Medical Device Registration Indonesia Service Made Clear

Medical device registration in Indonesia service helps companies prepare and manage the approvals required to import, distribute, or sell medical devices in Indonesia. Under Permenkes No. 62 of 2017 and Permenkes No. 11 of 2025, foreign manufacturers cannot register products directly under their overseas entity; an Indonesian legal entity must hold the NIE and manage the process through Regalkes, the Ministry of Health’s medical device licensing platform. 

For companies entering Indonesia, registration is more than just a product approval step. It influences license ownership, document readiness, approval speed, and ongoing compliance, helping your business feel assured and prepared. 

Key Takeaways

• Foreign manufacturers cannot register medical devices directly in Indonesia; the NIE must be held by an Indonesian legal entity or local license holder.
• The choice between PT PMA and local license holder affects NIE ownership, distributor flexibility, and long-term market control.
• Medical device registration in Indonesia depends on risk classification, from Class A to Class D, which affects the timeline, cost, and dossier requirements.
• A complete CSDT dossier, valid IDAK, CDAKB certificate, and manufacturer authorization are key to avoiding Regalkes submission delays.
• After NIE approval, companies must manage renewals, product updates, CDAKB compliance, adverse event reporting, and halal phase-in obligations.

What is a Medical Device Registration Indonesia Service? 

A medical device registration Indonesia service is professional support that helps companies obtain marketing authorization, or Izin Edar (NIE), from Indonesia’s Ministry of Health. 

It usually covers product classification, dossier preparation, submission through Regalkes, coordination with the license holder, and support during evaluation. Since medical devices are classified from Class A to Class D based on risk, the right setup helps reduce delays, distributor issues, or product update problems later. 

Can Foreign Companies Register Medical Devices in Indonesia Directly? 

No, a foreign manufacturer can’t register medical devices in Indonesia under its own foreign entity name. A foreign manufacturer needs an Indonesian legal entity or a qualified local license holder to act as the official applicant and holder of the medical device registration. There are two common routes: 

Factor	PT PMA	Local License Holder
NIE Ownership	Held by the manufacturer’s own entity	Held by the Local License Holder or distributor
Distributor Flexibility	Full — can appoint or change freely	Limited — switching may require a new NIE and a 6-month wait
Best suited for	Long-term presence, multiple product lines	Market testing, single SKU entry

For companies that prefer stronger control over registration and long-term operations, InCorp can also assist with PT PMA setup as part of the medical device market entry process. Talk to our team -> 

What are the Requirements for Medical Device Registration in Indonesia? 

Indonesia follows the ASEAN Common Submission Dossier Template (CSDT). A complete dossier covers three areas: the applicant, the product, and the manufacturer. The exact list depends on the device class and whether the product is imported or locally made. 

Applicant Documents 

• IDAK (Medical device distributor license linked to the company’s NIB) 
• CDAKB certificate (Good Distribution Practice for Medical Devices) 
• Notarized and apostilled Letter of Authorization from the manufacturer 

Product Documents 

Device description, intended use, classification rationale, model or variant list, specifications, and labeling in Bahasa Indonesia, including Instructions for Use. 

Technical Documents 

ISO 13485 certificate, ISO 14971 risk management report with Indonesia addendum, verification and validation data, and clinical evidence for Class C and D devices.

READ MORE:

• Investing in Medical Device Manufacturing: A Guide for Turkish Investors
• How US Manufacturers Can Import Medical Devices Without Establishing a Company in Indonesia
• Medical Device Registration in Indonesia – Updated Regulation

How Does the Medical Device Registration Process Work in Indonesia? 

Registering a medical device in Indonesia starts with confirming its classification. After preparing the required documents, submit your application through the Ministry of Health’s online system. The Ministry will evaluate the submission and issue a Notification of Existence (NIE) if approved. 

Steps	Descriptions	Responsible Party
Classification	Product or company data must be updated when required.	Manufacturer/consultant
Document preparation	Applicant, product, and technical documents are prepared.	Manufacturer and Indonesian applicant/license holder
Online submission	The application is submitted through the Ministry of Health system.	Indonesian applicant/license holder
Ministry review	The Ministry reviews the file and may request clarification.	Ministry of Health
Clarification response	Additional information is submitted if requested.	Indonesian applicant/license holder with manufacturer support
NIE approval	If approved, the device receives its distribution license number.	Ministry of Health
Post-approval update	Changes to product or company data must be updated when required.	Indonesian applicant/license holder

How Long Does It Take and How Much Does It Cost? 

Indonesia classifies medical devices into four risk classes under the ASEAN Medical Device Directive (AMDD). The class determines the government fee (PNBP), the official review timeline, and the depth of technical evaluation. 

Classification	Description	Estimated Timeline	Examples
Class A	Standard registration route for low-risk devices	3–4 months	Bandages, examination gloves
Class B	Low to medium-risk devices that need additional safety and effectiveness controls	4–5 months	Hearing aids, sutures
Class C	Medium to high-risk devices that need more rigorous technical evaluation	4–5 months	X-rays, infusion pumps, and surgical lasers
Class D	High-risk devices with the strictest regulatory controls and stronger clinical evidence requirements	5–7 months	Implantable devices, life-supporting devices

The timeline above is an estimate only. Actual processing time may vary depending on device classification, dossier completeness, Ministry of Health clarification requests, and the readiness of supporting documents. 

What Happens After Medical Device Registration Approved? 

Under Permenkes No. 11 of 2025, the license holder must keep the registration valid and ensure the product remains compliant after it enters the market. Key obligations include: 

• Renewing the NIE before its 5-year expiry 
• Updating product or labeling changes through Regalkes 
• Keeping the Letter of Authorization valid 
• Reporting adverse events when required 
• Maintaining CDAKB standards. 

Companies should also check halal requirements if the device contains animal-derived components. Halal certification is being phased in by device class, with Class A targeted for October 2026, Class B for October 2029, and Class C for October 2034. Devices that are not halal-certified must carry a “Non-Halal” label.

Why Use a Medical Device Registration Indonesia Service? 

A medical device registration service in Indonesia is especially helpful when the manufacturer lacks a local entity, needs to register complex Class C or D devices, or prefers to keep the NIE separate from a distributor, making the process less daunting and more manageable. 

The right support can help with: 

• Accurate product classification 
• CSDT-compliant dossier preparation 
• Regalkes submission in Bahasa Indonesia 
• Timely responses to Ministry clarification requests 
• Post-market support, including halal phase-in requirements 

This support is useful when the company is unfamiliar with Indonesia’s requirements or needs a clearer route to market.

Move Forward with the Right Medical Device Registration Indonesia Service 

InCorp Indonesia (an Ascentium Company) can act as an independent license holder for your medical device registration partner in Indonesia. We help you assist with: 

• Registration planning based on your device type and market entry needs 
• License holder support to help manage the NIE structure properly 
• Document preparation for a clearer submission process 
• Regalkes’ submission support through the Ministry of Health’s system 
• Post-approval compliance guidance for renewals, updates, and ongoing obligations 

Fill out the form below to ensure your device classification and choose the registration structure that fits your market entry plan.

Frequently Asked Questions