Indonesia Medical Device Registration Process Overview

1. Regulatory Authority

Medical device registration in Indonesia is overseen by the Ministry of Health (Kemenkes) through the Directorate General of Pharmaceutical and Medical Devices and the National Agency of Drug and Food Control (BPOM). All medical devices intended for distribution in Indonesia must obtain a Distribution Permit (Izin Edar) before being placed on the market. https://andamanmed.com/regulatory-services/medical-device-registration/indonesia/

2. Risk-Based Classification

Indonesia classifies medical devices into four risk classes (A to D), aligned with ASEAN Medical Device Directive (AMDD) principles:

• Class A — Low risk (e.g., bandages, tongue depressors)
• Class B — Low-moderate risk (e.g., hypodermic needles, suction equipment)
• Class C — Moderate-high risk (e.g., ventilators, infusion pumps)
• Class D — High risk (e.g., heart valves, implantable defibrillators, active implantable devices)

Classification determines the required documentation, evaluation pathway, and timelines. https://andamanmed.com/regulatory-services/medical-device-registration/indonesia/

3. Mandatory Local Representative

Foreign manufacturers must appoint a local agent (company or individual) in Indonesia to act as the license holder and handle the registration process. The local agent is responsible for submission, communication with authorities, post-market surveillance, and adverse event reporting. https://andamanmed.com/regulatory-services/medical-device-registration/indonesia/

4. Required Documentation

The core technical dossier typically includes:

• Device description and intended use
• Labeling and instructions for use (in Bahasa Indonesia)
• Risk analysis and management file
• Design verification and validation data
• Clinical evaluation report (for higher classes)
• Quality management system certificate (ISO 13485)
• Free Sale Certificate or Certificate of Conformity from country of origin
• Declaration of Conformity https://andamanmed.com/regulatory-services/medical-device-registration/indonesia/

5. Registration Pathways

• General pathway — Full technical evaluation by the Ministry of Health.
• ASEAN CSDT pathway — For devices already registered in other ASEAN countries, allowing reliance on Common Submission Dossier Template (CSDT).
• Special Access — For unregistered devices needed urgently (e.g., humanitarian use), temporary import permits may be granted. https://andamanmed.com/regulatory-services/medical-device-registration/indonesia/

6. Timeline and Fees

Timelines vary by class:

• Class A: ~3–6 months
• Class B: ~6–9 months
• Class C/D: ~9–18 months or longer

Official fees are charged for application processing, evaluation, and issuance of the distribution permit. https://andamanmed.com/regulatory-services/medical-device-registration/indonesia/

7. Post-Registration Obligations

After obtaining the Distribution Permit:

• Annual renewal may be required for certain classes
• Post-market surveillance and adverse event reporting to BPOM
• Compliance with labeling and advertising rules
• Obligation to maintain updated technical documentation https://andamanmed.com/regulatory-services/medical-device-registration/indonesia/

The Indonesian medical device registration process emphasizes local representation and alignment with ASEAN harmonization efforts while ensuring safety and quality for products entering the market. https://andamanmed.com/regulatory-services/medical-device-registration/indonesia/