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Medical device equipment health retail stethoscope
KBLI 47725★ Gold-Tier Intel

Medical Device Retail

Perdagangan Eceran Alat Kesehatan untuk Manusia

🛒 Section G — Wholesale & Retail Trade

✅Open· 100% ForeignMedium-Low RiskDirect Match

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.

Licensing & Requirements

What You Need

Risk LevelMedium-Low (Menengah Rendah)
License TypeNIB dan Sertifikat Standar
ProcessingOtomatis
Foreign Ownership100% Open
AuthorityBKPM / OSS
PP28/2025 Licensing Data1 scale
Mikro, Kecil, Menengah, BesarMedium-Low RiskNIB dan Sertifikat Standar⏱ OtomatisFiktif Positif
Post-License Obligations4
Menyediakan: a. Data Sumber Daya Manusia (SDM) b. Data sarana dan prasarana c. Daftar alat kesehatan yang dijual
Memiliki penanggung jawab pendidikan Diploma III dan telah mengikuti pelatihan pengelolaan toko alat kesehatan yang baik
Mengedarkan produk alat kesehatan tertentu yang telah memiliki izin edar
Menyampaikan laporan kegiatan usaha secara berkala setiap 6 bulan

→ Submit periodic business activity reports to regulator

All scales (Mikro/Kecil/Menengah/Besar)

Authority

Timeline

PMA

The izin edar requirement — the product-level gate

Step-by-step for a PT PMA medical device retail store

1
PT PMA incorporation— notary deed, AHU registration (~2–3 weeks)
2
Curate your product catalog— before applying for SS, confirm every product has a valid Kemenkes izin edar; products without izin edar cannot be stocked
3
For imported devices you distribute yourself: apply for API-U (Angka Pengenal Importir Umum) and obtain izin edar through PAK (Penyalur Alat Kesehatan) registration— this process takes 3–12 months per product category
4
For products already distributed by licensed PAK:— source from a registered Penyalur Alat Kesehatan who holds the izin edar; your role is retail only
5
NIB via OSS— register on oss.go.id, select 47725, Menengah Rendah path
6
SS application— OSS routes to Bupati/Walikota DPMPTSP; Otomatis issuance
7
Total timeline: 3— 5 weeks for store licensing; product izin edar procurement is the long-lead item (outsource by buying from licensed PAK to avoid this)

Post-issuance obligations

2020 → 2025

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

🏝The izin edar in practice
🛍
Read Full Guide on Bali Zero↗

KBLI 2025 Retail & E-Commerce: Online Selling, Boutiques & Specialty Shops

kita.balizero.com
Foreign Workers

TKA Eligible Positions

Kepmenaker 228/2019 — Category 16: Konstruksi

181 in category
1321Operational ManagerManajer Operasional
1324Purchasing ManagerManajer Pembelian
1321General ManagerManajer Umum
1324Procurement ManagerManajer Pengadaan
1324Technical ManagerManajer Teknis
3115Mechanical AdvisorPenasihat Permesinan
3115Machine Maintenance AdvisorPenasihat Perawatan Mesin
3113Electrical AdvisorPenasihat Kelistrikan
2144Mechanical EngineerAhli Mesin
2144Mechanical Maintenance EngineerAhli Perawatan Mesin

Kepmen 228/2019 lists 181 TKA-eligible positions in this category. Selection optimized using ISCO classification methodology.

KEDUA Provision — Directors & Commissioners Exemption
Directors and Commissioners who do NOT manage personalia can work without being listed in the jabatan.
Complementary Codes

Related Codes

47711Section G★

Clothing Retail

Perdagangan Eceran Pakaian

→
✅Open· 100% ForeignLow Risk
47712Section G★

Footwear Retail

Perdagangan Eceran Sepatu, Sandal, dan Alas Kaki

→
✅Open· 100% ForeignLow Risk
47713Section G

Clothing Accessories Retail

Perdagangan Eceran Perlengkapan Pakaian

→
✅Open· 100% ForeignLow Risk
47714Section G★

Bags, Wallets & Luggage Retail

Perdagangan Eceran Tas, Dompet, Koper, Ransel, dan

→
✅Open· 100% ForeignLow Risk
47721Section G★

Pharmacy (In-Store)

Perdagangan Eceran Sediaan Farmasi untuk Manusia di

→
✅Open· 100% ForeignMedium-High Risk
47722Section G★

Pharmacy (Standalone)

Perdagangan Eceran Sediaan Farmasi untuk Manusia

→
✅Open· 100% ForeignMedium-Low Risk
Zantara AIOSS Intelligence System
Context47725
Opening a medical device store in Bali? Your SS license comes automatically — but every product needs its own Kemenkes izin edar before you can sell it. Most investors miss this. Here's the full two-layer requirement.