China has accelerated the Emergency Approvals under the threat of Novel Coronavirus (“2019-nCoV”). National NMPA granted seven Emergency Approvals to Coronavirus Nucleic Acid Detection Reagent manufacturers in January, while provincial NMPA offices paid all-out efforts to help contain the virus.
NMPA published the “Notice of Importing Non-NMPA Approved Medical Devices” on Monday Jan 27, informing provincial counterparts to allow import none-NMPA approved devices but have FDA approval, CE mark, or Japan approval, to help contain the Coronavirus.
The Notice states the Emergency Approval prerequisites for overseas manufacturers:
It further specifies that “the provincial NMPA shall cooperate with local departments of Industry and Information Technology, Health and Customs to ensure smooth importation and customs clearance. provincial NMPA shall issue the Certificate of Import License if needed.”
For further terms, manufacturers can consult provincial NMPA, instead of national NMPA, to get quicker response.
As of February 5, provincial NMPA offices granted Emergency Approvals to 72 medical devices, with focus on protective supplies, sterilization and ventilation devices, including:
Diagnostics side, provincial NMPA streamlined review procedures. From regulatory submission to approval, it only took 2 days for a coronavirus nucleic acid detection kit to go to market. On January 28, Jiangsu provincial NMPA issued the Testing Report for the First Novel Coronavirus Nucleic Acid Detection Kit, describing the procedure of expedited regulatory process in the coronavirus pandemic. Please see the timeline HERE.
Innovation Approval and Priority Review, along with Emergency Approval are called Fast-Track Channels in China.
NMPA granted Priority Review Statusto an overseas manufacturer on January 22.
NMPA granted Innovation Device Statusto a domestic manufacturer on January 22.
For a comprehensive review on the three channels in 2019, please click HERE.