Japan's Regulation on SaMD

Japan’s Regulatory Requirements for Software as a Medical Device (SaMD)

Developing innovative products, including smart technologies, have been accelerating rapidly in the healthcare industry.  Many software applications and wearable devices are being launched that enable consumers the ability to collect health related data.  There is also a growing use of AI/ML technologies that perform diagnoses and/or testing.  In addition to hardware, stand-alone software that are installed on computers, smartphones and other information technology devices, and depending on their intended use and features, may itself constitute as medical device.  This terminology is Software as a Medical Device, or SaMD.

If the software is a SaMD and it is planned to be marketed in Japan, then it may be subject to the Japanese Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Device (PMD Act).  However, if the software falls outside the definition of a medical device, it is not subject to the regulations under the PMD Act and will only be subject to the general product safety and consumer protection law in Japan and no regulatory licenses is required.

Scope of SaMD

The PMD Act’s definition of medical devices is: “Medical devices are machinery or apparatus, etc. intended for use in the diagnosis, treatment or prevention of disease in humans or animals or intended to affect the structure or functions of the human or animal body, which are specified by Cabinet Order.”  The Act elaborated by stating that the definition of ‘equipment, etc.’ include software.  Therefore, software intended for use in disease diagnosis, treatment or prevention is subject to the PMD Act as a SaMD.

Based on its intended use, the following examples may be classified as SaMD:

• Clinical Decision Support: Software that supports medical professionals by providing diagnostic suggestions based on data analysis.

• Health Monitoring Apps: Consumer apps providing risk scores for lifestyle diseases based on user inputs and general health data.

Key Background Information on the Legal Framework for SaMD in Japan

• Primary Legislation: The development and commercialization of software that constitutes a medical device is regulated under the Japanese Act on Securing Quality, Efficacy, and Safety of Products Including Pharmaceuticals and Medical Devices (PMD Act).

• Scope: The PMD Act covers software installed on general-purpose computers, smartphones, and other IT devices if they are intended for medical use.

Key Requirements

1. Establishment License: Entities wishing to commercialize a medical device must obtain an establishment license before starting the business.

2. Product Approval or Registration: Each medical device, including software, must undergo individual approval or registration.

3. Quality and Safety Responsibilities: Distributors must ensure the quality and safety of the medical device, including collecting and reporting any safety events.

Definition and Scope

• The PMD Act’s definition of a medical device includes any equipment intended for medical purposes, explicitly incorporating software.

• The distribution of software electronically (e.g., selling software or licensing its use) is also regulated.

• Software used for diagnosing, treating, or preventing diseases is subject to regulation as a medical device unless it poses minimal risk to human life or health.

Ministerial Orders and Guidelines

• Ministerial Orders: Provide specific details on what constitutes a medical device, including software.

• MHLW Guidelines: Offer comprehensive evaluation criteria to determine if software qualifies as a SaMD. These include the software's purpose, functions, structure, advertisements, and marketing claims.

Specific Considerations for SaMD

The Ministry of Health, Labour, and Welfare (MHLW) in Japan has established specific guidelines to determine whether software qualifies as a medical device. Here are the key elements and questions that should be assessed:

1. Outline of the Software:What are the features, nature, and characteristics of the software?

2. Delivery Method:How is the software delivered to the end-users?

3. Intended Users:Who are the intended users of the software (e.g., healthcare professionals, general consumers)?

4. Intended Purpose:What is the software’s intended purpose?

5. Expected Results:What results is the software intended to achieve?

6. Command Handling:How does the software handle commands?

7. Data Processing Algorithms:What algorithms does the software use to process data?

8. Existence of Similar Products:Is there any similar product that is already classified as a medical device?

Steps for Detailed Assessment:

A. Diagnosis, Treatment, or Prevention:

1. Is the software intended for use in the diagnosis, treatment, or prevention of disease? If Yes: The software should be considered a medical device, unless it involves minimal risk. If No: Further assessment is needed to determine if it is for consumer or professional use.

B. Consumer Software Assessment:

1. Does the software only display, store, or transfer data? If yes, it is not considered a medical device.

2. Is the software intended for purposes other than medical or healthcare (e.g., sports performance management)? If yes, it is not considered a medical device.

3. Does the software only deliver information to users? If yes, it is not considered a medical device.

4. Does the software provide potential disease candidates based on input data?If yes, it is considered a medical device.

C. Healthcare Professional Software Assessment:

1. Does the software only provide information that is not used in medical decision-making? If yes, it is not considered a medical device.

2. Is the software intended for internal hospital administrative work or maintenance? If yes, it is not considered a medical device.

3. Does the software only store or transfer data without processing it for medical purposes? If yes, it is not considered a medical device.

4. Does the software process data for purposes other than diagnosing, treating, or preventing disease? If yes, it is not considered a medical device.

5. Does the software indicate possible candidate diseases based on input data?If yes, it is considered a medical device.

Disease Risk Indicating Software

Japan’s regulatory framework for Software as a Medical Device (SaMD) includes specific guidelines for software that indicates the presence or risk of disease. Here are the key points and criteria used to determine if such software is classified as a medical device:

Key Considerations

1. Purpose and Function:Software intended to diagnose disease or indicate disease risk is closely scrutinized. Software that merely provides general health information is typically not considered a medical device.

2. Publicly Known Information:Software delivering reliable, publicly known medical or pharmaceutical information is not considered a medical device.Information is deemed “publicly known” if it is generally recognized as scientifically substantiated from medical, pharmaceutical, and/or nutritional science perspectives.

3. Specific vs. General Risk Indication:Software targeting a specific individual’s risk of disease may be classified as a medical device. Software comparing an individual's data with statistical risk data from population groups without performing specific individual analysis is generally not classified as a medical device.

Detailed Criteria for Classification

1. Medical Analysis:Software that conducts independent medical analysis and provides disease risk indications is considered a medical device.Products using new, unique algorithms for disease indication fall under this category.

2. Target User:If the software targets healthcare professionals and provides data for medical decision-making, it is likely a medical device.If the software targets general consumers but does not process data for medical decision-making, it is typically not classified as a medical device.

3. Future Risk vs. Current Diagnosis:Software indicating a user may currently have a disease is more likely to be regulated. Software indicating future disease risks aimed at promoting general health is less likely to be classified as a medical device, unless explicitly intended for use in medical diagnosis or treatment.

Flowchart for Analysis

The guidelines include a flowchart to determine whether software constitutes a disease risk indicating medical device:

1. Does the software diagnose or indicate disease risk?Yes: Likely a medical device unless it involves minimal risk. No: Further evaluation is needed.

2. Is the software used by healthcare professionals?Yes: Evaluate if it aids in medical decision-making. No: Assess if it only provides general health information without specific risk analysis.

3. Does the software deliver reliable, publicly known information?Yes: Not a medical device. No: Further detailed evaluation required.

In summary, Japan's regulatory framework for SaMD is comprehensive, focusing on ensuring that software used for medical purposes meets rigorous standards for quality, safety, and efficacy. The guidelines provided by the Ministry of Health, Labour, and Welfare (MHLW) offer clear criteria for evaluating and classifying software as a medical device on a case-by-case basis.