Medical device and IVD registration in Indonesia requires approval from the Indonesian Ministry of Health (MoH). Manufacturers must submit a technical dossier for MoH review and approval, as well as obtain an importer as their in-country representative.
Pure Global simplifies the process with AI workflows that accelerate MoH submission preparation, along with local support and representation, all for a flat annual fee.
Indonesia’s medical devices market will reach $3.66B by 2029 (7.26% CAGR), and the IVD market$470.6M (4.59% CAGR). Growth is driven by rising healthcare spending, high medical device imports, and 90% public health coverage.
Indonesia's medical device regulator is the Indonesian Ministry of Health (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.
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.
To market in Indonesia, foreign manufacturers must:
We provide turnkey regulatory support in Indonesia, all for a flat annual fee:
Dossier preparation and submission, powered by AI-assisted workflows and regulatory experts.
In-country representation, with Pure Global serving as your Local Authorized Representative.
Post-market surveillance support, including vigilance reporting and authority communications.
Importer authorizations, post-approval modifications, and renewals.
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.
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.
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.
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.
When you partner with Pure Global, a single registration process opens doors to multiple countries. Our global subsidiaries make this streamlined path possible.
Whether looking for more information or ready to partner with us, we're here to guide you through every step of the regulatory process.
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