After obtaining:
the final step to legally sell medical devices in Indonesia is:
👉 NIE (Nomor Izin Edar)
This is the official marketing authorization issued by the Ministry of Health.
Without NIE:
Products cannot be sold
Importation is restricted
Distribution is not legally permitted
What is NIE (Nomor Izin Edar)?
The NIE (Nomor Izin Edar) is the official registration number granted to medical devices after approval.
It confirms that:
The product meets safety and performance requirements
Documentation complies with Indonesian regulations
The device is approved for commercial distribution
Regulatory Authority & System
NIE registration is managed by:
Ministry of Health (Kemenkes)
Directorate General of Pharmaceuticals and Medical Devices
Applications are submitted via:
👉 Regalkes system (online platform)
NIE Registration Requirements (CSDT Format)
Indonesia follows the ASEAN Common Submission Dossier Template (CSDT).
📄 Core Documentation
Executive Summary
Device Description
Intended Use
Labeling & IFU (Bahasa Indonesia mandatory)
Risk analysis
Product specifications
Manufacturing process
🧪 Additional (For Class B, C, D)
Clinical evaluation
Performance testing
Biocompatibility (if applicable)
📜 Legal Documents
Free Sale Certificate (FSC)
Letter of Authorization (LoA)
👉 Documents may require legalization/apostille
Step-by-Step NIE Registration Process (Practical & In-Depth)
Obtaining an NIE (Nomor Izin Edar) is not just a document submission—it is a structured regulatory review where the Ministry of Health evaluates whether your product is safe, compliant, and ready for the Indonesian market.
Below is how the process works in practice:
Step 1: Appoint a Local License Holder
Foreign manufacturers cannot register directly in Indonesia. You must appoint:
A local distributor (IDAK holder), or
An independent authorized representative
👉 This entity will:
Hold your NIE license
Submit the application via the Regalkes system
Act as your official regulatory contact
⚠️ Important:
Choosing the wrong partner can limit your ability to switch distributors later.
Step 2: Product Classification & Regulatory Strategy
Before preparing documents, your device must be classified into:
Class A (Low risk)
Class B (Low–Moderate)
Class C (Moderate–High)
Class D (High risk)
👉 This step determines:
Documentation depth
Clinical evidence requirements
Approval timeline
⚠️ Misclassification is a common issue and can lead to:
Rejection
Delays due to re-evaluation
Step 3: CSDT Dossier Preparation
Indonesia follows the ASEAN Common Submission Dossier Template (CSDT).
You must prepare:
Device description & intended use
Risk analysis
Manufacturing information
Labeling & IFU (Bahasa Indonesia mandatory)
For Class B, C, and D:
Clinical evaluation
Performance testing
👉 The dossier must be:
Structured
Consistent across all sections
Aligned with international standards (ISO 13485, FSC)
Step 4: Submission via Regalkes System
The complete dossier is submitted through the Regalkes online portal.
This includes:
Uploading technical documents
Entering product details
Paying government fees
👉 Accuracy is critical—any mismatch between documents and system data can trigger queries.
Step 5: Ministry of Health Review
The authority evaluates:
Product safety and performance
Documentation completeness
Compliance with Indonesian requirements
👉 This is not just administrative—it is a technical review process.
Step 6: Additional Information (AI) Phase
If the authority requires clarification:
Queries are issued through the system
You must respond within a defined timeline
👉 Delays usually happen here due to:
Incomplete responses
Misaligned documentation
Step 7: NIE Approval & Issuance
Once approved:
NIE number is issued
Product is legally approved for sale in Indonesia
👉 At this stage, your product can:
Be imported
Be distributed
Enter the commercial market
NIE Approval Timeline
Class | Timeline |
Class A | 10–15 working days |
Class B | 30–45 working days |
Class C/D | 60–90 working days |
👉 Delays occur during:
AI phase
incomplete documentation
NIE Government Fees (PNBP)
Class | Fee (IDR) |
Class A | 1,500,000 |
Class B | 3,000,000 |
Class C | 3,000,000 |
Class D | 5,000,000 |
How OMC Medical Simplifies NIE Registration
NIE registration involves coordination between technical documentation, regulatory systems, and local compliance requirements. OMC Medical ensures this process is handled efficiently and correctly from the start:
Regulatory Strategy & Classification
We determine the correct device classification and documentation pathway to avoid rejections.
Complete CSDT Dossier Preparation
Structured, compliant documentation aligned with Indonesian and international standards.
Regalkes Submission Management
Accurate data entry and document handling to prevent system-level errors.
AI Query Handling
Fast and precise responses to authority questions, reducing approval delays.
License Holding Flexibility
Independent model ensures you retain control over your product registration.
Move Forward with Confidence
A well-prepared NIE submission significantly reduces delays and approval risks.
👉 Contact OMC Medical today to start your Indonesia medical device registration process.
Frequently Asked Questions (FAQs)
Is NIE mandatory for medical devices in Indonesia?
Yes, NIE is mandatory. Without it, medical devices cannot be imported, marketed, or distributed in Indonesia.
Can foreign manufacturers apply for NIE directly?
No. Foreign manufacturers must appoint a local entity with an IDAK license to act as the license holder and submit the application.
What happens if NIE application is rejected?
In most cases, the authority issues an Additional Information (AI) request. Rejection occurs if requirements are not met or responses are insufficient.
What is Regalkes in Indonesia?
Regalkes is the Ministry of Health’s online system used for submitting and managing medical device registrations, including NIE applications.
