1. Understanding Medical Devices as Regulated Products
Medical devices represent a critical component of Indonesia’s healthcare infrastructure. From simple bandages to complex diagnostic equipment and life-saving implants, every medical device sold in Indonesia must undergo rigorous regulatory scrutiny by the Ministry of Health (Kementerian Kesehatan/Kemenkes) through its Directorate General of Pharmaceutical and Medical Devices (Ditjen Farmalkes).
Unlike consumer goods, medical devices directly impact patient safety and clinical outcomes. This is why Indonesia enforces strict registration requirements before any device can enter the market.
Medical Device Classification
According to Indonesian regulations, a medical device is any instrument, apparatus, machine, software, implant, reagent, or material intended for use in diagnosis, prevention, monitoring, treatment, or alleviation of disease, injury, or disability.
Regulatory Authority: Ministry of Health (Kemenkes)
Registration Portal: REGALKES (https://regalkes.kemkes.go.id/)
⚠️ Critical Requirement: All medical devices – whether manufactured domestically or imported from countries like Japan, USA, Germany, or China – must obtain an Izin Edar (Marketing Authorization) before distribution. This applies to devices ranging from examination gloves to MRI machines.
2. Why Medical Device Registration is Mandatory
Indonesia’s medical device registration system serves multiple critical purposes that protect both patients and healthcare providers:
- Patient Safety Assurance: Ensures devices meet international safety and performance standards before reaching Indonesian hospitals and clinics.
- Quality Control: Verifies that manufacturing processes comply with ISO 13485 and Good Manufacturing Practices (GMP).
- Performance Validation: Confirms that devices perform as claimed through clinical evidence and technical documentation.
- Traceability and Accountability: Establishes clear responsibility chains from manufacturers through distributors to end users.
- Post-Market Surveillance: Enables monitoring of device performance and adverse event reporting after market entry.
Legal Framework: Medical device registration in Indonesia is governed by several key regulations including Permenkes No. 62 of 2017 on Medical Device Distribution and Permenkes No. 1190/MENKES/PER/VIII/2010 on Medical Device Registration. Non-compliance can result in customs detention, product confiscation, fines up to IDR 2 billion, and import bans.
3. Medical Device Classification System
Indonesia classifies medical devices based on risk level, similar to the European Union’s classification system. Understanding your device’s classification is the critical first step in the registration process.
| Class | Risk Level | Examples | Evaluation Time |
|---|---|---|---|
| Class A (I) | Low Risk | Bandages, examination gloves, tongue depressors | 45 days |
| Class B (IIb) | Low-Moderate Risk | Surgical masks, infusion sets, blood pressure monitors | 90 days |
| Class C (IIc) | Moderate-High Risk | Syringes, surgical instruments, ventilators | 90 days |
| Class D (III) | High Risk | Cardiac pacemakers, stents, artificial joints, defibrillators | 120 days |
The classification determines:
- Documentation requirements and depth of technical evaluation
- PNBP fees
- Clinical evidence requirements
- Processing timeline
Device Categories by Technology Type
Beyond risk classification, devices are grouped into five technological categories:
- Electromedic Radiation: X-ray machines, CT scanners, radiation therapy equipment
- Electromedic Non-Radiation: ECG machines, ultrasound devices, patient monitors
- Non-Electromedic Sterile: Surgical instruments, implants, catheters
- Non-Electromedic Non-Sterile: Bandages, splints, examination tables
- In-Vitro Diagnostic (IVD): Blood test kits, pregnancy tests, COVID-19 rapid tests
4. Prerequisites: What You Need Before Registration
Before submitting a product registration, companies must establish the proper business structure and obtain necessary licenses:
4.1 Market Entry Route Selection
Foreign manufacturers have two primary options:
- Option A: Establish a Local Entity
- Form a PT (Limited Liability Company) or PT PMA (Foreign Investment Company)
- Obtain NIB (Business Identification Number)
- Register appropriate KBLI codes for medical device import/distribution
- Option B: Appoint an Authorized Distributor
- Partner with a licensed Indonesian distributor holding IDAK
- Provide Letter of Authorization (LOA) from manufacturer
- Distributor acts as legal registrant and responsible party
4.2 Medical Device Distributor License (IDAK)
IDAK (Izin Distribusi Alat Kesehatan) is the foundational license required for any entity wishing to import or distribute medical devices in Indonesia.
Key Requirements for IDAK:
- Registered Indonesian business entity (PT)
- Dedicated storage facility meeting Kemenkes standards (temperature control, security, proper ventilation)
- Qualified personnel including a pharmacist or technical expert
- Standard Operating Procedures (SOPs) for storage and distribution
Validity: 5 years (renewable)
4.3 Good Distribution Practice Certification (CDAKB) – Mandatory
🔴 New Requirement Alert: CDAKB certification is now mandatory before or alongside product registration. This represents a significant regulatory shift aimed at ensuring supply chain quality from import to end-user delivery.
CDAKB (Cara Distribusi Alat Kesehatan yang Baik) certifies that your distribution system complies with Good Distribution Practice standards.
CDAKB Requirements include:
- Facility audit demonstrating proper storage conditions
- Quality management system documentation
- Staff training records
- Equipment calibration and maintenance logs
- Temperature mapping and monitoring systems
IDAK vs CDAKB: Understanding the Difference
| Aspect | IDAK | CDAKB |
|---|---|---|
| Purpose | Legal authorization to distribute medical devices | Quality system certification for distribution practices |
| Nature | License/Permission | Certification/Compliance |
| Requirement Stage | Before any distribution activity | Before or with product registration |
| Focus | Business eligibility | Operational quality standards |
| Validity | 5 years | 5 years with surveillance audits |
| Can operate without? | ❌ No – Illegal to distribute | ❌ No – Cannot register new products |
5. Step-by-Step Registration Process
The registration process follows a structured pathway through Kemenkes’ REGALKES online portal:
Step-by-Step Registration Process:
- Classification Determination
Work with regulatory experts to accurately classify your device based on:
- Intended use and clinical purpose
- Duration of body contact (if applicable)
- Invasiveness level
- Active vs passive device characteristics
- Technical Documentation Preparation
Compile comprehensive technical dossier including:
- Certificate of Free Sale (CFS): From country of origin confirming the device is legally marketed there
- ISO 13485 Certificate: Quality Management System certification for medical device manufacturers
- Product Specifications: Detailed technical specifications, materials, dimensions, software details
- User Manual: Complete instructions in Bahasa Indonesia
- Clinical Evidence: For Class C and D devices, clinical trial data or literature reviews
- Risk Analysis: According to ISO 14971 standards
- Labeling and Packaging: All text must be in Bahasa Indonesia with mandatory information
- REGALKES Online Submission
Create account at https://regalkes.kemkes.go.id/ and:
- Upload all required documents in PDF format
- Complete online application forms with device details
- Pay PNBP (Non-Tax State Revenue) fees based on device class
- Submit application for Kemenkes review
- Kemenkes Technical Evaluation
Kemenkes evaluators review your submission for completeness, compliance with Indonesian standards, safety evidence, and labeling clarity. Evaluation typically takes 45-120 working days depending on device class.
- Approval and E-Registration Certificate
- Kemenkes issues Izin Edar (Marketing Authorization) valid for 5 years
- Registration number must be displayed prominently on product packaging
- Format: AKL (locally manufactured) or AKD (imported devices)
| Service Type | Evaluation Period | Fee (IDR) |
|---|---|---|
| Class A (I) New Registration | 45 working days | 1,500,000 |
| Class B (IIb) New Registration | 90 working days | 3,000,000 |
| Class C (IIc) New Registration | 90 working days | 3,000,000 |
| Class D (III) New Registration | 120 working days | 5,000,000 |
⏰ Timeline Tip: While official timelines range from 45-120 days, real-world approval often takes 3-6 months when accounting for documentation reviews, clarification requests, and administrative processing. Plan accordingly for product launches.
6. Common Registration Challenges and Solutions
Companies frequently encounter these obstacles during registration:
| Challenge | Impact | Solution |
|---|---|---|
| Incomplete documentation | Application rejection or delays of 2-4 months | Work with experienced consultants to ensure completeness before submission |
| Incorrect classification | Wrong fees, evaluation pathway, timeline | Conduct pre-submission classification consultation |
| Non-compliant labeling | Approval denial requiring resubmission | Have labels reviewed by regulatory expert before production |
| Insufficient clinical evidence | Requirement for additional studies or data | Prepare comprehensive clinical evaluation reports |
| Expired supporting certificates | Application on hold until renewal | Monitor certificate validity dates proactively |
7. Post-Registration Requirements
Registration approval is not the end – ongoing compliance is essential:
- Renewal: Submit renewal application 6 months before expiration
- Variation Registration: Required for changes in formulation, manufacturing site, or specifications
- Post-Market Surveillance: Report adverse events and device defects to Kemenkes
- CDAKB Surveillance Audits: Periodic inspections to maintain certification
- Labeling Updates: Must reflect current regulations and product information
8. Success Strategies for Medical Device Registration
Best Practices for Smooth Registration:
- ✅ Start the IDAK and CDAKB process 6-9 months before planned product launch
- ✅ Engage regulatory consultants familiar with current Kemenkes requirements
- ✅ Maintain organized document management system with version control
- ✅ Prepare all translations early – Bahasa Indonesia labeling takes time
- ✅ Build relationships with local distributors who understand regulatory landscape
- ✅ Monitor regulatory updates – requirements can change
- ✅ Budget adequately for testing, translation, and consulting fees beyond registration fees
9. How INSIGHTOF Consulting Indonesia Can Help
INSIGHTOF Consulting Indonesia is your trusted partner for medical device regulatory compliance, offering end-to-end support for both international manufacturers and local companies.
Our Comprehensive Services Include:
- ✅ IDAK License Application: Complete facilitation of distributor license acquisition
- ✅ CDAKB Certification: Facility assessment, documentation preparation, and audit support
- ✅ Product Classification Consultation: Accurate device classification based on regulatory expertise
- ✅ Technical Dossier Preparation: Compilation of all required documentation to Kemenkes standards
- ✅ Translation Services: Professional medical device documentation translation to Bahasa Indonesia
- ✅ REGALKES Submission and Follow-up: Application management from submission through approval
- ✅ Label Compliance Review: Ensuring packaging meets all Indonesian requirements
- ✅ Renewal and Variation Support: Ongoing compliance management
With over 700 successful registrations across food, cosmetics, and medical devices, INSIGHTOF combines deep regulatory knowledge with strong Ministry of Health relationships to accelerate your market entry.
Why Choose INSIGHTOF?
• Proven track record in medical device registrations
• Direct communication channels with Kemenkes officials
• Multidisciplinary team including regulatory affairs specialists, translators, and quality experts
• Transparent pricing and timeline estimates
• Post-registration support for compliance maintenance
Conclusion
Medical device registration in Indonesia is a structured but complex process requiring meticulous attention to regulatory requirements. Success depends on:
- ✅ Accurate device classification understanding
- ✅ Proper business licensing (IDAK and CDAKB)
- ✅ Complete technical documentation preparation
- ✅ Compliance with labeling and quality standards
- ✅ Strategic timeline planning
Whether you’re a multinational corporation launching innovative medical technology or a local startup distributing healthcare equipment, navigating Kemenkes registration requirements efficiently is critical for market success.
Don’t let regulatory complexity delay your market entry. Partner with experts who understand both the technical requirements and the practical realities of Indonesian medical device registration.
Ready to Register Your Medical Device in Indonesia?
INSIGHTOF Consulting Indonesia provides the expertise and support you need to achieve Kemenkes approval efficiently and compliantly. Contact us today to discuss your product and receive a customized registration strategy.
