On June 5, 2025, the Ministry of Health of Indonesia issued Government Regulation No. 28 of 2025 concerning the Implementation of Risk-Based Business Licensing for Medical Device Distribution Facilities.
Scope
Summary results of the Socialization of the Indonesian Ministry of Health.
Key Points
In Appendix II of Government Regulation No. 28 of 2025, it is mentioned that Medical Device Distributors that already have a Good Distribution Practice (GDP) Certificate are required to report the results of their internal audits annually via the email audit.cdakb@gmail.com.
The benefits of the Internal Audit Report for the Medical Device Distributors are as follows:
- Assessing the effectiveness of the quality management system for medical device distribution.
- Identifying problems early.
- Encouraging continuous improvement.
- Ensuring product quality and safety.
- Ensuring compliance with regulations.
The internal audit report serves as evidence of the Medical Device Distributor’s commitment to product quality assurance and safety, as well as compliance with regulations.
Attachment
See attached the slide of the presentation from the Indonesia Ministry of Health (provided in Indonesian, no English translation is available). [PDF]
Effective Date
5 June 2025
Implications to the Client
This regulation ensures that distributors maintain strong quality and compliance through regular internal audits, which benefits manufacturers by safeguarding product quality, safety, regulatory compliance, and continuous market access.
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