曾经卖爆的抗衰神器，如今卡在 “无证” 生死线

Core Viewpoint - The article highlights the impending regulatory changes for home-use radio frequency beauty devices, emphasizing the need for compliance with new medical device regulations to ensure consumer safety and industry integrity [2][3][4]. Group 1: Regulatory Changes - As of April 1, 2026, the National Medical Products Administration (NMPA) will classify radio frequency beauty devices as Class III medical devices, requiring them to obtain medical device registration certificates to be legally produced, imported, or sold [3][4]. - This regulatory shift aims to enhance consumer safety by mandating rigorous clinical validation and registration processes for these devices, which were previously categorized as personal care products [4][15]. Group 2: Industry Impact - The increase in regulatory requirements serves as a litmus test for companies, determining their operational capabilities and commitment to consumer safety [5][15]. - Brands like Tripollar, once leaders in the market, are now facing challenges due to non-compliance with the new regulations, highlighting the risks associated with the lack of necessary certifications [6][19]. Group 3: Company Case Study - Tripollar - Tripollar's radio frequency beauty device, priced at 2,750 yuan, has gained popularity for its claimed effectiveness in skin rejuvenation, but the company has not yet secured the required medical device registration [10][21]. - Despite previous success, including significant sales figures during promotional events, Tripollar is now under pressure to comply with the new regulations or risk being excluded from the market [29][30]. Group 4: Safety Concerns - The classification of radio frequency beauty devices as high-risk products stems from potential safety hazards, including burns and electrical issues, which can directly affect human physiology [15][33]. - The article notes that global regulatory bodies also categorize these devices as medical equipment, aligning China's regulations with international standards [15][19]. Group 5: Future Outlook - The article concludes that the future of the home-use beauty device market will depend on companies' ability to adapt to regulatory changes, with those prioritizing safety and compliance likely to succeed [41][42]. - The ongoing compliance race will determine which brands can continue to operate legally and which will face significant operational challenges or exit the market [38][39].