BPOM — Badan Pengawas Obat dan Makanan, Indonesia
Medical devices (alat kesehatan) in Indonesia are regulated by BPOM (Badan Pengawas Obat dan Makanan — National Agency of Drug and Food Control) and the Ministry of Health (Kemenkes) under the Permenkes (Ministerial Regulation) framework. The system classifies devices into three risk classes: Class 1 (low risk), Class 2 (moderate risk), and Class 3 (high risk).
A fundamental requirement of the Indonesian regulatory framework is that foreign medical devices can only be imported and sold by a local Indonesian company — either a PT (Perseroan Terbatas, limited liability company) or a BUMD. Wholly foreign-owned enterprises (PT PMA) or domestic companies with a valid distributor licence (Penyalur Alat Kesehatan / PAK) are eligible importers. This PT requirement is non-negotiable and must be secured before any registration submission can be made.
The registration is submitted through the e-Regalkes system, BPOM's online platform for medical device registration. The GMP certificate (Good Manufacturing Practice) issued by the manufacturer's home country regulatory authority is a mandatory supporting document for all Class 2 and Class 3 devices. For Korean manufacturers, this is typically the MFDS GMP certificate or ISO 13485 certification.
- Permenkes regulations — medical device regulatory framework
- Local Indonesian PT (company) required as importer and registration holder
- e-Regalkes portal for all BPOM device registration submissions
- GMP certificate mandatory for Class 2 and Class 3 devices
- PAK (distributor) licence required for the importing PT
BPOM Review Timelines by Device Class
Estimated BPOM processing times from accepted submission — Indonesia has some of the longest registration timelines in ASEAN for Class 2 and Class 3 devices.
Integrated Services for Indonesia BPOM Registration
BPOM Device Registration
End-to-end management of Class 1–3 device registration through the e-Regalkes portal — including Indonesian-language dossier preparation, GMP certificate coordination, deficiency response, and approval tracking. Classification analysis under the Permenkes framework and submission strategy for all device types included.
Local PT Company Support
The Indonesian PT requirement is the single biggest structural challenge for foreign device manufacturers. JNPMEDI APAC helps you establish or identify a compliant local PT — obtaining the PAK (distributor licence) and managing the PT relationship so regulatory accountability and commercial distribution remain structurally independent.
Post-Market & Compliance
Ongoing BPOM post-market compliance — adverse event reporting, registration renewal management (5-year cycles), product variation submissions, BPOM inspection readiness, and regulatory intelligence on Permenkes and BPOM regulatory updates affecting your registered devices in Indonesia.
Why JNPMEDI APAC for Indonesia BPOM Registration
Indonesia's PT requirement is the largest market entry barrier for foreign device manufacturers. Most companies end up making their distributor the PT — creating a lock-in that makes changing commercial partners later extremely costly. JNPMEDI APAC helps you structure the PT relationship so regulatory and commercial roles remain separate from day one.
For Korean manufacturers, the MFDS GMP certificate or ISO 13485 is the standard credential required by BPOM for Class 2 and Class 3 devices. JNPMEDI APAC — connected to JNPMEDI Korea — coordinates the GMP documentation process efficiently, reducing one of the most common causes of submission delays in Indonesia.
Indonesia has the largest population in Southeast Asia and a rapidly growing healthcare sector. The 210–390 day registration timeline is long, but the market size justifies early investment. JNPMEDI APAC typically recommends initiating Indonesia registration in parallel with faster markets — so you are commercially ready across SEA within the same overall timeline.
Indonesia BPOM Registration — FAQ
Yes, all foreign devices must be imported and registered through a locally incorporated Indonesian PT; this is non-negotiable under the Permenkes framework.
BPOM's online registration system where all Class 1–3 device submissions are made. Requires an active PT with valid PAK (distributor licence) to access.
210–300 days from accepted submission. PT setup takes 60–90 days and runs in parallel, so the overall project timeline from project start is approximately 270–390 days.
Yes, this is one of JNPMEDI APAC's core Indonesia services. Structuring the PT separately from your commercial distributor protects your ability to change distribution partners without triggering re-registration.