Radio Frequency Device requirements in China updated by NMPA

Radio Frequency device requirements in China have been updated by the National Medical Products Administration (NMPA) on July 8, 2024. This regulatory update is aimed at ensuring the safe and orderly development of RF devices, including radio frequency devices and radio frequency skin tightening devices, and will come into effect on April 1, 2026. Here's a comprehensive summary from a regulatory perspective.

Background and Rationale

Since 2021, the medical beauty industry has been under scrutiny due to various irregularities. To address these issues and safeguard consumer rights, multiple departments have launched special initiatives to regulate medical beauty services. In March 2022, the NMPA issued Notice No. 30, which reclassified radio frequency devices used for skin tightening, wrinkle reduction, pore contraction, skin lifting, acne treatment, scar treatment, and fat reduction as Class III medical devices. This reclassification necessitated stricter regulatory controls.

Following the 2022 announcement, the NMPA provided guidance through registration review principles and training via platforms like "Device Review Cloud Classroom." These efforts aimed to assist companies in the registration process and ensure compliance. Despite these efforts, the pandemic and other factors have delayed product inspections and clinical trials for handheld RF devices, primarily produced by home appliance companies. The new 2024 announcement aims to provide clear guidance and timelines for compliance.

Key Policy Points

1. Stricter Management for Class III Medical Devices

From April 1, 2026, Radio Frequency devices and radio frequency skin tightening devices that alter skin and subcutaneous tissue to achieve the intended therapeutic effects must obtain a medical device registration certificate. Products without this certification cannot be manufactured, imported, or sold.

2. Transition Period for Existing Products

For products that had already obtained a Class II medical device registration certificate before the 2022 announcement, these certificates will remain valid until their expiration date. If these certificates expire before April 1, 2026, manufacturers can apply for an extension until March 31, 2026. This transition period allows companies time to comply with the new regulations.

3. Support for Research and Development

The NMPA will continue to provide guidance and training for the registration of Class III medical devices. This includes performance validation, inspection and testing, and clinical evaluation, to help companies navigate the registration process more effectively.

Responsibilities of Companies

4. Quality and Safety Accountability

Manufacturers and registrants of RF devices and radio frequency skin tightening devices must ensure product quality and safety throughout the entire lifecycle. This includes establishing and maintaining a robust quality management system to ensure that all products on the market are safe and effective.

5. Reporting and Compliance

Companies that have not yet obtained a registration certificate must report their product development and registration plans to the provincial regulatory authorities. This includes committing to applicable safety standards, maintaining a quality management system, and managing customer complaints and adverse events. Provincial authorities will oversee and guide these companies to expedite their registration applications and ensure compliance.

6. Prohibition of False Advertising

Manufacturers and distributors must adhere to legal and regulatory requirements in their promotional activities. Product claims must be truthful and not misleading. RF products not regulated as medical devices must not imply or suggest medical uses. Product descriptions should avoid medical terminology that could confuse consumers about the product’s regulatory status.

Further information

Read the original NMPA announcement on radio frequency therapy device China requirements update.

Read our previous article on China RF Therapy Device classification clarification.

Discover our services for medical device registration, renewals and NMPA Legal Agent.

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