Medical Device and IVD Registration
Entering Indonesia's medical device market takes more than technical readiness. Our medical device registration in Indonesia service supports foreign manufacturers with classification, distribution licensing, document preparation and Ministry of Health submission, so your devices and IVD products are legally registered and market-ready.
We tell you what you will pay and how long each stage takes from the first conversation, so there are no surprise fees halfway through.
Already Have Your Technical Dossier?
Send your products and available documents. We assess three things before you commit:
- Device classification and SKU grouping
- Documentation readiness and gaps
- The right local market-entry structure
10+ Years Experience
Regulatory and licensing experience in Indonesia.
Transperant & Accurate Pricing
Accurately counting the number of SKUs and ensuring proper classification.
Local Market Access
Has a network and connections in the local healthcare sector.
Medical Device Registration Indonesia:
One Regulatory Strategy From Licensing to Approval
Support for foreign manufacturers entering Indonesia with medical devices, IVD products and specialist equipment such as radiation medical devices.
Medical Device Distribution License (IDAK)
We support the setup and approval of licensed medical device distributors in compliance with Ministry of Health requirements. This medical device distribution license is a prerequisite for importing and distributing registered products.
Includes
- Distribution licensing assessment
- Administrative requirements and product-list coordination
- Technical personnel and facility readiness
Good Distribution Practice Certificate (CDAKB)
We prepare and align quality systems, SOPs and facility readiness to meet Good Distribution Practice standards for medical devices.
Includes
- Quality-system review and SOP alignment
- Distribution documentation
- Storage, product control and certification support
Medical Device Registration to the Ministry of Health
We manage product classification, dossier preparation and submission for all device classes, then handle clarification requests until approval.
Includes
- Product classification and regulatory gap analysis
- Dossier preparation and Ministry submission
- Clarification management and registration monitoring
License Holder Service for Medical Device
We act as your official license holder with the Ministry of Health, fulfilling the mandatory in-country representation requirement. This role is also known as Local Authorised Representative (LAR) or Marketing Authorisation (MA) holder: the local entity that holds your product registration, so you do not need to set up your own Indonesian company first.
Includes
- Local structure assessment and market-entry coordination
- Distributor flexibility, so you can change distributors without losing approvals
- Specialist and post-registration support
In Vitro Diagnostic Registration (IVD)
IVD products can require a different regulatory assessment and additional performance and technical documentation. We support IVD classification, document review, technical dossier preparation, Ministry of Health submission and clarification management.
A Predictable Path From Product Assessment to Market Entry
Classification & Scope Review
Review product names, intended use, variants and applicable device category to determine the registration pathway.
Document Gap Analysis
Screen available documentation and identify missing, inconsistent or potentially problematic information before submission.
Dossier & Submission
Coordinate administrative and technical documents and manage Ministry of Health submission through the relevant system.
Evaluation & Approval
Monitor review, coordinate clarification responses and support the process through issuance of the relevant approval.
Not sure how your device is classified?
Run a quick check before step 01, then bring the result to your consultation.
The Questions Foreign Manufacturers Ask First
Do We Need an Indonesian Company?
Can You Screen Our Documents First?
Will Pricing and Timelines Be Clear?
Know the Rules Before You File
Indonesia medical device regulations, labeling, product grouping and the approval process: the four topics foreign manufacturers research first. Detailed answers are in the FAQ below.
01
Regulations and Regulator
02
Labeling Requirements
03
Grouping and SKU Scope
04
Approval Process
Three Things That Can Slow Down Your Registration
01
Incorrect Indonesia Medical Device Classification or SKU Scope
International classification does not automatically decide the Indonesian pathway. Wrong grouping across many SKUs creates unnecessary applications, cost and review cycles.
Our fix: We review your portfolio, intended use and product scope first, so the classification and registration strategy are accurate before budget is committed.
02
Incomplete or Inconsistent Documents
Manufacturers often have extensive documentation. The problem is inconsistency between manufacturer, product, facility and authorization documents, which triggers clarification requests.
03
Distribution and Local Representation Gaps
A product that is ready for export still needs an Indonesian market-entry structure, especially for specialist products such as radiation medical devices.
Our fix: Product Registration Indonesia can be your license holder partner for entering the Indonesian market. We also have a network in healthcare and radiation medical devices, which helps you reach the market more easily.
Transparent Planning Before You Commit
Your project cost depends on product count, classification, documentation readiness and local licensing structure. We explain each component upfront.
Government fees
PNBP fees depend on the application type and are shown separately from our fees.
Professional service fee
Quoted after a portfolio review, with no hidden charges added later.
Bulk registration
Flexible payment terms may apply when you register many SKUs at once.
Additional technical scope
Quoted separately and only where it applies to your product.
Government tariffs can change. Applicable PNBP and third-party costs are reconfirmed at engagement and at submission. Government review time is not a guaranteed end-to-end project duration.
Regulatory Accuracy Matters More Than a Generic Registration Service
Medical device market entry needs current regulatory interpretation, document control and local execution, not just filing a form.
Current Regulatory Framework
We assess the Indonesian requirements in force when your application is prepared.
Document Consistency
Manufacturer, product, facility and authorization documents need to tell one coherent regulatory story.
Structured SOP
A clear document checklist and proactive follow-up reduce avoidable back-and-forth with your regulatory team.
Transparent Engagement
Government fees, professional fees and extra scope are separated, so there are no surprise fees.
Your Indonesia Market Entry Does Not End With Approval
Registration is often the first regulatory milestone. We can support the next steps as your Indonesia strategy develops.
Distributor Selection
Assess Indonesian distributors based on commercial fit, product category and regulatory requirements.
Export & Import Assistance
Coordinate import-related documentation and market-entry requirements for approved products.
Radiation Medical Devices
Support additional regulatory and local distribution-readiness considerations for specialist products.
Company Registration
Establish your own Indonesian business entity when you are ready to move beyond third-party structures.
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.
- [email protected]
- +6221 5086 5603
- +62813 8543 0755
- Mon-Fri 9:00AM - 5:00PM
Frequently Asked Questions (FAQ)
What documents are required to register a medical device in Indonesia?
Medical device registration in Indonesia mainly requires three sets of administrative documents: registration documents from other countries, a Certificate of Free Sale (CFS) or equivalent evidence, and production facility documents, which are the most common bottleneck. Technical requirements follow international practice, and manufacturer quality-management documentation, Indonesian-language labeling and product information are also reviewed. The exact checklist depends on the product and its classification.
Is a CE Mark mandatory to register a medical device in Indonesia?
No. A CE Mark should not be assumed to be mandatory for every medical device registered in Indonesia. Whether CE-related evidence applies depends on the product and on the conformity documentation used in the registration dossier
How does Indonesia medical device classification work?
Indonesia classifies medical devices into Class A, B, C or D based on risk, and the class determines the registration pathway, documentation depth and review timeline. Classification is assessed from the intended purpose, technical characteristics, mode of action and the applicable criteria. Misclassification is a common cause of rejection, so the full product portfolio should be reviewed first.
What is IDAK, the medical device distribution license in Indonesia?
IDAK is the license that authorizes a company to distribute medical devices in Indonesia. Under the current risk-based business licensing framework, medical device wholesale distribution is a high-risk activity. IDAK is required before registered products can be imported and distributed.
Is CDAKB required for medical device distribution in Indonesia?
CDAKB is the Good Distribution Practice certificate for medical devices in Indonesia. Distributors must meet the applicable quality and distribution standards and, where certification is required, complete it before importing and distributing registered devices.
Do I need an import or distribution license for medical devices and IVD in Indonesia?
Yes. Medical devices and IVD products must be registered with the Ministry of Health, and the company that imports and distributes them needs an IDAK distribution license, with CDAKB where applicable. Manufacturers without a local entity can meet this through a license holder and an appointed licensed distributor.
What are the Indonesia IVD regulations and requirements?
Indonesia regulates IVD products under the same risk-based Ministry of Health framework as other medical devices, and additional performance and technical documentation is often required. Classification, intended use and the documents needed are assessed per product, and importers and distributors need the relevant licensing before IVD products can be imported or sold.
What are the labeling requirements for medical devices and IVD in Indonesia?
Medical device and IVD labels and instructions for use in Indonesia must meet local requirements, including labelling in Bahasa Indonesia, and must be consistent with the product information in the registration dossier. Labelling is checked together with the rest of the documents so inconsistencies are corrected before submission.
What is the approval process for medical devices in Indonesia, and how long does it take?
Medical device approval in Indonesia follows four stages: classification and scope review, document gap analysis, dossier submission to the Ministry of Health, then evaluation and approval. Published issuance timelines are 21 days for Class A, 36 days for Classes B and C, and 55 days for Class D, excluding preparation and clarification time. IDAK and CDAKB are prerequisites for importing and distributing registered products.
What is Radiation IDAK, and do radiation medical devices need it?
Radiation IDAK is the term used for the IDAK distribution license needed to distribute radiation medical devices in Indonesia. Radiation-emitting devices can carry additional specialist requirements on top of standard registration, so licensing and registration should be planned together. Product Registration Indonesia supports both. Our COO, Dr. Hussein H. Mashhour, MD, holds a certification in radiation medical devices, and our network in this sector helps coordinate the specialist requirements.
What makes a consultant reliable for registering medical devices in Indonesia?
A reliable medical device registration consultant in Indonesia has three qualities: clear legal standing; proven medical device knowledge with a good network in both commercial and regulatory circles; and the ability to prepare documents to the required standard and run the process to the agreed timeline.
What happens after a medical device is registered in Indonesia?
After registration in Indonesia, the approval is valid for a limited period and must be renewed. Post-market obligations, changes in product specifications and distributor updates must also be reported. Ongoing compliance and renewal support is available.
Strategic Regulatory Leadership
Dr. Hussein H. Mashhour, MD
Chief Operating Officer, Product Registration Indonesia
Dr. Hussein H. Mashhour, MD, brings more than a decade of hands-on experience in product registration and licensing across Indonesia’s regulated sectors. His role includes overseeing operational and regulatory processes for international companies navigating Indonesian market entry.
His experience spans health supplements, cosmetics, medical devices, food and beverages, and other regulated product categories.
