Industri Alat Kesehatan dalam Subgolongan 2101
Last updated · Sourced from OSS Indonesia
This group includes the manufacturing and processing of medical devices related to medical diagnosis and other products in subcategory 2011. This group encompasses the contraceptive product industry for external use, the medical diagnostic tools industry such as pregnancy tests, and the industry for medical pads, bandages, and similar items, as well as cosmetic cotton.
Operating license routes through Ministry of Health (Kemenkes) / BPOM, not OSS — Emerhub handles the application end-to-end.
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CPOB (Good Manufacturing Practice) certification mandatory for all production facilities.
BPOM Distribution Permit (NIE) required for each product SKU.
Foreign equity in branded pharmaceuticals open up to 100%; generic drugs may have local-partner requirements.
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.
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.
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.
Note. Pharmaceutical manufacturing (KBLI 21xxx) is on the PP 78/2019 Tax Allowance priority list.
Pharmaceutical manufacturing (CPOB facilities)
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.
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.
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.
We 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.
We 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.
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).
Documents and capabilities you must demonstrate at registration
Compliance and reporting duties throughout operation
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 |
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.
Ministry 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.
We file the OSS application with KBLI 21015 as your primary business activity, complete the risk-based assessment, and collect the NIB (Business Identification Number) for you — typically within hours of submission. You don't need to touch the OSS portal.
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. We prepare the application bundle, liaise with the competent ministry, and chase issuance through to the certificate. Statutory turnaround: 7 business days — real-world timing typically runs longer when site inspections or additional clarifications are requested.
Post-launch we run your monthly tax filings, quarterly LKPM (Investment Activity Reports), annual general meeting (RUPS), and any sector-specific reporting. You get a single point of contact and a monthly compliance digest — no Indonesian-language paperwork on your desk.
Class-level prerequisites that apply to every operator under this KBLI, independent of business scale. These commonly include minimum capital rules for PMA entities and spatial-planning (KKPR) conformance.
› Pharmaceutical companies must comply with the governance and operational procedures outlined in this regulation.
› This code is relevant as it covers pharmaceutical companies that were importing vaccines and related materials under the previous tax exemptions.
› This KBLI is impacted as it relates to the manufacturing of other pharmaceutical products that may involve controlled substances.
› Organizations dealing with narcotics must ensure compliance with the new categorization to prevent misuse.
› This code pertains to the manufacturing of pharmaceutical precursors, which are also subject to the new import/export regulations.
A plain-English explanation of this classification and the businesses it covers.
KBLI 21015 (Industri Alat Kesehatan dalam Subgolongan 2101) is the 5-digit Indonesian Standard Industrial Classification code for medical devices industry in subgroup 2101. It sits within Manufacturing Industry under the subgroup Pharmaceutical and Chemical Medicinal Product Industry (major group 21) in the official KBLI 2020 taxonomy maintained by Statistics Indonesia (BPS).
Any Indonesian or foreign-owned entity that intends to operate in medical devices industry in subgroup 2101 as a primary or secondary business activity must select this code on its NIB (Business Identification Number). The selected code determines the licensing instruments required, the issuing authority, and the ongoing compliance obligations.
Indonesia's OSS Risk-Based Approach uses the KBLI code to determine three things: (1) whether foreign investment is permitted and at what cap, (2) the risk-based licensing instruments required, and (3) the authority that issues each instrument. Choosing the wrong code can delay or invalidate your license.
Indonesia's BPS published the new KBLI 2025 taxonomy in early 2025. OSS, BKPM and the operating ministries have not yet adopted it — KBLI 2020 remains the active standard for business registration. This is what's coming for this specific code.
KBLI 21015 retains the same code number and scope in the new taxonomy. The activity description, hierarchy, and intended use of the code are preserved.
When OSS adopts KBLI 2025, we'll migrate your existing entity to the appropriate successor code as part of ongoing compliance — no action needed on your end now.
Talk to a specialistIndonesia's OSS Risk-Based Approach assigns a separate risk level for each of the four business scales. The licensing instruments required (NIB, Standard Certificate, Operating License) are determined by the risk level. Foreign-owned entities (PT PMA) must register at the Large scale, so the rightmost column applies to most foreign investors.
KBLI 21015 (Industri Alat Kesehatan dalam Subgolongan 2101) is the 5-digit Indonesian Standard Industrial Classification code for medical devices industry in subgroup 2101. It sits within the Manufacturing Industry category in the official KBLI 2020 taxonomy maintained by Badan Pusat Statistik (BPS).
Yes, KBLI 21015 is open to PMA at the class level, but Pres. Reg. 10/2021 carves out specific sub-activities that are restricted. A foreign investor can operate the unrestricted slices subject to the same BKPM Reg. 5/2025 capital rules.
KBLI 21015's risk levels per business scale: Micro High, Small High, Medium High, Large High. Foreign-owned entities (PT PMA) must register at the Large scale.
NIB + Operating Licence (Izin). KBLI 21015 is High risk at Large scale, so the Operating Licence requires substantive sector-regulator approval before the business can operate. Expect a multi-month review with technical submissions. 9 sector-specific PB UMKU permits also apply depending on the exact activity. See the requirements summary at the top of the page. Plus one basic requirement (KKPR) at the class level.
Sector regulator override: No fixed minimum, but GMP-compliant facility build typically IDR 50-100 billion+ required by BPOM / Kemenkes under PMK 26/2018 (Pelayanan Perizinan Berusaha Terintegrasi Sektor Kesehatan). This is higher than BKPM Reg. 5/2025's default IDR 2.5 billion paid-up; the higher number wins.
PT PMA setup typically takes 4-8 weeks: AHU registration (1-2 weeks), NIB issuance via OSS (immediate to 1 week), bank account opening (2-4 weeks). The licensing cycle for KBLI 21015 specifically takes 7 days at the Large business scale.
Yes — KBLI 21015 is on the Tax Allowance priority list (PP 78/2019). Eligible for 30% reduction of taxable net income over 6 years plus accelerated depreciation.
Authority depends on the investor profile. For PMA: Minister/Head of Agency. For domestic SME scale: typically Governor (for Provincial scope) or Regent/Mayor (Regency/City scope). Specific mapping is in §1 of this page.
Beyond the NIB, KBLI 21015 carries 9 PB UMKU permits across 1 sector regulator: Health & Medical Devices (9). Most operations only need 2-4 of these — the relevant set depends on which specific activities you actually perform; Emerhub maps the right subset before filing.
KBLIs in the same subgroup 2101: 21011 (Pharmaceutical Materials Industry for Humans); 21012 (Pharmaceutical Products Industry for Humans); 21013 (Animal Pharmaceutical Industry); 21014 (Pharmaceutical Industry for Animals). These are closely related activities — see the related-codes section below for full list.