The Latest Authoritative Release! Masks And Other Quarantine Products Export To Europe And The United States.

The outbreak of the new crown pneumonia is accelerating in the world, and more and more countries are facing severe tests. On the basis of domestic epidemic prevention and control, China is helping the global epidemic with high quality "made in China".

At present, there are more than 2000 medical device manufacturers approved by the drug regulatory authority in China, and the number of suppliers that foreign buyers can choose is adequate, and the quality of supply is guaranteed. As of April 4th, 54 countries and regions, as well as 3 international organizations and Chinese enterprises, have signed contracts for the procurement of medical materials.

In order to do a good job in the prevention and control of new crown pneumonia and economic and social development, support enterprises to resume production and resume production, and in view of the fact that enterprises are not familiar with the export policy of epidemic prevention materials, in April 4th, the China National Certification and accreditation supervision commission (CAC) provided a letter on the relevant requirements of the European Union and the United States for export of masks, such as masks, and the list of certification bodies with corresponding qualifications in China. Information guide for business reference.

(1) respirator

According to the European Union, masks are divided into two categories: medical masks and personal protective masks.

1. medical mask  

Medical masks should be labeled in accordance with European Union Medical Device Directive 93/42/EEC (MDD) or EU medical device Ordinance EU2017/745 (MDR), with the corresponding standard of EN14683. According to the sterile or non sterile condition of mask products, the conformity assessment modes are different. (1) sterile medical masks: CE certification must be conducted by authorized announcement bodies.

(2) non sterile medical masks: enterprises only need to carry out CE self compliance statement, and do not need to be certified by public notice institutions. After making the corresponding documents and test reports, you can complete the compliance statement yourself.

2. personal protective masks

Personal protective masks do not belong to medical devices, but they comply with the requirements of the European personal protective equipment Ordinance EU2016/425 (PPE). CE is certified and issued by the authorized announcement institution, with the corresponding standard of EN149.

Protective clothing is also divided into medical protective clothing and personal protective clothing. Management requirements are basically similar to those of respirators. Medical protective clothing is managed according to medical devices. Sterile medical protective clothing is required to be CE certified according to the European Union Medical Device Directive 93/42/EEC (MDD) or the European Union Medical Devices Ordinance EU2017/745 (MDR). Personal protective clothing is required to be CE certified in accordance with the European personal protective equipment Ordinance EU2016/425 (PPE).

1. the European Union Medical Device Directive 93/42/EEC (MDD) authorized announcement body inquiry address:

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

2. the European Union's medical devices Ordinance EU 2017/745 (MDR) authorized notice bodies:

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

3. the European Union's personal protective equipment Ordinance EU2016/425 (PPE) authorized notice body:

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

(1) respirator

The United States also manages medical masks and respirators equally. Medical masks are administered by the US Food and Drug Administration (FDA), while personal protective masks are managed by the National Institute of occupational safety and health (NIOSH).     

1. medical mask    

Medical masks should be registered through FDA, and enterprises will apply directly to FDA official website and submit relevant materials. There are two alternatives:

(1) the N95 mask, which has been registered by NIOSH, has been registered. When the product biological test, flame retardant test and blood penetration test pass, the product registration (510K) can be exempted, and the registration of FDA plant and the listing of medical devices can be carried out directly.

(2) if authorized by a manufacturer holding a 510K, it can use its 510K approval number to register and name the equipment as its manufacturer.

2. personal protective masks

The respirator should be registered through NIOSH, and the company will apply directly to NIOSH official website.

Management of medical protective clothing and personal protective clothing is also similar to the management of masks. Medical protective clothing is administered by the food and Drug Administration (FDA), and personal protective clothing is managed by the National Institute of occupational safety and health (NIOSH). Enterprises directly apply for registration in FDA or NIOSH.