The month of January is slowly passing by. Stephanie Huang shares her vision on the expected trends in the Chinese market for the coming year.
Revision of China Medical Device fundamental regulation
Order 650 will be finalized and published. After rounds of discussions, debates and changes, this landmark regulation revisits and re-modifies several critical existing requirements, including clearer clinical requirement, stronger supervision, better-defined responsibilities and heavier penalties.
Further encourage of green channel and innovative device application
There are 222 innovation application submitted and among which 65 products have been approved in 2019. First in China technology and products with substantial clinical benefits will be put onto the express registration lane. Better resources such as early-phase consultation dedicated appointed reviewer, and IP recognition and protection are allocated to ensure fast approval.
New China Agent Regulation
A legal agent will play a far more significant role in 2020 than ever before. NMPA published draft Guideline for Imported Medical Device Legal Agent, which is scheduled to be implemented early 2020. In this draft, China agent is imposed with new and additional responsibilities, such as maintaining an appropriate quality management system, risk control, liability compensation capacity, keeping track of sales and distribution to ensure products’ traceability, urging and assisting the overseas manufacturers to satisfy conditional approval requirements, and helping correction of Chinese IFU and label errors or discrepancies. Foreign manufacturers are expected to assess agent qualifications and ensure selected agent have sufficient knowledge and experience to perform the required duties. The Chinese agent may also scrutinize their partnered manufacturers before starting a collaboration.
Curious about the biggest trends in the Chinese market in the past year? Click here.