Medical Device Registration in Indonesia

Navigating Indonesia’s regulatory landscape for medical device post-market surveillance can be complex. With Andaman Medical’s expert PMS solutions, we take the burden off your shoulders by managing the entire process for you. From complying with local regulations to monitoring device performance and safety, we ensure your products remain compliant, reliable, and market-ready for long-term success.

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Why Register Your Medical Devices in Indonesia

Registering your IVD or medical device in Indonesia is more than just meeting regulatory requirements—it’s about gaining access to one of Southeast Asia’s largest and most rapidly growing healthcare markets.

 

At Andaman Medical, we provide comprehensive regulatory support to help you navigate Indonesia’s complex approval process with ease. From ensuring a seamless registration experience to maintaining ongoing compliance, we’re your trusted partner every step of the way.

 

Here’s why Indonesia is a key destination for your medical device registration:

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.

Why Choose Andaman Medical as Your Medical Device Registration Consultant in Indonesia?

Our Medical Device Registration Services

Registration Services

  • Standard product registration
  • Special access product registration
  • Renewal of product registration
  • Amendment and change notification
  • Product licence withdrawal

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Authorised Representative Services

  • Liaison with the local government agency on all regulatory issues, including amendments and change notifications
  • Regulatory monitoring to alert you to any changes or new regulations applicable to your product
  • Licence holding
  • Adverse event reporting and management
  • Product alert and recall tracking
  • Complaint handling

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Additional Support Services

  • Regulatory intelligence reports providing insights into market access routes and the latest regulatory landscape in your target market
  • Importation
  • Storage and warehousing
  • Relabeling
  • Online regulatory training

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What You Need to Know About Medical Device Registration in Indonesia?

For medical device registration in Indonesia, a company must first obtain an IDAK (Medical Device Distribution License) via the online licensing platform, which will be issued through the Online Single Submission (OSS) website. IDAK is valid for five years.

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:

1

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.

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2

Appoint a Local Distributor

  • The distributor must hold both a valid IDAK and GDPMD certificate.
  • Only one distributor can be appointed per product/brand.

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3

Appoint an Independent Third Party

  • For example, companies like Andaman Medical can act on behalf of the manufacturer or a local distributor.
  • The third party must also have an IDAK and GDPMD certification to proceed with registration.

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Device Registration and Licensing Rule

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

 

Classification of Medical Devices in Indonesia

  1. Medical Devices (Alat Kesehatan): Instruments, machines, or implants used to prevent, diagnose, treat, and cure diseases or improve bodily functions without containing drugs.
  2. In Vitro Diagnostics (IVD): Reagents, calibrators, kits, instruments, or systems used for diagnostics.
  3. Household Health Supplies (PKRT): Tools or materials for health maintenance and care used in households and public facilities.

Note: The term “medical devices” includes IVDs and PKRT.

Risk Classes: Medical devices are classified by risk according to the ASEAN Medical Device Directive (AMDD):

  • Class A: Low Risk
  • Class B: Low to Moderate Risk
  • Class C: Moderate to High Risk
  • Class D: High Risk

PKRTs have three risk classes:

  • Class 1: Low Risk
  • Class 2: Moderate Risk
  • Class 3: High Risk

The risk class determines the documentary requirements for registration, with higher classes requiring more documentation.

Medical Devices and IVDs can be grouped and registered as one application to obtain a Product Approval Licence. Grouping guidelines (not yet implemented as of March 2021) allow grouping if:

  • Products have the same intended use.
  • Products are used in combination for the same intended use.
  • There is sufficient similarity to simplify approval.

Grouping categories:

  • Single
  • Family
  • System
  • IVD Test Kit
  • IVD System
  • Group

Registration Process Overview

To register new medical devices, IVDs, and household health supplies (PKRT) in Indonesia, the process begins with obtaining a Licence ID through the oss.go.id system. Once the Licence ID is secured, all required documentation must be submitted online via the Kemenkes platform, in accordance with Regulation No. 62 of 2017.

Step 1: Upload Documentation

The registrant must upload the necessary documents, which vary according to the product’s risk class. These documents typically include device descriptions, pre-clinical studies, labelling, instructions for use, risk analysis, and any existing regulatory approvals or market authorizations. For products that contain or transmit radiation, additional documentation may be required. Some products may also need to undergo local testing in an accredited Indonesian laboratory.

Step 2: Payment

After uploading the documentation, the registrant has 7 calendar days to process the payment. It’s crucial to adhere to this timeline to avoid delays or rejection of the submission.

Step 3: Submission Limit

Each distributor licence holder is limited in the number of submissions they can make per working day:

  • Up to 2 new product registration applications.
  • Up to 5 renewal and/or change notification applications.

Step 4: Evaluation

Once payment is received, the Ministry of Health begins evaluating the submission. If all the submitted documentation meets the regulatory requirements, the Ministry will issue a Distribution Approval Number (NIE), also known as the Product Approval Licence or marketing authorization.

However, if the Ministry finds that the submitted documentation is incomplete or does not meet the necessary standards, they will request additional information. The registrant must provide the required documents, after which the Ministry will re-evaluate the submission. If the additional documentation meets the standards, the marketing authorization will be issued; otherwise, the submission will be rejected.

Step 1: Upload Documentation

The registrant must upload the necessary documents, which vary according to the product’s risk class. These documents typically include device descriptions, pre-clinical studies, labelling, instructions for use, risk analysis, and any existing regulatory approvals or market authorizations. For products that contain or transmit radiation, additional documentation may be required. Some products may also need to undergo local testing in an accredited Indonesian laboratory.

Step 2: Payment

After uploading the documentation, the registrant has 7 calendar days to process the payment. It’s crucial to adhere to this timeline to avoid delays or rejection of the submission.

Step 3: Submission Limit

Each distributor licence holder is limited in the number of submissions they can make per working day:

  • Up to 2 new product registration applications.
  • Up to 5 renewal and/or change notification applications.

Step 4: Evaluation

Once payment is received, the Ministry of Health begins evaluating the submission. If all the submitted documentation meets the regulatory requirements, the Ministry will issue a Distribution Approval Number (NIE), also known as the Product Approval Licence or marketing authorization.

However, if the Ministry finds that the submitted documentation is incomplete or does not meet the necessary standards, they will request additional information. The registrant must provide the required documents, after which the Ministry will re-evaluate the submission. If the additional documentation meets the standards, the marketing authorization will be issued; otherwise, the submission will be rejected.

Required Documents for Registration

The documentation required for registration includes:

  • Device Description: Detailed information about the medical device.
  • Pre-clinical Studies: Evidence from studies conducted before clinical trials.
  • Device Labelling and Instructions for Use: Clear labelling and user instructions to ensure proper usage.
  • Risk Analysis: Assessment of potential risks associated with the device.
  • Regulatory Approvals: Any existing approvals or market authorizations from other regulatory bodies.

Language Requirements

All documents must be submitted in either Bahasa (Indonesian) or English. This ensures that the evaluation process can be conducted efficiently by the Ministry of Health.

Outcome

The final outcome of the registration process can be either approval or rejection. If approved, the device will receive the NIE, allowing it to be marketed and distributed in Indonesia. If rejected, the registrant must address the deficiencies identified by the Ministry and may need to re-submit the application.

Typical Fees and Timelines

Fees
A fee is required for each new medical device registration, renewal, or change notification. This non-tax fee is invoiced automatically by the Ministry of Health upon submission to the Kemenkes platform. Payment must be made within seven calendar days. If payment is not processed by the deadline, the submission will expire, requiring a new submission.
Timelines
  • New Medical Device Registrations: Previously taking 6-9 months, the timeline is now 1-2 months under Regulation No. 62 of 2017 (effective from January 12, 2018), depending on the device class.
  • Additional Documentation: If required, 10-15 working days are allowed for submission. The Ministry will reevaluate within 10 working days with no additional fee.
  • Renewals: Generally, 34 working days, including any additional data submission.
Simplified Registration
The Ministry has simplified the process for certain Class A medical devices and Classes 1 and 2 household health supplies (PKRT). These devices include home-use items, non-sterile, and non-IVD that do not require special expertise or sterility. The simplified registration takes up to 36 working days, and if no additional documentation is needed, it can be processed in just 16 days.

Distribution Permit Notification

  • Arm sling
  • Body waste receptacle
  • Cane
  • Cane, crutch and walker tips and pads
  • Cold pack
  • Crutch
  • Dental floss
  • Elastic bandage
  • Floatation cushion
  • Hernia support
  • Hot or cold disposable pack
  • Hot/cold water bottle
  • Ice bag
  • Limb orthosis
  • Manual breast pump
  • Manual toothbrush
  • Mechanical wheelchair
  • Mechanical walker
  • Medical adhesive tape and adhesive bandage
  • Medical disposable bedding
  • Medical insole
  • Moist heat pack
  • Nipple shield
  • Non-resorbable gauze/sponge for external use
  • Ophthalmic eye shield
  • OTC Denture cleanser
  • Patient scale
  • Protective garment for incontinence
  • Scented or scented deodorized menstrual pad
  • Stand-on patient scale
  • Teething ring
  • Therapeutic massager
  • Truncal orthosis
  • Unscented menstrual pad
  • Tissue and cotton
  • Laundry Preparation
  • Cleaner
  • Baby and mother care products
  • Antiseptic and disinfectant
  • Fragrance
Medical Device and IVD new registrations
Class A Class B and Class C Class D
Government Fee IDR 1,500,000 IDR 3,000,000 IDR 5,000,000
Timeline Maximum of 45 working days Maximum of 60 working days Maximum of 80 working days
Medical Device and IVD renewals
Class A Class B and Class C Class D
Government Fee IDR 500,000 IDR 1,000,000
Timeline Maximum of 34 working days Maximum of 34 working days
Medical Device and IVD change notification
Class A Class B and Class C Class D
Government Fee IDR 500,000 IDR 1,000,000
Timeline Maximum of 40 working days Maximum of 40 working days
Medical Device and IVD renewal & change notification submitted together
Class A Class B and Class C Class D
Government Fee IDR 1,000,000 IDR 1,500,000
Timeline Maximum of 40 working days Maximum of 40 working days
For PKRT new registrations
Class 1 Class 2 Class 3
Government Fee IDR 1,000,000 IDR 2,000,000 DR 3,000,000
Timeline Maximum of working 45 days Maximum of 60 days Maximum of 75 days
For PKRT renewals
Class 1 Class 2 Class 3
Government Fee IDR 500,000 IDR 1,000,000
Timeline Maximum of working 34 days
For PKRT change notification
Class 1 Class 2 Class 3
Government Fee IDR 1,000,000 IDR 1,500,000
Timeline Maximum of working 40 days
For PKRT renewal & change notification submitted together
Class 1 Class 2 Class 3
Government Fee IDR 1,000,000 IDR 1,500,000
Timeline Maximum of working 40 days
Navigating medical device registration in Indonesia can be complex, but Andaman Medical is here to simplify the process and ensure you stay fully compliant. Connect with our experts today and take the first step toward smooth registration!
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