Medical Device Registration in Indonesia: Classes, Times, Renewal
Medical device registration in Indonesia: who applies, the four risk classes, the Ministry of Health's service times, and what keeps a registration valid.
- Permenkes No. 5 Tahun 2026 on Health Supplies, in force 4 May 2026 — Articles 41–42, 50–51, 55, 58, 85, 89–90, 96, 101, 104, 117 and 125, which revokes Permenkes No. 62 Tahun 2017
- Permenkes No. 11 Tahun 2025 on licensing standards for the health sector, in force 3 October 2025 — standards 3, 6 and 8
- Permenkes No. 4 Tahun 2014 on good distribution practice for medical devices — Article 2
- PP No. 42 Tahun 2024 on Halal Product Assurance — Articles 158, 161 and 162
Medical device registration in Indonesia means obtaining a marketing authorisation, the izin edar, from the Ministry of Health. A device can be imported only once it is granted (Permenkes 5/2026, Articles 50(1) and 58(4)).
An Indonesian distributor appointed by the manufacturer applies, and the device’s risk class decides how long the Ministry takes.
The rules changed in 2025 and 2026: the 2017 regulation most guidance still cites was revoked on 4 May 2026 (Permenkes 5/2026, Article 125).
Register before you sell
Registration comes before a device reaches the market. A device sold without a marketing authorisation has to be withdrawn, so the authorisation is best in hand before stock arrives (Permenkes 5/2026, Articles 89–90 and 117).
The four risk classes
Class A
Low risk. The shortest evaluation, and the first class whose animal-derived devices face the halal deadline.
Class B
Low to moderate risk. The same evaluation time as class C for a new imported device.
Class C
Moderate to high risk. A renewal includes a post-market surveillance report.
Class D
High risk. The longest evaluation, and a post-market surveillance report at renewal.
The classes are defined in Permenkes 5/2026, Article 55(2). Which class a device falls into is decided by the rules for that device, not chosen by the applicant.
How long evaluation takes, by class
- Class A 21
- Class B 36
- Class C 36
- Class D 55
Permenkes 11/2025, standard 3. Each application allows up to two rounds of corrections.
These are maximum service times, not how long registration takes from start to finish. The Ministry evaluates a renewal in 13 working days and a change in 16 (Permenkes 11/2025, standard 3).
Who holds the registration
A foreign manufacturer registers through an Indonesian medical device distributor: a PT or a co-operative holding a distributor licence and a good distribution practice certificate, and appointed by the manufacturer (Permenkes 11/2025, standards 3 and 6).
| Your own Indonesian company | An appointed distributor | |
|---|---|---|
| Holds the registration | Your company, as the licensed distributor | The distributor |
| Needs | A distributor licence and certificate, before applying | Already holds both |
| If the appointment ends | Within your own control | A new distributor obtains its own authorisation |
When a manufacturer changes distributor, the outgoing one can sell its remaining stock for six months from the new distributor’s authorisation, with the Ministry’s approval (Permenkes 5/2026, Article 51(1)(d); Permenkes 11/2025, standard 3).
A PT PMA, a foreign-owned limited liability company, can be the distributor under the health regulations, though whether its business classification allows it needs checking case by case. A wholly Indonesian-owned PT Local raises no ownership question.
MAM sets up either kind of company and handles the registration for clients, drawing on its experience of what the Ministry asks for in practice.
How medical device registration works
-
Licence and good distribution practice
The distributor holds its licence, then obtains the good distribution practice certificate, which the Ministry issues within 30 working days (Permenkes 11/2025, standard 8).
-
The appointment
The manufacturer appoints the distributor in writing (Permenkes 11/2025, standard 3).
-
The dossier
The distributor assembles the technical file for the device's class.
-
Evaluation
The Ministry evaluates the application within the service time for the class.
-
Authorisation issued
The device may then be imported and distributed.
What the application contains
- A quality management system document
- A free sale certificate or authorisation from the country of origin
- Technical and design data, and clinical evidence
- The risk management file
- The labelling and instructions for use
A declaration of conformity and the post-market procedures complete the file (Permenkes 11/2025, standard 3).
Keeping the registration
A renewal is filed at least nine months before the authorisation expires (Permenkes 11/2025, standard 3).
Between renewals the holder reports distribution and adverse events, has samples tested at least once while the authorisation is valid, and recalls any product that fails requirements (Permenkes 5/2026, Articles 85, 96, 101 and 104).
Halal certification applies only to devices made from or containing animal material. For those, the phase-in ends on 17 October 2026 for class A, 2029 for class B and 2034 for class C (PP 42/2024, Articles 158(1) and 161(1)).
A device not yet made from halal material may still be sold if its label states where the material comes from (Article 162(3)). How certification itself works is in halal certification in Indonesia.
What it means in practice
The distributor comes first: its licence and certificate take time before any device can be filed. Plan renewals nine months ahead, and settle the appointment’s term before relying on a distributor you do not own. Public health facilities buying devices must also prefer local content (Permenkes 5/2026, Articles 41–42).
The product standards some goods need are covered in how to obtain an SNI certificate, and the parallel rules for food in food and beverage registration.