为平稳有序推进射频治疗仪、射频皮肤治疗仪类医疗器械相关工作，结合产品研发实际，统筹考虑公众用械安全和产业有序发展需要，国家药监局研究决定，自2026年4月1日起，《关于调整〈医疗器械分类目录〉部分内容的公告》（2022年第30号）附件中09-07-02射频治疗（非消融）设备中射频治疗仪、射频皮肤治疗仪类产品，未依法取得医疗器械注册证的，不得生产、进口和销售。
已取得第二类医疗器械注册证的，原注册证在有效期内继续有效。原注册证在2026年4月1日前到期的，注册人可向原审批部门提出原注册证延期申请，延长期限最长不得超过2026年3月31日。
射频治疗仪、射频皮肤治疗仪类产品注册人、生产企业应当切实履行产品质量安全主体责任，全面加强产品全生命周期质量管理，确保上市产品安全有效。
特此公告。
相关网站链接：
https://www.cmde.org.cn/flfg/fgwj/ggtg/20240712144237121.html
For additional information regarding this alert, please contact:
VSCB Specialists
Email：Lisa.liu@vscbcorp.com
The following is an unofficial translation
subject:Announcement of the State Food and Drug Administration on Further clarifying the requirements for radiofrequency therapeutic instrument products (No. 84 of 2024)
Content: In order to steadily and orderly promote the work related to radiofrequency therapy equipment and radiofrequency skin therapy equipment, combined with the actual development of products, and overall consideration of the needs of public safety and industrial orderly development, the State Food and Drug Administration has decided that from April 1, 2026, "Announcement on the Adjustment of Part of the" Medical Device Classification Catalogue "(No. 30 in 2022) Annex 09-07-02 RF therapy (non-ablation) equipment, RF skin therapy equipment products, not legally obtained medical device registration certificate, shall not be produced, imported and sold.
Where the registration certificate of Category II medical devices has been obtained, the original registration certificate shall remain valid within the validity period. If the original registration certificate expires before April 1, 2026, the registrant may apply to the original examination and approval department for the extension of the original registration certificate, and the extension period shall not exceed March 31, 2026.
The registrants and manufacturers of radiofrequency therapeutic instruments and radiofrequency skin therapeutic instruments shall earnestly fulfill the main responsibility for product quality and safety, comprehensively strengthen the quality management of the whole life cycle of products, and ensure the safety and effectiveness of listed products.
It is hereby announced.
Related website links:
https://www.cmde.org.cn/flfg/fgwj/ggtg/20240712144237121.html
For additional information regarding this alert, please contact:
VSCB Specialists
Email：Lisa.liu@vscbcorp.com