IVD and Medical Device Registration
Entering Indonesia’s medical device market requires more than technical readiness. Our medical device registration service supports international manufacturers with end-to-end regulatory compliance, from distribution licensing to product approval, ensuring your devices are legally registered, market-ready, and aligned with Indonesian Ministry of Health requirements.
Seamless Compliance Support
End-to-End Service
We manage the full regulatory pathway from licensing to product registration.
Regulatory Expertise
Our team combines deep knowledge and experience to navigate complex regulatory landscapes.
Speed and Efficiency
Our proven strategies accelerate the registration and approval process for the Indonesian market.
Customized Support
Provide personalized guidance and dedicated support to ensure a smooth, worry-free journey.
Why Choose Our Medical Device Registration Service?
Medical device registration in Indonesia is governed by the Ministry of Health through the Regalkes system and requires strict compliance with risk-based classification, distribution readiness, and post-market obligations. Products must be registered under a licensed local entity and supported by compliant quality systems.
Product Registration Indonesia helps international manufacturers navigate these requirements by aligning technical documentation, regulatory strategy, and local representation under one coordinated framework. We support compliance with key regulations such as distribution licensing (IDAK), Good Distribution Practice (CDAKB), and product registration approval (AKL), ensuring your devices can be legally imported, distributed, and marketed in Indonesia.
Scope and Benefits of Our Service
Comprehensive medical equipment registration support, aligned with Indonesian Ministry of Health requirements.
Medical Device Distribution License (IDAK)
We support the setup and approval of licensed medical device distributors in compliance with MoH requirements.
Good Distribution Practice Certificate (CDAKB)
We prepare and align quality systems, SOPs, and facility readiness to meet GDP standards.support the setup and approval of licensed medical device distributors in compliance with MoH requirements.
Medical Device Registration to the Ministry of Health
We manage product classification, dossier preparation, and submission for all device classes.
Market Entry Support
Flexible market entry options supporting IVD and medical product registration for international manufacturers entering Indonesia.
License Holder Service
For manufacturers without a local entity, we act as a neutral license holder, keeping registrations secure and transferable.
Distributor Selection
We assist in identifying and assessing qualified local distributors aligned with regulatory and commercial requirements.
Undername Service
We enable faster market entry by registering products under an approved local structure without immediate company setup.
Company Registration Support
When you are ready to establish a local presence, we assist with compliant company formation in Indonesia.
License Holder Service
For manufacturers without a local entity, we act as a neutral license holder, keeping registrations secure and transferable.
Distributor Selection
We assist in identifying and assessing qualified local distributors aligned with regulatory and commercial requirements.
Undername Service
We enable faster market entry by registering products under an approved local structure without immediate company setup.
Company Registration Support
When you are ready to establish a local presence, we assist with compliant company formation in Indonesia.
Inquiry Form
Our team is prepared to discuss your business needs and address any questions you may have. Fill out our inquiry form, and we’ll respond within one business day.
Other ways to get in touch with us.
- info@productregistrationindonesia.com
- +6221 5086 5603
- +62813 8543 0755
- Mon-Fri 9:00AM - 5:00PM
Frequently Asked Questions (FAQ)
Do all medical devices need registration in Indonesia?
Yes. All medical devices and IVD products distributed in Indonesia must be registered with the Ministry of Health.
The requirements vary depending on the risk classification (Class A to D), but unregistered products cannot be legally imported or sold.
How are medical devices classified in Indonesia?
Devices are classified into Class A, B, C, or D based on risk level. Correct classification is critical, as it determines documentation depth, review timelines, and technical requirements. Misclassification is one of the most common causes of rejection.
Can foreign manufacturers register products without a local company?
Yes. Indonesian regulations require registrations to be held by a local entity, but foreign manufacturers can use an independent license holder.
We provide a neutral license holding to ensure regulatory compliance without tying your product to a single distributor.
What is the role of IDAK and CDAKB in medical device registration?
IDAK authorizes a company to distribute medical devices, while CDAKB confirms compliance with Good Distribution Practice.
Both are mandatory prerequisites before product registration and importation can proceed.
What documents are typically required for medical device registration?
How does Product Registration Indonesia reduce regulatory risk during the registration process?
Can Product Registration Indonesia support IVD registration specifically?
Is it possible to change distributors after registration?
What happens after a medical device is registered?
Registration approval is valid for a limited period and is subject to renewal. Post-market obligations, changes in product specifications, and distributor updates must also be reported.
We provide ongoing compliance and renewal support.
Strategic Leadership with
Dr. Hussein H. Mashhour, MD
As our Chief Operating Officer (COO), Dr. Hussein H. Mashhour, MD, brings over a decade of dedicated, hands-on experience in product registration and licensing across Indonesia’s most complex regulatory sectors. His strategic oversight ensures that our operational procedures and client services are built on proven, efficient processes. Start your journey with the confidence and clarity only an expert leader in both compliance and operations can provide.
