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.

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:

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

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:

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.

Appoint a Local Distributor

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

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.

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.

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
  • 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!

Medical device registration in Indonesia

All medical devices, whether manufactured domestically in Indonesia or imported, must be registered with the Ministry of Health via the Online Medical Device Registration platform (hereafter called the Kemenkes system).

Who can register a medical device in Indonesia?

In order to register a medical device in Indonesia, a company must first obtain a IDAK (Izin Distribusi Alat Kesehatan) or Medical Device Distribution License (MDDL) otherwise known as a distributor license. The IDAK/MDDC can be applied for via the online licensing platform and once approved it will be issued through Online Single Submission (OSS) website. Please note that IDAK is the new name for the IPAK (Izin Penyalur Alat Kesehatan) and SDAK (Sertifikat Distribusi Alat Kesehatan). All existing distributors who want to request a modification of their IPAK will receive an IDAK. The main difference between the SDAK and the IPAK is the validity which is limited to 5 (five) years for an IDAK and SDAK whilst no there is no time limit on the validity of an IPAK.

Currently, only local (Indonesian) companies can apply for the IDAK/MDDL. Foreign manufacturers, therefore, have three (3) possibilities to obtain an IDAK/MDDL and so register their medical device in Indonesia:

Set up a legal subsidiary entity

to register the medical devices. Please note that a foreign-owned company is required to have total investment value greater than IDR10 billion (US$760,000) according to regulation BKPM 14/2015 and that the establishment process can be complex and time consuming.

Appoint a local distributor

who has an IDAK/MDDL or SDAK/MDDC to register the medical devices

Appoint an independent third party

1a) such as Andaman Medical to register the medical devices directly on behalf of the foreign manufacturer. Andaman Medical is a fully certified SDAK/MDDC distributor license holder and acts directly on behalf of foreign manufacturers. See below for more on how we can help. 1b) such as Andaman Medical to register medical devices on behalf of a local distributor who has an IDAK/MDDL or SDAK/MDDC. This option is useful in case your preferred local distributor does not have an internal regulatory affairs service which can prove difficult if you have future change notifications to make. See below for more on how we can help. Once you have chosen your route-to-market and have ensured that the local company has the required and valid IDAK/MDDL or SDAK/MDDC, the holder of this distributor license may then proceed to register medical devices with the Ministry of Health.

Once you have chosen your route-to-market and have ensured that the local company has the required and valid SDAK/MDDC, the holder of this distributor license may then proceed to register medical devices with the Ministry of Health.  

As a signatory to the AMDD (ASEAN Medical Device Directive), Indonesia has integrated the ASEAN Common Submission Dossier Template (CSDT) into its online registration system (the Kemenkes platform).

Once the medical device has been registered via the Kemenkes platform, the Indonesian Ministry of Health will issue a Distribution Approval Number or NIE (Nomor Izin Edar) otherwise known as the Product Approval License.

The company which receives the NIE or Product Approval License is the Product License Holder. Please note that one medical device can only registered by one distributor license holder at a time. Multiple registrations of medical devices with different distributor license holders are not allowed in Indonesia and neither are license transfers. For manufacturers, it can prove difficult and costly should the existing product license holder not wish to relinquish their right to distribute the product in Indonesia. Hence the advantage of appointing an independent third party as the Product License Holder.

Classification of medical devices in Indonesia

There are three overriding product classifications in Indonesia:

  1. Medical Devices (Alat Kesehatan): which includes instruments, apparatus, machines and/or implants that do not contain drugs used to prevent, diagnose, cure and alleviate diseases, treat sick people, restore health to humans, and/or form structures and improve bodily functions.
  2. In vitro Diagnostics (Diagnostik in Vitro): which includes any reagents, reagent products, calibrators, control materials, kits, instruments, apparatus, equipment or systems.
  3. Household Health Supplies (Perbekalan Kesehatan Rumah Tangga or PKRT): which includes a tool, material, or mixture of materials for maintenance and care for human health, intended for use in households and public facilities.

Please note: in this webpage we will use the term medical devices to include medical devices as well as in-vitro diagnostics and household health supplies.

Medical devices in Indonesia are classified in terms of risk in accordance with the ASEAN Medical Device Directive (AMDD), which lists 4 classes:

Class A

Low Risk

Class B

Low to Moderate Risk

Class C

Moderate to High Risk

Class D

High Risk

PKRT in Indonesia are classified in terms of risk, which lists 3 classes:

Class 1

Low Risk

Class 2

Moderate Risk

Class 3

High Risk

The medical device risk class determines the necessary documentary requirements for registration. The higher the class of medical device, the more documentary information is required for submission in order to register.

Medical device grouping in Indonesia

Medical Devices and IVDs can be grouped and registered as one application in order to obtain one Product Approval License. Please note that the Ministry of Health has issued the following guidelines though they have not yet been implemented (as of March 2021). Groupings are allowed if the following conditions are met:

The grouping categories are as follows:

Medical device grouping in Indonesia Single

Single

Medical device grouping in Indonesia Family

Family

Medical device grouping in Indonesia System

System

Medical device grouping in Indonesia IVD Test

IVD Test Kit

Medical device grouping in Indonesia IVD Cluster

IVD System

Medical device grouping in Indonesia Group

Group

The registration process

All new medical devices, IVDs and household health supplies (PKRT) product registrations must be login first through oss.go.id system to get the License ID then submitted online all the requirements via the Kemenkes platform. The filing of applications for medical device product registrations shall follow the guidelines stated in Regulation No. 62 of 2017.

Once the necessary documentation has been uploaded according to the product’s risk class, the registrant has only 7 calendar days to process payment. Each distributor license holder has a maximum number of submissions that can be made in any 1 (one) working day:

  • 2 (two) new product registrations applications per working day
  • 5 (five) renewal and/or change notification applications per working day

Once payment is received, the Indonesian Ministry of Health will start to evaluate the submission. Should all documentation meet the requirements, then the Ministry of Health will issue the NIE or Product Approval License otherwise known as the marketing authorization. However, the Ministry of Health may consider that the documentation submitted does not meet the requirements and thereby request additional documentation. At this stage, the Ministry of Health in Indonesia will evaluate the submission again, and if successful a marketing authorization will be issued or if not, then the submission will be rejected.

What documents are required to register medical devices in Indonesia?

Various documentation is required to register a medical device in Indonesia and the list differs for in-vitro diagnostics which differs again for household health supplies. The languages accepted for submission are Bahasa (Indonesian) and English.  In general, you will be required to submit a device description, any pre-clinical studies, device labelling, instructions for use, a risk analysis and of course any existing regulatory approvals or market authorisations already obtained. 

Certain products require additional documentation such as those which contain or transmit radiation. And some specific products must undergo local testing in an accredited laboratory in Indonesia.

Typical fees and timelines (biaya dan timeline)

A fee is payable for each submission for new medical device registrations, renewals or change notifications. This is a non-tax fee. The Ministry of Health will raise the fee invoice automatically upon submission to the Kemenkes platform. Payment must be made within 7 (seven) calendar days. For whatever reason if payment is not processed within the deadline, the submission will expire, and a new submission will be required

Previously, new medical device registrations could take anything between 6 (six) to 9 (nine) months, however this has become shorter since regulation no. 62 of 2017 has been applied (effective from 12 January 2018). The general timeline to register new medical devices is 1 (one) to 2 (two) months depending on the class of the medical device.

Should any additional documentation be required to be submitted, then the Indonesian Ministry of Health will allow 10-15working days to provide/submit the additional data. The Ministry of Health will reevaluate the submission within a period of 10 working days. There is no fee for submitting extra documents.

For registration renewals the general timeline is 34 (thirty-four) working days. These are maximum total timelines should additional data be required.

Indonesia’s Ministry of Health has announced that it has simplified registration for certain Class A medical devices, and Classes 1 and 2 of household health supplies (PKRT). Certain class A medical devices are  devices that are for home use, can be used independently without requiring special expertise of health workers, not sterile medical devices, and not In Vitro Diagnostics medical device.

The simplified registration takes a maximum of 36 working days and if no additional supporting documentation is required, an application can be processed in just 16 days.

Distribution Permit Notification is only applicable for the following products:

Class A medical devices:

Class 1 household health products:

Class 2 household health products:

For Medical Device and IVD new registrations

Class Fee Timeline
Class A IDR 1,500,000 Maximum of working 45 days
Class B and Class C IDR 3,000,000 Maximum of 60 days
Class D IDR 5,000,000 Maximum of 80 days

For Medical Device and IVD renewals

Class Fee Timeline
Class A IDR 500,000 Maximum of working 34 days
Class B, C and D IDR 1,000,000

For Medical Device and IVD change notification

Class Fee Timeline
Class A IDR 500,000 Maximum of working 40 days
Class B, C and D IDR 1,000,000

For Medical Device and IVD renewal & change notification submitted together

Class Fee Timeline
Class A IDR 1,000,000 Maximum of working 40 days
Class B, C and D IDR 1,500,000

For PKRT new registrations

Class Fee Timeline
Class 1 IDR 1,000,000 Maximum of working 45 days
Class 2 IDR 2,000,000 Maximum of 60 days
Class 3 IDR 3,000,000 Maximum of 75 days

For PKRT renewals

Class Fee Timeline
Class 1 IDR 500,000 Maximum of working 34 days
Class 2 and 3 IDR 1,000,000

For PKRT change notification

Class Fee Timeline
Class 1 IDR 500,000 Maximum of working 40 days
Class 2 and 3 IDR 1,000,000

For PKRT renewal & change notification submitted together

Class Fee Timeline
Class 1 IDR 1,000,000 Maximum of working 40 days
Class 2 and 3 IDR 1,500,000

How Andaman Medical can help:

Andaman Medical is a regulatory affairs and market access consultancy that specializes in the registration, authorized representation, importation and master distribution of medical device and in-vitro diagnostics in Southeast Asia.

Our in-house team of local, experienced regulatory affairs specialists provide unrivalled assistance to medical device manufacturers and distributors alike who benefit from accessing real, on-the-ground expertise.

Our registration services include:

Our authorised representative services include:

We also offer additional support services such as:

Obtain a quote to register medical devices in Indonesia

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