• EnglishEnglish
    • Deutsch Deutsch
    • Italiano Italiano
    • Français Français
    • 日本語 日本語
    • 한국어 한국어

CISEMA - China Zertifizierung, Einkauf und Qualitätssicherung

  • Services
    • NMPA Registration – Medical Devices and IVDs
    • NMPA Registration & DMF – Pharmaceuticals
    • NMPA Registration – Cosmetics
    • NMPA Registration – Health Food
    • CML (China Manufacture Licence) – Pressure vessels
    • CCC (China Compulsory Certification) – Industrial and consumer goods
    • Others
      • Sourcing and Quality Control
      • Logistics and Customs Support
      • Sales Support
  • Events
    • Trade Fairs & Conferences
    • Seminars
    • Webinars
  • News & Knowledge
    • Regulatory News
      • Medical Devices and IVDs
      • Cosmetics
      • Pharmaceuticals & DMF
      • CCC
      • Pressure Vessels
    • Whitepapers
    • FAQ – NMPA Registration – Medical Devices and IVDs
    • Newsletter Sign Up
    • Others
      • Publications
      • Online Shop
  • About us
    • Partners
    • Company Profile
    • Testimonials
  • Locations
  • Newsletter Sign Up
Contact
  • Home
  • News
  • News
  • NMPA Registration in China
  • Medical Device
  • Radio Frequency Beauty Devices will be regulated as Medical Devices Soon

Radio Frequency Beauty Devices will be regulated as Medical Devices Soon

Tuesday, 27 April 2021 / Published in Medical Device, News, NMPA Registration in China

Radio Frequency Beauty Devices will be regulated as Medical Devices Soon

Considering the fact that Radio Frequency (RF) technology products are widely used in daily life and medical applications, the NIFDC (National Institute for Food and Drug Control) announced the technical guidelines (draft) for the product classification of radio frequency beauty products on April 16, 2021. Once implemented, RF devices for beauty treatments will very likely be regulated as class II or class III medical devices.

The draft proposes how the scope and classification would apply to RF beauty devices as below:

Product Scope

– Products using radio frequency energy on the human body (including but not limited to skin tissues and deep subcutaneous soft tissues) to achieve mild heating of the upper skin layer, improve blood circulation, etc.

– Products using radio frequency energy on the human body (including but not limited to skin tissues and deep subcutaneous soft tissues) to achieve human tissue, cellular pathology or physiological changes that may potentially impact or injure the body (such as edema, erythema, burns, microscopic scarring, subcutaneous fat necrosis collapse and other clinical conditions)

– Products that may directly be used for lipolysis, shaping, scar treatment, obvious changes in skin quality or other medical treatments that may potentially impact or injure the body (such as immediate tissue contraction reaction, tissue degeneration, cell apoptosis, etc.)

Classification of RF beauty products

Class II

Products emitting radio frequency energy that only reaches the dermis layer of the skin for the purpose of:

– mild heat generation
– improving blood circulation

without

– injuring the tissues below the dermis layer
– causing sudden reaction of tissue contraction
– degenerating the skin tissue or skin cells
– causing irreversible thermal injury (above first-degree burn)

Class III

Products emitting radio frequency energy that reaches below the dermis layer of the skin including the oral cavity and mucosa, or products using harmful treatment methods (potentially causing injuries to the skin) for the purpose of achieving human tissue, cellular pathology or physiological changes that may potentially impact or injure the body with the following results:

Edema or damage the barrier functions of the skin (dry or sensitive skin);
– Pain to the skin;
– First-degree burn or above (showing erythema reactions to the skin);
– Hyperpigmentation;
– Scarring; or
– Blisters

High-energy radio frequency products that may directly be used for lipolysis, shaping, scar treatment, obvious changes in skin quality or other medical treatments that may potentially impact or injure the body with the following irreversible results:

– Immediate tissue contraction reaction;
– Tissue degeneration;
– Cell apoptosis;
– Cell ablation; or
– Cell coagulation

The NIFDC is currently soliciting public comments on the draft until May 3, 2021.

By Jacky Li. Contact Cisema if you would like to learn more.

Tagged under: Radio Frequency

What you can read next

China Regulatory Framework for AI
Details You Should Notice for the New Cosmetics Registration and Filing Online Platform
Clinical Trials GMP management
Medical device clinical trial data submission – New registration requirements issued

Search

Categories

  • Fairs & Events
  • News
    • CCC
    • CEL
    • CML, SELO
    • Medical Devices Listing in Hong Kong
    • NMPA Registration in China
      • Cosmetics
      • Health Food
      • Medical Device
      • Pharmaceuticals & DMF
    • RoHS
    • Voluntary Product Certification
  • Publications
  • Seminars
  • Uncategorized
  • Webinars

Recent Posts

  • Submission of safety information for cosmetics ingredients

    Submission of safety information for cosmetics raw materials – Draft guidelines issued

    Submission of safety information for cosmetics ...
  • avoid animal testing in Chinaweb-2023

    How to avoid animal testing in China for cosmetics | Cisema Webinar

    China’s beauty and cosmetic market has be...
  • guidelines for medical devices registration

    Guidelines for medical devices registration in China – New development plans in 2023

    Guidelines for medical devices registration in ...
  • China DMF of API

    China DMF of API, Excipient & Packaging Materials: Market & Regulatory | Cisema Webinar

    “China DMF of API, Excipient & Packag...
  • pre-phase III drug clinical trial meeting guidelines

    Pre-phase III drug clinical trial meeting guidelines released

    Pre-phase III drug clinical trial meeting guide...

Archive

Cisema

With twelve locations and over ninety highly qualified employees, Cisema can offer you optimal support in China.

Services

  • Certification
  • Sourcing and Quality Control
  • Logistics and Customs Support
  • Sales Support

Dialogue

  • Contact us
  • Newsletter Signup
  • Events
  • News & Knowledge
  • Partners

Company

  • GTC
  • Privacy Statement
  • Legal Notice
  • About us
  • Locations
  • GET SOCIAL

© 2021 Cisema. All rights reserved.

TOP