In response to the State Council’s announcement on suspending the implementation of the article 11, paragraph 2 of “the Supervision and Administration of Medical Device regulation” (Order 650) in the special area BMTPZ (Hainan Boao Lecheng International Medial Tourism Pilot Zone) for those devices urgently needed but not yet registered within China, the Hainan provincial government introduced “the provisional rules for the administration of import medical device in urgent need of clinical use” quickly; it will be valid for a year and may be prolonged or adjusted at the end of the year. Based on the special rule for this special area, Hainan port would be the only option for clearance and Haikou customs would be responsible for the customs formalities.
Unlike the normal situation that device manufacturers are always the key supervision target, for this case the healthcare institutions are the focus of supervision from provincial health administrative department, provincial drug agency, Haikou city Custom as well as Hainan Entry-exit inspection and quarantine bureau. It will be the healthcare institution to submit the import application; they will be liable for harm to the patient(s) during usage. If the harm is related to product deficiency, healthcare institution may claim against the manufacturer in accordance with their agreement.
The rules composed by 23 articles set a series of requirements for both healthcare institutions and its personnel, the application procedures etc. Among which, only one article (article 18) talks about oversea manufacturer’s responsibility which includes strengthening of the training to make sure healthcare institution and its staff could use the device correctly; further focus is on the recall requirements.
For those companies who want to utilize this rule as a shortcut into the China market, to convince and educate the local Key Opinion Leaders will be the unavoidable mode of access.
The clinical data collected following clinical technical specification should be acceptable for later import device registration application. And once the device receives China-wide registration with a certificate issued, the provisional rule will not be applicable anymore for that device.
The provincial drug agency responsible for approval of the application will evaluate the USA of the device and when it achieves certain levels and performance effects, the agency informs the overseas manufacturer to apply for device registration with CNDA (previously CFDA). Import and use will be stopped if the manufacturer fails to timely submit the application.
Thanks for your attention and if you’re interested to know more about the policy and want to understand how to select the proper healthcare institution to work with, please do not hesitate to contact us.
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