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.
February 16, 2025
Approximately 5 minutes
Medical Device License Amendment in Indonesia: Changes, Renewal, and Halal Compliance
Medical Device License Amendment in Indonesia: Changes, Renewal, and Halal Compliance
Maintaining market access for medical devices in Indonesia requires adherence to the Ministry of Health (MoH) regulations regarding license maintenance. This includes mandatory renewal every five years, obtaining approval for product changes via amendments, and ensuring compliance with evolving Halal requirements.
Acceptable License Amendments
Changes to an approved medical device require an amendment to the existing license (NIE) only if they are classified as minor administrative or design adjustments. All other significant changes necessitate submitting a new registration application.
Changes permitted under the Decree of Ministry of Health's No. 62 /2017 (article no. 30) include:
- Packaging: Dimension and size changes.
- Labeling: Content modifications.
- Product Specifications: Changes to product codes, product numbers, and some product sizes.
- Stability: Adjustments to product stability (temperature and expiry).
- Administrative: Changes to distributor(s) or Tax ID number.
The fee for a license amendment is IDR 1,000,000 (approx. US$65-70), and the typical approval timeline is within 3 months.
License Renewal Process
Product licenses are generally valid for up to 5 years and must be renewed to maintain legal distribution.
- Submission Deadline: Renewal applications should be submitted at least 9 months before the expiration date.
- Distribution Reporting: As part of the renewal process, distribution activity data must be submitted through the E-Report system.
- Fees: The renewal fee is IDR 1,000,000 (approx. US$65-70) per product.
- Combined Application: A license renewal can be combined with a license amendment in a single application for a government fee of IDR 1,500,000. Combined processes are typically approved faster, often within 10-15 working days.
Evolving Halal Requirements
Manufacturers must monitor and comply with Indonesia's evolving Halal product requirements, which are crucial for market access.
- General Principle: Products containing animal, plant, microbe, or process material must undergo Halal certification and bear the “HALAL” logo.
- Non-Halal Products: Products that do not meet Halal standards must be appropriately labeled as “Non-Halal Product.”
- Current Guidance: For many common medical devices that do not contain and have not been contaminated by animal materials, Halal certification may not be required immediately, but manufacturers must stay informed to adjust labeling when official regulations are fully implemented. Specific products, like porcine heart valves, are obviously Non-Halal and must be labeled as such.
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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
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)**.