Introduction
Medical device registration in Indonesia is a crucial compliance step for foreign companies looking to enter one of Southeast Asia’s fastest-growing healthcare markets. The Ministry of Health (Kementerian Kesehatan, MoH) oversees the import, distribution, and use of all medical devices to ensure that products meet strict safety, quality, and performance standards.
With increasing demand for medical equipment, especially in hospitals and clinics, the Indonesian government has tightened oversight to protect patients and ensure fair competition. This makes proper registration not just a legal formality but also a key business strategy for gaining trust from healthcare providers, distributors, and consumers.
Since all licensing is now centralized under the OSS (Online Single Submission) system, the registration process has become more streamlined—but also more closely monitored. Companies must ensure that their OSS data aligns with the documents submitted to the Ministry Of Health. Even small inconsistencies can cause delays, rejections, or costly reapplications.
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What is Medical Device Registration in Indonesia?
Medical device registration in Indonesia is the official approval process by which the Ministry of Health (Kementerian Kesehatan, MoH) authorizes medical devices to be legally imported, distributed, and used within the country. Without this approval, products cannot enter the Indonesian market, and companies risk customs rejection, penalties, or even product recalls.
The registration process is designed to ensure that all medical devices—whether imported or locally manufactured—meet the government’s strict requirements on safety, quality, and effectiveness. This protects patients, ensures fair competition in the healthcare industry, and aligns Indonesian regulations with international standards.
Medical device registration applies to three main groups of businesses:
The registration framework is also aligned with international benchmarks, such as the ASEAN Medical Device Directive (AMDD), which harmonizes standards across Southeast Asia. This makes it easier for products registered in Indonesia to meet recognition standards in other ASEAN countries.
In practical terms, medical device registration verifies compliance across several areas, including:
- Product safety and performance data.
- Clinical evidence for higher-risk devices.
- Quality management systems (e.g., ISO 13485 certification).
- Labeling and packaging in accordance with Indonesian language and regulatory requirements.
By completing the registration process, companies obtain an official certificate (AKL for imported devices or AKD for locally manufactured devices), which is valid for five years and renewable. This certificate not only provides legal access to the Indonesian market but also builds trust with hospitals, clinics, and healthcare providers who prefer products with proven compliance.
Legal Framework for Medical Device Registration
⚠️ Why this matters: Without proper registration, products may be blocked at customs, withdrawn from the market, or incur penalties.
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How Medical Device Registration Operates in Indonesia?
The process varies depending on classification (Class A – low risk, Class D – high risk).
Foreign manufacturers must appoint a local Indonesian entity (Foreign Investment Company (PT PMA) or distributor) as the license holder.
Devices are classified into four categories based on risk:
- Class A – low risk (e.g., bandages).
- Class B – moderate risk.
- Class C – higher risk.
- Class D – highest risk (e.g., implants, life-support equipment).
Includes:
- ISO 13485 certificate or equivalent QMS evidence.
- Free Sale Certificate from the country of origin.
- Product testing reports.
- Labeling and packaging information.
The Directorate General of Pharmaceutical and Medical Devices conducts technical and administrative evaluations.
If approved, the MoH (Ministry of Health) (Ministry of Health) issues a registration certificate valid for five years, renewable with surveillance.
Common Mistakes in Medical Device Registration
Benefits of Medical Device Registration in Indonesia
- Market Access: Legal entry into one of ASEAN’s largest healthcare markets.
- Consumer Trust: Products with AKL/AKD certificates gain credibility with hospitals and distributors.
- Compliance Assurance: Avoid fines, product recalls, and customs rejections.
- Business Growth: Certification supports long-term expansion and partnerships.
Step-by-Step: How to Register a Medical Device in Indonesia (2025)
- Step 1: Appoint a local authorized representative (PT PMA or distributor).
- Step 2: Determine device classification (Class A–D).
- Step 3: Prepare required documentation (ISO, Free Sale, testing).
- Step 4: Submit application via OSS and MoH (Ministry of Health) portal.
- Step 5: Undergo technical evaluation by MoH (Ministry of Health).
- Step 6: Obtain AKL/AKD certificate valid for five years.
- Step 7: Ensure post-market surveillance and renewals.
Key Takeaways
✅ Foreign companies must appoint a local authorized representative.
✅ Device classification determines process length and requirements.
✅ Documentation must be complete and aligned with OSS.
✅ Approval is valid for five years, renewable.
✅ Case studies show delays happen without full compliance.
FAQ: Medical Device Registration in Indonesia
Only Indonesian entities (PT PMA or local distributors) can hold licenses on behalf of foreign manufacturers.
Average processing time is 6–12 months depending on classification and documentation.
Five years, renewable with post-market surveillance.
No. A local authorized representative is mandatory
Products may be seized, distributors penalized, and licenses revoked.
How MAM Corporate Solutions Can Support
Medical device registration in Indonesia is not just a legal requirement—it’s a gateway to trust, compliance, and market growth. By following the step-by-step process, aligning documentation, and working with experienced partners, foreign companies can successfully enter Indonesia’s healthcare market.
Contact MAM Corporate Solutions today or fill in the form below for expert assistance with medical device registration, company formation, and compliance in Indonesia.
- Define the mission and
- Ensure compliance with laws and consult legal
- Prepare sufficient capital (especially for foreign founders).
- Establish a transparent governance
- Set up efficient systems for fundraising and donations.
- Stay compliant with tax and reporting obligations
