China Amends Regulations on Supervision and Management of Medical Devices; Prior Marketing Approval Requirement to Import Medical Devices Remains Unchanged


On March 31, 2014, China Premier Mr.Li Kequiang signed Decree No. 650 on the amended Regulations on Supervision and Management of Medical Devices (“the amended regulations”), which update the original regulations1 released in January 2000. In comparison to the original regulations, the amended regulations ease the supervision and management of low risk medical devices, establish a monitoring and recording system for distribution and usage stages, and increase penalties for violations and noncompliance. The amended regulations will enter into force on June 1, 2014.

The significant changes contained in the amended regulations are as follows:

- Refining the definition of medical devices: The amended regulations newly include in vitro diagnosis reagents and calibrators into the category of products defined as medical devices. They also expand the description of the purpose of medical devices by including: (a) “life support or maintenance”; and (b) “to collect information for diagnosis or treatment utilizing human sample testing.”

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