Indonesia: New MOH Regulation Sets Standards for Risk-Based Licensing in Health Sub-Sector

Indonesia continues strengthening its regulatory landscape with the release of the Regulation of the Minister of Health (Permenkes) No. 11/2025, issued on 12 November 2025. This regulation introduces updated Business and Product Service Standards for risk-based licensing in the health sub-sector, marking an important step in enhancing service quality, safety, and transparency across the country’s health ecosystem.

This new framework aligns with Indonesia’s national effort to modernise regulatory oversight while supporting the growth of the local medical and healthcare industry.

What the Regulation Covers

The updated regulation outlines a comprehensive set of standards and requirements for health-related businesses and product services operating under a risk-based licensing (OSS RBA) system. Key areas addressed include:

1. Updated Business Standards

The regulation clearly defines operational standards that must be met by health facilities and providers, depending on their risk classification. These include requirements related to:

• Facility infrastructure

• Competency of health personnel

• Operational procedures that ensure safety and reliability

2. Product and Service Standards

For medical and healthcare service providers, the regulation specifies the minimum service levels needed to maintain patient safety and quality of care.

3. Alignment with OSS RBA

The document harmonises health-sector licensing with Indonesia's broader Online Single Submission Risk-Based Approach (OSS RBA), ensuring consistency and simplifying business processes.

4. Compliance and Monitoring

The Ministry of Health reinforces stricter monitoring to ensure that licensed entities comply with the updated standards, with a focus on:

• Safety management

• Service quality

• Proper documentation and reporting

  
  

Why This Matters for the Industry

This regulation is especially relevant for stakeholders entering or operating in Indonesia’s dynamic healthcare and medical device market:

More Predictable Licensing

Clearer business and product standards mean more predictable timelines and requirements for approvals.

Improved Accountability

Standardisation ensures consistent evaluation and oversight across the health sector.

Better Market Readiness

Industry players can plan their compliance strategies, reducing regulatory uncertainty.

What Manufacturers, Distributors, and Healthcare Providers Should Do Next

• Review the full regulation to assess any changes that impact current or future business activities.

• Ensure alignment with updated standards, particularly for documentation, facility readiness, and service delivery.

• Prepare for potential inspections or compliance checks, as monitoring is expected to strengthen under this regulation.

  
  

Final Thoughts

Indonesia’s introduction of Permenkes No. 11/2025 reflects the country’s continued commitment to modernising its healthcare regulatory framework. By enhancing clarity and strengthening the risk-based licensing process, the Ministry of Health is helping create a safer, more reliable, and more efficient health ecosystem for both local and international stakeholders.

This updated regulation is a valuable opportunity for businesses to reassess and strengthen their compliance strategies in one of Southeast Asia’s fastest-growing healthcare markets.