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:
- FDA approval, CE mark, or Japan approval
- testing report,
- solid Quality Management System (QMS)
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.
What are Approved?
As of February 5, provincial NMPA offices granted Emergency Approvals to 72 medical devices, with focus on protective supplies, sterilization and ventilation devices, including:
- 2 medical protective masks
- 14 medical surgical masks
- 17 disposable medical masks
- 9 disposable medical protective clothing
- 10 disposable surgical gowns
- 2 reusable surgical gowns
- 2 disposable medical caps
- 1 disposable surgical cap
- 1 medical isolation bed
- 1 isolation cabin
- 1 disposable surgical towel pack
- 1 disposable sterile surgical sheet
- 1 disposable medical examination glove
- 1 disposable medical surgical glove
- 1 non-invasive ventilator
- 1 nasal plug catheter
- 1 heating breathing tube
- 1 infrared thermometer
- 1 high-flow respiratory humidifier
- 1 digital mobile X-ray machine
- 1 disposable interventional surgery bag
- 1 disposable tracheal intubation bag
- 1 disposable sputum suction bag
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.
Other Fast-Track Channels in January
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.
- Uptake Medical: Transbronchial hot steam catheter
NMPA granted Innovation Device Statusto a domestic manufacturer on January 22.
- Shenzhen Saier Bio: Systemic lupus erythematosus (SLE) gene methylation detection kit
For a comprehensive review on the three channels in 2019, please click HERE.