NO.1

EU personal protective masks (non medical devices)

The European standard of the European Union for personal protective masks is en149. According to the standard, masks are divided into three categories ffp1 / FFP2 / ffp3, which need to meet the requirements of the European Union (EU) 2016 / 425 Personal Protective Equipment Directive (PPE). The mainstream respirators are FFP2 / ffp3.

Certification process:

 

1. Type test report of products

2. Review of technical documents

3. Factory quality system review

4. Issue CE certificate

5. Product export

Note: it is necessary to select a license issuing agency with the ability to issue PPE, and the license issuing agency will issue ce-ppe certificate after passing the review of en149 report.

 

NO.2

EU medical masks (medical devices)

The European standard of medical masks is en14683. According to the standard, medical masks are divided into three categories: type IA / type II / type IIR. Type Ia is used for patients and other populations during an epidemic, and Type II and Type IIR are used for healthcare workers. The requirements of EU 2017 / 745 (new medical device MDR) need to be met. Masks belong to class I devices in the European Union, but they are divided into class I non sterile and sterile.

 

1. Non sterile mask (only available at this stage)

1) Preparation of technical documents

2) Provide product en14683 test report (including product biological report)

3) Provide declaration of conformity

4) Appointed EU authorized representative to complete European registration

Time estimate: 4-5 weeks

2. Sterile mask (it is very difficult to implement the new MDR at this stage)

1) Sterilization confirmation

2) ISO13485 system certification

3) Preparation of technical documents

4) Provide test reports (biology, performance, sterility, etc.)

5) Review by the announcement Agency (at present, almost no announcement agency is willing to receive orders)

6) Obtain CE certificate

7) Appointed EU authorized representative to complete European registration

Time estimate: 1-2 years, so this year is almost impossible!

 

Test standard

1) Biological evaluation: iso10993-1, - 5, - 10 (routine three items)

2) Bacterial filtration efficiency: en 14683:2019 Appendix B

3) Respiratory impedance: Annex C of EN 14683:2019

4) Splash resistance: ISO 22609:2004

5) Bioburden: Appendix D of EN ISO 11737-1:2018 and en 14683:2019 (no less than 5 tests in the same batch)

 

US medical mask export

Medical masks, which belong to non 510 (k) exempt products in FDA, not only need factory registration and product listing, but also need to prepare fda510 (k) documents, submit them to FDA for review, and only after passing the review can they enter the U.S. market.

1) The company cooperates to provide product materials, which are classified and confirmed by our company;

2) Our company provides the basic product information and documents required for the preparation of fda510k technical documents. Your company prepares test data and related products according to the list;

3) Fda510k application report is prepared by our company;

4) The company pays the fda510k audit fee, and our company submits the registration application to FDA;

5) The audit time is controlled by FDA, and other organizations have no right to control it. Some projects have long FDA inspection procedures;

6) After the 510k application is approved, the company will obtain the fda510k market pre payment notice (PMN letter) issued by FDA;

7) After the company pays the annual certification fee of FDA manufacturer, the company stops the enterprise registration and product listing;

8) The products were successfully exported to the United States.

 

FDA registration cycle of respirator during the outbreak: 1 week

 

Covid-19 emergency mask FDA code, the application process is as follows: (not applicable to N95 mask)

 

1) Provide product information, determine product category and determine application path;

 

2) Fill in the FDA application form;

 

3) Sign the contract and pay the agency fee, while the US agency service is signed and effective;

 

4) Pay US dollars to FDA;

 

5) Submit registration application materials to FDA for approval (enterprise registration and product listing);

 

6) Registration approval is completed and approval number is obtained;

 

7) Issue certificate of registration on behalf of the company;

 

8) The end of the project (FDA renews the next year's registration at the end of each natural year).