Indonesia's medical device regulatory system is governed primarily by the Ministry of Health (MoH) and the National Agency of Drug and Food Control (BPOM). The regulatory framework aims to ensure the safety, quality, and efficacy of medical devices available in the Indonesian market while supporting the growth of both local manufacturing and appropriate importation of technologies not yet available domestically.

Classification System for Medical Devices in Indonesia

Indonesia follows a risk-based classification system similar to many global regulatory frameworks:

Class A Devices (Low Risk)

• Examples: Simple wound dressings, non-sterile examination gloves, non-invasive medical furniture
• Characterized by minimal potential harm to patients
  
  

Class B Devices (Low to Moderate Risk)

• Examples: Surgical gloves, infusion sets, most diagnostic equipment
• Present moderate risk in case of malfunction or misuse
  
  

Class C Devices (Moderate to High Risk)

• Examples: Ventilators, dialysis machines, implantable devices
• Could pose significant risk to patients if they malfunction
  
  

Class D Devices (High Risk)

• Examples: Heart valves, implantable defibrillators, active implants
• Devices that sustain or support life, with highest regulatory scrutiny
  
  

Registration Requirements for Locally Manufactured Devices

Local manufacturers must navigate several regulatory steps to bring a medical device to market in Indonesia:

Business Licensing

• Obtain a Single Business Number (NIB) through the Online Single Submission (OSS) system
• Secure a Medical Device Production License (Izin Produksi Alat Kesehatan)
• Obtain a Production Certificate of Medical Devices and Household Health Supplies (SPP)
  
  

Good Manufacturing Practice (GMP) Certification

• Mandatory compliance with Indonesia's GMP requirements
• Regular facility inspections by MoH representatives
• Appropriate quality management systems documentation
  
  

Product Registration

• Complete product dossier submission to the MoH through the e-HALRIS system
• Technical documentation including design specifications, risk analysis, and verification/validation data
• Clinical evaluation reports appropriate to the device classification
• Labeling in Bahasa Indonesia with all required elements
  
  

Distribution License

• Obtain a Medical Device Distribution License (AKD - Alat Kesehatan Dalam Negeri)
• Compliance with Good Distribution Practices (GDP)
• Establishment of appropriate post-market surveillance systems
  
  

Import and Registration Process for Foreign Medical Devices

Foreign manufacturers must partner with Indonesian entities to access the market:

Local Representation Requirement

• Foreign manufacturers cannot directly register products
• Must appoint an Indonesian legal entity as authorized representative
• The representative must be a registered medical device distributor or importer
  
  

Import Licensing

• The local representative must obtain:
• Business Identification Number (NIB) which serves as the basic Import License
• Medical Device Import License (AKL - Alat Kesehatan Luar Negeri)
• Good Distribution Practice certification
  
  

Product Registration Process

• Pre-registration consultation (recommended for high-risk devices)
• Online submission through e-HALRIS system
• Comprehensive documentation including:
  • Certificate of Origin
  • Certificate of Free Sale from country of origin
  • ISO 13485 certification
  • Full technical documentation
  • Clinical evaluation documentation
  • Declaration of Conformity
  • Indonesian-language labeling 
• Laboratory testing may be required for certain device categories
  
  

Timeline and Fees

• Registration timelines vary by classification:
  • Class A: 40-60 working days
  • Class B: 60-80 working days
  • Class C: 80-100 working days
  • Class D: 100-120 working days
• Registration fees are based on device classification and company status (large vs. small/medium enterprise)
• Registration is valid for 5 years and must be renewed
  
  

Special Considerations for Different Device Categories

Software as Medical Device (SaMD)

• Requires specific documentation related to cybersecurity
• Validation of software functioning in Indonesian technology environment
• Data privacy compliance with Indonesian regulations
  
  

In Vitro Diagnostic Devices (IVDs)

• Additional testing may be required at BPOM-designated laboratories
• Performance evaluations in Indonesian population groups may be requested
• Special considerations for COVID-19 and other infectious disease diagnostics
  
  

Implantable Devices

• Rigorous clinical evaluation requirements
• Special post-market surveillance obligations
• Extended record-keeping requirements for traceability
  
  

Local Content and Transfer of Technology Requirements

Indonesia has implemented policies to encourage local manufacturing:

TKDN (Tingkat Komponen Dalam Negeri) Program

• Government incentives for devices with higher local content percentages
• Preferential treatment in government procurement for devices with higher TKDN scores
• Gradual requirements for technology transfer for certain device categories
  
  

Strategic Partnerships

• Foreign manufacturers are encouraged to establish joint ventures with local companies
• Knowledge transfer programs may be required for high-technology devices
• Research and development collaborations with Indonesian institutions are viewed favorably
  
  

Post-Registration Requirements

Once a medical device is registered, ongoing compliance is necessary:

Post-Market Surveillance

• Mandatory adverse event reporting
• Regular safety updates to regulatory authorities
• Tracking and traceability systems for higher-risk devices
  
  

Advertising and Promotion

• Pre-approval required for promotional materials
• Strict regulations on claims and representations
• Special considerations for direct-to-consumer advertising
  
  

Facility Inspections

• Regular inspections of manufacturing and distribution facilities
• Quality management system audits
• Unannounced inspections possible for high-risk device manufacturers
  
  

Halal Certification Considerations

Though not mandatory for all medical devices, Halal certification is increasingly important:

• Required for devices containing animal-derived materials
• Becoming a market advantage even when not legally required
• May impact packaging and material selection decisions
  
  

Recent Regulatory Changes and Future Directions

Recent updates to Indonesia's regulatory framework include:

Electronic Registration System

• Full implementation of e-HALRIS system
• Streamlined registration process with greater transparency
• Electronic tracking of application status
  
  

Harmonization Efforts

• Greater alignment with ASEAN Medical Device Directive
• Recognition of certain international standards and certifications
• Movement toward accepting more ASEAN Common Submission Dossier Templates (CSDT)
  
  

Special Pathways

• Expedited registration for innovative technologies addressing critical healthcare needs
• Special considerations for orphan devices serving small patient populations
• Emergency Use Authorization provisions for public health emergencies
  
  

Strategic Considerations for Market Entry

For successful medical device registration in Indonesia:

Market Research and Preparation

•  Understand the competitive landscape and regulatory requirements
•  Identify appropriate local partners with strong regulatory experience
•  Prepare comprehensive documentation tailored to Indonesian requirements
  
  

Partner Selection

• Conduct thorough due diligence on potential representatives
• Ensure they have appropriate licenses and regulatory expertise
• Establish clear contractual relationships regarding regulatory responsibilities
  
  

Regulatory Strategy

• Consider starting with lower classification devices to establish relationship with authorities
• Engage in pre-submission consultations for complex or innovative devices
• Budget for potential clinical evaluations or local testing requirements