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Indonesia Medical Device Registration

Badan Pengawas Obat dan Makanan (BPOM) approval timelines and requirements

2-4 months
Typical Timeline
3
Device Classes
No
MDSAP Accepted
Required
Indonesia Authorized Representative

Indonesia Medical Device Registration Overview

Indonesia medical device registration through BPOM typically takes 2-4 months for Class A devices. The official BPOM target is 1-2 months, but realistic timelines include preparation, documentation review, and potential questions from regulators.Indonesia uses a 3-class (A, B, C) risk-based classification system. Foreign manufacturers must appoint a Indonesia Authorized Representative to register devices in Indonesia. Registration is valid for 5 years.

Registration Timeline by Device Class

Indonesia uses a 3-class (A, B, C) risk-based classification system.

Class A

Notification

Low Risk
Official
1-2 months
Realistic
2-4 months

• Simplified notification

Class B

Registration

Medium Risk
Official
3-6 months
Realistic
4-9 months
With Prior Approval
3-5 months

Accelerated with: ASEAN MRA countries, FDA, EU CE Mark

• ASEAN harmonization applies

Local Testing RequiredGMP/QMS Required

Class C

Full Registration

Highest Risk
Official
6-12 months
Realistic
9-18 months
With Prior Approval
6-10 months

Accelerated with: ASEAN MRA countries, FDA, EU CE Mark

• Clinical data may be required

Clinical Trial RequiredLocal Testing RequiredGMP/QMS Required
Expedited Pathways

ASEAN Medical Device Directive (AMDD)

Harmonized registration within ASEAN

20-30% faster
Eligibility: Products registered in ASEAN MRA countries
Prior Approval Recognition

Existing approvals from other regulatory authorities can accelerate your Indonesia registration.

ASEAN MRA
Harmonized registration
2-4 months
FDA 510(k)
Documentation support
2-3 months
EU CE Mark
Documentation support
2-3 months
Key Requirements
  • Indonesia Authorized Representative
  • Bahasa Indonesia labeling
  • Local testing from accredited labs
  • ISO 13485 certification
  • Free Sale Certificate
Registration Validity:

5 years

Registration Process Flowchart

Indonesia Medical Device Registration Process

Step-by-step BPOM registration process. Total estimated timeline: 2-4 months.

Step 1: Pre-Submission Preparation

1-3 months

Gather technical documentation, quality management system (QMS) records, and clinical data required by BPOM. Appoint a Indonesia Authorized Representative.

Step 2: Application Submission

1-2 weeks

Submit complete registration dossier to BPOM including device description, risk analysis, and testing reports.

Step 3: Administrative Review

2-4 weeks

BPOM reviews application for completeness. May request additional documents or clarifications.

Step 4: Technical Evaluation

1-2 months

In-depth technical assessment of device safety and performance. BPOM may issue questions.

Step 5: Registration Approval

1-2 weeks

Upon successful review, BPOM issues Indonesia market authorization certificate.

Summary: The Indonesia medical device registration process through Badan Pengawas Obat dan Makanan (BPOM) consists of 5 main steps: Pre-Submission Preparation → Application Submission → Administrative Review → Technical Evaluation → Registration Approval.
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Timelines are estimates based on 2024-2025 data. Last updated: 2025-12-01.