Local Regulatory Experts
Connect with regulatory affairs consultancies specializing in this region.
Qualtech Consulting Corporation
Taiwan, China, Japan, Singapore, Hong Kong, Malaysia, Philippines, Vietnam, Australia, Germany, Korea, Thailand, USA
A specialized medical device consulting firm offering a one-stop solution for complex global regulatory challenges. We offer real-time regulatory and clinical support, local representation, and QMS services across 13 markets, ensuring efficient market entry and compliance.
Product Registration Indonesia
Jakarta, Indonesia
A professional regulatory consulting firm assisting companies with Medical Device, Cosmetic, and Food product registration (BPOM & MoH) and business establishment in Indonesia.
Registrar Corp
Hampton, Virginia (HQ), Shenzhen, China, London, United Kingdom, Paris, France, Madrid, Spain, Hyderabad, India, Kuala Lumpur, Malaysia, Tel Aviv, Israel, Guatemala City, Guatemala, Cape Town, South Africa
A global FDA compliance firm assisting businesses in the food, medical device, drug, and cosmetic industries with registration, U.S. Agent services, labeling, and regulatory software solutions.
ARQon Pte. Ltd.
Singapore (HQ), Malaysia, Vietnam, Indonesia, Philippines, Thailand, Taiwan, Hong Kong, South Korea, Switzerland, USA, Australia, New Zealand, Rwanda, India, Sri Lanka
We are a premier regulatory consultancy firm specializing in medical devices, in-vitro diagnostics (IVD), and pharmaceuticals. Founded in 2014, the company offers a comprehensive suite of services ranging from product development strategy and clinical trials to product registration and post-market surveillance. With a team of experts possessing vast experience in regulatory authorities and industry, we bridge the gap between scientific innovation and regulatory compliance, ensuring patient safety while fostering medical advancement. The company also provides unique business matching services through its ATTOPOLIS platform and training through the International Medical Device School.
December 16, 2025
Approximately 5 minutes
The Role of the Indonesian 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.
Related Articles
Approximately 5 minutes
Navigating Medical Device Registration in Indonesia: MoH Approval, CSDT, and Local Agents
Medical device registration in Indonesia, overseen by the MoH, requires a **local, licensed Sole Importer** to hold the non-transferable product license (NIE). The process utilizes the **ASEAN CSDT** and classifies devices into four risk classes (A-D), with review times ranging from 15 to 45 days, and mandates **ISO 13485** certification and **Reference Country** approval.
Approximately 5 minutes
In Vitro Diagnostics (IVD) Product Registration in Indonesia: Classification and Local Requirements
IVD device registration in Indonesia is managed by the Ministry of Health (MoH) and requires a **local, licensed distributor** to hold the non-transferable product license. The process follows **GHTF/AMDD** guidelines for risk-based classification (Class A-D) and mandates both **Reference Country approval** and specific testing for high-risk devices like HIV reagents, with review timelines ranging from 30 to 90 days.
Approximately 5 minutes
Mandatory Local Labeling for Medical Devices in Indonesia: MoH Requirements
Medical device labeling in Indonesia is strictly governed by the Ministry of Health (MoH) and requires key information, particularly the **Intended Use** and **Instructions For Use (IFU)**, to be translated into **Bahasa Indonesian**. Labels, which include the marketing license number (**AKL Number**), can be affixed by the local license holder **after** customs clearance, ensuring compliance for domestic distribution.
Approximately 5 minutes
Medical Device License Amendment in Indonesia: Changes, Renewal, and Halal Compliance
Maintaining a medical device license (NIE) in Indonesia requires amendments for minor changes, renewal every five years, and adherence to evolving **Halal certification** requirements. Minor changes, such as labeling or packaging size, require an amendment application (IDR 1,000,000) that is typically approved within **3 months**, whereas all other significant changes necessitate a **new registration submission**.
Approximately 5 minutes
Mandatory Post-Market Surveillance (PMS) for Medical Devices in Indonesia
Post-Market Surveillance (PMS) is mandatory for medical devices in Indonesia, aligning with **ASEAN Post Market Vigilance guidelines**. The local **medical device dealer** is responsible for mandatory reporting of **Adverse Events (AEs)** and submitting **distribution records** through the MoH's online **E-Report and E-Watch Systems**, with severe events requiring reporting within **48 hours**.