AI glossary · Basic · Safety & alignment · Healthcare & bio
SaMD
SaMD (Software as a Medical Device) is a program that is treated as a medical device because it serves medical purposes such as diagnosing, treating, preventing or managing disease through software alone, without being part of a separate piece of medical equipment.
About this term
- Level
- Basic · Technical terms you often meet in AI news
- Category
- Industry AI
- Fields
- Safety & alignment
- Industries
- Healthcare & bio
- Added
- 2026-10-10
How it works
SaMD runs on general-purpose computing environments such as smartphones, PCs and the cloud. It takes in medical data such as images, biosignals and test results, analyzes them, and produces outputs such as flagged abnormal findings, risk scores or treatment recommendations. SaMD that includes AI usually uses a machine learning model trained on large amounts of medical data as its core engine. By contrast, software that operates as part of hardware, such as software controlling the machine inside an MRI scanner, is usually not considered SaMD and is classified separately.
SaMD and software in a device
SaMDSoftware itself is the medical device
- Runs on smartphones, PCs, the cloud
- Analyzes medical data to support decisions
- Software alone requires approval
Software in a devicePart of equipment
- Runs inside equipment such as MRI
- Controls or drives hardware
- Regulated together with the equipment
공통 Both are regulated if they serve a medical purpose
Why it matters
If a piece of software qualifies as SaMD, it must receive medical device approval or certification from each country's regulator before it can be sold and used. So for medical AI companies, whether a product is SaMD and what risk class it falls into greatly affects development time and cost. For patients, this system acts as a safeguard that filters out unverified diagnostic programs. An international regulatory forum has published a definition and risk classification framework for SaMD, which many countries refer to.
Things to know
Not every health-related app is SaMD. Apps that do not directly claim a medical purpose, such as step counting or general wellness information, are often excluded from being medical devices. The line is often drawn less by function than by 'what the product claims to do.' AI models can be continually updated with new data, and whether each update requires new approval is an important regulatory issue. As a result, new oversight approaches are being discussed, such as getting a change plan approved in advance.
Example
A typical example of SaMD is an AI reading-assistance program that marks spots suspected of being lung nodules when a chest X-ray is uploaded. It runs on a server or in the cloud connected to the hospital's imaging system, and the radiologist refers to the areas marked by the AI before making the final reading. Products like this can be supplied to hospitals only after receiving medical device approval.