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 30, 2024
Approximately 5 minutes
In Vitro Diagnostics (IVD) Product Registration in Indonesia: Classification and Local Requirements
In Vitro Diagnostics (IVD) Product Registration in Indonesia: Classification and Local Requirements
In Indonesia, the registration and approval of In Vitro Diagnostic (IVD) products are overseen by the Ministry of Health (MoH). All IVD devices must secure a registration number and a product license (marketing license) from the MoH before they can be legally imported and distributed. The registration process is considered relatively fast and cost-effective.
Classification and Review Timelines
IVD device classification in Indonesia is harmonized according to the ASEAN Medical Devices Directive (AMDD) and closely follows Global Harmonization Task Force (GHTF) guidelines. The classification determines the required documentation and the official timeline for approval:
| IVD Classification | Time Frame (Working Days) | Government Fee (Approx.) |
|---|---|---|
| Class A | 30 days | US$115 (IDR 1,500,000) |
| Class B | 60 days | US$230 (IDR 3,000,000) |
| Class C | 60 days | US$230 (IDR 3,000,000) |
| Class D | 90 days | US$340 (IDR 5,000,000) |
Note: For novel devices, the Director General may request a scientific review by an expert team, which will add time to the process but no additional fee.
Mandatory Local and Technical Requirements
For a foreign manufacturer to successfully register an IVD product, several requirements must be met:
- License Holder Requirement: The product license must be issued to a local, licensed distributor in Indonesia. This license is non-transferable and can only be held by one entity per product at a time. The local distributor acts as the sole authorized representative.
- Reference Country Approval: Reference country approval (such as from the EU, US, Japan, etc.) is required prior to submitting the IVD device registration application to the MoH.
- Technical Documentation:
- IVD Instruments: Require IEC 61010-1:2001 reports.
- Class II and Class III IVD Devices: Require performance/characteristic evaluation reports.
- Special Testing: Applications for high-risk IVD devices, specifically HIV reagents and kits, require performance test reports generated at the Indonesia Reference National Laboratory Hospital (RSCM).
Once issued, the IVD product license is valid for up to 5 years.
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
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)**.