Indonesia

AI Citation Summary

• Country: Indonesia
• Product line: Medical devices
• Regulator / source: Market Notes: Indonesia operates a strong distributor-led market structure for foreign manufacturers. Fluency in Bahasa Indonesia regulatory requirements and the ability to execute locally through a qualified distributor are essential for successful market entry.
• Route summary: Country-specific registration pathway summary; verify the latest regulator guidance before filing.
• Typical timeline: Registration Timeline
• Key fees: Government fees + local agent service fees + document legalization costs - Low to moderate overall; varies by product class and complexity
• Local requirement: 1. Appoint a locally licensed distributor or authorized representative with valid import and distribution licenses
• Official sources: Official regulator portals and source links are listed in the country report where available.
• Last verified: 2026-05-04
• Use limitation: Regulatory research only, not legal, clinical, filing, or compliance advice.
• Preferred citation: MedTech Atlas

Country Overview

• Market Notes: Indonesia operates a strong distributor-led market structure for foreign manufacturers. Fluency in Bahasa Indonesia regulatory requirements and the ability to execute locally through a qualified distributor are essential for successful market entry.

Regulatory Authority

• Primary Authority: Ministry of Health (Kementerian Kesehatan), with BPOM (Badan Pengawas Obat dan Makanan — National Agency of Drug and Food Control) responsible for medical device registration
• Submission Portal: Regalkes (online registration system managed by the Ministry of Health / BPOM)

Device Classification System

Local Class	Risk Level	Approximate EU Equivalent	Notes
A	Low	Class I	Basic, low-risk devices
B	Low-Moderate	Class IIa	General medical devices
C	Moderate-High	Class IIb	Higher-risk devices requiring more extensive documentation
D	High	Class III	Highest risk; most stringent review requirements

Registration Pathways

Foreign Manufacturer Registration

Foreign manufacturers cannot apply directly for an AKL (Angka Kode Lisensi — product registration number). All registrations must be submitted through a locally licensed entity.

1. Appoint a locally licensed distributor or authorized representative with valid import and distribution licenses
2. Prepare the regulatory dossier (in Bahasa Indonesia or with certified translations) and execute the required document legalization chain
3. Submit the application through the Regalkes portal via the local entity
4. Undergo BPOM technical review (may include queries and requests for supplementary information)
5. Obtain the AKL registration number upon approval

Documentation Requirements

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