For foreign medical device manufacturers, Indonesia represents one of Southeast Asia’s most dynamic and promising healthcare markets. With a growing middle class and increased healthcare investment, demand for imported devices from diagnostic tools to implantables is on the rise.
But before entering the market, every product must comply with the Indonesia medical device registration guidelines issued by the Ministry of Health (MoH). These guidelines are not simply procedural checklists; they are comprehensive rules that shape how medical devices are classified, documented, distributed, and monitored.
Failing to follow these guidelines can result in costly delays, product rejections, or even denial of market access. This article will walk you through the essentials of the Indonesian guidelines, focusing on localization requirements, the Regalkes system, and post-market compliance.
By understanding these Ministry of Health regulations and preparing thoroughly, you can avoid common pitfalls and accelerate market entry.
Regulatory Authority and Legal Framework
Medical device regulation in Indonesia is governed by the Ministry of Health (Kementerian Kesehatan, MoH). The legal foundation is Regulation of the Minister of Health No. 62/2017, which requires all medical devices to obtain a Nomor Izin Edar (NIE) before being distributed or sold.
Indonesia aligns with the ASEAN Medical Device Directive and uses the ASEAN Common Submission Dossier Template (CSDT) for registrations, along with a risk-based classification system (Classes A–D) similar to global standards.
Indonesia also aligns with the ASEAN Medical Device Directive (AMDD), which harmonizes regulatory practices among ASEAN countries. However, the MoH adapts AMDD provisions to fit local policies, meaning that CE marking or FDA clearance alone is insufficient.
The entire registration process is now centralized in the Regalkes system, MoH’s online platform that manages submission, evaluation, and approval.
For context on how classification works under these regulations, see our article on Types of Medical Devices and Their Classification in Indonesia.
Localization Requirements in Indonesian Guidelines
One of the most distinctive features of Indonesia’s guidelines is the emphasis on localization. Even if a product has already been cleared in Europe, the US, or China, it must be adapted to Indonesian standards:
- Language Requirements: All labels, packaging, and Instructions for Use (IFU) must be translated into Bahasa Indonesia. All foreign regulatory documents (e.g. CFS, GMP certificates) must be notarized and legalized by an Indonesian Embassy or apostilled, and the Letter of Authorization should cover a full 5-year term to match the registration validity
- Legalization of Foreign Documents: Certificates such as the Certificate of Free Sale (CFS), Good Manufacturing Practice (GMP), and Letter of Authorization (LoA) must be legalized or apostilled before submission.
- Adaptation of Technical Files: Technical documentation must be compiled into an Indonesian-format registration dossier, following local templates. A Device Master File (DMF) and Product Information File (PIF) must be structured according to Indonesian templates, even if the manufacturer already complies with EU MDR or FDA requirements.
Example Pain Points:
- Europe (CE Mark): CE compliance does not exempt companies from submitting additional localized documents.
- China: Companies face frequent delays due to document legalization at embassies.
- United States (FDA): FDA labeling formats must be adjusted to Indonesian guidelines, particularly for Bahasa translation and risk warnings.
Core Requirements of Medical Device Registration Guidelines
The Indonesian guidelines outline a comprehensive set of requirements that must be met before submission. These include:
- Legal Documents:
- LoA from manufacturer to local representative
- Certificate of Free Sale (CFS)
- GMP or ISO 13485 certificate
The LoA from the manufacturer to the local representative must be embassy-legalized and ideally valid for at least five years to ensure the NIE remains valid for its full term. Likewise, the local distributor’s IDAK license (distribution permit) is mandatory.
As of July 2024, the MoH enforces that distributors hold an official Good Distribution Practice certificate (CDAKB) – mere compliance is not enough before any new device can be registered.
- Technical Documents:
- Device Master File (DMF)
- Clinical Evaluation Report (for Class B–D devices)
- Biocompatibility, electrical safety, and shelf-life test reports (if applicable)
- Product label and IFU in Bahasa Indonesia
For Class C and D devices, be prepared to provide additional evidence or local testing data, as MoH may require local clinical evaluations or safety tests for invasive or high-risk products.
- Local Distributor Requirements:
- Distributor must hold an IDAK license (Izin Distribusi Alat Kesehatan)
- Compliance with CDAKB certification (Good Distribution Practice for Medical Devices)
These requirements ensure that only safe, effective, and high-quality products reach Indonesian patients, while also creating accountability for both manufacturers and distributors.
Regalkes System: Digital Backbone of Registration
Itu Regalkes system is the core digital platform through which all medical device registrations are processed. It provides a structured pathway for submission, but also introduces unique challenges for foreign manufacturers.
Key Functions of Regalkes:
- Submission Portal: Upload dossiers, certificates, and supporting documents.
- Evaluation Workflow: MoH reviewers send clarification requests directly through the platform.
- Fee Management: Government fees (PNBP) are paid and tracked online.
- Approval & NIE Issuance: Once approved, the system generates the official registration certificate.
Note: the Regalkes interface is in Bahasa Indonesia and has strict file naming conventions, so foreign manufacturers should work closely with local experts to navigate it.
Challenges Manufacturers Face:
- Technical Glitches: System downtime or upload errors can delay submissions.
- Clarification Cycles: MoH frequently requests clarifications, which extend evaluation timelines.
- Format Rigidness: Files must follow strict naming and size requirements.
Plan submissions with some buffer time – the Regalkes portal occasionally undergoes maintenance shutdowns (e.g. a scheduled closure in Dec 2024) that temporarily halt new applications.
Expect at least one round of clarification queries from MoH; timely responses through the system are crucial to keep your application on track.
👉 For a deeper explanation of how NIE is strategically managed, see our article on Medical Device Registration in Indonesia: NIE, Risk Classes & Regulatory Strategy.
Post-Market Compliance Under the Guidelines
The Indonesian guidelines extend beyond initial registration. Manufacturers and distributors are also responsible for post-market obligations, which include:
- Surveillance & Vigilance: Reporting adverse events or product failures to MoH (Serious incidents must be reported promptly – delays can lead to sanctions).
- Renewal of NIE: Every registration is valid for 5 years and must be renewed. An NIE license is typically valid for up to 5 years (sometimes shorter if tied to the LoA’s expiry). Begin the renewal process several months before expiry to prevent any lapse in your market authorization.
- Random Inspections: MoH may audit distributors or request updated safety data.
- Penalties: Non-compliance may lead to suspension, revocation of NIE, or fines.
This ongoing compliance framework ensures that medical devices remain safe and effective throughout their lifecycle in Indonesia.
Keep in mind emerging requirements like halal certification for devices with animal-origin components, which are being phased in under recent regulations.
Why PRI’s Expertise Matters
While the guidelines are publicly available, navigating them in practice is complex. Common barriers include document legalization, Regalkes submission errors, and local representation issues.
Registrasi Produk Indonesia (PRI) helps manufacturers by:
- Preparing complete and compliant dossiers.
- Acting as a local representative and license holder, ensuring flexibility in distributor management.
- Liaising with MoH to resolve clarifications quickly.
- Supporting post-market surveillance and renewal requirements.
We stay on top of new MoH regulations (for example, the latest halal compliance mandates) so you don’t get caught off guard.
Unlike relying on a single distributor, PRI can hold the product license (NIE) on your behalf. This means you retain the flexibility to manage or change distributors without risking your registration.
Our local team’s familiarity with the Regalkes system and MoH expectations allows us to resolve clarification requests swiftly and get your product to market faster.
Kesimpulan
Itu Indonesian medical device registration guidelines provide a detailed framework to ensure that only safe, effective, and high-quality devices reach patients. However, for foreign manufacturers, these guidelines represent both an opportunity and a challenge.
Regulations will continue to evolve; for instance, Indonesia is introducing halal product assurance for certain medical devices, so staying informed and compliant is an ongoing effort. With expert guidance, however, manufacturers can confidently navigate these changes.
By understanding localization requirements, mastering the Regalkes system, and committing to post-market compliance, manufacturers can secure timely approvals and maintain long-term market access.
At Product Registration Indonesia, we specialize in guiding companies through every step of the guidelines, from document preparation to license holding and post-market compliance. Contact us for a free consultation to simplify your path into the Indonesian market.
