The Ministry of Health of the Republic of Indonesia has issued Decree No. HK.01.07/MENKES/951/2026, introducing technical guidelines for the product licensing of software-based medical devices distributed within Indonesia.
The guideline sets out requirements and procedures for obtaining a Medical Device Product License for software-based medical devices, with the aim of ensuring their safety, performance, and quality.
The guideline covers Software as a Medical Device (SaMD), Software in Medical Device (SiMD), and Artificial Intelligence-enabled Medical Devices (AIMD), including certain Machine Learning-enabled Medical Devices (MLMD).
Read the full guideline here: Guidelines for Product Licensing of Software-Based Medical Devices [PDF] in Indonesian. English translation is not available.
Purpose of the Guideline
To provide technical guidance on the requirements and procedures for obtaining a product license for software-based medical devices distributed within the territory of the Republic of Indonesia.
The guideline is intended to support the safety, performance, and quality of software-based medical devices throughout the licensing process.
Scope of Application
The guideline covers the following categories of software-based medical devices:
1. Software as a Medical Device (SaMD)
SaMD is a standalone software-based medical device that can be used for one or more medical purposes, where the software does not form part of medical device hardware in performing those purposes.
2. Software in Medical Device (SiMD)
SiMD is software embedded in and forming part of a medical device, which functions to control the performance of or provide certain functions to the medical device.
3. Artificial Intelligence-enabled Medical Device (AIMD)
AIMD is a system or application that uses artificial intelligence technology to perform functions related to medical purposes.
A system or application is classified as an AIMD or Machine Learning-enabled Medical Device (MLMD) only where it has a medical purpose and its output is intended to support:
- Clinical consideration
- Diagnosis
- Monitoring of medical conditions
- Determination of therapy
- Other medical actions
The use of artificial intelligence and machine learning for non-medical functions, including administrative data management, data storage, or operational functions that do not affect the medical function of the device, is not included within the definition of a medical device.
Reference Standards
The guideline identifies several standards that may be used as references for implementing a quality management system for software-based medical devices, including:
- ISO 13485 – Medical devices — Quality management systems — Requirements for regulatory purposes
- ISO 14971 – Medical devices — Application of risk management to medical devices
- ISO 60601-1 – Medical electrical equipment – Part 1: General requirements for basic safety and essential performance
- ISO 61010-1 – General safety requirements
- IEC 62366-1 – Medical devices – Part 1: Application of usability engineering to medical devices
- IEC 62304 – Medical device software – Software life cycle processes
- IEC 82304 – Health Software – General Requirements for Product Safety
- IEC 63450 – Artificial Intelligence-enabled Medical Devices – Methods for the Technical Verification and Validation
- IEC 63521 – Machine Learning-enabled Medical Device – Performance Evaluation Process
- ISO 27001 – Information Security Management System
Local Clinical Validation in Indonesia
Certain imported software-based medical devices are required to undergo local clinical validation in Indonesia to ensure that their performance, safety, and benefits are appropriate for the target population.
This requirement applies where the software-based medical device:
- Has been further developed and/or retrained using data representing the Indonesian population; and/or
- Uses artificial intelligence technology with a moderate to high risk level, particularly where it is used for diagnosis, screening, or clinical decision-making.
Local clinical validation may be conducted at:
- Hospitals
- Universities
- Accredited laboratories
- Technical implementation units under the Ministry of Health
Validation may also be supported by the relevant technical implementation units responsible for biomedical and health genomics services.
Timing of Local Clinical Validation
Local clinical validation may be conducted in parallel with the Medical Device Product License application by submitting clinical and performance evidence from the manufacturer.
The results of the local clinical validation must be submitted no later than one year after the Medical Device Product License is issued.
The clinical evidence requirements for software-based medical device licensing are provided in Table 3.2 on Page 23 of the guideline.
Labeling Requirements
The labeling requirements for software-based medical devices are provided in Table 3.3 on Page 27 of the guideline.
At minimum, labeling should provide sufficient information to support product identification, safe and proper use, and traceability.
This includes:
Product Identification
- Product name
- Software version
- Product owner or manufacturer identification
Safety and Use Information
- Intended use
- Instructions for use
- Performance information
- Warnings
- Other relevant safety information
The information should be clearly presented and easy to understand.
Labeling may be provided through physical or non-physical formats, including labels, Instructions for Use (IFU), operating guides, or other relevant electronic information.
Changes to Product Licenses for Software-Based Medical Devices
Changes to product licenses for software-based medical devices are divided into two main categories.
1. Changes Affecting Intended Use, Main Function, or Clinical Performance
Where a change affects the intended use, main function, or clinical performance of the software:
A new medical device registration is required.
2. Changes That Do Not Affect Safety, Usefulness, or Quality
Where a change does not affect the safety, usefulness, or quality of the software-based medical device:
An amendment to the existing product license may be submitted.
For changes that do not fall within either category, Business Actors are required to report the changes to the Minister together with the necessary data and information for further evaluation.
Each change must also be documented within the quality management system in accordance with applicable laws and regulations.
Implications to Clients
All software-based medical devices distributed in Indonesia should comply with the technical requirements and procedures set out in the guideline.
Manufacturers and license holders should review whether their products fall within the definitions of SaMD, SiMD, AIMD, or MLMD and assess the corresponding licensing requirements.
Companies should also review software labeling to ensure that sufficient information is provided for product identification, safe and proper use, performance, warnings, and traceability.
For certain imported software-based medical devices, local clinical validation in Indonesia may be required, depending on the device characteristics and applicable criteria.
Companies should also establish appropriate change-control procedures to determine whether future software changes require a new registration, an amendment to an existing product license, or reporting to the Minister for further evaluation.
Effective Date
7 September 2026
For Inquiries
For inquiries or support regarding medical device regulatory requirements in Indonesia, please contact sales@andamanmed.com.