Medical Devices: CFDA

Registration, evaluation, and approval of medical devices imported into China are conducted by the China Food and Drug Administration of China (CFDA). According to CFDA regulations medical devices fall into three categories, in a similar system as used in Europe, but with generally more stringent classifications.

The approbation process includes the three main steps: type testing, clinical trials, administrative evaluation and publication. As per current practice, for imported products clinical trials can mostly be avoided - however there are some exceptions to this rule. The registration authority for all imported Medical Devices is the CFDA.

Type Testing: The type testing is straightforward, takes approximately 6 weeks, and requires samples to be sent to China. All samples of medical devices – except consumables – will be returned to applicants. The Chinese definition of “medical devices” includes the software used for its proper application; the testing process may include testing software related security aspects.  Type tests undertaken outside of China are in general accepted for class 1 products, might be partially accepted for class 2 products, and are not accepted for class 3 products.

Administrative Evaluation and Publication: The last step is the formal application for SFDA registration: The procedure starts with a check of completeness and consistency of documentation by the Administrative Reception Service of SFDA. The ensuing technical review is performed by the Center for Technical Evaluation of SFDA. The final evaluation and decision is made by the Medical Device Department of SFDA. A notification of approval is sent to the applicant by the Administrative Reception Service of SFDA; the approval is valid for 4 years.