Recently, the novel coronavirus pneumonia epidemic situation in China has gradually improved, but the situation abroad is not optimistic.
In order to ease the tension between the supply and demand of respirators and other epidemic prevention materials, the main epidemic countries and regions in Europe and the United States have recently issued temporary or emergency measures for the supervision of respirators and other epidemic prevention materials.
What are the changes in the current policy requirements for exports to Europe and the United States? How to classify the protective masks with high voice on the market?
Measures for European and American countries to deal with the shortage of medical protective masks and other materials as below:
In March 2, 2020, U.S. Department of health and social services (HHS) announced the need to urgently authorize Emergency Use Authorization (Emergency Use Authorization, abbreviated as EUA) personal respiratory protection equipment and in vitro detection kit during the outbreak of the new crown pneumonia outbreak.
Relevant product manufacturers and strategic reserves can make requests to the US Food and Drug Administration (FDA)([email protected]) to add their products to the authorized products for emergency use.
Subsequently, FDA revised the emergency licensing requirements for respirator products on March 24, March 27, and March 28, 2020. For masks, there are the following main instructions:
NIOSH approved filter masks:
1, Filter masks (electric or non electric) approved by NIOSH can be used by medical institutions during the new crown public health emergency without application;
2, Manufacturers or strategic reserves are allowed to apply to FDA for emergency use authorization of expired respirators;
3, On March 28, 2020, in order to alleviate the serious shortage of filter protective masks, FDA further expanded the scope of authorizing the emergency use of NIOSH approved filter masks. All masks that have been contaminated and then purified can also be authorized in emergency use.
Non NIOSH approved disposable filter masks:
1, On March 24, 2020, due to the sharp change in the severity of the epidemic in the United States, the FDA decided to increase the authorization of emergency use of non NIOSH approved disposable filter respirators, believing that such products are also suitable for protecting public health in emergency situations.
2, On March 28, 2020, in order to alleviate the serious shortage of disposable filter masks, FDA will further expand the scope of authorizing the emergency use of disposable filter masks not approved by NIOSH, and all masks that have been decontaminated after being contaminated can also be authorized for use in an emergency.
There are two types of product requirements that are urgently authorized:
1, Meet one of the following standard:
·N100, P100, R100
·N99, P99, R99
·N95, P95, R95
2,Products meeting the following conditions:
- European CE certification
- Australian ARTG registration
- Approved by Health Canada
- Japan PMDA or MHLW license
Unfortunately, the Chinese standard GB 2626 for respirators has not been recognized by FDA as an alternative standard for emergency authorized respirators. For masks manufactured according to Chinese standards, manufacturers need to send an application email titled “Non-NIOSH-Approved Respirator" to [email protected] for authorization.
On March 13, 2020, the European Commission published in the official journal of the European Union the recommendations on conformity assessment and market supervision procedures for medical devices and personal protective equipment (PPE) during the outbreak (Communication recommendation (EU) 2020 / 403). The main suggestions are analyzed as follows:
Second: in the novel coronavirus pneumonia outbreak, European bulletin agencies need to prioritize some personal protective equipment compliance applications.
Interpretation: This proposal is aimed at the notified body, not the suppliers, to enhance the market circulation efficiency of epidemic prevention products, not to say that the products can not meet the basic requirements of European regulations.
Third: for personal protective equipment (PPE) products manufactured according to non EU standards, conformity assessment can be conducted with reference to the technical solutions recommended by who, provided that the above technical solutions meet the basic health and safety requirements.
Interpretation: For personal masks, in addition to the European technical standard EN 149, the basic requirements of the World Health Organization (who) for effective protective equipment can also be referred to.
Please note that this only provides another choice for the basis of product conformity assessment. For example, the respirator protection products meet the requirements of ASTM f2100 level 1 in the United States, and can also be considered as meeting the technical requirements of the European Union. This suggestion is not to say that there is no bottom line for the requirements of respirator protection products.
Seventh: if the market surveillance agency finds that the personal protective equipment products or medical equipment meet the basic requirements of Regulation (EU) 2016 / 425 or Directive 93 / 42 / EEC, or Regulation (EU) 2017 / 745, so as to ensure adequate health and safety level, even if the conformity assessment procedure including CE marking has not been completed, they can be authorized to sell these products in the EU market for a limited period of time.
Interpretation: This article shows that even if the anti epidemic materials such as masks and gloves have not obtained CE certification, they can be authorized by the EU market supervision agency, so as to sell such products in the EU market. However, special attention should be paid to the exception of the normal market supervision procedures and the normal conformity assessment procedures of the European notified bodies, which does not mean that the basic quality and safety requirements for suppliers' products are exempted, but only that the EU official audit procedures are conditionally simplified. In special cases where normal procedures have not been fulfilled, the supplier may export only after obtaining the authorization of the official supervisory authority.
Eighth: PPE or medical equipment without CE mark can also be purchased by relevant competent departments of Member States and enter the EU after safety assessment, provided that such products are only provided for medical personnel and will not enter the normal distribution channels for the public.
Interpretation: This article indicates that anti epidemic materials such as masks and gloves without CE mark can also enter the EU, provided that such products will not enter the normal distribution channels for the public to use and are purchased by the official authorized organizations.
It can be seen that the proposal document is more aimed at the suggestions of official audit. The products provided by suppliers still need to meet certain technical requirements before they can be accepted by the EU market.
Export compliance requirements of common masks in European and American countries
Basic requirements of the regulations for mask products as below:
Common medical masks (FXX) belong to class II medical devices in FDA, FDA factory registration and application 510 (K) before listing, the application process as below:
Conduct product testing and factory GMP audit→Prepare 510 (K) technical documents and submit them to FDA for review→510 (k) approval from FDA→Complete factory registration and device listing
NIOSH certification required, the application for certification shall be implemented in accordance with NIOSH's guidelines. The specific certification is operated by npptl laboratory under NIOSH. The process as below:
Send samples to NIOSH lab for testing→Submit technical data, including quality system data→NIOSH issued certification
The European standard for medical masks (non sterile) is EN 14683, need to meet EU 2017 / 745 requirements. Authentication process: Preparation of technical documents→Provide test paper→Provide declaration of conformity→Designated EU authorized representative to complete registration
According to standard EN149, need to meet the requirements of the European Union's personal protective equipment directive 2016 / 425 (PPE). Authentication process: Type test report of product→Review of technical documents→Factory quality system review→Issue CE certificate