MEDEXPERT is a professional consulting company, who focuses on China CFDA registration which is mandatory requirements to export medical devices in China.
1 Our experts understand the CFDA requirements and have experience in CFDA registration for more than 5 years.
2 Our registered clients are doing good business in China.
3 One stop and comprehensive Service.
4 We keep good relationship with CFDA and the testing Centers, and understand the latest regulation, so we can ensure efficient registration without any hassle in a short time.
China is the most stable and growing market in the world. Living standard is growing at a fast pace and due to that demand for good quality for Dental, Surgical & Medical Appliances is increasing day by day. To export to China, there is a mandatory requirement for CFDA registration.
CFDA: The China Food and Drug Administration
CFDA documents that provide detailed rules for medical device registration and licensing Practice.
The CFDA is responsible for registration of medical devices for the Chinese market. All medical devices have to be classified by the CFDA according to its risk in 3 classes. Depending on the risk factor, medical devices required the testing depending on the class of medical device
1 For medical devices of class I:Product Tests are sometimes Required
2. For medical devices of class II: products tests are always required and clinical trials are sometimes required.
3. For medical devices of class III: product tests are always required and clinical trials are always required