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Recently, the National Medical Products Administration issued an announcement clearly classifying radiofrequency therapeutic apparatus, radiofrequency skin treatment apparatus, and other products as Class III medical devices. Starting from April 1, 2024, such products will be prohibited from production, import, and sale without approval. This marks the official end of the "wild growth" era for the home RF beauty device industry.
With the improvement of living standards, the home RF beauty device market has reached a scale of tens of billions. However, behind the prosperity, there are issues such as excessive promotion, uneven product quality, and even consumer burn incidents. Previously, controversies within the industry regarding the nature of these devices also highlighted the urgency of strengthening regulation.
After the new regulations are issued, companies will need to bear the primary responsibility for product quality and safety, and strengthen full lifecycle management. Products that meet the conditions will be managed as Class III medical devices with the highest regulatory level, requiring strict clinical trials and approval. This will raise the industry threshold and promote competition to return to product strength and R&D capabilities.
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