Notice on Issues Concerning the Filing of Class I Medical Devices
Regulations for the Supervision and Administration of Medical Devices (State Council Decree No. 650) will be effective as of June 01, 2014. According to the Regulations, Class I medical device is subject to filing administration. The relevant issues concerning the filing of Class I medical devices (including Class I in-vitro diagnostic reagents) are hereby notified as follows:
（I）Filing of Class I medical devices
(I)The filing of medical devices is a process that the filing entity of medical device (hereinafter refers to as the filing entity) submits the filing documents for Class I medical devices to the food and drug regulatory authority and the food and drug regulatory authority files the filing documents submitted by the filing entity.
(II) The medical devices subject to filing refer to the medical devices listed in the catalogue of Class I medical devices and the Class I in-vitro diagnostic reagents listed in the sub-catalogue of classification of in-vitro diagnostic reagents.
To apply for filing of domestic Class I medical devices, the filing entity shall submit the filing documents to the food and drug regulatory authority of the city consisting of districts. To apply for filing of overseas Class I medical devices, the filing entity shall submit the filing documents to China Food and Drug Administration. The medical devices from Hong Kong, Macao and Taiwan shall be filed by reference to the overseas medical devices.
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