Coronavirus Spurs Emergency Device Approvals in China; Reveals Lessons for Manufactures to Speed Market Entry (I)

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Coronavirus Spurs Emergency Device Approvals in China; Reveals Lessons for Manufactures to Speed Market Entry (I)

While the Novel Coronavirus (COVID-19) has caused a tragic loss of life in China, the crisis demonstrates the flexibility of the country’s health agency. In just a couple of weeks, dozens of essentials detection kits, medical devices and supplies received accelerated regulatory approval.

Thankfully, the outbreak appears to be contained and could be over by April, according to Academician Zhong Nanshan in a February 11 Reuters interview. As the crisis winds down, this incident may have a variety of implications on medical device manufacturers, including lessons for expedited market entry, a greater push for electronic document submission and challenges to ongoing clinical trials.

Emergency Approvals for Devices and Diagnostics

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 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.”

As of February 5, provincial NMPA offices granted Emergency Approvals to 72 medical devices, with a focus on protective supplies, ventilation devices and sterilization.
Diagnostic devices benefited as well, as provincial NMPAs streamlined review procedures. For example. the First Novel Coronavirus Nucleic Acid Detection Kit moved from submission to approval in only two days.  On January 28, Jiangsu Province issued the Testing Report and granted Emergency Approval for the test kit. Within two weeks, National NMPA granted seven Emergency Approvals to devices employing the nucleic acid method of testing for the virus.

(For details on the expedited regulatory process, see CMD’s recent article: Two Days to Get Emergency Approval.)

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About ChinaMed Device, LLC 

ChinaMed Device, LLC (www.ChinaMedDevice.com) provides regulatory and commercialization turnkey solutions for medical device, IVD, CDx and combination products in China. As a qualified NMPA (CFDA) legal representative with offices in Boston and Beijing, we can represent manufacturers for the complete product life cycle without their need to create a local entity in China. Our NMPA (CFDA) regulatory services include strategy, registration, local type testing, product technical requirement (PTR), clinical evaluation report (CER), clinical trial, GMP and post-market surveillance (AE, recall, inspection, etc.). Our commercialization services include market research, reimbursement, partnership strategy and distribution qualification.