Aesthetic and wellness devices.
Class A–B devices for aesthetic, dermatology, and longevity practice.
Aesthetic and wellness devices are the category in which Southeast Asia has been a residual market and is becoming a first-class one. Decoded represents Class A and Class B devices — primarily energy-based, light-based, and topical-application devices — for clinic-led distribution. The firm is selective: device launches require a regulatory dossier per market, a clinical-evidence pack a practitioner respects, a service-and-warranty footing the firm can stand behind for the contract term, and pricing that does not collapse the brand on entry into Indonesia, Vietnam, and the Philippines.
The opportunity.
- Class A–B
- Risk classification scope
- Clinic-direct
- Channel posture
- ASEAN-MD
- Harmonisation lens
Regulatory landscape.
Medical-device classification under ASEAN Medical Device Directive lineage, with country-specific dossier requirements in SG (HSA), MY (MDA), ID (BPOM), TH (Thai FDA), VN (DAV), PH (FDA). Reimbursement landscape evolving — covered in Journal F.5.
Channel landscape.
Direct distribution to dermatology and aesthetic practices, hospital outpatient, longevity clinics, and a small set of contracted training partners. No third-party reselling.
What Decoded looks for in a devices brand.
- 01
ISO 13485 manufacturing with current notified-body or comparable audit.
- 02
Clinical-evidence pack at a standard a Singapore-trained practitioner respects.
- 03
Service-and-warranty footing the firm can underwrite across the contract term.
- 04
Per-SKU regulatory classification clear enough to file in parallel across at least four markets.
- 05
Pricing architecture that survives Singapore reference, Malaysian listing, and Indonesian import duty.