In March 2022, the State Food and Drug Administration issued the “Announcement on Adjusting Parts of the “Medical Device Classification Catalog”” (2022 No. 30, hereinafter referred to as “Announcement No. 30”), clarifying that the “Medical Device Classification Catalog” “09 Physical Therapy Equipment” sub-category, the first-level product category “07 High Frequency Treatment Equipment” and the second-level product category “02 Radiofrequency Treatment (Non-Ablation) Equipment” in the second-level product category “02 Radiofrequency Treatment (Non-Ablation) Equipment” include radio frequency therapy instruments and radio frequency skin therapy instruments to be managed as the third category of medical devices. Starting from April 1, 2024, no one shall produce, import and sell such products without obtaining a medical device registration certificate in accordance with the law.
In July, the State Food and Drug Administration issued the “Announcement on Further Clarifying the Relevant Requirements for Radiofrequency Therapeutic Device Products” (No. 84 of 2024) and its policy interpretation, clarifying that the regulations on the implementation of Class III medical device management for radiofrequency therapeutic devices and radiofrequency skin treatment device products will be postponed for two years. This means that radio frequency beauty devices, which were supposed to usher in new industry management regulations in April this year, have a two-year “grace period” and will only enter the “mechanical brand” era from April 1, 2026.
Why change to Class III devices?
As the highest risk medical equipment, the design, production, sales and use of Class III medical devices are strictly regulated by the state to ensure the safety, effectiveness and quality controllability of the products.
1. High safety: Class III medical devices must undergo strict clinical trials and safety assessments before being put on the market to ensure that they will not cause harm to human health under normal use conditions. This strict quality control process greatly reduces health risks caused by product defects.
2. Exact curative effect: Due to scientific verification and evaluation, the three types of medical devices usually have relatively clear curative effects when treating or assisting in the treatment of specific diseases, and can provide patients with more precise and effective treatment options.
3. Prevent complications: Using high-quality Class III medical devices can help reduce complications caused by equipment failure or improper operation, ensure patient treatment safety, and improve the quality of life.
What are the differences between different categories of medical devices?
my country conducts classified management of medical devices based on their product safety. The classification catalog is formulated by the state food and drug administration department in accordance with the medical device classification rules:
The first category is medical devices with low risk, and routine management can ensure their safety and effectiveness. Such as: surgical instruments (knives, scissors, forceps, tweezers, hooks), scraping boards, medical X-ray films, surgical gowns, surgical caps, examination gloves, gauze, bandages, drainage bags, etc.
The second category is medical devices with moderate risks that require strict control and management to ensure their safety and effectiveness. Such as medical suture needles, blood pressure monitors, thermometers, electrocardiographs, electroencephalographs, microscopes, acupuncture needles, biochemical analysis systems, hearing aids, ultrasonic disinfection equipment, non-absorbable sutures, etc.
The third category is medical devices that have higher risks and require special measures to be strictly controlled and managed to ensure their safety and effectiveness. Such as: implantable pacemaker, corneal contact lens, intraocular lens, ultrasonic tumor focusing knife, hemodialysis device, implantable equipment, vascular stent, comprehensive anesthesia machine, dental implant materials, medical absorbable sutures, intravascular catheters, radiofrequency treatment equipment, etc.
Wuhan Half the Sky Class III certificate, quality guaranteed!
Class III medical device certification is the country’s highest level of recognition of the safety and effectiveness of medical devices, which means that the products have been rigorously reviewed and meet the most stringent standards.
The gynecological radiofrequency therapy device independently developed by Wuhan Half the Sky belongs to the third category of national regulatory devices (National Medical Approval No. 20163010318). As the drafter of China’s “gynecological radiofrequency therapy device” industry standard, we not only lead the trend in technological innovation, but also set industry benchmarks in product quality, safety and treatment effects.
