The Ministry of Health of the Republic of Indonesia has issued Regulation of the Minister of Health No. 11 of 2025 (“the Regulation”) concerning Business and Product/Service Standards for Risk-Based Licensing in the Health Sub-sector.
The Regulation comprises 40 articles and 1 appendix and introduces updated requirements for licensing within the health sub-sector, covering the following business activities:
- Health services
- Pharmaceuticals, medical devices, and household health supplies
- Vector and disease-carrying animal control
To read the full regulation: Regulation of the Minister of Health of the Republic of Indonesia No. 11 of 2025 [pdf]
Key Updates
1. New Definition of Labelling
As stated on page 400, labeling is defined as objective, complete, and non-misleading information presented in the form of images, colors, text, or a combination thereof, either in physical or electronic format, attached to the packaging, included inside the packaging, or provided as a link that forms part of the container and/or packaging.
2. Updates on the Evaluation Timeline Process
As stated on page 409, the Ministry of Health (MOH) has outlined updated timelines for conformity assessments related to registration, renewal, modification, and notification processes, summarized as below:
Class Risk | New Registration | Renewal | Change and Renewal | Notifications |
A | 21 | 13 | 16 | 12 |
B | 36 | 13 | 16 | 12 |
C | 36 | 13 | 16 | 12 |
D | 55 | 13 | 16 | 12 |
3. Additional Requirements for Renewal Application
Specific to in-vitro diagnostic devices intended for screening Transfusion-Transmitted Infections (TTIs), the following additional requirements shall apply:
- Documentation showing that the sensitivity and specificity values meet the required standards for Transfusion-Transmitted Infection (TTI) screening tests in accordance with applicable regulations; and
- Validation test results from a laboratory or testing facility designated by the Minister.
For the in-vitro diagnostic category, a validation test report shall be submitted from one of the following laboratories:
- Accredited laboratory in Indonesia
- Certified testing facility
- Laboratory or testing facility in Indonesia appointed by the Ministry of Health
Effective Date
Although the regulation is dated 3 October 2025, in accordance with Article 37, its implementation is not yet in effect, as the authority system continues to refer to the previous regulation. Further clarification or technical guidance may be issued by the Ministry of Health in due course.
Implications to Clients
Stakeholders should note that implementation timelines and procedural transitions will depend on forthcoming technical guidance from the Ministry of Health. We will continue to monitor developments and inform you once the new requirements take effect and their direct implications for your products are confirmed.
Contact us at sales@andamanmed.com for guidance, or click the button below for support in Indonesia.
