registration, and improve the quality management system. From April 1, 2024, enterprises that have not obtained medical device production and business licenses (recording) shall not engage in the production and sales of related products.

(2) For other products whose contents have been adjusted, from the date of publication of this announcement, the drug regulatory authorities shall, in accordance with the Measures for the Administration of Medical Device Registration and Filing, and the Announcement on the Announcement of the Application Materials Requirements for Medical Device Registration and the Format of Approval Documents, etc. , and accept medical device registration applications according to the adjusted categories.

For medical devices that have been accepted but have not yet completed registration approval (including initial registration and renewal registration), the drug regulatory department will continue to review and approve according to the original acceptance category. If registration is approved, a medical device registration certificate will be issued, and it will be indicated in the remarks column of the registration certificate. Adjusted product management category.

For registered medical devices, if the management category is adjusted from the third category to the second category, the medical device registration certificate will continue to be valid within the validity period. If renewal is required, the registrant shall apply to the corresponding drug regulatory department for renewal of registration according to the changed category 6 months before the expiration of the medical device registration certificate. Registration certificate.

If a registration change occurs within the validity period of the medical device registration certificate, the registrant shall apply to the original registration department for registration change. If the original registration certificate is issued in accordance with the original “Medical Device Classification Catalog”, the product management category after the implementation of the announcement shall be indicated in the remarks column of the registration document for the change of products involved in this announcement.

(3) Drug supervision and administration departments at all levels should strengthen the publicity and training of the content adjustment of the “Medical Device Classification Catalog”, and effectively do a good job in the review and approval and post-marketing supervision of related products.

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National Medical Products Administration, 28-03-22
; https://www.nmpa.gov.cn/ylqx/ylqxggtg/20220330144627167.html?type=pc&m=