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Help CenterMassager Exported to Europe and the United States Need What Certification
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Massagers exported to Europe and the United States certification requirements
First, the European Union market mandatory certification CE certification of the core directives and standards:
Electromagnetic compatibility (EMC Directive): need to pass the EN 55014-1 (radiation) and EN 55014-2 (anti-interference) test
Low Voltage Directive (LVD): need to comply with the EN60335-1 (General Safety Requirements) and the EN 60335-2-32 (special safety standards for massage equipment) ROHS 2.0 Directive: Restrictions on lead, mercury, cadmium and other hazardous substances, need to submit a chemical substance test report Technical documentation requirements: including product manuals, circuitry, risk assessment reports, chemical substance testing report. ROHS 2.0 Directive: Restriction of lead, mercury, cadmium and other hazardous substances, need to submit chemical substance test reports
Technical documentation requirements: including product specifications, circuit design diagrams, risk assessment reports, Declaration of Conformity (DOC), etc.
Process: Laboratory testing, a preparation of technical documents → sign the DOC → affixed with the CE marking
Labeling and manuals
The product needs to be permanently marked with the CE marking, and the official language (e.g., English) of the European Union. The product must be permanently marked with the CE marking, and provide the EU official language (such as English, German) instructions
Second, the U.S. market certification requirements
UL1647 test report (Amazon mandatory)
test content: assessment of electrical safety, material flame retardancy, mechanical strength, etc., the applicable standards for UL1647 (personal care equipment safety standards) process: send samples to UL accredited laboratory testing → get a test report → submit to Amazon review FDA registration (if applicable) Scope of application: laboratory testing a preparation of technical documents → sign the DOC → paste the CE mark label and instructions Applicable)
Scope of application: If the product claims medical use (such as relief of cervical pain), need to be submitted to the FDA according to the Class I medical device business registration and product listing process: submit business information, product description → Get FDA registration number.
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