Indonesian Ministry of Health (MoH)
Indonesia's Ministry of Health is the national authority responsible for medical device policy, market authorization, and post-market oversight through its pharmaceutical and medical device organization.
The Ministry of Health of Indonesia is the national authority responsible for health policy and for regulating medical devices and household health products. Medical device functions sit within the Directorate General of Pharmaceuticals and Medical Devices (Direktorat Jenderal Farmasi dan Alat Kesehatan), rather than in a stand-alone agency.
Which Ministry of Health units regulate medical devices?
Under the Ministry's current organizational structure, specialized directorates divide responsibilities for medical device production and distribution and for medical device control. Their work includes policy implementation, technical standards, product authorization, oversight of manufacturers and distributors, inspections, and post-market controls.
Manufacturers should use the current Ministry organization and portal instructions because unit names and responsibilities can change when the Ministry updates its structure. The Ministry's official organization page reflects the structure under Ministry of Health Regulation No. 21 of 2024.
What does the Ministry require before a device can be sold?
A medical device generally needs a marketing authorization before lawful supply. Indonesia classifies devices into Classes A, B, C, and D according to risk. Classification determines the review route and evidence expected. A foreign manufacturer also needs an appropriately licensed local company to hold the authorization and manage local regulatory responsibilities.
The current framework includes Ministry of Health Regulation No. 5 of 2026 on Health Supplies, which revoked Regulation No. 62 of 2017. Regulation No. 5 of 2026 retains the marketing-authorization requirement and the Classes A–D risk framework; applicants must also follow current implementing rules for classification, licensing, labeling, distribution, and vigilance. See our Indonesia medical device regulations guide, classification overview, and the Ministry's official Directorate General overview for current information.
Does every medical device follow the same Indonesian pathway?
No. The route depends on device risk class, intended purpose, origin, product grouping and the applicant's licensed local role. Manufacturers should confirm the current classification and dossier requirements before filing rather than treating one Ministry of Health approval as universal. Pure Global's Indonesia market guide explains the country-specific registration pathway.
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