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07/05/2020

Foundation

Conformity and authorized for the import of PPE: latest updates

These days we are constantly busy finding information related to the compliance characteristics of masks and PPE. Here are a series of links to articles on the essential safety requirements of the current regulations.

1. Conformity PPE (updated 7th May)

In order to enter European markets, international manufacturers shall work with certification companies that are authorized to certify PPE according to regulation (EU) 2016/425, Personal Protective Equipment:
https://ec.europa.eu/growth/tools-databases/nando/index.cfm?fuseaction=notifiedbody.main

Please see also EU Commission on conformity assessment and market surveillance procedures within the context of the COVID-19 threat under
https://eurlex.europa.eu/legal-content/EN/TXT/?uri=uriserv:OJ.LI.2020.079.01.0001.01.ENG

The European Commission has published Commission Recommendation (EU) 2020/403 on conformity assessment and market surveillance procedures within the context of the COVID-19 threat.

https://eur-lex.europa.eu/legal-content/EN/TXT/?qid=1586260931727&uri=CELEX%3A32020H0403
with a corrigendum available here:
https://eur-lex.europa.eu/legal-content/EN/TXT/?qid=1586261134786&uri=CELEX:32020H0403R(01)

EU has authorized the following notified bodies, however, every company was authorized to do certain type of tests:

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

Tests of masks are performed by laboratories. Below you find a list of laboratories in Europe, which are accredited for the scope EN 14683 and / or EN 149:

https://european-accreditation.org/coronavirus-outbreak-accredited-laboratories-for-face-masks-testing/
There are also some bilateral agreements:

https://ec.europa.eu/growth/tools-databases/nando/index.cfm?fuseaction=mra.main

Chinese GB standards are not part of bilateral agreement with EU yet.

In China, PPE manufacturers:

- could be authorized for production with GB standards and test reports for GB standards shall be realized by authorized laboratories for GB standards in China:
In Chinese: https://las.cnas.org.cn/LAS_FQ/publish/externalQueryL1.jsp
In English: https://las.cnas.org.cn/LAS_FQ/publish/externalQueryL1En.jsp

- could be authorized for production for European markets if the products will be tested and certified by EU-authorized notified bodies and the quality system shall be ISO 13485, approved and certified by authorized quality system certification companies for medical devices.

Please refer also the Chinese website:
http://gkml.samr.gov.cn/nsjg/rzjgs/202004/t20200416_314332.html
This website has highlighted the different standards in China and in Europe, which could be good reference for Chinese companies to refer in order to prepare the right dossier of documents for exportation. This website also indicated authorized companies for quality system and EU-authorized notified body in China for PPE, both excels attached.

Please refer also European Safety Federation that has published suspicious certificates for PPE.
https://www.eu-esf.org/covid-19/4513-covid-19-suspicious-certificates-for-ppe
The above website is always under update.

2. PPE white list

Announcement No. 12 (2020) of the Ministry of Commerce, the General Administration of Customs, and the State Administration for Market Regulation on Further Enhancing Quality Oversight for Exported Epidemic Prevention and Control Supplies.

Chinese: http://www.gov.cn/zhengce/zhengceku/2020-04/26/content_5506162.htm
English: http://english.mofcom.gov.cn/article/newsrelease/significantnews/202004/20200402959471.shtml
This announcement authorized possible exportation for products approved by NMPA AND / OR with qualified international product certifications and relevant quality system. Two declarations are necessary for product tracking, which is obligated for Chinese exporter and International importer to provide.

According to Announcement No.12 (2020), on the website of http://en.cccmhpie.org.cn/ there is regular update of:

- Name List of Medical Devices and Supplies Companies with Certification / Authorization from other Countries
- Name List of Non-Medical Use Face Masks Companies with Certification / Authorization from other Countries
NMPA registration verification and manufacturer contact with CE approval will be provided to member companies gratis. Non member companies please send request to commercial office.

Remind: NMPA announcement on 1st April.
English: http://english.nmpa.gov.cn/2020-04/01/c_468094.htm

Chinese: http://www.nmpa.gov.cn/WS04/CL2138/376203.html

The Chinese link has published as the last attachment approved medical devices and supplies companies with Chinese standards, authorized for exportation.
The list is in Chinese languages. Our bi-lingual team could provide NMPA registration verification.


Remind: Italian customs has defined declaration and tracing procedure for every single importation to avoid speculation.

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