CFDA Updates: Notice on “Requirements of Using Chinese Language for the Name, Resident and Production Address of Applicants, Registration Agents and Filers on Import Medical Devices”.

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CFDA Updates: Notice on “Requirements of Using Chinese Language for the Name, Resident and Production Address of Applicants, Registration Agents and Filers on Import Medical Devices”.

On August 8th, CFDA issued a drafted notice on “Requirements of Using Chinese Language for the Name, Resident and Production Address of Applicants, Registration Agents and Filers on Import Medical Devices”.

In this notice, CFDA asks all the applicants, registrants and filers to use Chinese languages for the name, resident and production address in medical device registration.

1.   Principle of Using Chinese

a.   Use simplified Chinese on enterprise name, resident and production address.

b.   Chinese enterprise name, resident and production address should be consistent with the content in foreign language.

c.   The same enterprise shall use the same Chinese enterprise name.

d.   Chinese enterprise name shall not be the same as the name of other medical device registrants or filers.

2.   Related procedures and registration dossier requirements

a.   For CFDA approved medical devices, applicants or filers can add the Chinese language for enterprise name, resident and production address by applying for the certificate modification

b.   Applicants or filers should apply for the certificate modification if they want to change their Chinese enterprise name, resident and production address.

c.   Enterprise should submit the declaration about Chinese content of enterprise name, resident and production address.

d.   In the situation of using one enterprise name, resident and production address, applicants or fillers can provide only 1 original copy of declaration if they have the same content in the declaration.

3.   Time Requirements

a.   Once the notice is published, the applicants or filers of approved medical devices can add Chinese language for enterprise name, resident and production address by processing the certificate modification.

b.   From January 1st2018, applicants should use Chinese language for enterprise name, resident and production address to fill out the related column in application form when they apply for registration, extension, modification or filing.

c.   For CFDA approved Class I medical devices that doesn’t have Chinese enterprise name, resident and production address on records, enterprises should modify the information before December 31st, 2018.

From January 1st 2019, all the Class I medical devices produced after January 1st 2019 should use Chinese language for enterprise name, resident and production address on their IFUs and labels, which should be consistent with the Chinese content on CFDA records.

d.   For CFDA approved Class II or III medical devices with same enterprise name, resident and production address, enterprises should at least get 1 certificate of modification document that contains Chinese enterprise name, resident and production address. For other valid certificates, applicants don’t need to do the modification. They can add the Chinese info in certification extension or other modification processes.

From January 1st 2019, all the Class II/III medical devices produced after January 1st 2019 should use Chinese language for enterprise name, resident and production address on their IFUs and labels, which should be consistent with the Chinese content on CFDA certificate (or modification documents).

4.   For medical devices from Hongkong, Macau and Taiwan, they don’t need modification if they have simplified Chinese enterprise name, resident and production address.

 


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