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Original Title: 8: List of Certification Bodies with CE Certification Capability for Masks and Other Epidemic Prevention Supplies in China The official website of the General Administration of Market Supervision issued a guide to the market certification of masks and other epidemic prevention supplies exported to the European Union and the United States. Please collect it! Information Guide for Market Certification of Masks and Other Epidemic Prevention Supplies Exported to the European Union and the United States In order to do a good job in COVID-19 pandemic prevention and control and economic and social development, and support enterprises to resume work and production, in view of the fact that enterprises are not familiar with the export policy of epidemic prevention materials, the following information guide is provided for enterprises to refer to the relevant access requirements for the export of epidemic prevention supplies such as masks to the European Union and the United States,Medical Full Body Coverall, as well as the directory of domestic certification bodies with corresponding qualifications and capabilities. I. EU's Requirements for Access to Masks and Other Epidemic Prevention Supplies (I) Masks The European Union divides masks into two categories according to their use: medical masks and personal protective masks. 1. Medical mask Medical masks shall be affixed with CE mark in accordance with EU Medical Device Directive 93/42/EEC (MDD) or EU Medical Device Regulation EU2017/745 (MDR), and the corresponding standard is EN14683. According to the aseptic or non-aseptic status of mask products,Full Body Disposable Coverall, the conformity assessment mode is also different. (1) Sterile medical masks: must be CE certified by an authorized notified body. (2) Non-sterile medical masks: The enterprise only needs to make a CE self-declaration of conformity, and does 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 mask Personal protective masks are not medical devices, Antivirus Disposable Mask with CE Certificate ,KN95 Face Mask, but they are required to meet the requirements of the European Union Personal Protective Equipment Regulation EU2016/425 (PPE). The authorized notified body carries out CE certification and issues certificates. The corresponding standard is EN149. (2) protective suit; Protective suit are also divided into medical protective suit and personal protective suit, and the management requirements are basically similar to those of masks. Medical protective suit are managed according to medical devices, in which sterile medical protective suit need to obtain CE certification according to EU Medical Device Directive 93/42/EEC (MDD) or EU Medical Device Regulation EU2017/745 (MDR), while non-sterile medical protective suit only need CE self-declaration. Personal protective suit are CE certified in accordance with the European Union Personal Protective Equipment Regulation EU2016/425 (PPE). Expand the full text (III) Address of the EU Notified Body 1. The inquiry address of the notified body authorized by EU Medical Device Directive 93/42/EEC (MDD): https://ec.europa.eu/growth/tools-da...body&dir_id=13 2. EU Medical Device Regulation EU 2017/745 (MDR) Authorized Notified Body Enquiry Address: https://ec.europa.eu/growth/tools-da...body&dir_id=34 3. EU Regulation on Personal Protective Equipment EU2016/425 (PPE) Authorized Notified Body Enquiry Address: Two, the United States requires access to epidemic prevention supplies such as masks. (I) Masks Medical masks and protective masks are also managed differently in the United States, with medical masks managed by the Food and Drug Administration (FDA) and personal protective masks managed by the National Institute for Occupational Safety and Health (NIOSH). 1. Medical mask Medical masks need to be registered by FDA, and enterprises apply directly to FDA's official website and submit relevant materials.
There are two other options: (1) N95 mask that have been registered by NIOSH may be exempted from product marketing registration (510K) and directly undergo FDA factory registration and medical device listing if the product passes the biological test, flame retardant test and blood penetration test. (2) If authorized by a 510K-holding manufacturer, may use its 510K approval number as its foundry for enterprise registration and device listing. 2. Personal protective mask Protective masks need to be registered through NIOSH, and enterprises can apply directly on the NIOSH official website. (2) protective suit; The management of medical protective suit and personal protective suit is similar to that of masks, in which medical protective suit is managed by the Food and Drug Administration (FDA) and personal protective suit is managed by the National Institute of Occupational Safety and Health (NIOSH). Enterprises directly apply for registration with FDA or NIOSH. 3. List of Certification Bodies with CE Certification Capability for Masks and Other Epidemic Prevention Supplies in China 4. List of institutions that can carry out certification of medical device management system (ISO13485) in China A Picture to Understand: Information Guide for Market Certification of Masks and Other Epidemic Prevention Supplies Exported to the European Union and the United States (Photo source: Shi Shuo Xin Yu) Source | State Administration for Market Regulation (SAMR) Official Website Quality and Certification Shi Shuo Xin Yu Editor | Testing WeChat Platform ID: testbbs Reprint Please Specify Declarations: 1. Part of the graphic information comes from the Internet, and the copyright belongs to the original author. If there is any infringement,Medical Full Body Coverall, it shall be informed in time and deleted after verification; ⊙ Note: If you reprint the original content of this platform/edit articles or directly quote the content of this platform, please indicate the source: test (WeChat ID: testbbs), infringement will be prosecuted. Return to Sohu to see more Responsible Editor:. zjyuan-group.com