Author: Cyber Blue Equipment
Source: Cyber Blue Equipment
Edited by: Mike
State Administration for Market Regulation has released a directory of certification agencies, and machinery companies and dealers can contact you with confidence.
NO.1
Masks allow large-scale exports
On April 7, according to Xinhua News Agency, 3M, the largest mask manufacturer in the United States, announced that it has reached an agreement with the US government to be allowed to continue exporting N95 protective masks to Canada and Latin America during the COVID-19 pandemic. It can be seen that the spread of the epidemic has caused a large gap in medical supplies such as masks in various countries.
htmlOn April 5, the official microscope of the General Administration of Customs issued a message saying that the US FDA released a document on its official website stating that masks produced in China that have not been certified by NIOSH have been authorized by EUA. This marks that the KN95 mask produced in accordance with Chinese standards has been officially recognized by the United States.At present, domestic mask manufacturers produce masks at an average rate of 0.5 seconds per piece, and many companies are exporting them abroad to solve the medical supplies gap. Among them, quality and export certification have become the most urgent matters.
Recently, the State Administration for Market Regulation issued the "Guidelines for the Export of Masks and other Epidemic Prevention Supplies in the EU and the United States Market Certification Information", which stipulates that enterprises are not familiar with the export policies of epidemic prevention materials, mask exports, and the list of domestic certification agencies.
NO.2
Export EU requirements
1. EU access requirements for masks and other epidemic prevention supplies
(I) Masks The EU divides masks into two categories according to their purpose: medical masks and personal protective masks.
1. Medical mask
Medical masks must be labeled with CE marks in accordance with EU Medical Device Directive 93/42/EEC (MDD) or EU Medical Devices Regulation EU2017/745 (MDR). The corresponding standard is EN14683. Depending on the sterile or non-sterile state of the mask product, the conformity assessment model adopted is also different.
(1) Sterile medical masks: CE certification must be carried out by an authorized notice agency.
(2) Non-sterile medical masks: Enterprises only need to conduct CE self-conformity declaration and do not need to pass the certification of the notice agency. After preparing the corresponding documents and test reports and other materials, you can complete the declaration of conformity by yourself.
2. Personal protective mask
Personal protective mask does not belong to medical devices, but must comply with the EU Personal Protective Equipment Regulation EU2016/425 (PPE) requirements. The authorized notice agency shall conduct CE certification and issue a certificate. The corresponding standard is EN149.
(II) Protective clothing
Protective clothing is also divided into medical protective clothing and personal protective clothing, and the management requirements are basically similar to masks. Medical protective clothing is managed in accordance with medical devices. Among them, sterile medical protective clothing must obtain CE certification in accordance with EU Medical Device Directive 93/42/EEC (MDD) or EU Medical Device Regulation EU2017/745 (MDR). Non-sterile medical protective clothing only requires CE self-declaration. Personal protective clothing must obtain CE certification in accordance with the EU Personal Protective Equipment Regulation EU2016/425 (PPE).
(III) EU Announcement Body query address
1. EU Medical Device Directive 93/42/EEC (MDD) inquiry address: https://ec.europa.eu/growth/tools-databases/nando/index.cfm?fuseaction=directive.notifiedbodydir_id=13
2. EU Medical Devices Regulation EU2017/745 (MDR) inquiry address: https://ec.europa.eu/growth/tools-databases/nando/index.cfm?fuseaction=directive.notifiedbodydir_id=34
3. Announcement agencies authorized by the EU2016/425 (PPE) are inquiry address: https://ec.europa.eu/growth/tools-databases/nando/index.cfm?fuseaction=directive.notifiedbodydir_id=155501
NO.3
Export to the United States
United States to access masks and other epidemic prevention supplies
(I)Mask
The United States also manages medical masks and protective masks, among which medical masks are managed by the U.S. Food and Drug Administration (FDA), while personal protective masks are managed by the U.S. National Institute of Occupational Safety and Health (NIOSH).
1. Medical mask
Medical masks must be registered through the FDA, and the company directly applies to the FDA official website and submits relevant materials.There are also two optional ways:
(1) N95 masks that have been registered with NIOSH. If the product biological test, flame retardant test and blood penetration test pass, the product registration (510K) can be exempted from the product market registration (510K), and FDA factory registration and medical device listing can be directly carried out.
(2) If authorized by a manufacturer holding 510K, it can use its 510K approval number for enterprise registration and device listing as its foundry.
2. Personal protective mask
Protective masks must be registered through NIOSH, and the company applies directly on the NIOSH official website.
(II) Protective clothing
The management of medical protective clothing and personal protective clothing is similar to the management of masks. Medical protective clothing is managed by the U.S. Food and Drug Administration (FDA), while personal protective clothing is managed by the U.S. National Institute of Occupational Safety and Health (NIOSH). The company directly applies for registration with the FDA or NIOSH.
NO.4
Official: Domestic CE certification agency
According to the State Administration for Market Regulation, the list of certification agencies in China that have the ability to CE certification of masks and other epidemic prevention supplies:
NO.5
Official: Medical device management system certification agency
Institutions that can carry out medical device management system (ISO13485) certification in China
END
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