A hair-removal device is a regulated product almost everywhere it is sold. The approvals below are the ones MLAY holds and can evidence; the certificates themselves are available to appointed partners on request.
Product approvals
Individual models carry the approvals their markets require. The specification sheet on each product page lists exactly which ones that model holds — approvals are granted per device, not per company, and a certificate held for one model does not cover another.
Quality system
The factory operates an ISO 13485 quality management system for medical devices, audited under MDSAP so that a single audit satisfies several regulators at once. Social compliance is certified to SA8000.
Requesting documents
Appointed distributors receive the full dossier for their market as part of the appointment. If you are evaluating MLAY and need to see a specific certificate before you commit, ask — we would rather you checked.
Certified where you sell
Our products hold China NMPA, United States FDA, Japan PSE, EU CE, Middle East SFDA, Australia TGA and Canada MDL approvals.
Every approval MLAY holds
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FDA
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CFDA
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ISO 13485
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ISO 13485 (QMS)
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PSE (Denan)
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SFDA
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CE
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METI
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PSE
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RoHS
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RoHS NPS
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SA8000
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SGS
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National High-tech Enterprise
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Design Patent
Request certification documents
Tell us the models and the market and we will send the relevant certificates.