Market Overview
Indonesia's medical device market is one of the largest in Southeast Asia, driven by a population of 270+ million and increasing healthcare expenditure.
Foreign manufacturers must work with local distributors or establish a local presence. All medical devices require registration with BPOM before they can be legally distributed in Indonesia.
Key Requirements
- CDAKB certification for distributors
- BPOM product registration (Izin Edar)
- Indonesian language labeling
- Import licenses for each shipment
Device Classification System
Indonesia classifies medical devices into three risk categories, similar to international standards:
Non-invasive devices, reusable surgical instruments, devices with minimal risk to patients
Examples
Requirements
- Technical documentation
- Declaration of conformity
- Basic safety testing
Short-term invasive devices, devices administering or exchanging energy, devices with moderate risk
Examples
Requirements
- Clinical evidence
- Quality management system
- Performance testing
- Biocompatibility data
Long-term implantable devices, life-sustaining devices, devices with highest risk to patients
Examples
Requirements
- Full clinical trials data
- Extensive safety testing
- Quality audit
- Post-market surveillance plan
In Vitro Diagnostics (IVD)
IVD medical devices have a separate registration pathway and classification system. These include reagents, calibrators, control materials, instruments, and software used for diagnostic testing.
IVD Categories
- • Blood typing and tissue typing
- • Infectious disease screening
- • Companion diagnostics
- • Clinical chemistry analyzers
Additional Requirements
- • Performance evaluation data
- • Stability testing results
- • Reference material certification
- • Quality control specifications
Licensing Process
Company Establishment
Establish a legal entity in Indonesia (PT PMA for foreign investors or local PT) with appropriate KBLI codes for medical device activities
CDAKB Certification
Obtain Good Distribution Practice for Medical Devices certification. This requires proper facilities, trained personnel, and quality systems
Product Registration
Register each medical device with BPOM. Submit technical documentation, clinical evidence, and safety data based on device classification
Import License
Obtain import licenses (SPI - Surat Persetujuan Import) for each shipment of medical devices
Distribution License
Receive distribution authorization (Izin Edar) allowing legal sale and distribution of the medical device in Indonesia
Relevant KBLI Codes
These KBLI codes are commonly used for medical device business activities:
Important Considerations
- Local Presence: Foreign companies must work through local partners or establish a PMA company
- Timeline: Full registration process can take 6-12 months depending on device class
- Renewals: Distribution licenses must be renewed every 5 years
- Post-Market: Ongoing vigilance reporting and adverse event monitoring required
Frequently Asked Questions
Further Reading
From Emerhub Blog
Need Help with Medical Device Registration?
Navigating Indonesia's medical device regulations requires expertise. Our team can help with company setup, CDAKB certification, and product registration.