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:

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:

1. Executive Summary.
2. Device Labeling and Instructions for Use (IFU). (Note: Some documents, especially IFU and labeling for home-use products, must be translated into Indonesian (Bahasa)).
3. Risk Analysis Report and Clinical Evaluation Report (CER).
4. ISO 13485 Certificate.
5. Declaration of Conformity and Free Sales Certificate.
6. 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.