Medical Device Registration Indonesia
Navigate Regulatory Challenges with Ease. The Indonesian healthcare market is growing rapidly, offering significant opportunities for foreign and local businesses. However, navigating the complex regulatory requirements can be challenging. At Product Registration Indonesia, we simplify the medical device registration process so you can focus on bringing your products to market efficiently and confidently.
Why Register Medical Devices in Indonesia?
Indonesia’s growing healthcare market presents tremendous opportunities for medical device manufacturers. However, the complex regulations enforced by the Ministry of Health (MOH) require detailed attention and understanding to achieve successful product registration. Our experienced team ensures your devices meet all legal requirements, providing you with a strategic advantage in a competitive market.
Our Medical Device Registration Service
Regulatory Consultation
Our experts assess your device’s classification (Class A to D) and provide a clear roadmap for compliance, minimizing potential delays.
Document Preparation
We handle all required administrative and technical documentation, including:
• Company Registration (NIB)
• Distributor License (IPAK)
• Good Manufacturing Practice (GMP) Certificate
• Executive Summaries, Device Descriptions, Risk Analysis, and Validation Reports
Submission and Monitoring
We manage the entire submission process through the MOH’s e-registration system, ensuring timely progress updates.
Post-Approval Support
We provide ongoing support to maintain compliance, assist with renewals, and address any modifications required to keep your products on the market.
Why Chose Us?
Deep Regulatory Knowledge
Our experts stay up to date with the latest MOH and ASEAN directives, ensuring a smooth and compliant registration process.
Local Expertise
Partner with us to benefit from our local connections and in-depth understanding of the Indonesian regulatory landscape.
Tailored Solutions
Whether you need to register a simple Class A product or a high-risk Class D device, our services are customized to meet your specific needs.
Benefits of Our Services
Fast Approval Times
With our streamlined document preparation and submission process, we help you bring your products to market sooner.
Risk Mitigation
Our local expertise ensures that you avoid costly mistakes and regulatory hurdles, giving you peace of mind.
End-to-End Compliance
From registration to post-approval maintenance, we cover every aspect of regulatory compliance, saving you time and effort.
Get Started Today
Ready to simplify your medical device registration process? Contact us now for a free consultation, and let our experts guide you every step of the way. Don’t let regulatory challenges delay your market entry—act now and secure your success.
Clients Testimonial
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Frequently Asked Questions (FAQ)
How long does the registration process take?
The registration process usually takes between 6-12 months, depending on the device classification and documentation.
What types of medical devices need registration?
All medical devices, from low-risk Class A products to high-risk Class D devices, must be registered with the Indonesian Ministry of Health.
Trusted by Leading Brands Across Industries
Here are some of the companies that have partnered with us to navigate regulatory compliance and successfully bring their products to market.
