Hi colleagues,
Some of you may have many questions on provincial Emergency Approval to help China contain the Coronavirus outbreak. We called Beijing NMPA on February 25, asking the procedures of emergency approval, the device usage after the infection period, and if the devices are still needed given that the outbreak is contained in some areas of the country.
Background
On January 27, the NMPA authorized the import of non-NMPA approved medical devices to combat COVID-19, provided the devices met certain standards.
"The Notice of Importing Non-NMPA Approved Medical Devices," published by the NMPA Center of Medical Device Evaluation (CMDE), informs provincial counterparts to allow the import of non-NMPA approved medical devices to help contain the coronavirus as long as those devices have the following:
- FDA approval, CE Marking, or Japan approval;
- Testing report; and
- Solid Quality Management System (QMS)
The notice 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 NMPAs shall issue the Certificate of Import License if needed."
Procedures for Emergency Approval
Application for Emergency Approval shall first be submitted.
"First you have to apply to see if you are qualified for the emergency pathway. The application materials include your home-country-approval, standards you are complied with and QMS certificate. If you are qualified, we will assign the staff to help you get approval." the Beijing NMPA staff says.
In the registration process, the NMPA staff will help you do a gap analysis to compare your standards and Chinese ones; the clinical trial can be supplemented after market approval.
Device Usage after Outbreak
There are differences between emergency import and emergency approval.
"If you choose emergency 'import', as your devices can only be on the market in the time of outbreak, the procedure is very much simplified; If you go for emergency 'approval', you have to go through every registration step and we will issue you a Registration Certificate." The staff explained.
What Devices are Needed?
According to the staff, the following devices are still hugely needed:
- medical masks
- protective clothing
- infrared temperature measurement device
- respiratory anesthesia equipment
- medical oximeters
- telemedicine related software
- IVD reagents and instruments used for virus detection
"Beijing NMPA is committed to utilize Green Channel to help domestic and overseas manufacturers to speed up review and emergency approval." He added.
In One Day, National NMPA Approved Three Coronavirus Diagnostics
While provincial NMPAs pay all-out efforts to expedite emergency approval, the national NMPA regulates higher-risk devices and diagnostics.
NMPA issued Emergency Approval Notice to three Coronavirus diagnostics on February 22, including one antibody detection reagent (colloidal gold method) and two nucleic acid detection reagents (thermostatic amplification chip method). "NMPA will continue to grant Emergency Approvals to help contain the Coronavirus." The notice states.
From late January, within two weeks, National NMPA granted seven Emergency Approvals to devices employing the nucleic acid method of testing for the virus, before the Guideline on Coronavirus Nucleic Acid Detection Reagent published on February 12.
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Grace Fu Palma
ChinaMed Device, LLC
MA, U.S.
gpalma@ChinaMedDevice.com978-390-4453
www.ChinaMedDevice.com------------------------------