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Overview Β· 8 markets
A buyer-side primer on the global regulatory landscape for aesthetic equipment. Each market separates cosmetic-equipment rules from medical-device rules β we cover the cosmetic-equipment pathway, since that is where our current product range operates.
Covered in detail below
Cosmetic + medical, side by side
Linked .gov authorities
Verify before importing
Common confusions
Quick comparison
| Feature | Medical device | Cosmetic equipment |
|---|---|---|
| Classification | Class I/II/III with risk-based registration | General consumer electrical product |
| Time to market | 18β24 months notification + audits | Weeks (general electrical safety) |
| Cost | Notified body fees + ongoing audits | Manufacturing compliance only |
| Sales channel | Often prescription / licensed-only | General professional and consumer |
| Marketing claims | Diagnostic / therapeutic permitted | Cosmetic enhancement only |
| Our current range | Not applicable | β Where we sit |
Pre-purchase checklist
Identify your local cosmetic-equipment authority
Confirm electrical safety standard (CE / UKCA / FCC / KC / PSE / RCM / SASO)
Verify HS code with your customs broker (typically 8543.70 or 9019.10)
Confirm importer registration (EORI / CNPJ / trade licence)
Check operator licensing for your specific procedure
Review labelling and language requirements
Check individual product page for any medical-device clearance flags
How to read this hub
Determine whether your intended use is cosmetic (aesthetic enhancement without medical claims) or medical (diagnosis, treatment, therapy). The same equipment can fall in either category. Most aesthetic salon and consumer applications are cosmetic.
See the country tabs below. Each market has a medical-device authority and a separate cosmetic-equipment framework. Follow the cosmetic pathway for your imports.
If a specific product in our range carries medical-device clearance for your market, it is labeled on that product detail page. Default range positioning is cosmetic equipment.
By region
United States β FDA (medical) + FDA General Wellness Policy (cosmetic). State-level operator licensing varies. FDA detail β
Canada β Health Canada MDL (medical) + Cosmetic Notification (cosmetic). Quebec adds French-language obligations under Bill 96.
Brazil β ANVISA RDC (medical) + ANVISA cosmetic notification. Importer CNPJ required. State ICMS varies.
8 markets
FDA medical Β· General Wellness cosmetic Β· state operator licensing
EU MDR medical Β· Cosmetic Regulation 1223/2009 Β· LVD/EMC electrical
UK MDR + UKCA medical Β· Cosmetic Regulation 2013 Β· post-Brexit framework
TGA ARTG medical Β· RCM general electrical Β· state operator licensing
Health Canada MDL medical Β· Cosmetic Notification Β· Quebec Bill 96
PMDA θ¬ζ©ζ³ medical Β· ε粧ε cosmetic Β· PSE electrical
ANVISA RDC medical Β· cosmetic notification Β· CNPJ + ICMS
MOHAP medical Β· ESMA cosmetic Β· Dubai DHA Β· free zones
Common questions
Each country regulator independently determines the line between cosmetic and medical. Hardware that is cosmetic in one market may be medical in another, based on local risk classification and historical regulatory choices.
We provide technical data sheets, declarations of conformity for general consumer electrical safety, and HS code references. We cannot advise on your legal compliance β that is your authority call.