If masks imported from Europe and America need to be sold, they must obtain CE (European certification) and FDA certification (US certification) before they can be sold in the European and US domestic markets. Below is a summary of the European regulatory requirements for the export of medical masks and protective masks, as well as the FDA regulatory requirements for exports to the United States, including the details of applying for certification

The EU market

There are two main differences in the management of masks in the European market: personal protective masks and medical masks.

. Personal protective masks are mainly used for industrial protection, while medical masks are mainly used in hospitals

1. Medical masks

The corresponding European standard for medical masks is EN14683, which is pided into three categories based on BFE, respiratory impedance, and splash resistance: Type I, Type II, and Type IIR According to the European Medical Regulations 2017/745/EU, masks can be managed as Class I devices. According to whether the product is sterile or non sterile, the certification mode is different.

(1) Non sterile: follow the path of self compliance declaration, without the need for institutional review. The processing process is as follows:

a. Write CE MDR technical documents B. Find an authorized representative from the European Union C. Develop DOC; Register products in Europe

(2) Sterility: If masks and protective clothing are sterile and are products of Is in the European Union, the processing process is as follows:

a. Establish an ISO13485 quality management system B. Write CE MDR technical documents C. Find an authorized representative from the European Union D. Obtain ISO13485 certificate and CE certificate issued by the notified body

2. Protective masks

The European standard for protective masks is EN149, which is pided into three categories: FFP1/FFP2/FFP3 according to the standard. Protective masks need to meet the requirements of the European Union Personal Equipment Directive (PPE), and they belong to the complex design of products. Exporting to the European Union requires authorized notified bodies to conduct certification and issue certificates. The required information for certification includes:

(1) product type test reports

(2) technical document review

(3) factory quality system

The US market

The US regulations also differentiate between medical masks and industrial protective masks, with medical masks controlled by FDA and protective masks controlled by NIOSH

1. Medical masks

The regulatory agency for medical masks in the United States is the FDA. In the FDA system, masks are classified as surgical masks, pediatric masks, and surgical masks with antibacterial/antiviral agents.

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Function of testing report:

1. Project bidding: Issue authoritative third-party CMA/CNAS qualification report

2. Online e-commerce platform entry: Quality inspection report recognized by major e-commerce platforms

3. Used as a sales report: issuing legally effective testing reports to make consumers more confident

4. Papers and research: Provide professional personalized testing needs

5. Judicial services: providing scientific, fair, and accurate testing data

6. Industrial problem diagnosis: Verify the troubleshooting and correction of industrial production problems

100% inspection and testing process:

1. Telephone communication and confirmation of requirements

2. Recommend solutions and confirm quotations

3. Mail samples and arrange testing

4. Progress tracking and result feedback

5. Provide reports and after-sales service

6. If urgent or priority processing is required

Testing and testing characteristics:

1. The testing industry is fully covered, meeting different testing needs

2. Fully cover the laboratory and allocate localized testing nearby

3. Engineers provide one-on-one services to make testing more accurate

4. Free initial testing, with no testing fees charged

5. Self service order delivery for free on-site sampling

6. Short cycle, low cost, and attentive service

7. Possess authoritative qualifications such as CMA, CNAS, CAL, etc

8. The testing report is authoritative and effective, and is generally used in China