Indonesia Enforces Annual Internal Audits for Medical Device Distributors

On September 16, 2025, Indonesia’s Ministry of Health issued “MoH Letter FK.02.02/E.VI/3964/2025,” providing clear operational instructions requiring all medical device distributors to submit an annual internal audit report to the Ministry.

The letter confirms active enforcement of audit obligations for all medical device distributors operating in the country, as introduced on June 5, 2025 under “Government Regulation No. 28 of 2025 on Risk-Based Business Licensing” (PP No. 28/2025), and clarifies submission procedures and compliance expectations.

Together, the regulation and the Ministry’s notification establish annual internal audits as a mandatory requirement for medical device distribution activities nationwide.

Regulatory Background

The internal audit obligation stems from PP No. 28/2025, which introduced enhanced controls under Indonesia’s risk-based business licensing framework for regulated sectors, including medical devices.

Annex II of PP No. 28/2025 establishes internal audits as a core requirement for holders of the Medical Device Good Distribution Practice (CDB) Certificate. CDB guidance issued by the Ministry of Health specifies that audits must be conducted at least once per calendar year and formally submitted as part of ongoing compliance.

Scope and Applicability

The annual internal audit requirement applies to all companies holding a Medical Device Good Distribution Practice (CDB) Certificate in Indonesia, including:

All licensed medical device distributors
Headquarters as well as all registered branch offices
Distributors representing foreign manufacturers and overseas brand owners

Internal audits are therefore a licensing-linked regulatory obligation, rather than an internal quality initiative.

Regulatory Objectives

The Ministry of Health outlined clear objectives behind the introduction of mandatory annual internal audits, with the overarching goal of strengthening systemic control rather than introducing procedural burden.

According to official guidance, the audits are intended to:

Evaluate the effectiveness of quality management systems
Identify compliance and operational risks at an early stage
Drive continuous improvement in distribution practices
Safeguard medical device quality and patient safety
Ensure sustained compliance with Indonesian medical device regulations

These goals align Indonesia’s medical device distribution oversight more closely with international regulatory practices.

Annual Internal Audit Content and Submission

Under PP No. 28/2025, medical device distributors’ mandatory internal audit report must demonstrate full implementation of Medical Device Good Distribution Practice (CDB) requirements and assess the effectiveness of both operational controls and quality management systems.

While the regulation does not prescribe a standardized audit template, audit documentation must be sufficiently detailed to support regulatory review and inspection. In practice, internal audit reports are expected to address:

Warehouse operations and storage conditions
Adequacy and maintenance of facilities and equipment
Competence and oversight of the Technical Responsible Person
Documentation systems and distribution traceability
Results of internal self-assessments
Corrective and Preventive Actions (CAPA) and follow-up effectiveness

The Ministry of Health’s notification further clarifies implementation requirements by instructing distributors to submit their annual internal audit report electronically to audit.cdbakb@gmail.com.

The internal audit report is also a mandatory supporting document for CDB certificate renewal, which is conducted every five years. Failure to conduct or submit the audit may result in renewal delays or enforcement actions. For foreign manufacturers and overseas brand owners, distributor non-compliance will have implications on market continuity in Indonesia.

Next Steps for Distributors and Overseas Principals

In light of active enforcement, distributors and foreign principals should take structured compliance action, focusing on whether internal audits operate as effective regulatory controls rather than post hoc documentation exercises.

Key actions include:

Assessing existing internal audit procedures against PP No. 28/2025 requirements and enforcement expectations
Establishing a documented annual audit plan that covers all operational sites
Assigning clear accountability for audit execution, reporting, and submission
Ensuring CAPA are implemented, tracked, and closed within defined timelines
Integrating audit outcomes into CDB certificate renewal planning

For foreign manufacturers, attention should be placed on how distributor audit practices align with both Indonesian CDB requirements and global quality system standards. This includes confirming audit timing, documentation robustness, and how audit findings are managed in ways that support licensing continuity and long-term market access.

Final Thoughts

The Ministry of Health’s enforcement of PP No. 28/2025 marks a decisive step in strengthening Indonesia’s medical device distribution oversight. Annual internal audits and mandatory submission are now clearly established compliance obligations with direct licensing consequences.

For business leaders, internal audits should be treated as a strategic regulatory requirement rather than an administrative formality. Distributors that institutionalize robust audit processes will be better positioned to manage regulatory risk and operate reliably in Indonesia’s increasingly regulated medical device market.

For foreign manufacturers, aligning global quality systems with Indonesia-specific distributor compliance requirements can be operationally complex and resource-intensive. To understand how Indonesia’s annual internal audit requirements affect distributor oversight and compliance strategy, get in touch with Cisema for tailored regulatory guidance.