Consulting

Based on the potential risks and intended use, medical devices are divided into three management categories by SFDA of China (State Food and Drug Administration). All medical devices need to be registered according to Medical Device Registration Administration in order to be sold and used in China.
Different countries have different regulations about medical devices, relying on the deep understanding of various regulations and abundant practical experience, Osmunda could help your products be easily approved by SFDA and be widely applied into the Chinese market.
Osmunda Medical Device Consulting Organization (Guangzhou, Beijing, Shanghai, Suzhou, Shenzhen and Jinan) is the largest and most professional consulting company in the field of medical device in China. All Osmunda Consultant team members are from sizeable medical devices enterprises, well-known notified bodies and testing organizations. We are well versed in global various medical device quality system certification and product registration, such as SFDA registration, QSR 820 system, FDA registration, ISO 13485 system, CE certification etc. Our service includes clean room design, clinical trail, third party audit, training of regulations and standards, etc.
Our headquarters is in Guangzhou, and we have five branch offices (Beijing, Shanghai, Suzhou, Shenzhen, and Jinan) which could provide high-speed local services and communication. By far, Osmunda has successfully assisted nearly 1,200 domestic and foreign enterprises in achieving various medical devices registration and certification. We will be your trustful partner and your most professional guide.