Navigating Indonesia's Medical Device Regulatory Framework

Indonesia, with a population exceeding 275 million, is the world's fourth most populous country and a significant market for medical devices, relying heavily on innovative imported products. Government initiatives to enhance healthcare services and the country's growing appeal as a medical tourism destination offer substantial opportunities for medical device manufacturers.

Device Classification and Regulatory Pathways

Understanding Regulatory Requirements in Indonesia

Regulatory Authority

The Ministry of Health of the Republic of Indonesia (MOH) plays a pivotal role in ensuring the safety and compliance of medical devices entering the market. The MOH evaluates and classifies medical devices into four risk categories, from class A (lowest risk) to class D (highest risk), with the classification influencing the complexity of the registration process.

Classification

Medical devices in Indonesia are classified based on their risk level, impacting the registration requirements. The classification system guides manufacturers through the necessary steps to achieve compliance and market access.

Key Requirements

To market in Indonesia, foreign manufacturers must:

  • Appoint an importer as their local representative responsible for holding the registration license and managing the importation process.
  • Compile and submit a comprehensive technical dossier for MOH evaluation, with the process varying in complexity depending on the device's risk class.
How We Can Help

Tailored Support for Market Entry

Our services aim to simplify your regulatory journey in Indonesia:

  • Assistance with product classification and identification of the regulatory pathway.

  • Support in compiling the technical dossier required for registration with the MOH.

  • Representation as your local representative, handling the registration process, overseeing the importation process, and managing post-market compliance.

We Provide Access To 28+ Markets Worldwide

Our team of experts and local representatives, supported by partnerships with hundreds of clinical labs and the extensive GRIP database for over 100 countries, accelerates product launches and ensures compliance across 28 countries.

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