Keep Up With The Trend Of Medical Devices Localization In China: Background, Policy, Regulation, And Case Study


Part 1: Comparison of imported vs. Domestic medical devices in China.

In this section, it compared the class II and class III NMPA initial registration approvals for the years 2018 to 2021. The domestic and imported devices are displayed for comparison in the two charts. Obviously, whether of class II or class III devices, imported devices are always higher to domestic devices. Following that, it discusses the top 5 medical device approvals by the NMPA in 2020 and 2021. Then, a number of medical device types that are common in China are presented. Also highlighted are the sales volume and the reasons why imported device outnumber domestic devices.

Part 2: Drivers for domestic medical device development and imported substitution

In this section, innovative medical device special approval program are described and the data are from recent years. Also added was domestic development, which was broken down into four categories: market expansion, policy assistance, technology iteration, and cost management. Finally, it talks about China polices related to domestic procurement.

Part 3: China localization modes for international medical device manufactures

It explains the faster market approval before getting into the localization mode section. Uses guidelines to fully comprehend the registration dossier and QMS registration inspection. Additionally, it gives an example to explain China localization in several modes and to highlight the advantages and disadvantages.