Breaking News | Regis Successfully Assists Viora V30 in Obtaining NMPA Approval

First Domestic Approval for a 3-in-1 Multifunctional Aesthetic Device via Pure Equivalent Device Clinical Evaluation Pathway

Recently, the Skin Treatment Device V30 (Registration Certificate No.             : National Medical Device Import) represented by             officially obtained approval from the National Medical Products Administration (NMPA) for market launch. Beijing Regis Medical Technology Co., Ltd. provided full clinical evaluation services for this project, leading the way in overcoming industry-level challenges in the clinical evaluation of multifunctional composite devices, and facilitating efficient regulatory approval.

Product Platform & Technology

The V30 is a multifunctional aesthetic platform integrating multi-energy source technologies. Equipped with three core modules—the V-IPL intense pulsed light handpiece, V-ST radiofrequency handpiece, and V-Nd:YAG laser handpiece—it can flexibly customize treatment plans for different patient demographics and skin types. Covering multiple areas including the face, neck, and body, its indications include wrinkle reduction, hair removal, vascular lesions, pigmented lesions, and acne. It is a representative product with high functional integration and broad indication coverage among current aesthetic energy-based devices.

High functional integration and broad indications mean the complexity of clinical evaluation increases exponentially. The comparative argumentation of equivalent devices across multiple technical pathways and indications has always been a high-barrier step in the registration of imported Class III aesthetic devices; very few similar complex integrated devices in the industry can obtain approval through the pure equivalent device pathway.

Clinical Evaluation Breakthrough

Facing this tough challenge, the Regis project team firmly adopted the pure equivalent device clinical evaluation pathway, eliminating the need for additional clinical trials and maximizing the compression of the approval timeline while reducing R&D costs for the client. Based on a deep understanding of aesthetic device regulations and the technical landscape, the team precisely selected three marketed comparator devices and conducted systematic difference analysis around core dimensions such as technical principles, structural design, performance parameters, and clinical indications. Simultaneously, supported by comprehensive non-clinical research data and layered argumentation based on hundreds of clinical literature references for comparator devices, the team resolved risks one by one and closed all difference points, ultimately forming a complete set of clinical evaluation materials with rigorous logic, sufficient data, and strong traceability, which successfully passed the NMPA review.

Strength & Benchmark

The success of this project is not only a market breakthrough for the product itself but also another proof of Regis's ability to tackle high-difficulty registration challenges. During project execution, the team relied on a mature full-process project management system to achieve precise node control, instant response to needs, and rapid resolution of challenges, delivering on service commitments with results:

"Projects others cannot handle, we can secure;
Projects others can handle, we do more steadily and efficiently."

This product has also become the first 3-in-1 multifunctional aesthetic energy-based device in China approved via the pure equivalent device clinical evaluation pathway, setting a new industry benchmark for the registration application of similar highly integrated aesthetic devices.

Vision & Prospect

Deeply engaged in medical device NMPA & global registration, quality systems & regulatory consulting, clinical operations, and medical affairs, Regis Group consistently focuses on high-precision tracks including ophthalmology, aesthetic energy sources, implantable/interventional devices, AI software, and surgical robots. With solid regulatory expertise, rich project experience, and full-process butler-style services, we provide domestic and international clients with integrated solutions from registration strategy planning to approval execution. In the future, we will continue to be professional-centered and client-oriented, helping more high-quality medical devices efficiently enter the Chinese market.

This content is compiled and published by the [Regis Group] Medical Device Compliance Team. It is intended for medical device registrants, in vitro diagnostic (IVD) manufacturers, software-based medical device manufacturers, and sterile implantable device manufacturers, among others, to help medical device companies understand the relevant requirements. It may serve as internal learning reference material for clinical, medical, and regulatory affairs personnel in the medical device field.