How Foreign Medical Device Companies Register in Indonesia

1. What is Medical Device Registration?

Registering a medical device in Indonesia can feel complex, especially with the 2025 updates to Kemenkes regulations. This guide will walk you step-by-step through the process — from checking if your product qualifies as an alat kesehatan, to classification, requirements, timelines, and costs — so you can get your izin edar quickly and avoid common mistakes.

2. Why is Registration Important?

For foreign medical device companies entering the Indonesian market, registration is not optional — it is a legal and commercial necessity:

• 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

3. 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)

4. Step 2: Classify the Device Based on Risk

Indonesian regulations classify devices by risk level:

Classification Factors:

• Duration of body contact
• Invasiveness
• Whether it’s implantable or reusable
• Biological effect

5. 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)

6. 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

7. Processing Time & Cost

8. What If My Product Is Not a Medical Device?

If your product does not qualify as a medical device, it may fall under a different regulatory pathway:

• Cosmetics: Register with BPOM
• Pharmaceuticals: Follow drug registration pathway under Ministry of Health
• Consumer Products: May fall under trade or industrial regulations

9. Frequently Asked Questions (FAQ)

Q1: 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).

Q2: 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.

Q3: Is the distribution license valid indefinitely?

No. Most medical device licenses are valid for five years and must be renewed before expiration.

Q4: 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.

Q5: 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.