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 China | Category 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%) |
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 Requirement | ISO 45001 Clause | OHSAS 18001 Clause | OHSAS 18001 Requirement | Comment |
|---|---|---|---|---|
| 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 context | 4.1 | - | 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 parties | 4.2 | 4.4.3.2 | Participation 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 system | 4.3 | 4.1 | General requirements (in part) | No Change |
| OH&S management system | 4.4 | 4 4.1 | Management system General requirements | Minor Change |
| Leadership and worker participation (title only) | 5 | 4.4.3 | Communication, 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 commitment | 5.1 | 4.4.1 | Resources, roles, responsibility, accountability and authority | No Change |
| OH&S Policy | 5.2 | 4.2 | OH&S policy | No Change |
| Organizational roles, responsibilities and authorities | 5.3 | 4.4.1 | Resources, roles, responsibility, accountability and authority | No Change |
| Consultation and participation of workers | 5.4 | 4.4.3.2 | Participation and consultation | The organisation shall implement item a- item e |
| Planning (title only) | 6 | 4.3 | Planning (title only) | - |
| Actions to address risks and opportunities (title only) | 6.1 | 4.1 4.3.1 | General requirements Hazard identification, risk assessment and determining controls | - |
| General | 6.1.1 | 4.4.6 | Operational Control | - |
| Hazard identification and assessment of risks and opportunities (title only) | 6.1.2 | 4.3.1 | Hazard identification, risk assessment and determining controls | - |
| Hazard identification | 6.1.2.1 | 4.3.1 | Hazard identification, risk assessment and determining controls | No Change |
| Assessment of OH&S risks and other risks to the OH&S management system | 6.1.2.2 | 4.3.1 | Hazard identification, risk assessment and determining controls | Pay attention on "Assessemnt other risks to OH&S management system" |
| Identification of OH&S opportunities and other opportunities to the OH&S management system | 6.1.2.3 | - | New Requirement | Pay attention on "Assessemnt other opportunities to OH&S management system" |
| Determination of legal requirements and other requirements | 6.1.3 | 4.3.2 | Legal and other requirements | No change |
| Planning action | 6.1.4 | 4.4.6 | Operational Control | The organization shall take into account the hierarchy of controls |
| OH&S objectives and planning to achieve them (title only) | 6.2 | 4.3.3 | Objectives and programme(s) | - |
| OH&S objectives | 6.2.1 | 4.3.3 | Objectives and programme(s) | No Change |
| Planning to achieve OH&S objectives | 6.2.2 | 4.3.3 | Objectives and programme(s) | No Change |
| Support (title only) | 7 | 4.4 | Implementation and operation (title only) | - |
| Resources | 7.1 | 4.4.1 | Resources, roles, responsibility, accountability and authority | No Change |
| Competence | 7.2 | 4.4.2 | Competence, training and awareness | No Change |
| Awareness | 7.3 | 4.4.2 | Competence, training and awareness | No Change |
| Communication | 7.4 | 4.4.3.1 | Communication | No Change |
| General | 7.4.1 | 4.4.3.1 | Communication | No Change |
| Internal communication | 7.4.2 | 4.4.3.1 | Communication | No Change |
| External communication | 7.4.3 | 4.4.3.1 | Communication | No Change |
| Documented information (title only) | 7.5 | 4.4.4 4.5.4 | Documentation Control of records | No Change |
| General | 7.5.1 | 4.4.4 4.5.4 | Documentation Control of records | No Change |
| Creating and updating | 7.5.2 | 4.4.5 4.5.4 | Control of documents Control of records | No Change |
| Control of documented information | 7.5.3 | 4.4.5 4.5.4 | Control of documents Control of records | No Change |
| Operation (title only) | 8 | 4.4 | Implementation and operation (title only) | - |
| Operational planning and control (title only) | 8.1 | 4.4.6 | Operational control | - |
| General | 8.1.1 | 4.4.6 | Operational control | - |
| Eliminating hazards and reducing OH&S risks | 8.1.2 | 4.3.1 4.4.6 | Hazard identification, risk assessment and determining controls Operational control | No Change |
| Management of change | 8.1.3 | 4.3.1 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) | 8.1.4 | 4.4.6 | Operational control | - |
| General | 8.1.4.1 | 4.4.6 | Operational control | - |
| Contractors | 8.1.4.2 | 4.3.1 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 |
| Outsourcing | 8.1.4.3 | 4.3.2 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 response | 8.2 | 4.4.7 | Emergency preparedness and response | No Change |
| Performance evaluation (title only) | 9 | 4.5 | Checking (title only) | - |
| Monitoring, measurement, analysis and performance evaluation (title only) | 9.1 | 4.5.1 | Performance measurement and monitoring | - |
| General | 9.1.1 | 4.5.1 | Performance measurement and monitoring | - |
| Evaluation of compliance | 9.1.2 | 4.5.2 | Evaluation of compliance | No Change |
| Internal audit (title only) | 9.2 | 4.5.5 | Internal audit | No Change |
| General | 9.2.1 | 4.5.5 | Internal audit | No Change |
| Internal audit programme | 9.2.2 | 4.5.5 | Internal audit | No Change |
| Management review | 9.3 | 4.6 | Management review | Follow the discusssion item a- item g |
| Improvement (title only) | 10 | 4.6 | Management review | - |
| General | 10.1 | 4.6 | Management review | - |
| Incident, nonconformity and corrective action | 10.2 | 4.5.3 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 improvement | 10.3 | 4.2 4.3.3 4.6 | OH&S Policy Objectives and programme(s) Management review | Improvement action and record shall be maintained |
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.
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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