Medical Device Registration in Indonesia
Your Gateway to Southeast Asia’s Healthcare Market - Indonesia
Looking to register your medical device or IVD in Indonesia? This is more than a regulatory requirement. It is a strategic step toward market entry in one of Southeast Asia’s largest and fastest-growing healthcare markets.
At Andaman Medical, we manage the full medical device registration process in Indonesia from start to finish. Our end-to-end regulatory services cover everything from initial approvals to post-market surveillance and MDR support, ensuring your products achieve approval efficiently and remain fully compliant for long-term success.
Why Register Your IVDs or Medical Devices in Indonesia?
- Enter a rapidly expanding healthcare market with strong demand for advanced medical technologies and IVD solutions
- Strengthen your market entry strategy in Southeast Asia’s largest economy
- Maintain full regulatory compliance through expert local guidance and MDR support
- Build a strong regional presence in a key ASEAN healthcare hub
Partner with Andaman Medical for seamless medical device registration in Indonesia. We handle the regulatory complexity so you can stay focused on delivering high-quality healthcare solutions.
Access to a Growing Market
Access to a Growing Market
Indonesia is Southeast Asia’s largest economy with a rapidly expanding healthcare sector, driven by a growing middle class and increased government healthcare spending. Registering your medical devices allows access to this lucrative market, offering significant growth opportunities for manufacturers.
Regulatory Compliance
Regulatory Compliance
Compliance with Indonesia’s Ministry of Health regulations ensures that your products meet local safety, quality, and performance standards, which is essential for legal distribution and maintaining a positive market reputation.
Enhanced Market Credibility
Enhanced Market Credibility
Registered devices gain credibility and trust among healthcare providers and consumers. Regulatory approval signals that your products have met stringent local requirements, enhancing your brand’s reputation and competitive positioning in the market.
Reduced Risk of Legal Penalties
Reduced Risk of Legal Penalties
Registering medical devices helps avoid legal issues, fines, and product recalls that could arise from selling unregistered or non-compliant products. It ensures that your business operations align with Indonesian laws and regulations.
Faster Market Entry and Expansion
Faster Market Entry and Expansion
Proper registration streamlines the process of bringing your products to market and facilitates quicker approval for new or updated versions of your devices, supporting faster scaling and adaptation to market needs.
Improved Patient Access and Outcomes
Improved Patient Access and Outcomes
By registering your devices, you help make advanced medical technologies accessible to healthcare providers and patients, contributing to improved diagnosis, treatment, and overall healthcare outcomes in Indonesia.
What You Need to Know About Medical Device Registration in Indonesia?
Options for Foreign Manufacturers to Enter the Indonesian Market
To qualify for IDAK and GDPMD certification, the applicant must be a company legally established in Indonesia. Foreign manufacturers have three main routes:
Set up a legal subsidiary entity
- Requires an investment of over IDR 10 billion (approx. US$760,000), excluding land and buildings.
- Registered under KBLI 46691 (Wholesale Trade of Laboratory Equipment, Pharmaceutical Devices, and Medical Devices for Humans).
- Allowed under BKPM Regulation No. 4 of 2021, Article 12.
- Cannot be combined with retail trade activities as per Government Regulation No. 29 of 2021.
Once the route-to-market is chosen and the Indonesian entity holds a valid IDAK and GDPMD certificate, they may proceed with device registration via the Kemenkes (MoH) platform. Upon approval, the MoH will issue a Distribution Approval Number (NIE: Nomor Izin Edar).
According to Minister of Health Regulation No. 62 of 2017, Article 13, each medical device (under one trade name/brand name) may only be registered by one license holder—either a distributor or importer. Multiple registrations or license transfers are not permitted.
For foreign manufacturers, appointing an independent third party as the Product License Holder can provide better control over product registration, compliance, and market entry strategy
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