July 13, 2018
China National Drug Administration (CNDA) (formerly known as CFDA) has issued a new policy for Hong Kong medical device manufacturers to enter Mainland China market. CNDA can now accept Certificate of Listing and Certificate to CNDA as marketing approval and Quality Management System certificates which are the necessary documents for medical device registration in China. The further explanation about these two documents are elaborated as below:
1. “Certificate of Listing” are for medical devices under the Medical Device Administrative Control System (MDACS) with legal manufacturers in Hong Kong, for listing of Class II/III/IV general medical devices and Class D in vitro diagnostic (IVD) medical devices. As for the guidelines can refer to [GN-02] Guidance Notes for Listing Class II, III & IV Medical Devices and [GN-06] Guidance Notes for Listing In Vitro Diagnostic (IVD) Medical Devices
2. “Certificate to CNDA” is for medical devices which are not entitled to be listed under the MDACS Class I general medical devices and Class A/B/C IVD medical devices. As for the application guidance for the “Certificate to CNDA”, it is as follows:
Local manufacturers can now apply for the “Certificate to CNDA” from MDCO, provided the fulfilment of the following conditions:
1. The manufacturers are included in the list of local manufacturers under the MDACS (Please refer to “[GN-08] Guidance Notes for Listing of Local Manufacturers” for details of application);
2. The concerned devices are manufactured by the listed local manufacturers; and
3. The concerned devices have been sold to local healthcare facilities within two years counting from the application date of the “Certificate to CNDA”.
An application for the “Certificate to CNDA” must be made using the application form (MD-CNDA), which can be downloaded on MDCO's official website and submitted according to the same route as for new medical device registration application submissions.