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The release of Announcement No. 30 will drive companies to earnestly fulfill their primary responsibility for product quality and safety, comprehensively strengthen quality management throughout the product lifecycle, ensure the safety and effectiveness of marketed products, and promote industry standardization. According to Announcement No. 30, compliant products should be managed as Class III medical devices. Public information shows that China has strict classifications for medical devices, with Class III being the highest level and requiring stringent control. Under regulations, relevant products must demonstrate their safety and effectiveness, and obtain a registration certificate before production and sale. As is well known, proving the safety and effectiveness of medical devices requires clinical trials, which typically demand significant time and funding. This high 'threshold' not only makes it difficult for small household appliance companies to enter the medical device industry but also eliminates enterprises focused solely on quick profits without investing in product R&D, forcing brand competition to return to a contest of product strength and R&D capability.

As people's income levels rise, home-use radiofrequency beauty devices, which claim to offer 'skin tightening and wrinkle reduction' functions, have leveraged the psychological demand for 'high appearance' and advertising effects, with their market share exceeding tens of billions of yuan. However, behind the beauty device consumption boom, issues such as exaggerated efficacy claims, uneven product quality, and frequent safety incidents have occurred. Previously, media reported that a home-use radiofrequency beauty device recommended by a top livestreamer had temperatures far exceeding limits, resulting in burns for some consumers. The news once trended on Weibo. Similar problems have led to numerous complaints, with no shortage of related accusations on social media. These all reflect consumers' expectations for standardized management of radiofrequency beauty devices. Yet, the industry has long faced a dispute over whether radiofrequency devices 'belong to medical devices or small household appliances,' which has also sparked controversy over how to regulate them. This further underscores the urgent need to strengthen oversight of the industry.

Recently, the National Medical Products Administration issued the 'Announcement on Adjusting Certain Contents of the Medical Device Classification Catalog' (hereinafter referred to as 'Announcement No. 30'), clarifying that radiofrequency therapy devices and radiofrequency skin therapy devices are to be managed as Class III medical devices. Starting from April 1, 2024, such products must not be produced, imported, or sold without legally obtaining a medical device registration certificate. This means that radiofrequency beauty devices have ended a decade of 'unregulated growth.'