Exporting medical devices to Indonesia involves a few essential licenses that can feel like a complex puzzle. The big question often is: Which comes first—IDAK, CDAKB, or product approval? The answer is straightforward but crucial: IDAK must come first, then CDAKB, and only after that can you apply for product approval (NIE).
Let’s clarify what each license means and the proper sequence.
1. IDAK: Your Distribution License Foundation
Izin Distribusi Alat Kesehatan (IDAK) is the official license from Indonesia’s Ministry of Health (Kemenkes) that allows a local company (like a PT or CV) to legally distribute medical devices in Indonesia.
Without IDAK:
- The local company cannot legally distribute medical devices.
- They cannot access the e-RegAlkes portal to submit product dossiers.
Think of IDAK as the “driver’s license” your local distributor needs to operate in the Indonesian market.
2. CDAKB: Certificate of Distribution Authorization for Medical Devices
Next up is the CDAKB (Surat Izin Penyalur Alat Kesehatan Berbasis Komersial)—a commercial distribution authorization issued to local distributors or importers who hold a valid IDAK.
- CDAKB is a formal permit confirming that the distributor is authorized to commercially distribute specific categories or classes of medical devices.
- This certificate is a prerequisite for submitting registration dossiers on behalf of foreign manufacturers.
- It aligns the scope of the distributor’s business with the types of devices they plan to market.
In short, CDAKB confirms that your local partner is not only licensed but also authorized to handle the specific kinds of devices you want to import or sell.
3. NIE: The Product Approval Number Comes Last
Only after your local partner holds both a valid IDAK and CDAKB can they submit your product dossier via the e-RegAlkes portal to apply for the Nomor Izin Edar (NIE)—the official product approval number.
Without NIE:
- Importation, marketing, and distribution of your medical device are illegal in Indonesia.
- CE certificates or international approvals won’t suffice.
4. Why Getting the Sequence Right Matters
Submitting a product dossier before the distributor secures IDAK and CDAKB is an automatic rejection. Regulators will see this as a sign that you don’t understand the local system, inviting more scrutiny and delays.
Skipping CDAKB or IDAK risks:
- Denied portal access for dossier submission.
- Administrative roadblocks and prolonged approval times.
- Legal complications in distribution and import.
The Correct Sequence Is IDAK → CDAKB → NIE
- Ensure your local distributor holds a valid IDAK.
- Confirm they have a CDAKB covering your medical device category.
- Only then submit the product dossier to get the NIE.
This order isn’t just a bureaucratic formality; it’s the key to a smooth, compliant market entry.
How INSIGHTOF Helps You Navigate This Process
The Indonesian medical device regulatory framework can be complex, but it doesn’t have to be overwhelming. At INSIGHTOF, we guide foreign manufacturers and their local partners through every step—from securing IDAK and CDAKB to dossier preparation and NIE submission.
With our expertise and close ties to Kemenkes regulatory officials, we help you avoid costly mistakes and accelerate your device’s approval.
Do you need assistance registering your product in Indonesia?
Contact us today to start your registration process.
