Industry News

Distinguish through government registration control information

2020-07-02

Since medical masks are registered or controlled according to medical devices in most countries or regions, consumers can further distinguish through relevant registration control information. The following takes three countries and regions in China, the United States and Europe as examples for analysis.

China

Medical masks belong to the second category of medical devices in China, and are registered and managed by the provincial drug regulatory department. You can query the medical device access number by checking the medical device. The link is:

http://www.nmpa.gov.cn/WS04/CL2590/

 

United States

Mask products that have been approved by the US FDA can be inquired through the official website to check the registration certificate number. The link is:

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm

In addition, according to the latest FDA policy, it is currently a mask that recognizes Chinese standards when certain conditions are met. The links to its authorized companies are:

https://www.fda.gov/media/136663/download

 

EU

Medical masks exported to the EU can be queried through authorized notifying agencies. Among them, the address of the notifying agencies authorized by the EU Medical Device Directive 93/42/EEC (MDD) is:

https://ec.europa.eu/growth/tools-databases/nando/index.cfm?fuseaction=directive.notifiedbody&dir_id=13

 

The enquiry address of the notified body authorized by the EU Medical Device Regulations EU 2017/745 (MDR) is:

https://ec.europa.eu/growth/tools-databases/nando/index.cfm?fuseaction=directive.notifiedbody&dir_id=34

Medical masks