Indonesia is one of the fastest-growing medical device markets in Southeast Asia. With a population of more than 270 million and a rapidly expanding healthcare sector, demand for medical devices is increasing steadily, making medical device registration services in Indonesia more crucial than ever. However, for foreign manufacturers, entering this market is not as simple as shipping products and finding distributors. Have you considered Indonesia for your portfolio’s market expansion destination? Do you find it difficult to understand where to start?
All medical devices must go through a rigorous registration process with the Indonesian Ministry of Health (MoH) before they can be legally marketed. This requirement ensures safety, quality, and efficacy, but it also means that manufacturers face significant regulatory hurdles. That is why professional medical device registration services in Indonesia have become indispensable for companies from Europe, China, and the United States looking to establish their presence.
Regulatory Landscape in Indonesia
Medical device regulation in Indonesia is overseen by the Ministry of Health (Kementerian Kesehatan) through its dedicated online platform called Regalkes for medical device registration.
All applications are submitted through the MoH’s Regalkes online portal, which is aligned with ASEAN standards. The framework follows international standards such as the ASEAN Medical Device Directive (AMDD) and takes into account global best practices. Registration is mandatory for all device classes, from low-risk consumables to high-risk implantable devices.
- Legal Basis: Peraturan Menteri Kesehatan (Permenkes) No. 62 of 2017, which establishes the obligation of obtaining a Nomor Izin Edar (NIE) for all medical devices before importation/marketing.
- Classification: Medical devices are categorized into four risk classes (A, B, C, D) following the AMDD framework, ranging from low-risk to high-risk devices. Devices are classified into four risk categories: *Class A (low risk), Class B (low-moderate), Class C (moderate-high), and Class D (high risk).
- Representation: Foreign manufacturers cannot register products directly. They must appoint a akuocal license holder or distributor registered with MoH.
- Ministry of Health now requires a CDAKB (Good Distribution Practice) certificate as a prerequisite for product registration starting July 1, 2024. This underscores why expert guidance is critical in navigating updated rules
For a deeper look at classification, see our article on Types of Medical Devices and Their Classification in Indonesia.
Why Foreign Manufacturers Face Challenges
Although the regulatory framework is clear, the practical execution varies depending on the origin country, creating different pain points for manufacturers:
🇪🇺 Europe (CE Mark Holders)
- European manufacturers often assume that CE certification guarantees automatic approval in Indonesia. However, MoH requires localized documentation, including labeling in Bahasa Indonesia and appointment of a local license holder.
- Additional technical dossiers, such as Device Master File (DMF) must align with Indonesian templates, not just EU MDR standards.
- Even with a CE Mark, Indonesian regulators require a locally formatted dossier and compliance with national requirements
- European (and all foreign) manufacturers must issue an LoA appointing the local representative. Note that this LoA must be notarized and legalized or apostilled to be accepted by MoH
🇨🇳 China
- Chinese companies face challenges with document legalization and translation. Certificates of Free Sale (CFS) and Good Manufacturing Practice (GMP) documents must be legalized or apostilled, a process that can add several months to the registration process. Indonesia joined the Apostille Convention in 2022, meaning documents from many countries can be apostilled instead of consular legalized. However, since China is not a party to that convention, Chinese manufacturers still face longer consular legalization processes, which often add weeks to the timeline. Emphasizing the need for professional guidance to handle these steps efficiently.
- Many Chinese manufacturers also underestimate the importance of CDAKB certification (Good Distribution Practice for Medical Devices) for their local partners. As of 2024, having a local distributor with a CDAKB certificate is mandatory for new registrations, which many companies from China (and elsewhere) might overlook.
Insider PRO Tip: For Chinese manufacturers, it is critical to clearly state the exact region, district, and sub-district where both the company and factory are located, and to provide an official statement letter from the respective government offices. In addition, MoH often requires a formal information letter confirming whether the manufacturer operates as an OEM
🇺🇸 United States (FDA Approval Holders)
- While FDA approval demonstrates product quality, Indonesia requires a different risk-based registration pathway.
- Indonesia’s MoH will still conduct a technical review of even FDA-approved devices, and for high-risk (Class C and D) devices, they may request additional clinical evidence or specific format reports to meet local standards
- Labeling requirements are stricter: Bahasa Indonesia Instructions for Use (IFU) must be submitted. Thus, Instructions for Use (IFU) and labels must be translated, which is a common stumbling block.
- Some high-risk devices require additional clinical evaluation reports in line with Indonesian standards, even if extensive FDA data already exists.
Medical Device Registration Services in Indonesia Explained
Professional registration services are designed to help manufacturers overcome these hurdles efficiently. At Product Registration Indonesia (PRI), services typically include:
- Risk Classification & Pre-Submission Consultation
- Identify the correct class (A–D) under MoH and AMDD rules.
- Developing grouping or bundling strategies to optimize registration can save time & cost.
We often find manufacturers waste months registering items separately that could have been bundled – an expert prevents such missteps
- Document & Dossier Preparation
- Compilation of legal documents: LoA, CFS, GMP, ISO 13485.
- Creation of technical files: Device Master File, clinical evaluation, and labeling.
Each document – from legalized LoA and CFS to the Device Master File – must align with Indonesian templates. Any missing or mismatched information can trigger MoH queries and delay approval. Our team ensures all documentation is correct on the first go.
- Distributor License (IDAK) & CDAKB Certification
- Assistance in obtaining IDAK (Izin Distribusi Alat Kesehatan) for local partners, which now requires compliance with CDAKB standards.
- We guide local partners through the CDAKB audit and certification process, which is now a critical precondition for product registration.
- Product Registration (NIE)
- Submission through the Regalkes system.
- Handling data clarifications and follow-up with MoH evaluators.
After submission via Regalkes and payment of fees (PNBP), MoH’s review can take anywhere from 2 to 4 months, depending on device class. Upon approval, the NIE license is valid for 5 years and must be renewed to continue marketing the device.
- License Holding & Custodianship
- For manufacturers without a local entity, PRI offers neutral license-holding services.
- This arrangement ensures that companies are not tied to one distributor, maintaining flexibility in market strategy.
Without a neutral license holder, switching distributors means starting a new registration from scratch, causing costly delays. Our custodianship service prevents that scenario, giving manufacturers flexibility in their go-to-market strategy
Step-by-Step Process Overview
Here is a simplified overview of the medical device registration process in Indonesia:
| Stage | Key Activities | Responsible Party |
| 1. Classification | Determine risk class (A–D) | Manufacturer + Consultant |
| 2. Document Preparation | Legal documents, technical dossier, ISO certificates | Manufacturer + Consultant |
| 3. Local Representation | Appointment of license holder obtains the IDAK (with MoH oversight) | Local Distributor / Consultant |
| 4. Submission | Upload dossier via Regalkes online system, pay government fees (PNBP) | Consultant |
| 5. Evaluation | Clarifications, technical review by MoH (MoH evaluators may ask for clarification or extra documents; responding promptly is critical to avoid rejection) | Consultant |
| 6. Approval | Issuance of NIE (Nomor Izin Edar). Class A devices can sometimes be approved in a few weeks if straightforward, whereas Class D devices might take a few months | MoH |
| 7. Post-approval | NIE renewal and post-market vigilance (NIE is valid for 5 years; renewal is required for continued sales) | Local Distributor / Consultant |
For more details on NIE and its strategic role, see our article on Medical Device Registration in Indonesia: NIE, Risk Classes & Regulatory Strategy.
Why Work with Expert Consultants Like Product Registration Indonesia
Partnering with a specialized consultant provides three key advantages:
- Efficiency & Accuracy – Avoid delays due to incomplete documentation or misunderstanding of local requirements.
Over 50% of initial submissions by companies new to Indonesia receive requests for correction or additional data – we strive to get it right the first time to avoid such delays
- Regulatory Liaison – PRI acts as a bridge between foreign manufacturers and the Indonesian Ministry of Health.
Our consultants stay updated on the MoH’s latest requirements and maintain communication with regulators, so any clarifications during evaluation are handled smoothly
- Market Flexibility – With license-holding services, companies can maintain control over their product registrations, switching distributors if needed without losing regulatory approvals.
Kesimpulan
Entering Indonesia’s medical device market offers tremendous potential but requires strict compliance with MoH regulations. Each step—from classification and document preparation to CDAKB certification and NIE approval—demands expertise and local insight.
That’s why working with a trusted consultant is not just a convenience, but a strategic decision that ensures smooth market entry.
At Product Registration Indonesia, we specialize in medical device registration services in Indonesia. Contact us today for a free consultation and discover how we can help you bring your products to market faster and with full compliance.
In summary, complying with MoH regulations is challenging; partnering with an expert for medical device registration services in Indonesia turns it into a smooth process.
Don’t let regulatory hurdles delay your entry — contact us today for a free consultation.
