IVD Medical Device Registration in Indonesia
IVD Medical Device Registration in Indonesia
Our experienced regulatory affairs specialists provide comprehensive support, from initial classification and submission to post-market compliance, ensuring your IVD devices meet all regulatory requirements by the government in Indonesia.
IVD Medical Device Registration Support for Regulatory Approval – Indonesia
Indonesia’s healthcare sector presents strong growth potential, supported by government initiatives to strengthen the domestic medical device industry. The Ministry of Health of the Republic of Indonesia (Kemenkes) actively encourages the development and availability of medical technologies to support the country’s expanding healthcare needs.
At Andaman Medical, our regulatory affairs specialists provide comprehensive support throughout the IVD registration process. From initial device classification and regulatory submission to post-market compliance, we help ensure your IVD devices meet the regulatory requirements established by the Indonesian government.
Why Register Your IVD Medical Device in Indonesia?
Registering your IVD device in Indonesia allows manufacturers to access one of Southeast Asia’s largest and rapidly growing healthcare markets. Compliance with national regulatory requirements ensures that diagnostic devices can be legally distributed while supporting the country’s efforts to expand access to reliable medical technologies.
Registering your IVD device in Indonesia offers numerous advantages for your business:
Access to a Growing Market
Access to a Growing Market
The demand for advanced diagnostic solutions is on the rise in Indonesia, driven by increased healthcare spending and a growing awareness of the importance of early disease detection. By registering your IVD device in Indonesia, you tap into a large and emerging market with significant growth potential.
Regulatory Compliance
Regulatory Compliance
Registering your IVD device ensures compliance with the regulatory requirements set by the Indonesian Ministry of Health. This compliance not only helps in avoiding legal issues but also builds trust and credibility with healthcare providers.
Potential Market Entry and Expansion
Potential Market Entry and Expansion
Successfully registering your IVD device is the first step towards establishing a strong market presence in Indonesia. It enables collaborations with local distributors, healthcare institutions, and government programs. Additionally, it lays the foundation for future product launches and market expansion strategies.
Registration Process Overview
Here’s a step-by-step overview to help you through the registration process for IVDs in Indonesia:
Classification
Submission
Evaluation
ApprovalClassification
Medical devices in Indonesia are classified into three main categories as it dictates the regulatory requirements and submission details:
- Medical Devices (Alat Kesehatan)
- In Vitro Diagnostics (Diagnostik in Vitro)
- Household Health Supplies (Perbekalan Kesehatan Rumah Tangga or PKRT)
Classification of Medical Devices in Indonesia
Medical devices in Indonesia are classified based on risk in accordance with the ASEAN Medical Device Directive (AMDD):
- Class A: Low Risk
- Class B: Low to Moderate Risk
- Class C: Moderate to High Risk
- Class D: High Risk
Household Health Supplies (PKRT) are also classified by risk:
- Class 1: Low Risk
- Class 2: Moderate Risk
- Class 3: High Risk
The classification determines the necessary documentation for registration. Note that higher-risk classes require more detailed information.
Submission
Prepare and submit the necessary documents to the regulatory authority. This includes:
- product specifications
- labelling.
- evidence of compliance with safety and performance standards.
Accepted submission languages are Bahasa (Indonesian) and English. Higher-risk devices (Class C and D) will need more comprehensive documentation.
Evaluation
The submission process is facilitated through the Kemenkes platform, which integrates the ASEAN Common Submission Dossier Template (CSDT). Once submitted, your application will be assessed by the regulatory authority to ensure all criteria are met.
Approval
After a successful evaluation, the Indonesian Ministry of Health will issue a Distribution Approval Number or NIE (Nomor Izin Edar), also known as the Product Approval Licence. This authorization allows you to market and distribute your device within Indonesia.
Why Choose Andaman Medical?
Our expert guidance through the region's evolving regulatory landscape ensures your product remains compliant, allowing you to bring your products to market efficiently and effectively.
Experienced In-house Team
across 7 Southeast Asian Countries
Full Control with Seamless
Distributor Switching
Singular Point of Contact
for Registration
QMS Compliance
ISO 13485 Certified
Overcome Language Barrier
With Multilingual Local Team
One-Stop Access
into Southeast Asia