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, 2024
Approximately 5 minutes
Navigating Medical Device Registration in Indonesia: MoH Approval, CSDT, and Local Agents
Medical Device Registration and Approval in Indonesia
Medical devices and In Vitro Diagnostic (IVD) products must secure a registration number and a product license (known as the Distribution Approval Number, or NIE - Nomor Izin Edar) from the Ministry of Health (MoH) before they can be legally imported and sold in Indonesia. The MoH serves as the sole governing authority, overseeing pre-market evaluation, post-market surveillance, and standardization.
Key Requirements for Foreign Manufacturers
The Indonesian regulatory structure places crucial responsibility on a local entity:
- License Holder Requirement: Foreign manufacturers cannot hold the license directly. Registration must be submitted by a local entity, which must be a local, licensed distributor or a Sole Importer (Local Agent). This entity holds the NIE on behalf of the foreign manufacturer.
- Non-Transferability: The product license is non-transferable, and only one license can be valid per device at any given time. Transferring a license requires canceling the original and submitting a new application, a process that mandates the cooperation of the original license holder.
- Reference Country Approval: While Home Country approval is not required, foreign manufacturers must provide evidence of approval from a designated Reference Country (Australia, Canada, European Union, Japan, or the United States).
- Quality System Certification: Registration mandates a valid ISO 13485 certificate to certify the quality system of the manufacturing facilities.
Classification and Review Timeline
Indonesia's medical device classification system follows the Global Harmonization Task Force (GHTF) guidelines and the ASEAN Medical Devices Directive (AMDD), dividing devices into four risk categories. The review time is relatively quick compared to other markets in the region:
| Risk Class | Description | Review Timeline (Approx.) | Government Fee (Approx.) |
|---|---|---|---|
| Class A | Low risk | 15 days | US$115 (IDR 1,500,000) |
| Class B | Low to moderate risk | 30 days | US$230 (IDR 3,000,000) |
| Class C | Moderate to high risk | 30 days | US$230 (IDR 3,000,000) |
| Class D | High risk | 45 days | US$340 (IDR 5,000,000) |
Documentation and Compliance
Applications are submitted through the MoH's online registration system (Kemenkes platform) using documentation largely based on the ASEAN Common Submission Dossier Template (CSDT). Required documents typically include:
- Executive Summary.
- Device Labeling and Instructions for Use (IFU). (Note: Some documents, especially IFU and labeling for home-use products, must be translated into Indonesian (Bahasa)).
- Risk Analysis Report and Clinical Evaluation Report (CER).
- ISO 13485 Certificate.
- Declaration of Conformity and Free Sales Certificate.
- Manufacturer's Letter of Authorization to the local agent.
Product licenses are valid for two to five years, depending on the validity of the Letter of Authorization, and can be renewed through an administrative process.
Related Articles
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**.
Approximately 5 minutes
The Role of the Indonesian Ministry of Health (MoH) in Medical Device Regulation
The Indonesian Ministry of Health (MoH) is the central regulatory body for medical devices, responsible for **pre- and post-market evaluation, standardization, and GMP certification**. The MoH utilizes the **Government e-Catalogue** for public procurement transparency and enforces **Good Method of Distribution of Medical Devices (CDAKB)**, while aligning its risk classification system (Classes A-D) with the **ASEAN Medical Devices Directive (AMDD)**.