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.
January 16, 2025
Approximately 5 minutes
Mandatory Local Labeling for Medical Devices in Indonesia: MoH Requirements
Mandatory Local Labeling for Medical Devices in Indonesia: MoH Requirements
Medical device labeling in Indonesia is strictly regulated by the Ministry of Health (MoH) to ensure user safety and compliance. For foreign manufacturers, ensuring accurate translation and inclusion of all required elements is critical for domestic distribution.
Language and Content Mandates
The fundamental requirement for medical device labeling in Indonesia is the use of the local language for key safety and usage information:
- Language Requirement: All essential information, including the Intended Use and the complete Instructions For Use (IFU), must be clearly written in Bahasa Indonesian (Indonesian Language).
- IFU Minimum Content: The IFU must contain, at a minimum, the intended use/function, clear instructions for use, contraindications, and warnings—all in Bahasa.
- Label Format: Labels may use a combination of pictures, colors, and writing.
Essential Labeling Elements
Every medical device label or accompanying documentation must contain the following information:
- Product Identification:
- Product name and/or trade name.
- Batch or lot number.
- Expiration date.
- Company Information:
- Name and address of the company (license holder/distributor).
- Regulatory Information:
- Marketing License (AKL Number), which is the official product registration number issued by the MoH.
- Safety and Usage:
- Intended use and Instructions For Use (IFU) in Bahasa Indonesian.
- Warnings in Bahasa Indonesian.
Responsibility and Affixing Labels
The responsibility for ensuring local labeling compliance falls on the local entity that holds the marketing license (Independent License Holder or licensed distributor).
- Affixing Location: Labels can be affixed to the medical devices after customs clearance but before the product is distributed or sold in the domestic market. This post-clearance labeling flexibility is a key aspect of managing logistics for imported goods.
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
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)**.