This page covers the regulatory authority, device classification, registration process, local representative requirements and FAQs for medical device registration in Indonesia. Medical devices in Indonesia are regulated by the Ministry of Health (Kemenkes), and EVERBIZ can support you through the entire process from classification to registration.
1. Regulatory Framework
Medical devices in Indonesia are regulated by the Directorate of Medical Device and Household Health Product Assessment under the Ministry of Health (Kementerian Kesehatan, Kemenkes). The main legal bases are:
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Permenkes No. 62/2017 – marketing authorization for medical devices, IVDs and household health products (PKRT)
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Permenkes No. 11/2025 – the latest amendment, strengthening requirements for in-country representatives of foreign manufacturers and post-market responsibilities
Submissions are made via the Regalkes system (regalkes.kemkes.go.id), and all documents must be translated into Indonesian (Bahasa Indonesia). The classification rules are aligned with the ASEAN AMDD and the CSDT submission template is used.
2. Risk Classification
Indonesia uses four risk classes (consistent with the AMDD):
| Class | Risk | Examples |
|---|---|---|
| Class A | Low | Surgical dressings, examination gloves |
| Class B | Low–moderate | Syringes, stethoscopes |
| Class C | Moderate–high | Anaesthesia machines, X-ray machines |
| Class D | High | Pacemakers, implantable defibrillators |
3. Prerequisites for Registration
Foreign manufacturers cannot apply directly and must first meet the following requirements:
1. Local entity / authorized representative: Appoint a legal License Holder in Indonesia – usually an importer holding an IDAK or an independent third-party representative. Each brand name can be registered by only one License Holder; multiple registrations or transfers are not permitted.
2. IDAK (Medical Device Distribution License): Izin Distribusi Alat Kesehatan – the basic license for a local entity to import or distribute medical devices. Applied for via the OSS (Online Single Submission) system, valid for 5 years.
(IDAK is the new unified name for IPAK / SDAK.)
3. CDAKB (Good Distribution Practice for Medical Devices certification): Cara Distribusi Alat Kesehatan yang Baik – a mandatory certification ensuring supply chain quality, now required before or at the same time as product registration. Requirements include temperature-controlled storage, a qualified technical person in charge (PJT), SOPs, etc.
4. Facilities and personnel: an office, an owned warehouse or one leased for ≥2 years, and at least one technical person in charge (PJT).
4. Registration Process
Step 1 — Open a Regalkes account: The local License Holder opens an account on the Regalkes platform.
Step 2 — Prepare the CSDT dossier
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CSDT technical dossier (ASEAN common template)
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ISO 13485 certificate (mandatory for foreign manufacturers)
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Letter of Authorization (LOA) – legalized by the Indonesian embassy (KBRI) or apostilled, covering a 5-year period
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CFS (Certificate of Free Sale) – legalized by the embassy
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GMP certificate
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Risk management report (ISO 14971, including an “Indonesian annex”)
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Indonesian labeling and IFU
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Local test reports for special products (see below)
Step 3 — Submit the application and pay the PNBP fee: Official fees (by risk class, for reference):
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Class A: about IDR 1,500,000 (about USD 125)
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Class B / C: about IDR 3,000,000 (about USD 225)
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Class D: about IDR 5,000,000 (about USD 350)
Payment deadline: payment must be made within 7 days of invoice generation; otherwise the application lapses and must be resubmitted.
Step 4 — Administrative + technical review: Administrative review checks the completeness of documents.
Technical review assesses product safety, effectiveness, performance, labeling and risk management.
Step 5 — Respond to deficiencies: Requests for additional information must be answered within 10–15 working days, otherwise the application is rejected.
Step 6 — Obtain the NIE (marketing authorization number): Nomor Izin Edar – the number required to sell in the Indonesian market.
5. Local Testing Requirements (Special Categories)
Some products must be tested by accredited laboratories in Indonesia:
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Single-use sterile syringes – local sterility testing
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Gauze, cotton, sanitary pads, panty liners, adult diapers – local fluorescence and absorbency testing
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Condoms – local burst and leakage testing
6. Registration Timelines
| Item | Time |
|---|---|
| Classification check | 7 calendar days |
| Class A registration | About 1–2 months |
| Class B / C registration | About 1–2 months |
| Class D registration | About 1–2 months (additional hard-copy dossier required) |
| Renewal (changes) | About 34 working days |
Since Permenkes 62/2017 took effect, registration times have fallen from 6–9 months to 1–2 months.
7. Validity and Renewal
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NIE validity: 5 years
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Renewal can be submitted within 9 months before expiry
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Applications submitted after expiry are treated as new applications
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Before renewal, importers must submit import/distribution reports on e-report.alkes.kemkes.go.id
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Changes (packaging, labeling, accessories, address, etc.) must be processed while the certificate is valid
8. Post-Market Obligations
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Adverse event reporting (vigilance) – serious events must be reported promptly; delays are penalized
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e-report import and distribution reports – submitted annually
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Recalls and field safety corrective actions
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Ongoing CDAKB compliance – maintaining the quality system on the distribution side
9. Halal Certification (Phased Mandatory Requirement)
Indonesia’s Halal Product Assurance Law is being implemented in phases:
| Class | Halal certification deadline |
|---|---|
| Class A | October 2026 |
| Class B | October 2029 |
| Class C | October 2034 |
| Class D | To be determined |
Devices that are not yet Halal-certified and contain animal-derived ingredients must carry a “Non-Halal” label. We recommend assessing product ingredients early.
10. E-Catalogue
Medical devices supplied to public hospitals must be registered in the government E-Catalogue system, which requires:
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A valid NIE
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Compliance with GDP requirements
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The E-Catalogue is the preferred channel for public healthcare procurement and is currently being upgraded to Version 6
11. Recent Key Changes
| Time | Change |
|---|---|
| 2025 | Permenkes 11/2025 issued, strengthening requirements for foreign manufacturers’ in-country operating licenses and post-market reporting |
| 2025 | CDAKB certification made mandatory – must be obtained before or at the same time as product registration |
| October 2025 | Indonesia KFA database launched, unifying medical product identification |
| 2025–2026 | Migration to E-Catalogue Version 6 begins |
| October 2026 | Halal certification deadline for Class A medical devices |
Strategic Value and Challenges
Opportunities:
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Southeast Asia’s largest economy and one of the world’s most populous countries
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Transparent public procurement through the E-Catalogue
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The CSDT under the AMDD framework can be reused for technical files in other ASEAN countries
Challenges:
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Single License Holder rule – changing distributors requires re-registration, so appointing an independent third-party holder is recommended
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The Regalkes system is entirely in Indonesian, with strict file-naming rules
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KBRI embassy legalization is time-consuming
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Halal and CDAKB requirements keep tightening
How EVERBIZ Can Help
EVERBIZ has offices in Shanghai, Hong Kong, Germany, Austria, Singapore, Malaysia, Thailand and Vietnam. For the Indonesia market, we offer:
- Product classification and registration pathway planning
- Preparation and review of registration dossiers
- Local authorized representative / registration holder arrangements
- Submission, responses to deficiency letters and progress tracking
- Post-market compliance maintenance (changes, renewals, adverse event reporting)
Contact us for a Indonesia medical device registration plan and quote, or see our registration services for other countries and regions.
Indonesia Medical Device Registration FAQs
Which authority regulates medical devices in Indonesia?
The Directorate of Medical Device and Household Health Product Assessment under the Ministry of Health (Kementerian Kesehatan, Kemenkes); the main legal basis is Permenkes No. 62/2017.
How do foreign manufacturers register in Indonesia?
Through a local Indonesian company holding a medical device distribution license (IDAK), which submits the registration application in the Regalkes system.
How long is an Indonesian medical device registration valid?
Registrations are generally valid for 5 years, but no longer than the manufacturer’s letter of authorization, and must be renewed before expiry.
Do medical devices need Halal certification?
Indonesia is phasing in Halal certification requirements for medical devices; see the “Halal Certification” section on this page for scope and deadlines.