In order to further deepen the reform of the medical device review and approval system, the National Medical Products Administration has decided to adjust some content of the Medical Device Classification Catalog based on the development of the medical device industry and the reality of the regulatory work and according to the related requirements of the Regulation on the Supervision and Administration of Medical Devices and the Medical Device Classification Catalog Dynamic Adjustment Work Procedures. The relevant matters are hereby announced as follows:
I. Adjustments
The content of 27 categories of medical devices involved in the Medical Device Classification Catalog is adjusted, with the specific adjustments as shown in the attachment.
II. Implementation requirements
(I) The radiofrequency therapeutic instrument and radiofrequency skin therapeutic instrument products in 09-07-02 radiofrequency (non-ablative) equipment involved in the adjustments in the attachment can be applied for registration according to the Measures for the Administration of Registration and Filing of Medical Devices (Order of State Administration for Market Regulation (No. 47)) from the date of this announcement. From April 1, 2024, radiofrequency therapeutic instrument and radiofrequency skin therapeutic instrument products for which medical device registration certificates have not been received according to law shall not be produced, imported, or sold.
Related registrants and manufacturers of radiofrequency therapeutic instrument and radiofrequency skin therapeutic instrument products shall effectively fulfill their primary responsibility for product quality safety and comprehensively strengthen product lifecycle quality management, to ensure the safety and effectiveness of the marketed products. From the date of this announcement, related registrants and manufacturers of radiofrequency therapeutic instrument and radiofrequency skin therapeutic instrument products shall actively report to the provincial medical products administration departments where they are located (or where the agents are located for imported products) on the development and registration plans for their products as medical devices, the applicable safety standards and undertakings, the production quality management systems and the operation thereof, customer complaint handling, adverse event systems and the implementation thereof, etc. The provincial medical products administration departments shall establish enterprise credit files, strengthen the inspection of registrants and manufacturers of such products, and urge them to implement their primary responsibility, accelerate product registration, and improve their quality management systems. Related enterprises that have not received medical device production or operation permits (filing) shall not engage in the production and sale of related products from April 1, 2024.
(II) For other products involved in the adjustments, the medical products administration departments shall accept medical device registration applications according to the categories after adjustment and pursuant to the Measures for the Administration of Registration and Filing of Medical Devices, the Announcement on Releasing Medical Device Registration Application Data Requirements and Approval Document Formats, etc.
For medical devices of which the registration has been accepted but has not been approved (including initial registration and registration renewal), the medical products administration departments shall continue to review and approve them according to the original acceptance categories, and, for those approved for registration, issue the medical device registration certificates, with the product management categories after adjustment indicated in the remarks column of the said certificates.
For registered medical devices of which the management categories are adjusted from Class III to Class II, their medical device registration certificates shall continue to be valid within the periods of validity. If renewal is required, the registrant shall apply for renewal of the registration with the corresponding food and drug administration according to the changed category 6 months before the expiration of the medical device registration certificate. If the renewal of registration is approved, the medical device registration certificate shall be issued according to the adjusted product management category.
In the event of changes in registration within the periods of validity of medical device registration certificates, registrants shall apply to the original registration departments for changes in registration. If the original registration certificates were issued according to the original Medical Device Classification Catalog, for products involved in this announcement, the product management categories after the implementation of this announcement shall be indicated in the remarks column of the registration change documents.
(III) Medical products administration departments at different levels shall strengthen publicity and training related to the adjustments in the Medical Device Classification Catalog and effectively accomplish the review and approval and post-marketing regulation of related products.
Attachment: Table of Adjustments to Some Content of Medical Device Classification Catalog
I. Adjustments
The content of 27 categories of medical devices involved in the Medical Device Classification Catalog is adjusted, with the specific adjustments as shown in the attachment.
II. Implementation requirements
(I) The radiofrequency therapeutic instrument and radiofrequency skin therapeutic instrument products in 09-07-02 radiofrequency (non-ablative) equipment involved in the adjustments in the attachment can be applied for registration according to the Measures for the Administration of Registration and Filing of Medical Devices (Order of State Administration for Market Regulation (No. 47)) from the date of this announcement. From April 1, 2024, radiofrequency therapeutic instrument and radiofrequency skin therapeutic instrument products for which medical device registration certificates have not been received according to law shall not be produced, imported, or sold.
Related registrants and manufacturers of radiofrequency therapeutic instrument and radiofrequency skin therapeutic instrument products shall effectively fulfill their primary responsibility for product quality safety and comprehensively strengthen product lifecycle quality management, to ensure the safety and effectiveness of the marketed products. From the date of this announcement, related registrants and manufacturers of radiofrequency therapeutic instrument and radiofrequency skin therapeutic instrument products shall actively report to the provincial medical products administration departments where they are located (or where the agents are located for imported products) on the development and registration plans for their products as medical devices, the applicable safety standards and undertakings, the production quality management systems and the operation thereof, customer complaint handling, adverse event systems and the implementation thereof, etc. The provincial medical products administration departments shall establish enterprise credit files, strengthen the inspection of registrants and manufacturers of such products, and urge them to implement their primary responsibility, accelerate product registration, and improve their quality management systems. Related enterprises that have not received medical device production or operation permits (filing) shall not engage in the production and sale of related products from April 1, 2024.
(II) For other products involved in the adjustments, the medical products administration departments shall accept medical device registration applications according to the categories after adjustment and pursuant to the Measures for the Administration of Registration and Filing of Medical Devices, the Announcement on Releasing Medical Device Registration Application Data Requirements and Approval Document Formats, etc.
For medical devices of which the registration has been accepted but has not been approved (including initial registration and registration renewal), the medical products administration departments shall continue to review and approve them according to the original acceptance categories, and, for those approved for registration, issue the medical device registration certificates, with the product management categories after adjustment indicated in the remarks column of the said certificates.
For registered medical devices of which the management categories are adjusted from Class III to Class II, their medical device registration certificates shall continue to be valid within the periods of validity. If renewal is required, the registrant shall apply for renewal of the registration with the corresponding food and drug administration according to the changed category 6 months before the expiration of the medical device registration certificate. If the renewal of registration is approved, the medical device registration certificate shall be issued according to the adjusted product management category.
In the event of changes in registration within the periods of validity of medical device registration certificates, registrants shall apply to the original registration departments for changes in registration. If the original registration certificates were issued according to the original Medical Device Classification Catalog, for products involved in this announcement, the product management categories after the implementation of this announcement shall be indicated in the remarks column of the registration change documents.
(III) Medical products administration departments at different levels shall strengthen publicity and training related to the adjustments in the Medical Device Classification Catalog and effectively accomplish the review and approval and post-marketing regulation of related products.
Attachment: Table of Adjustments to Some Content of Medical Device Classification Catalog
National Medical Products Administration
March 28, 2022
March 28, 2022