The National Medical Products Administration (NMPA) of China issued the Regulations on July 8, 2024 to steadily promote the relevant work of high-frequency treatment devices and high-frequency skin treatment devices, and take into account the requirements of public equipment safety and orderly development of the industry.
Annex 09-07-02 of the “Notice on Partial Adjustment of the Medical Device Classification Catalog” (No. 30/2022) High-frequency treatment devices and high-frequency skin treatment devices products cannot be manufactured, imported, or sold unless a medical device registration certificate is obtained in accordance with the law from April 1, 2026.
If the company holds an existing medical device registration certificate, it will remain valid for the period of validity of the registration certificate held. However, if the registration certificate held expires before April 1, 2026, the extension of the registration certificate can be applied for to the examination and approval department, and the extension period cannot exceed March 31, 2026.
Registrants and manufacturers of high-frequency treatment devices and high-frequency skin treatment devices should faithfully fulfill their responsibilities for product quality and safety, comprehensively strengthen quality management throughout the entire life cycle of products, and ensure the safety and effectiveness of commercially available products.
Please refer to the link below for more information.
https://www.nmpa.gov.cn/ylqx/ylqxggtg/20240708095205154.html
国家药监局关于进一步明确射频治疗仪类产品有关要求的公告（2024年第84号）
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〈
www.nmpa.gov.cn
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