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Enquiry: When Importing Medical/Optical Devices to China, What are the Required Approval Procedures?

相片:查询:进口隐形眼镜等医疗器械须审批或接受商检吗?
相片:查询:进口隐形眼镜等医疗器械须审批或接受商检吗?
According the current Medical Device Classification Catalogue – as well as its new edition which will come into effect on 1 August 2018 – all optical devices (including contact lenses), medical instruments and endoscopes categorised as Class III (high risk) must be officially registered. All such registrations are handled by the China Food and Drug Administration (CFDA), which reports directly to the State Council, and must comply with the Regulations on the Supervision and Administration of Medical Devices.

Under the terms of the Regulatory Guide for the Examination and Approval of the Initial Registration of Imported Medical Devices, any overseas manufacturer / distributor looking to import such medical devices to China for the first time must submit all of the required registration application documents to the CFDA. Such submissions may be delivered in person to the CFDA’s headquarters in Beijing or mailed and can be made either by the company’s registered China office or by its duly appointed mainland legal representative. Once secured, the required registration certificate is valid for five years and may be extended at the discretion of the CFDA.

In the case of businesses trading in Class III medical devices, a business licence must also be secured from the local CFDA office. In line with the Regulations on the Supervision and Administration of Medical Devices and other prevailing legal requirements, all such devices must be labelled in Chinese and come with an accompanying Chinese language operating manual. Furthermore, they must also undergo the relevant entry / exit inspection as mandated by China’s General Administration of Customs.

For further details, please refer to the following links:

CFDA Updates Classification Catalogue of Medical Devices

Regulations on Medical Device Usage and Management Amended 
Content provided by Picture: HKTDC Research
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