Steps Guide to import China KN95 Face Mask to EU Countries

In China, there are two major type of Face Mask- 3 ply Face Mask and KN95 Face Mask.

The EU Medical Device Directive /Medical Device Regulation and Personal Protective Equipment Regulation control and regulate the import and sales of Face Mask in Europe.

The below table show the different regulations between China Regulation and EU Directive & Regulation. The China Face Mask Manufacturer should comply with both regulation before import the Face Mask to EU Market.

Category of Face Mask in ChinaCategory of Face Mask in Europe
Face Mask (GB/T32610-2016)
Respiratory protection Mask (GB 2626-2006)
KN90(90%), KN95(95%), KN 100(99.7%)
Personal Protective Equipment
Personal Protective Face Mask
EN149:2001 +A1:2009
3 Type : FFP1, FFP2 and FFP3
Disposable Surgical Face Mask (YY0469-2011)
Medical ace Mask (YY/T0969-2013)
Medical Device
Medical Face Mask EN14683:2019 Medical Masks Type I (95%), Type II (98%), Type IIR (98%)
KN 95 CE Certification

There are three popular Face Masks in China. There are 3 individual  ways to import to EU market. The Table may give you the hints and steps how to get CE Mark.

Mask CategoryMedical Mask (Non Sterile)Medical Mask ( Sterile)Personal Protective Equipment
Directive / RegulationMedical Device Directive / Medical Device RegulationMedical Device Directive / Medical Device RegulationPersonal Protective Regulation
CategoryMedical Device
Class I (non Sterile)
Medical Device
Class I (Sterile)
PPE
(Category III)
Harmonised StandardEN 14683EN 14683 & Sterilization Standard EN 149
Technical FileRequiredRequiredRequired
Quality SystemRequiredRequiredRequired
Conformity AssessmentSelf DeclarationAssessment by Notified BodyAssessment by Notified Body
CE CertificateNot Necessary1 Copy 2 Different Copies
Declaration o conformityRequiredRequiredRequired
CE MarkRequiredRequired
(CE plus 4 digit of Notified body number)
Required
(CE plus 4 digit of Notified body number)

Call us for CE Mark Certification NOW ! Tel : 23664622

Personal Protective Equipment

According to the EU PPE regulation requirements, Manufacturer / Importer must have the (Module B) and (Module C2) CE certificate / (Module D) CE certificate issued by the notified body to be sold in the EU.

The (Module C2) CE certificate is valid for half a year. The notified body needs to conduct a Module D review within half a year. Afterwards, the (Module C2) CE certificate will be replaced by the (Module D) CE certificate.

Manufacturer must obtain at least two Module B certificate together with (Module C2) or the (Module D) certificate from the notified body.

KN95 China get CE Certification

If you need further information about CE Mark Certification procedures, please leave contact information info@gabriel.hk / call 2366 4622 for enquiry.

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