Beijing, July 8, 2024 – The National Medical Products Administration (NMPA) has issued Announcement No. 84 of 2024, introducing new requirements for radiofrequency therapy devices and radiofrequency skin therapy devices. This move aims to ensure a smooth and orderly progression in the regulation of these medical devices, balancing the needs for public safety and industry development.
Effective April 1, 2026, products under the category 09-07-02 "Radiofrequency (Non-Ablative) Equipment" from the 2022 Announcement No. 30 must have a valid medical device registration certificate to be manufactured, imported, or sold. Devices without such certification by this date will not be permitted on the market.
For those devices already holding a second-class medical device registration certificate, the current certificates will remain valid until their expiration. If a certificate is due to expire before April 1, 2026, the registrant can apply for an extension with the original approval department. However, extensions will not be granted beyond March 31, 2026.
Manufacturers and registrants of radiofrequency therapy devices are urged to take significant responsibility for product quality and safety. They must enhance the comprehensive management of product quality throughout the lifecycle to ensure that all marketed products are safe and effective.
This latest move underscores the NMPA's commitment to maintaining high standards for medical device safety and effectiveness, fostering both public health protection and orderly industrial growth.
MEDTECH NEWS
NMPA Announces New Requirements for Radiofrequency Therapy Devices
09 07 2024The National Medical Products Administration (NMPA) announced new regulations requiring all radiofrequency therapy devices and radiofrequency skin therapy devices to obtain valid medical device registration certificates by April 1, 2026, to ensure product safety and quality. Certificates expiring before this date can be extended until March 31, 2026.