Medical Device Retail
Perdagangan Eceran Alat Kesehatan untuk Manusia
🛒 Section G — Wholesale & Retail Trade
Retail sale of medical devices and health equipment — the license for stores selling blood pressure monitors, glucometers, wheelchairs, crutches, hospital beds, nebulizers, surgical instruments, and other alat kesehatan. **Every single product you sell must hold a valid izin edar (market authorization) from the Ministry of Health (Kemenkes).** The izin edar is product-specific, not store-specific — your store license (SS) covers the right to operate; the izin edar covers the right to sell each individual device. Foreign investors in Bali's health tech and medical tourism supply chain often miss this two-layer requirement.
What You Need
PP28/2025 Licensing Data1 scale
Post-License Obligations4
→ Submit periodic business activity reports to regulator
All scales (Mikro/Kecil/Menengah/Besar)
Risk: Menengah Rendah (Medium-Low). NIB + Sertifikat Standar (SS) — automatic issuance (Otomatis) by Bupati/Walikota via OSS.
Authority
Bupati/Walikota (district/city head).
Timeline
Otomatis — automatic SS issuance, no initial physical inspection.
Terbuka — 100% foreign ownership allowed.
The izin edar requirement — the product-level gate
Every medical device sold in your store needs its own izin edar alat kesehatan from Kemenkes (Direktorat Jenderal Kefarmasian dan Alat Kesehatan). Without it, the device cannot legally be sold in Indonesia — even if your store license (SS 47725) is valid. This is not optional and not grandfathered.
How to verify: check the national SIHALKES database (regalkes.kemkes.go.id). Every legitimate medical device should show a registered izin edar with SKU, manufacturer, and importer details.
Step-by-step for a PT PMA medical device retail store
Post-issuance obligations
- Only sell products with valid izin edar — inspectors cross-reference SIHALKES
- Maintain procurement records showing izin edar numbers
- Report product incidents/complaints to Kemenkes
- Periodic reports to Dinas Kesehatan
New KBLI 2025 code — did not exist in KBLI 2020. Previously, medical device retail may have been classified under general retail or pharmaceutical retail. PP28/2025 creates this as a distinct, dedicated classification requiring specific SS.
Bali Intelligence
Why medical device retail matters in Bali
Bali's expanding medical tourism corridor (Sanur-Denpasar-Ubud) has created genuine demand for:
- Home healthcare equipment for long-stay expats and retirees (blood pressure monitors, glucometers, nebulizers, mobility aids)
- Sports medicine/rehabilitation devices (braces, compression gear, physiotherapy equipment) for the active expat and digital nomad demographic
- Clinic supply — smaller clinics in tourist areas sometimes source consumables and non-critical devices from retail stores rather than wholesale PAK channels
Current market reality: Bali has relatively few specialist medical device retailers. Guardian and Watson's pharmacies carry limited ranges. The gap between clinic supply and retail consumer demand is underserved — a genuine business opportunity.
The hardest part of this business is not the SS license — it's ensuring your entire catalog has valid Kemenkes izin edar. Common categories:
- Blood pressure monitors, glucometers, thermometers — most major brands (Omron, Accu-Chek, Beurer) have registered izin edar through Indonesian distributors
- Mobility aids (wheelchairs, crutches) — patchy coverage; generic unbranded imports often lack izin edar
- Cosmetic devices (facial massagers, LED therapy devices) — regulated as Alat Kesehatan Rumah Tangga Kelas 1 — require izin edar but classification is easier than medical-grade devices
PMA strategy: Most PMA entrants take the retail-from-PAK path: source products from licensed Penyalur Alat Kesehatan (PAK) who already hold the izin edar, rather than importing and registering devices directly. This trades gross margin for speed-to-market. Once volume grows, direct import + own izin edar registration becomes economically justified.
KBLI 2025 Retail & E-Commerce: Online Selling, Boutiques & Specialty Shops
kita.balizero.comTKA Eligible Positions
Kepmenaker 228/2019 — Category 16: Konstruksi
Kepmen 228/2019 lists 181 TKA-eligible positions in this category. Selection optimized using ISCO classification methodology.
KEDUA Provision — Directors & Commissioners Exemption
- 47721 — Apotek/Pharmacy (if your store also sells OTC medications or prescription drugs)
- 47722 — Toko Obat (if OTC meds and supplements are part of your product range but not prescription)
- 46471 — Wholesale Medical Devices / PAK (if you want to supply other clinics and retailers, not just sell retail)
- 86105 — Private Clinic (if your device store is co-located with a clinic)
Related Codes
Clothing Retail
Perdagangan Eceran Pakaian
Footwear Retail
Perdagangan Eceran Sepatu, Sandal, dan Alas Kaki
Clothing Accessories Retail
Perdagangan Eceran Perlengkapan Pakaian
Bags, Wallets & Luggage Retail
Perdagangan Eceran Tas, Dompet, Koper, Ransel, dan
Pharmacy (In-Store)
Perdagangan Eceran Sediaan Farmasi untuk Manusia di
Pharmacy (Standalone)
Perdagangan Eceran Sediaan Farmasi untuk Manusia