Shanghai Food and Drug Administration addressed on 7th December 2017 that “the medical device register policy” starts to pilot in the Shanghai Free Trade Zone. From now on, the medical device register can, on the case basis, entrust the other party to produce the medical device which is in badly needed.
The current medical device policy requires the medical device register to have its own factory for manufacturing. However, “the reformation on medical device register policy” unbinds the registration for medical device and the manufacturing permit. Under the pilot policy, the qualified medical device applicator can apply for the medical device registration certificate separately and for the manufacturing, it can entrust to the other party the one who has the manufacturing qualification and ability.
The medical device register policy reformation mainly covers the following points.
- The medical device applicator in the Shanghai Free Trade Zone who has the medical device registration certificate can be regarded as the medical device register.
- The medical device applicator can be the medical device manufacturing enterprise (including the group company), the R&D institution and scientific research personnel.
- The medical device under pilot only covers Grade II and Grade III (including the innovation medical device).
- It is allowed that the medical device register in the Shanghai Free Trade Zone directly entrust the medical device manufacturing enterprise in Shanghai to produce sample and products. It means that the sample medical device is allowed to be produced even in its incubation period.
- It is allowed that the medical device register in the Shanghai Free Trade Zone can entrust several parties to manufacture at the same time.
- It is allowed that the entrusted manufacturing party in Shanghai can apply for the manufacturing permit based on the medical device registration certificate of its client.
- It is allowed that the medical device manufacturing enterprise which is located in the Pudong New Area can apply for the pilot qualification.
The new policy encourages the manufacturing enterprise specialized for the researching and development of medical device to enter into the medical device industry. We understand that if this policy is found feasible in the Shanghai Free Trade Zone, it may be expanded to nationwide in the future.
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Mr. Mike Chang
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