Insight Blog

2016 Medical Device Registration Overview in China (Domestic Medical Device vs Imported Medical Device)

As 2016 comes to an end, how about a summary of the product licensing status for medical devices in China?


A brief description of the registration situation of domestic & imported medical devices this year

The number of registered imported products is less than that of returned products and the number of registered domestic products is more than that of returned products.



The CFDA approved 1702 registered items in total:

                • 378 imported class II products
                • 522 imported class III products
                • 802 domestic class III products (in the first ten months of 2016).



The following is a detailed summary of monthly registered medical devices distribution. In the first ten months of 2016, on average, ~170 product registrations were approved monthly, and maintained relatively steady over the course of the year.



For Class III medical device, the amount of listed domestic class III medical devices in the first ten months is 1.5 times that of imported class III medical devices. The following is a comparison chart illustrating the monthly trend of approved products.



Conversely, the CFDA rejected 1371 registration certificates, of which:

1051 applications were imported class II and III medical devices (77%)

320 were domestic class III medical devices (23%).



The following chart shows the monthly trend of rejected registration certificates published by the CFDA. Except rejected registration certificates centrally published by CFDA monthly in January, the monthly number of rejected registration certificates from February to November is ~48, or 2.2 returned products per working day.


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