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.

ISO 45001 RequirementISO 45001 ClauseOHSAS 18001
Clause
OHSAS 18001 RequirementComment
Context of the organization (title only)4-New requirement
[see also 4.6 h) in Management review]
High Level Structure
Understanding the organization and its context4.1-New requirement
[see also 4.6 h) in Management review]
External Issue- Political, Economics, Social, Technology, Environment and Legal
Internal Issue - Strength, weakness, Opportunities & Threat
Understanding the needs and expectations of workers and other interested parties4.24.4.3.2Participation and consultation (in part)
[see also 4.6 b) and c) in Management review]
Interested Parties Identification - Shareholder, Top Mgt, Worker, Union, Safety Committee, Trade Rep, Subcon
Their Needs & expectation
Determining the scope of the OH&S management system4.34.1General requirements (in part)No Change
OH&S management system4.44
4.1
Management system
General requirements
Minor Change
Leadership and worker participation (title only)54.4.3Communication, participation and consultation (title only)ISO 45001 emphasizes that the issue of health and safety are now integrated into the overall organization's management system
Leadership and commitment5.14.4.1Resources, roles, responsibility, accountability and authorityNo Change
OH&S Policy5.24.2OH&S policyNo Change
Organizational roles, responsibilities and authorities5.34.4.1Resources, roles, responsibility, accountability and authorityNo Change
Consultation and participation of workers5.44.4.3.2Participation and consultationThe organisation shall implement item a- item e
Planning (title only)64.3Planning (title only)-
Actions to address risks and opportunities (title only)6.14.1
4.3.1
General requirements
Hazard identification, risk assessment and determining controls
-
General6.1.14.4.6Operational Control-
Hazard identification and assessment of risks and opportunities (title only)6.1.24.3.1Hazard identification, risk assessment and determining controls-
Hazard identification6.1.2.14.3.1Hazard identification, risk assessment and determining controlsNo Change
Assessment of OH&S risks and other risks to the OH&S management system6.1.2.24.3.1Hazard identification, risk assessment and determining controlsPay attention on "Assessemnt other risks to OH&S management system"
Identification of OH&S opportunities and other opportunities to the OH&S management system6.1.2.3-New RequirementPay attention on "Assessemnt other opportunities to OH&S management system"
Determination of legal requirements and other requirements6.1.34.3.2Legal and other requirementsNo change
Planning action6.1.44.4.6Operational ControlThe organization shall take into account the hierarchy of controls
OH&S objectives and planning to achieve them (title only)6.24.3.3Objectives and programme(s)-
OH&S objectives6.2.14.3.3Objectives and programme(s)No Change
Planning to achieve OH&S objectives6.2.24.3.3Objectives and programme(s)No Change
Support (title only)74.4Implementation and operation (title only)-
Resources7.14.4.1Resources, roles, responsibility, accountability and authorityNo Change
Competence7.24.4.2Competence, training and awarenessNo Change
Awareness7.34.4.2Competence, training and awarenessNo Change
Communication7.44.4.3.1CommunicationNo Change
General7.4.14.4.3.1CommunicationNo Change
Internal communication7.4.24.4.3.1CommunicationNo Change
External communication7.4.34.4.3.1CommunicationNo Change
Documented information (title only)7.54.4.4
4.5.4
Documentation
Control of records
No Change
General7.5.14.4.4
4.5.4
Documentation
Control of records
No Change
Creating and updating7.5.24.4.5
4.5.4
Control of documents
Control of records
No Change
Control of documented information7.5.34.4.5
4.5.4
Control of documents
Control of records
No Change
Operation (title only)84.4Implementation and operation (title only)-
Operational planning and control (title only)8.14.4.6Operational control-
General8.1.14.4.6Operational control-
Eliminating hazards and reducing OH&S risks8.1.24.3.1
4.4.6
Hazard identification, risk assessment and determining controls
Operational control
No Change
Management of change8.1.34.3.1
4.4.6
Hazard identification, risk assessment and determining controls
Operational control
Review Hazard identification, risk assessment and determining controls when change happen
Procurement (title only)8.1.44.4.6Operational control-
General8.1.4.14.4.6Operational control-
Contractors8.1.4.24.3.1
4.4.3.1
4.4.3.2
4.4.6
Hazard identification, risk assessment and determining controls
Communication
Participation and consultation
Operational control
Proper control and comunication with contractors including participation and consultation
Outsourcing8.1.4.34.3.2
4.4.3.1
4.4.6
Legal and other requirements
Communication
Operational control
ISO 45001 requires organisation control, monitor the outsourcing processes and also reduce the possible impact of outsourced activities
Emergency preparedness and response8.24.4.7Emergency preparedness and responseNo Change
Performance evaluation (title only)94.5Checking (title only)-
Monitoring, measurement, analysis and performance evaluation (title only)9.14.5.1Performance measurement and monitoring-
General9.1.14.5.1Performance measurement and monitoring-
Evaluation of compliance9.1.24.5.2Evaluation of complianceNo Change
Internal audit (title only)9.24.5.5Internal auditNo Change
General9.2.14.5.5Internal auditNo Change
Internal audit programme9.2.24.5.5Internal auditNo Change
Management review9.34.6Management reviewFollow the discusssion item a- item g
Improvement (title only)104.6Management review-
General10.14.6Management review-
Incident, nonconformity and corrective action10.24.5.3
4.5.3.1
4.5.3.2
Incident investigation, nonconformity, corrective action and preventive action (title only)
Incident investigation
Nonconformity, corrective action and preventive action
No Change
Continual improvement10.34.2
4.3.3
4.6
OH&S Policy
Objectives and programme(s)
Management review
Improvement action and record shall be maintained

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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