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Product positioning
Our current product range operates under cosmetic-equipment regulations worldwide โ not registered as medical devices. This page explains the difference between the two regulatory categories, the cosmetic pathway in each major market, and what to verify before importing. If a specific product in our range later carries medical-device clearance, it will be explicitly labeled on that product page.
The category we operate in
Two distinct regulatory categories worldwide. Our current product range sits in cosmetic equipment.
Equipment for cosmetic and aesthetic enhancement โ sold without medical, diagnostic, or therapeutic claims. Operates under general consumer electrical safety frameworks worldwide.
Typical examples
Salon-grade IPL ยท RF skin tightening ยท microneedling ยท body contouring ยท hair removal ยท microdermabrasion ยท cavitation ยท LED therapy โ when marketed for cosmetic enhancement
Regulatory pathway
Typical manufacturers: Professional aesthetic equipment manufacturers
Equipment marketed for diagnosis, treatment, or therapeutic purpose โ requires medical device registration in every market. Multi-year notification cycles, notified body audits, often prescription-only sale. Some products in our range may move into this category over time; any such product will be clearly labeled.
Typical examples
Surgical lasers ยท therapeutic body contouring with weight-loss claims ยท prescription-only dermatology equipment ยท diagnostic imaging ยท monitored treatment devices
Regulatory pathway
Typical manufacturers: Class II medical device manufacturers
Regulatory landscape
Each market separates medical-device regulation from cosmetic-equipment regulation. Below shows the authority for each, the medical framework you do not need, and the cosmetic pathway your import follows.
U.S. Food and Drug Administration (FDA)
Medical device framework
Medical devices fall under FDA Class I/II/III with 510(k) or PMA pathway. Operator licensing varies by state.
Cosmetic pathway (our category)
Cosmetic equipment operates under FDA General Wellness Policy and FDCA Section 201(i). Low-risk products promoting general wellness without specific disease claims fall outside FDA medical device scope.
MHRA โ Medicines and Healthcare products Regulatory Agency
Medical device framework
Post-Brexit UK MDR 2002 with UKCA marking required for medical devices.
Cosmetic pathway (our category)
Cosmetic equipment falls under Cosmetic Products Regulation 2013 and general consumer electrical product safety. UKCA marking applies to electrical safety, not medical certification.
National Competent Authority + Notified Body (per member state)
Medical device framework
EU MDR 2017/745 governs medical devices via CE marking issued by Notified Bodies.
Cosmetic pathway (our category)
Cosmetic equipment falls under Cosmetic Products Regulation (EC) 1223/2009 with national notification. Electrical safety via LVD 2014/35/EU and EMC 2014/30/EU.
TGA โ Therapeutic Goods Administration
Medical device framework
Medical and therapeutic devices require ARTG (Australian Register of Therapeutic Goods) listing.
Cosmetic pathway (our category)
Cosmetic equipment outside therapeutic claims falls under general consumer electrical safety (RCM mark). State health departments may regulate professional operator licensing.
Health Canada โ Medical Devices Directorate
Medical device framework
Medical Device Regulations classify devices Class I-IV. Class II+ requires Medical Device Licence (MDL).
Cosmetic pathway (our category)
Cosmetic equipment notified via Health Canada Cosmetic Notification โ lighter framework than medical device licensing. Quebec adds French-language documentation obligations (Bill 96).
PMDA โ Pharmaceuticals and Medical Devices Agency
Medical device framework
Medical devices (ๅป็ๆฉๅจ) under ่ฌๆฉๆณ. Class I-IV classification with PMDA approval/certification.
Cosmetic pathway (our category)
Cosmetic equipment (็พๅฎนๆฉๅจ) and ๅ็ฒงๅ fall outside ่ฌๆฉๆณ medical chapter. PSE (Product Safety Electrical Appliance) certification applies to electrical safety of all consumer products.
ANVISA โ Agรชncia Nacional de Vigilรขncia Sanitรกria
Medical device framework
Medical devices regulated under RDC norms. Importer requires CNPJ and ANVISA registration.
Cosmetic pathway (our category)
Cosmetic equipment notified via ANVISA cosmetic notification (Notificaรงรฃo) โ lighter framework than medical device registration. State ICMS varies.
MOHAP โ Ministry of Health and Prevention + ESMA
Medical device framework
Medical devices register with MOHAP. Dubai-specific rules administered by DHA.
Cosmetic pathway (our category)
Cosmetic equipment falls under ESMA general consumer product standards. Free zone setups have separate frameworks; mainland trade requires DED-issued trade licence.
Pre-purchase self-check
Confirm your intended use is cosmetic / aesthetic only
Diagnostic, therapeutic, or medical-treatment claims trigger different regulation in most markets. The same hardware can sit on either side of the line depending on how it is marketed and used.
Identify your local cosmetic-equipment regulator
See the Regions section above for the cosmetic pathway in your country. Bookmark the official site โ that is the source of truth, not vendor marketing.
Confirm the HS code your customs broker will declare
Aesthetic equipment typically classifies as HS 8543.70 (electrical machines with individual functions) or HS 9019.10 (mechano-therapy / massage apparatus). Final code is your broker call.
Verify importer registration requirements
Some markets require importer registration even for cosmetic equipment โ e.g. Brazil CNPJ, UAE trade licence, EU/UK EORI numbers.
Confirm electrical safety conformity for your market
CE / UKCA / FCC / KC / PSE / RCM / SASO etc. apply to consumer electrical products regardless of medical classification.
Check professional operator licensing in your jurisdiction
Some jurisdictions require licensed operators for specific equipment categories (e.g. IPL, RF, laser). Check with your local health or consumer protection authority.
Review packaging and labelling obligations
Language requirements (French in Quebec, Portuguese in Brazil, multi-language in EU). Electrical conformity marks where applicable.
Check the product page for individual product certification
If a specific product in our range carries medical-device clearance (FDA, CE MDR, TGA, etc.), it is labeled on that product detail page. Default range positioning is cosmetic equipment.
Common questions
Our current product range operates as cosmetic equipment โ not registered as medical devices. Cosmetic and medical are two distinct regulatory categories worldwide, and cosmetic equipment is the right category for the overwhelming majority of professional aesthetic salon, spa, and home-use applications. <strong>If a specific product in our range carries medical-device clearance, it will be explicitly labeled on that product page</strong> โ check the individual product detail page for current classification status.
Aesthetic use targets cosmetic improvement (skin appearance, body shape, hair) without diagnostic or therapeutic claims. Medical use involves diagnosis, treatment of disease, or therapeutic claims โ and falls under each country medical device framework. The same equipment can fall in either category depending on how you market, use, and document it. Most regulators look at the manufacturer and seller intended-use statements, not the hardware itself.
In most countries, yes โ aesthetic salon and spa use is generally within cosmetic equipment scope. Some jurisdictions require operator licensing (e.g. esthetician or cosmetologist licence in many US states; specific certifications for IPL or RF in EU and Australia). Check with your local consumer protection or health authority for your specific procedure and equipment type.
On request: technical data sheet (voltage, frequency, power rating, dimensions, weight, materials), declaration of conformity for general consumer electrical safety, commercial invoice with HS code suggestion, packing list, certificate of origin, ISPM-15 phytosanitary stamp confirmation for wood crates, factory ISO 9001 certificate. Country-specific shipment documentation is detailed on the /ship-to country pages.
If your broker is asking for medical-device documentation, the conversation is about your declared intended use. Most professional aesthetic equipment imports are clarified as cosmetic equipment and the request resolves. <strong>Check the specific product detail page</strong> โ if that product carries medical-device clearance, the supporting documentation is listed there. If your use case genuinely requires medical-device documentation that we do not currently hold for that product, talk to a Class II medical device manufacturer.
We provide technical specs, HS code references, and country-specific cosmetic-pathway documentation. We cannot advise on your legal compliance โ that is your authority call.