How to Secure a Medical Device License in Indonesia — and Use Thailand as a Springboard for ASEAN Expansion
For many international manufacturers, Indonesia often becomes the next logical destination after gaining approval in the EU, US, or China. With a rapidly expanding healthcare infrastructure, a growing middle class, and rising public investment in hospitals, the market appears ready for global medical technology.
Yet, securing a medical device license in Indonesia is not as straightforward as it might look on paper. The process is managed by the Ministry of Health (MoH) and comes with unique requirements that can surprise even experienced exporters.
Why Indonesia Registration Matters
Before any medical device can be imported, distributed, or sold in Indonesia, it must obtain an official Nomor Izin Edar (NIE) — the country’s equivalent to a marketing authorization. Without it, no legal sales or public tenders are possible.
Product registration also determines whether your company can access LKPP’s e-Katalog, the national procurement system used by public hospitals. In other words, regulatory compliance in Indonesia is not just about following the law — it is about gaining access to the largest healthcare market in Southeast Asia.
A strong registration strategy builds trust with hospitals, distributors, and government buyers. It turns compliance into a competitive advantage.
ASEAN Alignment, Indonesian Adaptation
Indonesia is part of the ASEAN Medical Device Directive (AMDD), which aims to harmonize medical device regulation across the region. While this framework resembles EU and US systems, Indonesia applies its own interpretation of those standards.
Every device must still pass through a local MoH risk classification and dossier review — even if it already has CE Mark or FDA approval.
Some local adaptations include:
| Requirement | Local Application |
|---|---|
| Language | All documents, including IFU, must be translated into Bahasa Indonesia. |
| Legalization | Certificates like CFS and GMP must be legalized or apostilled. |
| Format | Dossier must follow MoH’s Regalkes templates, which differ from EU MDR or FDA structures. |
In short: international approval helps, but does not replace Indonesian evaluation.
Core Elements of Medical Device License in Indonesia
Each registration component in Indonesia carries both regulatory and business weight. Understanding their role is essential for success.
| Component | Purpose | Business Significance |
|---|---|---|
| Device Master File (DMF) | Describes product design, performance, and safety. | Demonstrates reliability and supports regulatory confidence. |
| Local Representation | Appointing an MoH-licensed distributor with a valid IDAK. | Determines who “owns” your product license and your control over future distribution. |
| Legal Documents (LoA, CFS, GMP) | Proof of authorization, quality, and manufacturing standards. | Early legalization avoids embassy delays that can slow market entry. |
| Labeling in Bahasa Indonesia | Ensures usability and patient safety. | Builds market credibility and avoids rejection or recall. |
| CDAKB Certification | Good Distribution Practice for Medical Devices. | Mandatory from July 2024; confirms that your distributor meets MoH standards. |
Together, these form the foundation for obtaining a medical device license in Indonesia.
Proven Best Practices for Medical Device License in Indonesia
1. Start early with documentation
Legalization and translation can take weeks or even months. Preparing LoA, CFS, and GMP documents early prevents last-minute delays.
2. Group products smartly
Indonesia allows product grouping under similar device categories. For large portfolios — especially consumables — this strategy reduces costs and processing time.
3. Use neutral license holding
Instead of registering under a single distributor, many companies use an independent License Holder. This approach preserves ownership of the registration, allows flexibility to change distributors, and strengthens your negotiating power.
4. Adapt to local expectations
Compliance in Indonesia is not purely technical. Marketing claims, visuals, and materials must reflect cultural sensitivities. Devices containing animal-derived ingredients, for instance, may need Halal declarations.
By 2026, Halal certification will become mandatory for certain Class A devices — early preparation is key.
5. Prepare for post-market obligations
MoH expects active post-market surveillance. Implement systems for adverse event reporting and performance tracking to ensure ongoing compliance.
Thailand as a Gateway for Multi-Country Registration
For manufacturers operating in Asia, Thailand offers a strategic base to manage multi-country submissions across ASEAN — including Indonesia.
1. Shared ASEAN Framework
Both countries apply the AMDD structure and use similar dossier formats (CSDT). Preparing technical files in Thailand allows easy adaptation for Indonesia — often with minimal additional documentation.
2. Established Regulatory Infrastructure
Thailand’s regulatory consultants and License Holders already manage hundreds of ASEAN-wide submissions. Using a Thai partner simplifies coordination, legalizations, and translation support for Indonesia filings.
3. Efficiency through Synergy
A company with Thai FDA registration can reuse validated ISO 13485 certificates, GMP documents, and Free Sale Certificates across ASEAN markets. With proper planning, a single regional dossier can feed into multiple country applications, including Malaysia, Indonesia, and Vietnam.
4. Business Continuity
By maintaining product ownership through a neutral regional License Holder in Thailand, manufacturers gain flexibility to manage Indonesian distributors while retaining control over all market licenses.
In short, Thailand is not just a nearby country — it’s the perfect regulatory springboard for ASEAN expansion.
Conclusion
Gaining a medical device license in Indonesia opens the door to one of Asia’s largest and most dynamic healthcare markets. But it requires more than paperwork — it demands strategy.
By localizing documentation, using neutral license holding, aligning with AMDD standards, and leveraging Thailand as a regional base, foreign manufacturers can turn regulatory compliance into a growth engine across Southeast Asia.
Credits: Productregistrationindonesia.com
