MOH Indonesia Medical Device Registration
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 seeking Indonesia Medical Device Registration.
Understanding Regulatory Requirements in Indonesia
Regulatory Authority
Indonesia's medical device regulator is the National Agency of Drug and Food Control (NADFC), a division of the Indonesian Ministry ofHealth (MoH). Pure Global can assist with Indonesia's medical device registration and act as your local representative, ensuring MoH approval to sell in the Indonesian market.
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.
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.
Frequently
Asked Questions
What is the regulatory authority for medical device registration in Indonesia?
The Ministry of Health Indonesia (MOH) is the regulatory authority responsible for the registration of medical devices in Indonesia. They oversee the compliance and approval processes necessary for market access.
How are medical devices classified in Indonesia?
Medical devices in Indonesia are classified based on their risk level. This classification, regulated by MOH Indonesia, determines the registration requirements and guides manufacturers through the necessary compliance steps for market access.
What are the key requirements for foreign manufacturers to market medical devices in Indonesia?
Foreign manufacturers must appoint an importer as their local representative. This representative is responsible for holding the registration license and managing the importation process. Additionally, manufacturers must compile and submit a comprehensive technical dossier for MOH evaluation, with the complexity of this process varying depending on the device's risk class under Indonesia medical device regulations.
Is it mandatory to register all medical devices before selling them in Indonesia?
Yes, all medical devices must be registered with the MOH before they can be marketed or sold in Indonesia. This ensures that all medical devices meet the necessary regulatory and safety standards under MDR Indonesia.
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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Whether looking for more information or ready to partner with us, we're here to guide you through every step of the regulatory process.