What is Medical Device Registration?
Medical device registration in Indonesia is a regulatory process to ensure that all medical products entering, circulating, or being sold in the country meet safety, quality, and performance standards as set by the Ministry of Health (Kemenkes). The registration is mandatory for local and international manufacturers and distributors.
Why is Registration Important?
- Legal Compliance with Indonesian regulations (Permenkes, AMDD, etc.)
- Access to Market including hospitals, clinics, and e-commerce platforms
- Consumer Safety through approved and monitored devices
Step 1: Determine If Your Product is a Medical Device
To begin registration, first verify if your product qualifies as a medical device:
- Intended Use: Diagnose, monitor, prevent, or treat diseases.
- Indications for Use: The targeted condition or user group.
Examples:
- Glucose meter (for diabetes)
- Infusion pump (for controlled drug delivery)
Refer to the Ministry of Health’s classification guidelines or consult with regulatory consultants like INSIGHTOF.
Step 2: Classify the Device Based on Risk
Indonesian regulations classify devices by risk level:
| Class | Risk Level | Examples |
|---|---|---|
| A | Low | Surgical gloves, stethoscope |
| B | Low-Moderate | Infusion set, blood pressure cuff |
| C | Moderate-High | X-ray machines, dialysis machine |
| D | High | Heart stents, pacemakers |
Classification Factors:
- Duration of body contact
- Invasiveness
- Whether it’s implantable or reusable
- Biological effect
Step 3: Prepare Registration Requirements
You’ll need to submit five main documents:
- Form A: Administrative documents
- Form B: Product information
- Form C: Product specifications and quality assurance
- Form D: Instructions for use
- Form E: Post-market surveillance plan
Other typical requirements:
- GMP certificate
- Free Sale Certificate
- Risk management file
- Clinical data (for Class C & D)
Step 4: Submit via Online Portal
Use the official Kemenkes portal: www.regalkes.kemkes.go.id
A. Pre-Registration Phase:
- Submit product details
- Product classification review (within 7 days)
- Pay PNBP fees and upload proof (within 10 days)
B. Registration Phase:
- File evaluation and technical review
- Deficiency correction (within 30 days, max 2x)
- Final decision: approval, request for clarification, or rejection
Processing Time & Cost
| Device Class | Estimated Time | Cost (PNBP Fee) |
| Class A | ~30 days | Lowest tier |
| Class B | ~45 days | Medium tier |
| Class C/D | ~60 days | Higher tier |
Note: Fees vary based on complexity and classification.
What If My Product Is Not a Medical Device?
- Cosmetics: Register with BPOM
- Pharmaceuticals: Follow drug registration pathway under Ministry of Health
- Consumer Products: May fall under trade or industrial regulations
Frequently Ask Question (FAQ)
Who is required to register medical devices in Indonesia?
All manufacturers, importers, and distributors intending to market medical devices in Indonesia must register the product and obtain a distribution permit from the Ministry of Health (Kemenkes).
Can a foreign company register directly with Kemenkes?
No. Foreign companies must appoint a local representative or licensed distributor in Indonesia who will act as the Marketing Authorization Holder.
Is the distribution license valid indefinitely?
No. Most medical device licenses are valid for five years and must be renewed before expiration.
What’s the difference between medical device registration and BPOM registration?
Medical device registration is handled by the Ministry of Health, while BPOM (Indonesia’s Food and Drug Authority) handles registration for cosmetics, food, supplements, and pharmaceuticals.
Do I need to have a manufacturing facility in Indonesia to register my device?
No, you don’t need a local manufacturing facility. However, you must appoint a registered local distributor in Indonesia who is responsible for regulatory compliance and product distribution.
Your appointed distributor must have warehouse certifications, such as:
- IDAK (Izin Distribusi Alat Kesehatan) – Medical Device Distribution License
- CDAKB (Cara Distribusi Alat Kesehatan yang Baik) – Good Distribution Practice for Medical Devices
This ensures your products can be legally stored, handled, and distributed within Indonesian territory.
Help Navigating Indonesian Registration?
If you’re developing or distributing medical devices in Indonesia, partner with INSIGHTOF to ensure a smooth and compliant registration process—backed by deep local expertise and experience in Kemenkes regulations.
Do you need assistance registering your product in Indonesia?
Contact us today to start your registration process.
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