IVD Medical Device Registration in Indonesia

Indonesia’s healthcare sector has great potential for growth. The Ministry of Health Republic Indonesia (Kemenkes) is encouraging local medical device production.

Our experienced regulatory affairs specialists provide comprehensive support, from initial classification and submission to post-market compliance, ensuring your IVD devices meet all regulatory requirements by the government in Indonesia.

Why Register Your IVD Medical Device in Indonesia?

Registering your IVD device in Indonesia offers numerous advantages for your business:

Our IVD Medical Device Registration Services

Regulatory Strategy

Tailored regulatory strategy based on your medical device's classification and target market in Indonesia.

Dossier Preparation

Compiling and reviewing all necessary documentation in  compliance with Kemenkes requirements.

Submission Management

Managing the entire submission process, including communication with Kemenkes.

Post-Market Compliance

Assist in adverse event reporting, change notifications and more.

Registration Process Overview

Here’s a step-by-step overview to  navigating the IVD registration process in Thailand: 

Step 1: Classification

Medical devices in Indonesia are classified into three main categories as it dictates the regulatory requirements and submission details:

  • Medical Devices (Alat Kesehatan) 
  • In Vitro Diagnostics (Diagnostik in Vitro)
  • Household Health Supplies (Perbekalan Kesehatan Rumah Tangga or PKRT)
Classification of Medical Devices in Indonesia 

Medical devices in Indonesia are classified based on risk in accordance with 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
Household Health Supplies (PKRT) are also classified by risk: 
  • Class 1: Low Risk 
  • Class 2: Moderate Risk
  • Class 3: High Risk
The classification determines the necessary documentation for registration. Note that higher-risk classes require more detailed information.

Step 2: Submission

Prepare and submit the necessary documents to the regulatory authority. This includes:

  • product specifications
  • labelling
  • evidence of compliance with safety and performance standards
Accepted submission languages are Bahasa (Indonesian) and English. Higher-risk devices (Class C and D) will need more comprehensive documentation.

Step 3: Evaluation

The submission process is facilitated through the Kemenkes platform, which integrates the ASEAN Common Submission Dossier Template (CSDT). Once submitted, your application will be assessed by the regulatory authority to ensure all criteria are met.

Step 4: Approval

After a successful evaluation, the Indonesian Ministry of Health will issue a Distribution Approval Number or NIE (Nomor Izin Edar), also known as the Product Approval Licence. This authorization allows you to market and distribute your device within Indonesia. 

Step 1: Classification

Medical devices in Indonesia are classified into three main categories as it dictates the regulatory requirements and submission details:

  • Medical Devices (Alat Kesehatan) 
  • In Vitro Diagnostics (Diagnostik in Vitro)
  • Household Health Supplies (Perbekalan Kesehatan Rumah Tangga or PKRT)
Classification of Medical Devices in Indonesia 

Medical devices in Indonesia are classified based on risk in accordance with 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
Household Health Supplies (PKRT) are also classified by risk: 
  • Class 1: Low Risk 
  • Class 2: Moderate Risk
  • Class 3: High Risk
The classification determines the necessary documentation for registration. Note that higher-risk classes require more detailed information.

Step 2: Submission

Prepare and submit the necessary documents to the regulatory authority. This includes:

  • product specifications
  • labelling
  • evidence of compliance with safety and performance standards
Accepted submission languages are Bahasa (Indonesian) and English. Higher-risk devices (Class C and D) will need more comprehensive documentation.

Step 3: Evaluation

The submission process is facilitated through the Kemenkes platform, which integrates the ASEAN Common Submission Dossier Template (CSDT). Once submitted, your application will be assessed by the regulatory authority to ensure all criteria are met.

Step 4: Approval

After a successful evaluation, the Indonesian Ministry of Health will issue a Distribution Approval Number or NIE (Nomor Izin Edar), also known as the Product Approval Licence. This authorization allows you to market and distribute your device within Indonesia. 

Typical Fees and Timeline (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
  • 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
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 new registrations:
Class Fee Timeline
Class A IDR 500,000 Maximum of working 34 days
Class B, C and D IDR 1,000,000

Why Choose Andaman Medical as Your IVD Consultant in Indonesia?

Get Expert Help Today

Contact us today to discuss how Andaman Medical can be your trusted partner for IVD registration and market access in Southeast Asia. Our experienced team is ready to help you achieve your commercial goals in this dynamic, fast-growing region.
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