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1. Laws and regulations related to epidemic prevention and control supplies, the texts of which may be accessed through the listed links.
(1) Standardization Law of the People’s Republic of China
Relevant articles:
Article 2 Mandatory standards must be implemented. The State shall encourage the adoption of voluntary standards.
Article 25 Products and services that do not meet mandatory standards shall not be manufactured, sold, imported or provided.
Article 26 Technical requirements for export products and services shall be in accordance with contractual obligations.
http://www.sac.gov.cn/sbgs/flfg/fl/bzhf/201803/t20180323_342012.htm
(2) Regulations for the Supervision and Administration of Medical Devices
According to the Regulations for the Supervision and Administration of Medical Devices and related rules and regulations, China classifies medical devices including in vitro diagnostic reagents into three categories according to risk levels. Medical masks and protective clothing are regulated according to the standards for Class Ⅱmedical devices. Goggles and face shields are regulated according to the standards for Class Ⅰmedical devices in China. Medical ventilators are regulated according to the standards for Class Ⅱ and Class Ⅲ medical devices. Medical thermometers are regulated according to the standards for Class Ⅱ medical devices.
http://www.nmpa.gov.cn/WS04/CL2076/331389.html
(3) Regulations of the People’s Republic of China on Certification and Accreditation
Chapter Ⅲ and Chapter Ⅵ of the Regulations of the People’s Republic of China on Certification and Accreditation concerning the engagement of certification activities and the legal liability for violation of certification activities are related to the certification of epidemic prevention products.
http://gkml.samr.gov.cn/nsjg/rzjcs/201902/t20190215_282266.html
2. Information of standards of epidemic prevention products, including Chinese national standards list of epidemic prevention products, comparison information of Chinese and foreign standards related to epidemic prevention products, list of Chinese national standards in foreign language related to epidemic prevention products, and equivalence of standards information regarding face masks issued by foreign countries. The web link is:
http://www.sac.gov.cn/sacen/FAC/
3. Regulatory requirements and standards for coronavirus reagent test kits and protective equipment in China. The web links are:
http://english.nmpa.gov.cn/2020-03/30/c_467202.htm?From=singlemessage&isappinstalled=0
4. Registration information of medical devices in China. The web link is:
http://www.nmpa.gov.cn/WS04/CL2582/
5. Certification guide for export of masks and other epidemic prevention products to the European Union and the United States, including the directory of domestic certification bodies with qualifications related to masks and other epidemic prevention products as Notified Bodied of EU. The web links are:
http://www.cnca.gov.cn/xxgk/hydt/202004/t20200404_58016.shtml
http://www.cnca.gov.cn/xxgk/hydt/202004/t20200415_58103.shtml
6. Qualification verification is required for medical devices and protection equipment inspection bodies and testing laboratories according to Article 57 of the Regulations for the Supervision and Administration of Medical Devices and Article 16 of the Regulations of the People’s Republic of China on Certification and Accreditation.
The directory of inspection and testing organizations for medical devices and protection equipment with national qualification verification can be accessed through the following web link.
