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China FDA aims to improve medical device regulations

The China Food and Drug Administration is seeking to strengthen regulations around the groups that conduct trials for medical devices, according to a ministry notice seeking public opinion.

The main purpose of the draft policy is to open up the market by increasing the number of clinical trial conductors and to speed up product innovation and approval, Joe Jin, a partner at management consulting company Roland Berger, said in a Aug. 9 interview.

According to the ministry, institutions conducting clinical trials for medical devices should have the relevant technical experience and trial management expertise.

Institutions must be certified medical institutions, with a ranking of tier 2A or above, and have specific systems — a medical device clinical trial management department and system, qualified personnel, standardized operating procedures — already in place.

Furthermore, clinical trials for high-risk class 3 medical devices should be conducted by tier-three medical institutions, the ministry said.

The policy is also expected to improve quality and risk control for medical device products, Roland Berger's Jin said.

"There are higher requirements for the hospitals, especially if you want to do class 3 [devices] ... for these products, you have to be more qualified and there will be higher standards."

In China, a medical device is classified by its degree of risk, based on factors such as structural characteristics and whether it makes contact with the body. Class 3 medical devices include those which are implanted into the body, pose potential risks to the body or are used for life support.