Legal Updates

Business Licensing Reform in the Health Sub-sector under Minister of Health Regulation Number 11 of 2025

4/11/2025
Ivonnie Wijaya, Steven Aristides Wijaya
Legal Updates
Reformasi Perizinan Berusaha di Sub-sektor Kesehatan melalui Permenkes Nomor 11 Tahun 2025

Summary

Minister of Health Regulation Number 11 of 2025 concerning Business Activity Standards and Product/Service Standards in the Implementation of Risk-Based Business Licensing for the Health sub-sector (“MoH Regulation 11/2025”) was issued by the Minister of Health on October 3, 2025 and took effect on its date of promulgation on the same date. This Regulation was issued as a mandate to implement further provisions of Government Regulation Number 28 of 2025 concerning the Implementation of Risk-Based Business Licensing (“GR 28/2025”).

The main objective of this regulation is to establish standards, norms, and criteria that serve as the sole reference in the implementation of risk-based business licensing (PBBR) throughout the health sub-sector. The regulation aims to enhance the investment ecosystem, facilitate ease of doing business, and ensure transparent and accountable supervision.

Background and Context

MoH Regulation 11/2025 was issued to implement the mandate of GR 28/2025 concerning the Implementation of Risk-Based Business Licensing. As stipulated in the 'Considering' section, the aforementioned PP mandates every technical minister to establish business activity standards and product/service standards specific to their sector.

This MoH Regulation serves to fulfill this mandate for the health sub-sector. Its main objective, as stipulated in Article 3, is to enhance the investment ecosystem and ease of doing business. This is manifested in two ways: 

  1. making the issuance of Business Licenses [Perizinan Berusaha (PB)] and Business Licenses to Support Business Activities [Perizinan Berusaha Untuk Menunjang Kegiatan Usaha (PB UMKU)] in the health sector more effective and simpler; and

  2. creating a supervision and sanctioning system that is more transparent, structured, and accountable.

Comparison with Previous Regulations

MoH Regulation 11/2025 serves to replace and revoke standards previously stipulated in several regulations. MoH Regulation 11/2025 revokes:

  1. Minister of Health Regulation Number 26 of 2018 concerning Electronically Integrated Business Licensing Services for the Health Sector (“MoH Regulation 26/2018”).

  2. Minister of Health Regulation Number 14 of 2021 concerning Business Activity and Product Standards in the Implementation of Risk-Based Business Licensing for the Health Sector (“MoH Regulation 14/2021”)

  3. Minister of Health Regulation Number 8 of 2022 concerning the Amendment to Minister of Health Regulation Number 14 of 2021 concerning Business Activity and Product Standards in the Implementation of Risk-Based Business Licensing for the Health Sector (“MoH Regulation 8/2022”).

  4. Minister of Health Regulation Number 17 of 2024 concerning the Second Amendment to Minister of Health Regulation Number 14 of 2021 concerning Business Activity and Product Standards in the Implementation of Risk-Based Business Licensing for the Health Sector (“MoH Regulation 17/2024”).

Aspect MoH Regulation 14/2021, MoH Regulation 8/2022, and MoH Regulation 17/2024 MoH Regulation 11/2025
Focus of Partial Amendments MoH Regulation 8/2022 specifically amended standards related to dialysis services. MoH Regulation 17/2024 amended standards for Pharmacies, Clinics, Dialysis, Hyperbaric, PBF, and Hygiene Sanitation. This regulation comprehensively establishes new standards for all PB and PB UMKU in the health sub-sector, replacing standards that were previously stipulated in various places and amended partially.
Grouping of License Standards Business activity and product standards were regulated jointly in one Annex. Licenses are grouped more clearly within the body of the regulation (Articles 4-6) into Business Licenses (PB) (main licenses) and Business Licenses to Support Business Activities (PB UMKU) (supporting licenses), with technical details in the Annex.
Transitional Provisions The transitional provisions of MoH Regulation 17/2024 (second amendment to MoH Regulation 14/2021) provided 1 year for business actors who already held licenses to adjust. Applications being processed before the new OSS system (based on GR 28/2025) is ready will continue to be processed using MoH Regulation 14/2021 (and its amendments). Previously issued licenses remain valid.

Key Provisions

The main substance of this regulation is reflected in several key provisions:

Regulatory Aspect Description Article
Grouping of Business Licenses (PB)

PB for the health sub-sector is grouped into 3 main business activities:

  1. Health Services (Hospitals, Clinics, Healthy Homes, Healthy Centers, Medical Labs, Eye Banks, etc.).
  2. Pharmaceuticals, Medical Devices, & PKRT (PBF, Pharmacies, Drug Stores, Medical Device Distributors, etc.).
  3. Vector and Disease-Carrying Animal Control.
 Article 4 paragraph (1), Article 5
Grouping of PB UMKU

PB UMKU (supporting) is grouped into 3 types:

  1. Supporting Health Services (e.g., dialysis services in Hospitals, stem cell banks in Hospitals, eye banks, medical evacuation).
  2. Supporting Pharmaceuticals, Medical Devices, & PKRT (e.g., Medical Device/PKRT Distribution Licenses, CPOB/CDOB Certificates, PSEF Registration Marks).
  3. Supporting Environmental Health (e.g., Hygiene Sanitation Worthiness Certificates).
 Article 4 paragraph (2), Article 6
Annex (Technical Standards) Complete details of business activity standards and product/service standards for every type of PB and PB UMKU (including KBLI, scope, requirements, facilities, human resources, services, obligations, etc.) are stipulated in a highly detailed Annex that forms an integral part of this MoH Regulation. Article 7, Article 17
Basic Requirements

Business actors must hold a PB, obtained after fulfilling 3 basic requirements:

  1. Suitability of Spatial Utilization Activities (KKPR).
  2. Environmental Approval.
  3. Building Approval (PBG) and Certificate of Worthiness (SLF).
 Article 8 paragraphs (2) & (3)
Types of Risk-Based PB

PB issuance through the OSS System is based on risk level:

  1. Low Risk: NIB (Business Identification Number [Nomor Induk Berusaha]).
  2. Medium-Low Risk: NIB and Standard Certificate (self-declaration/without verification). 
  3. Medium-High Risk: NIB and Standard Certificate (with verification).
  4. High Risk: NIB and License.
 Article 13 paragraph (2)
Authority The Minister, Governor, and Regent/Mayor have authority over issuance, guidance, supervision, and sanctions. However, for Foreign Investment (PMA), the entire process (issuance, guidance, supervision, sanctions) is conducted by the Minister. Article 9, Article 11
Supervision Mechanism Supervision consists of Routine Supervision (examination of periodic reports and routine field inspections) and Incidental Supervision (based on complaints or urgent needs). Article 21
Routine Inspection Frequency

The frequency of routine field inspections for PB is based on risk:

  1. Medium-Low Risk: Once every 2 years.
  2. Medium-High Risk: Once every year.
  3. High Risk: Once every year. (PB UMKU Inspection: Once every year).
 Article 23 paragraph (1)
Sanctions: Warning Issued in stages (first, second, third). The business actor must fulfill obligations within 14 days (or more if necessary) from the imposition of the warning sanction. Failure to comply will result in the sanction being escalated to the next stage. Article 29, Article 30
Sanctions: Temporary Suspension Imposed if the obligations in the third warning are not met. The business actor must fulfill obligations within 30 days (or more). This sanction may be followed by a fine and/or compulsory enforcement actions. Article 31
Sanctions: Administrative Fine Imposed if the temporary suspension obligations are not met, or may be imposed concurrently. The business actor must pay the fine within 30 days (or more). Failure to comply may result in compulsory enforcement actions and/or license revocation. Article 32
Sanctions: compulsory enforcement actions This sanction is specific to the pharmaceutical, medical device, and PKRT fields. It can take the form of product recalls, destruction, blocking of electronic systems, closure of access to license applications, or sealing. Non-compliance may lead to license revocation. Article 33
Sanctions: License Revocation This is the final sanction, which may be the revocation of the Standard Certificate, License, NIB, and/or PB UMKU. If the NIB is revoked, the business actor may only submit a new application at the earliest 1 year after the revocation. Article 34
Right to Object Business actors have the right to file an objection to administrative sanctions through the OSS System no later than 10 days after the sanction is imposed. The authorized official must conduct a re-examination. Article 35
Transitional Provisions (Ongoing Processes) PB and PB UMKU applications that are still in process, not yet verified, or not yet effective when the OSS System is adjusted to GR 28/2025, will continue to be processed based on MoH Regulation 14/2021 (and its amendments). Article 37
Transitional Provisions (Issued Licenses) PB and PB UMKU that were issued before the implementation of the risk-based OSS System according to GR 28/2025, are declared to remain valid and their validity period will be updated accordingly. Article 38
Closing Provisions (Revocation) Revokes MoH Regulation 26/2018. And, revokes MoH Regulation 14/2021, MoH Regulation 8/2022, and MoH Regulation 17/2024 insofar as they regulate PB and PB UMKU standards now stipulated in MoH Regulation 11/2025. Article 39

Annex

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The Annex constitutes the core of this Regulation, providing detailed technical standards for all business activities and products/services covered under this framework. This Annex is divided into six main parts categorizing each type of license:

Part Part Title Examples of Standards Regulated (Not Limited To)
A Business Licenses (PB) for the Health Services Sector
  1. Health Tool and Facility Safety Institutions (IPAFK)
  2. Government and Private Hospitals,
  3. Clinics (Main, Primary, Supporting Primary),
  4. Healthy Homes and Healthy Centers,
  5. Primary Hospitals and Ship Hospitals, 
  6. Blood Management Units, Opticians, Medical Laboratories, Eye Banks, Stem Cell/Tissue Banks, Plasma Banks.
B Business Licenses (PB) for the Pharmaceutical, Medical Device, and PKRT Sector
  1. Pharmaceutical Wholesalers (PBF) and their Branches,
  2. Natural Medicine Material Wholesalers (PBOBA) and Natural Medicine Materials,
  3. Cosmetics Wholesalers (PBK),
  4. Medical Device Distributors (DAK) and their Branches,
  5. Pharmacies and Drug Stores,
  6. Natural Medicine Material Stores, Cosmetics Stores, Medical Device Stores,
  7. Pharmaceutical/Natural Medicine/Cosmetics Market Stalls and Herbal Medicine Stalls.
C Business Licenses (PB) for the Vector and Disease-Carrying Animal Control Sector Implementation of Vector, Disease-Carrying Animal, and Residential Pest Control (including at airports, ports, and state cross-border points).
D Business Licenses to Support Business Activities (PB UMKU) for the Health Services Sector
  1. Operation of Stem Cell Labs in Hospitals,
  2. Operation of Cell/Tissue Banks in Hospitals,
  3. Service-Based Stem Cell Therapy Research, 
  4. Dialysis Services, Hyperbaric Medicine, Nuclear Medicine, Radiotherapy,
  5. Operation of Organ Transplantation in Hospitals,
  6. Operation of Eye Banks in Hospitals,
  7. Blood Management Units in Hospitals, 
  8. Implementation of Health Examinations for Prospective Migrant Workers.
E Business Licenses to Support Business Activities (PB UMKU) for the Pharmaceutical, Medical Device, and PKRT Sector
  1. Determination of Plasma Fractionation Facilities,
  2. Medical Device Distribution Licenses (Domestic & Import),
  3. PKRT Distribution Licenses (Domestic & Import),
  4. Good Manufacturing Practice (CPB) Certificates for Medical Devices & PKRT,
  5. Good Distribution Practice (CDB) Certificates for Medical Devices,
  6. Training Certificates for Medical Device Store Management,
  7. Registration Marks for Electronic Pharmacy System Operators (PSEF),
  8. Statements for Technical/Industrial Pharmacist Persons-in-Charge.
F Business Licenses to Support Business Activities (PB UMKU) for the Environmental Health Sector
  1. Hygiene Sanitation Worthiness Certificates (SLHS),
  2. Health Worthiness Certificates (SLS),
  3. Food Hygiene Sanitation (HSP) Labels

Each individual standard in the Annex then further details various aspects, ranging from the relevant KBLI, scope, specific technical requirements, facility and infrastructure obligations, equipment standards, human resource qualifications, to service standards that must be met by business actors.

Conclusion

MoH Regulation 11/2025 represents the implementation of the risk-based business licensing policy in the health sub-sector, as mandated by GR 28/2025. It establishes a clear and standardized framework for the issuance of business licenses through the OSS system, classifying licenses by risk level to determine the appropriate licensing requirements.

Key takeaways include:

  1. The obligation to comply with the business activity and product/service standards as set out in the Annex to this regulation; and

  2. The supervision and sanction mechanisms that correspond to the risk level and compliance level of business actors.

This framework is expected to streamline licensing processes, enhance legal certainty, and ensure higher quality and safety standards across the health sub-sector.

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