Entering the Chinese market offers tremendous opportunity for medical device companies, but it is not without risk.

As a professional China medical device regulatory affairs consulting company, Regis Solution with many years of efforts in the field of medical device regulatory affairs, has established sound and stable cooperation with numerous manufacturers in China, the U.S., EU, Japan and South Korea, Israel etc providing them with high-quality and efficient services to help them introduce their products into medical device market of China.

Regis Solution's consultants are mostly with more than 10 years of experience in medical device regulatory affairs consulting industry。Proficient in NMPA system and registration procedures，with rich and professional experience in registration of medical devices，we can help you obtain NMPA approval for your medical device or IVD. Our consultants in Beijing work directly with the NMPA on daily basis，coordinating the submission of regulatory documents，answering NMPA follow up questions and providing insights on how to navigate the evolving regulatory landscape in China.