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December 16, 2025
Approximately 5 minutes
Role of the Ministry of Health (MoH) in Medical Device Regulation
The Role of the Indonesian Ministry of Health (MoH) in Medical Device Regulation
The Indonesian Ministry of Health (MoH), headquartered in Jakarta, functions as the central regulatory body for the nation's medical device industry. Since its establishment as a separate entity in 1966, the MoH has evolved to prioritize and oversee all aspects of public health and healthcare infrastructure, including the complete regulatory lifecycle of medical devices.
Core Regulatory Functions
The MoH is responsible for the comprehensive oversight of medical devices and IVD products throughout their market lifecycle:
- Pre-Market Evaluation: Assessing and approving devices before they can be imported or sold.
- Post-Market Evaluation: Monitoring devices once they are on the market, including surveillance and reporting of adverse events.
- Standardization and Legislation: Creating and enforcing regulatory guidelines and laws that govern the industry.
- Certification: Overseeing Good Manufacturing Practices (GMP) and the implementation of the Good Method of Distribution of Medical Devices (CDAKB), which standardizes quality control in the distribution chain.
Harmonization with ASEAN Standards
A significant recent focus for the MoH has been regulatory harmonization. Indonesia’s medical device classification system is closely following Global Harmonization Task Force (GHTF) guidelines and is being harmonized according to the ASEAN Medical Devices Directive (AMDD). This system classifies devices into four risk classes: A, B, C, and D, ranging from low to high risk, which determines the registration pathway and required documentation.
Key Regulatory Platforms
The MoH utilizes key digital systems to manage both market entry and public procurement:
- Online Registration Systems: The MoH manages the platforms used by local License Holders to submit applications for product registration (NIE).
- Government e-Catalogue (e-Katalog): This online purchasing system was established to increase transparency and prevent corruption in government procurement, especially in public hospitals. Oversight of the e-Catalogue has recently been moved under the MoH, removing the previous requirement for price negotiations overseen by the LKPP (Government Goods and Services Procurement Organization). This shift streamlines the process for manufacturers to list their products for public tenders.
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