Foreign Investor FeasibilityKBLI 21015
§ 01
Foreign investment rules
Indonesia's BUPM (Investment Business Fields) regulation places this code into one of five tracks. The track determines whether a foreign investor (PMA) can operate in this activity at all, and under what conditions.
Status · Open with carve-outs
Open to foreign investment, with carve-outs
KBLI 21015 is open as a class — a 100% foreign-owned PT PMA can be incorporated under this code — but Pres. Reg. 10/2021 carves out 1 specific sub-activity that are off-limits or restricted for foreign capital. The rest of the activity remains open to PMA. The carved-out items are listed below; any of them needs to be either avoided, served via an Indonesian operator, or structured around case-by-case.
Listed restrictions
Requires SME / cooperative partnership
1- Class A medical device industryPartnership with Cooperatives and UMKMSector: Health
Tax incentives
Foreign-investor tax benefits available for this KBLI under PMK 130/2020 (Tax Holiday) and PP 78/2019 (Tax Allowance). Both require approval — see the linked guide for the application path.
Eligible for Tax Allowance
30% reduction of taxable net income over 6 years, accelerated depreciation, 10-year loss carryforward. Mutually exclusive with Tax Holiday.
Note. Pharmaceutical manufacturing (KBLI 21xxx) is on the PP 78/2019 Tax Allowance priority list.
Sector capital requirement
Higher minimum capital required by BPOM / Kemenkes
Pharmaceutical manufacturing (CPOB facilities)
Required paid-up
No fixed minimum, but GMP-compliant facility build typically IDR 50-100 billion+
Regulation
PMK 26/2018 (Pelayanan Perizinan Berusaha Terintegrasi Sektor Kesehatan)
Note. CPOB certification is the binding gate, not a flat capital number — meaningful capex needed for clean-room facility build.
BKPM Reg. 5/2025's default is IDR 2.5 billion paid-up + IDR 10 billion commitment per KBLI. The figure above is the binding override for this activity — the higher number wins.
§ 02
Regulations governing KBLI 21015
Current status, what each regulation actually requires for this activity, and how it ties to the PB UMKU sector permits below. Click through for the plain-English summary.
- President of the Republic of Indonesia
- House of Representatives of the Republic of Indonesia
- Indonesia, Kementerian Kesehatan
§ 03
How we handle your KBLI 21015 setup
Emerhub is a corporate-services provider in Indonesia. We do the legal and regulatory legwork for foreign investors so you can focus on the business itself. Here's what the engagement looks like.
- 1
Confirm the optimal structure for your business
2–3 business daysWe confirm KBLI 21015 is the right primary code for your business, advise on secondary codes you may also need, and finalize the holding structure with you before any filing.
What we need from you- Founders' passport copies and proof of residence
- Intended share split and board composition
- 2
Incorporate your PT PMA
7–10 business daysWe draft the Articles of Association before a notary, register the entity with the Ministry of Law & Human Rights (Kemenkumham), and obtain the company's tax ID (NPWP). Under BKPM Reg. 5/2025, paid-up capital is IDR 2.5 billion (~USD 160K) — the cash actually deposited at incorporation. The IDR 10 billion+ figure many sources still cite is the total investment commitment per KBLI, realised over time via your LKPM reports.
Get an exact quote and timeline for KBLI 21015, scoped to your specific business plan.
Request a quote§ 06
Licensing requirements in detail
Specific permits, application requirements and ongoing obligations vary by business scale and the sub-activity within this KBLI. We file these on your behalf — this section is for transparency on what we'll be handling. Switch between scales below; by default we show Large (the PMA scale).
What's required to operate
NIB
Preparation only — additional permit needed below
Operating License (Izin)
Important: NIB is issued for the preparation stage. Commercial operation requires a full Operating License (Izin) issued by the competent ministry after a substantive review of the operator's capability, facility, and compliance. Operating with NIB alone exposes the entity to penalties, blacklisting, and contract invalidation.
Processing time
7Days
Statutory turnaround
Application requirements
8Documents and capabilities you must demonstrate at registration
- 01Have a document outlining the plan for the type, specifications, quantity, and source of raw materials, as well as the source and amount/volume of energy and water needed to carry out industrial business activities for 1 (one) production cycle or for a duration of 6 (six) months ahead.
- 02Have documents in the form of: a. Machine specifications and/or equipment list b. Photos of machines/equipment c. Sales/rental agreement that proves: 1) Control (ownership/rental) of machines to produce health equipment industry products and quality testing equipment 2) Compliance of installed production capacity with business data
- 03Have a human resources organizational structure document that includes at least: a. Company leadership, Head of production, Head of quality control, Head of human resources development, and/or b. Head of marketing.
- 04Have a flowchart document for: a. Procurement, receipt, and storage of raw materials b. Production process c. Quality control process d. Packaging, storage, transportation, and distribution of production results
- 05Possess documentation in the form of photos proving the availability of occupational accident handling facilities and rest areas for workers.
- 06Have documents outlining the specifications and intended use of the produced goods.
- 07Have a work agreement document that proves the ownership of employees working as Technical Responsible Person (PJT) for Medical Devices.
- 08Have a Statement of Commitment to Comply with Good Manufacturing Practices (GMP) for Medical Devices.
Ongoing obligations
6Compliance and reporting duties throughout operation
- 01Have proof of submission of mandatory validated Industrial Data every 6 (six) months in accordance with the laws and regulations in the industrial sector.
- 02Ensure the safety and security of equipment, processes, production results, storage, and transportation, in accordance with applicable laws and regulations.
- 03Possess periodic calibration documents for quality control equipment or periodic results from independent laboratory tests on the produced products.
- 04Have a document in the form of a disaster evacuation SOP, including the arrangement of workplace safety signs.
- 05Possess a Quality Management System certificate (ISO 9001).
- 06Have at least 1 (one) Technical Responsible Person who has a Good Manufacturing Practice (GMP) training certificate for Medical Devices.
Issuing authority
The authority that issues the license depends on your situation.
| Authority | Applies when |
|---|---|
| Minister/Head of Agency | All of them |
| Minister/Head of Agency | Foreign Investment |
§ 05
Auxiliary permits (PB UMKU)
PB UMKU permits sit on top of the main NIB and Sertifikat Standar — each is issued by a different ministry, and only when a specific operational activity is performed. This KBLI carries 9 candidate permits across 1 regulator; most operations only need a handful. Emerhub maps your operation to the exact set, files them, and tracks renewals.
Health & Medical Devices
9 permitsMinistry of Health (Kemenkes / BPOM). Applies to manufacturing, importing, distributing, or operating medical devices, hospitals, clinics, diagnostic services, and pharmacies. Most device permits are class-based (Class A/B/C/D); facility permits attach to the specific site.
- Certificate of Good Manufacturing Practices for Household Health Supplies (CPPKRTB)Sertifikat Cara Pembuatan Perbekalan Kesehatan Rumah Tangga yang Baik (CPPKRTB)14 requirements1 obligationMinistry of Health
- Certificate of Good Manufacturing Practices for Medical Devices (CPAKB)Sertifikat Cara Pembuatan Alat Kesehatan yang Baik (CPAKB)14 requirements1 obligationMinistry of Health
- Domestic distribution license for medical devicesIzin edar alat kesehatan dalam negeri6 requirements5 obligationsMinistry of Health
- Domestic Health Supply Distribution License (PKRT)Izin edar Perbekalan Kesehatan Rumah Tangga (PKRT) dalam negeri6 requirements5 obligationsMinistry of Health
Speak to Emerhub
Get your KBLI 21015 setup handled end-to-end.
Emerhub is a corporate-services provider in Indonesia. We handle PT PMA incorporation, licensing, tax registration and monthly compliance — so you focus on operating the business.