Overview:

The Coronavirus outbreak in China has led to an extraordinary demand of some medical devices. The NMPA (Chinese health authority) started granting emergency approval to some imported medical device, provided that they meet certain regulatory and quality standards. To qualify for NMPA emergency, medical devices need to be approved by USA’s FDA, Japan’s PMDa, or CE Marked Additionally, they need to have all the appropriate testing reports and manufactured under Quality Management System (QMS). 

Emergency import Vs. Emergency Approval:

There are differences between emergency import and emergency approval.

• Emergency ‘import’, means a device can only be on the market in the time of outbreak and the procedure is usually much more simplified
• Emergency ‘approval’, means going  through all the registration steps once approved the NMPA will issue a Registration Certificate to the Manufacturer.   The certificate will allow the sell of the product on the market after the end of the outbreak.

Registration Process for Emergency Approval:

For eligible medical devices, the application for Emergency Approval shall be first submitted to provincial NMPA with other materials, such as a copy of the approval in the country of origin (FDA, EU or Japan), ISO 13485 certificate and technical testing report. Then an NMPA staff will perform a gap analysis to compare the applicant standards to Chinese standards. The clinical trial data can be supplemented after market approval.

What Devices Qualify for Emergency Approval ?

• Medical masks
• Protective clothing
• Infrared temperature measurement device
• Respiratory anesthesia equipment
• Medical oximeters
• Telemedicine related software
• IVD reagents and instruments used for virus detection