On 12 May 2020, the AFMPS published a new version of its guidelines for verification of the compliance and sustainability of surgical face masks, initially published on 30 March 2020.
The initial guidelines reflected the derogations from the rules for CE marking and conformity assessment described in the European Commission Recommendation 2020/403 of 13 March 2020 on conformity assessment and market surveillance procedures in the context of the COVID-19 threat.
They also provided that, given the current exceptional circumstances, the AFMPS may accept test reports according to international standards that can guarantee a quality comparable to that, which would have been obtained if the tests were carried out according to the EN 14683 standard. These alternative standards include:
- USA: ASTM F2100
- China: YY 0469:2011 and YY/T: 0969-2013
Demonstration of compliance may take the form of test reports or a certificate issued by a third party. Where compliance with these alternative standards is sufficiently documented, non-CE marked surgical masks following these standards can be accepted.
The guidelines provide a list of institutes accredited by the Chinese government for the standard in question. Test reports from laboratories that do not appear on that list will not be accepted.
The guidelines also provide an overview of the documents that are essential for CE marked and non-CE marked surgical face masks in the context of the COVID-19 pandemic.
- For non-sterile surgical face masks with CE marking, an EU declaration of conformity is required;
- For sterile surgical face masks with CE marking, an EU declaration of conformity as well as a sterilization certificate issued by a notified body designated under the Medical Devices Directive 93/42/EEC or the Medical Devices Regulation (EU) 745/2017 are required.
- For surgical face masks without CE marking, test reports from an accredited laboratory are required along with an indication of the alternative standard used.
The new version of the guidelines allows the retail sale of surgical face masks not bearing the CE mark through normal distribution channels. Under the previous guidelines the distribution of surgical masks not bearing the CE mark was permitted only through pharmacies. This change results from the amendment of the Ministerial Order of 23 March 2020 n special measures in the context of the COVID-19 pandemic.