In order to do a good job in the prevention and control of the new crown pneumonia epidemic and economic and social development, and support enterprises to resume work and production, in view of practical problems such as enterprises not being familiar with the export policy of epidemic prevention materials, the following information guide is hereby provided for the reference of enterprises on the relevant access requirements for the export of masks and other epidemic prevention supplies to the EU and United States and the list of domestic certification bodies with corresponding qualifications and capabilities.

1. EU access requirements for masks and other epidemic prevention supplies

(1) Masks

The European Union divides masks into two categories based on their use: medical masks and personal protective masks.

1. Medical masks

Medical masks are required to be CE marked in accordance with the EU Medical Device Directive 93/42/EEC (MDD) or the EU Medical Device Regulation EU2017/745 (MDR), and the corresponding standard is EN14683. Depending on the sterile or non-sterile state of the mask product, the conformity assessment mode adopted is also different.

(1) Sterile medical masks: CE certification must be carried out by an authorized notified body.

(2) Non-sterile medical masks: Enterprises only need to make a CE self-declaration of conformity, and do not need to be certified by a notified body. After preparing the corresponding documents and test reports, you can complete the declaration of conformity by yourself.

2. Personal protective masks

Personal protective masks are not medical devices, but they need to meet the requirements of the EU Personal Protective Equipment Regulation EU2016/425 (PPE), CE marking and certificate issued by an authorized notified body, and the corresponding standard is EN149.

(2) Protective clothing

Protective clothing is also divided into medical protective clothing and personal protective clothing, and the management requirements are basically similar to those of masks. Medical protective clothing is managed in accordance with medical devices, of which sterile medical protective clothing needs to obtain CE certification in accordance with the EU Medical Device Directive 93/42/EEC (MDD) or EU Medical Device Regulation EU2017/745 (MDR), and non-sterile medical protective clothing only needs to be CE self-declaration. Personal protective clothing (PPE) is CE marked in accordance with the EU Personal Protective Equipment Regulation EU2016/425 (PPE).

(iii) The address of the EU Notified Body

1. Inquiry address of Notified Body authorized by EU Medical Device Directive 93/42/EEC (MDD):

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

2. Notified Body Inquiry Address of EU Medical Device Regulation EU 2017/745 (MDR):

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

3. Notified Body Inquiry Address of EU Personal Protective Equipment Regulation EU2016/425 (PPE):

https://ec.europa.eu/growth/tools-databases/nando/index.cfm?fuseaction=directive.notifiedbody&dir_id=155501

Second, the United States has access requirements for masks and other epidemic prevention supplies

(1) Masks

United States also manage medical masks separately from protective masks, with medical masks managed by the United States Food and Drug Administration (FDA) and personal protective masks managed by the United States National Institute for Occupational Safety and Health (NIOSH).

1. Medical masks

Medical masks need to be registered with the FDA, and companies can apply directly to the FDA official website and submit relevant materials. There are also two options:

(1) N95 masks that have been registered with NIOSH can be exempted from product marketing registration (510K) if the product biological test, flame retardant test and blood penetration test are passed, and the FDA factory registration and medical device listing can be directly carried out.

(2) If authorized by the manufacturer holding the 510K, it can use its 510K approval number as its foundry for business registration and device listing.

2. Personal protective masks

Protective masks need to be registered with NIOSH, and companies can apply directly on the NIOSH official website.

(2) Protective clothing

The management of medical gowns and PPE is similar to that of masks, with the United States Food and Drug Administration (FDA) managing medical gowns and PPE being managed by the United States National Institute for Occupational Safety and Health (NIOSH). Businesses apply for registration directly with the FDA or NIOSH.

3. List of certification bodies in China with CE certification capabilities for masks and other epidemic prevention supplies

4. List of institutions that can carry out medical device management system (ISO13485) certification in China

Source: State Administration for Market Regulation