Recently, INREEDI’s core product, the BeaShape® Radiofrequency Skin Therapy Device, officially obtained NMPA Class III medical device registration, becoming the first Class III device approved in China’s sound-light-electrical energy sector for periorbital anti-aging applications. BradyKnows provided full-process regulatory compliance services for this project, from submission acceptance on July 30, 2025, to approval on June 24, 2026, completing the entire process in just over ten months.
In terms of clinical strategy, BradyKnows did not follow the common randomized controlled design, but instead customized a single-arm target value trial protocol for this project. The study enrolled only 60 subjects, achieving a 100% primary efficacy endpoint rate, and establishing complete traceability of product lifecycle safety data as well as long-term anti-aging efficacy data. This design significantly compressed the clinical timeline and reduced R&D and registration costs, while successfully passing NMPA review with high-quality evidence-based medical data, filling the gap in the market for domestically produced compliant periorbital radiofrequency aesthetic devices.
The periorbital region features thin skin tissue structure and dense distribution of blood vessels and nerves, presenting significantly higher clinical risks compared to other aesthetic indications such as the face. As a result, NMPA review standards for related indications are considerably more stringent, which has long kept the domestic market for high-end periorbital rejuvenation devices dominated by imported products. The successful approval of INREEDI’s product not only solidifies its core competitiveness with high-standard clinical data, but also provides a replicable benchmark model for domestic high-end aesthetic medical devices to achieve regulatory compliance and innovation realization under a rigorous regulatory environment.
As a professional CRO institution deeply specialized in the high-risk medical device sector, BradyKnows has long focused on clinical and regulatory strategies for active and implantable innovative devices. In this project, our team leveraged an efficient approach combining a single-arm target value design with a small sample size to help the client achieve rapid approval in the periorbital indication, one with the highest regulatory barriers, further validating its mature methodology in the high-entry-barrier medical device registration space.
Previously, BradyKnows leveraged the Hainan Real-World Study pathway to assist Advanced Bionics, a global leader in cochlear implants, in securing registration for an active implantable device without the need for traditional clinical trials. We also supported registration of the ZAP-X Radiosurgery System for head and neck applications through a single-arm target value design. Additionally, BradyKnows helped United Imaging’s independently developed world-first integrated CT-Linac successfully obtain approval via the innovative review channel.
Looking ahead, BradyKnows will continue to integrate internationally advanced regulatory concepts with local compliance practices, offering diversified regulatory solutions for innovative medical device companies through pathways such as single-arm target value design and non-clinical data bridging. We remain committed to empowering high-end medical device enterprises and accelerating the compliance and commercialization of domestically developed innovative products.
