Since medical masks are registered or controlled according to medical devices in most countries or regions, consumers can further distinguish them through relevant registration and control information. The following is an example of China, the United States and Europe.
China
Medical masks belong to the second class of medical devices in China, which are registered and managed by the provincial drug regulatory department, and can be queried by medical devices to query the medical device access number. The link is:
http://www.nmpa.gov.cn/WS04/CL2590/。
United States
Mask products that have been approved by the US FDA can be queried through its 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 POLICY of the FDA, it is currently recognized as a Mask of Chinese Standards under certain conditions, and the link of its authorized enterprises is:
https://www.fda.gov/media/136663/download。
European Union
Export of EU medical masks can be made through authorized Notified Bodies, of which the Notified Body 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 notified body enquiry address authorized by the EU Medical Device Regulation EU 2017/745 (MDR) is:
https://ec.europa.eu/growth/tools-databases/nando/index.cfm?fuseaction=directive.notifiedbody&dir_id=34。
Post time: Apr-17-2022