Guidelines on market access for medical devices in China

Summary 

China’s medical device market is among the biggest and fastest growing in the world. However, recent policies and regulations can sometimes restrict market access for foreign companies.

Global Affairs Canada is please to make available the Guidelines on Market Access for Medical Devices in China market report to Trade Commissioner Service (TCS) clients looking to access China’s medical device market. This updated 44-page report will help Canadian medical device companies seeking opportunities in China understand the latest regulatory framework.

The report covers a wide range of topics including: 

• Regulatory overview: understand Chinese regulatory authorities and their responsibilities, regulations that determine market access, product distribution, after sale service; newly established Marketing Authorization Holder (MAH) system for medical devices, and special policies in Hainan Boao Lecheng International Medical Tourism Pioneer Zone.
• Pre-registration guidelines：what one needs to know before registering your medical device in China. The report lays out the requirements by device class, technical requirements, Chinese standards, labeling, product testing, clinical trials, etc.
• Clinical evaluation:  learn more about criteria for exemption from clinical trials, clinical trial procedures, acceptance of overseas clinical trial data and the new regulation over acceptance of real-world data.
• Registration pathway: key information on the traditional pathway for product registration and a fast track for innovative medical device registration. 
• Quality management system and post-market guidelines: learn about China’s quality management requirements for medical device distribution and sales, and post-market related policies eg. certificate update and renewal, overseas manufacturer inspection, adverse events and recalls, and re-evaluation. 

Please note that in order to receive a complete copy of this report, your organization must be a qualified TCS client.

The TCS is committed to supporting Canadian companies and organizations that have meaningful economic ties to Canada, the potential to contribute significantly to Canada's economic growth, and the capacity and commitment to internationalization.

For a full copy of the report, please contact Ms. Dana Duan, Trade Commissioner the Embassy of Canada to the PRC at nan.duan@international.gc.ca. Please note that the report is only available in English.