New regulations for overseas medical device enterprises will be implemented on January 1st, 2019.

Notice about Using Chinese Description in Name of the Registration Applicant and the Filing Applicant for Imported Medical Devices’ (2017 No. 131) on October 31st, 2017. The publishment of the notice brings lots of changes on imported medical devices marketing in China.

According to the notice, registration applicants, registers and recording applicants who apply for marketing medical devices in China shall use Chinese description for the name, the home address and the manufacturing address. The Chinese enterprise name shall not be same as other names of applied and marketed enterprises.

For recorded imported Class I medical devices, the Chinese description-unrecorded enterprises shall apply for recording information alteration before December 31st, 2018, adding Chinese enterprise name.

For registered imported Class II & III medical devices, with the situation of the same enterprise name, the enterprises shall at least apply for one medical device registration certificate or registration alteration for the Chinese description. For other valid medical device registration certificates, the enterprises are allowed to apply for recording item alteration of Chinese description with the application for continuation registration or other alterations.

Since January 1st, 2019, for all the imported Class II and Class III medical devices that are manufactured after January 1, 2019, the enterprise name in the instructions and label shall include Chinese description, and the Chinese description shall be consistent with the corresponding Chinese description in this product (or the other product of the same enterprise name) registration certificate (or registration change document).

To acquire EN version of the NMPA Notice, you can download here.

 

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