近年来，随着中国医美市场的迅猛发展，光电类医美设备成为行业热点。然而，这类设备若用于医疗用途，必须按照国家药监局（NMPA）规定申请第三类医疗器械注册证（简称“三类证”）。三类证是医疗器械中监管最严格、审批难度最高的类别，适用于具有较高风险、需采取特别措施保障安全有效的设备。过去，部分光电设备以“生活美容”名义规避监管，但随着政策趋严，监管部门明确要求凡涉及皮肤治疗、组织修复等医疗行为的设备，均须取得三类证方可上市销售。这一门槛大幅提升行业准入标准，加速市场洗牌，促使企业加大研发投入与合规建设。目前，包括热玛吉、超皮秒、黄金微针等主流光电设备已陆续完成或正在推进三类证申报。获得三类证不仅意味着产品安全性和有效性得到官方背书，也成为医美机构采购和消费者信任的重要依据。未来，合规将成为医美光电设备企业生存与发展的核心竞争力。
In recent years, with the rapid growth of China’s medical aesthetics market, light- and energy-based aesthetic devices have become a major industry focus. However, when used for medical purposes, these devices must obtain a Class III Medical Device Registration Certificate (commonly known as a ‘Class III Certificate’) in accordance with regulations set by China’s National Medical Products Administration (NMP A). The Class III certificate represents the strictest regulatory category for medical devices—reserved for high-risk products requiring stringent controls to ensure safety and efficacy. Previously, some photonic devices circumvented regulation by being marketed under the guise of ‘cosmetic’ or ‘wellness’ use. But as regulatory scrutiny intensifies, authorities now clearly stipulate that any device involved in skin treatment, tissue repair, or other medical procedures must secure a Class III certificate before commercialization. This heightened barrier has significantly raised entry standards, accelerating industry consolidation and compelling companies to invest more in R&D and compliance. Leading devices such as Thermage, PicoSure, and gold microneedle systems are either already certified or actively pursuing Class III approval. Obtaining this certification not only validates a product’s safety and effectiveness through official endorsement but also serves as a critical factor in procurement decisions by clinics and trust-building among consumers. Going forward, regulatory compliance will be the cornerstone of competitiveness for companies in the medical aesthetics photonics sector.
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