How to Determine Medical Device or not, for Combined Products

Here is the summary of how to determine the applicability of a product as a medical device when it combines multiple functions.


<Program + Program>
This is clearly defined for programs. A program that combines the functions of a medical device and a non-medical device is classified as a Software as a Medical Device (SaMD).

• "Guidelines on the Applicability of Programs to Medical Devices" 3. Basic Concept of Applicability (Ministry of Health, Labour and Welfare) https://www.pmda.go.jp/files/000240233.pdf
  • "When determining the medical device applicability of a program with multiple functions, if at least one function meets the definition of a medical device program, the entire product will be subject to distribution regulations as a medical device. In this case, care must be taken to appropriately distinguish between the functions that meet the definition of a medical device and those that do not, such as by ensuring that labeling and advertising do not mislead users into believing that the non-medical device functions are included in the scope of approval or certification as a medical device."
• However, for programs, those equivalent to Class I are excluded from being medical devices.
  • "In determining the medical device applicability of a program, programs that pose almost no risk to human life and health even if they have side effects or functional failures (equivalent to general medical devices (Class I medical devices)) are excluded from the scope of medical devices."
• Inquiry Contact: The contact point for inquiries regarding the applicability of a program as a medical device is the Compliance and Narcotics Division, Pharmaceutical Safety and Environmental Health Bureau, Ministry of Health, Labour and Welfare. Please consult them after reviewing the guidelines and the SaMD one-stop consultation service website. https://www.pmda.go.jp/review-services/f2f-pre/strategies/0011.html

<Physical Product + Program>
The aforementioned guidelines also state that in this case, the product as a whole should be judged for its applicability as a medical device, and it is reasonable to assume that the same judgment as for programs should be applied. In other words, if at least one of them falls under the definition of a medical device, the entire product should be considered a medical device.

• "Guidelines on the Applicability of Programs to Medical Devices" 2 (3) Scope of these Guidelines (Ministry of Health, Labour and Welfare) https://www.pmda.go.jp/files/000240233.pdf
  • In addition, 2 (2) explicitly states that recording media are not included in physical products. This is because SaMD was originally defined as a program alone or a recording medium on which a program is recorded, so it is thought that this was intended to clarify that medical device programs accompanied by a physical product are also covered by these guidelines and, by extension, the SaMD one-stop consultation service.
• Inquiry Contact: The contact point for inquiries regarding the applicability of a program as a medical device is the Compliance and Narcotics Division, Pharmaceutical Safety and Environmental Health Bureau, Ministry of Health, Labour and Welfare. Please consult them after reviewing the guidelines and the SaMD one-stop consultation service website.

<Physical Product + Physical Product>
How about a combined product of a physical medical device and a physical non-medical device?

• As far as I have searched, I have not been able to find any official documents that clearly stipulate this judgment.
• The following is my personal opinion.
  • Although there are no clear guidelines from public institutions, I believe that there is a high possibility that it will be classified as a medical device. The basis for this is as follows.
    • Although it is a program, the aforementioned judgment on the applicability of SaMD serves as an important guideline.
    • "If at least one function meets the definition of a medical device program, the entire product will be subject to distribution regulations as a medical device."
    • It is reasonable to apply this concept to physical medical devices as well. Conversely, if we ask whether a product can be considered a non-medical device as a whole even if one function is that of a medical device, it is difficult to imagine, considering the risk to the body. Therefore, it seems natural to think that a combined product of a physical medical device and a non-medical device falls under the category of a medical device.
• Inquiry Contact: Since this is a physical product, the inquiry contact for applicability will be the prefectural pharmaceutical affairs division.

<If You Don't Want It to Be a Medical Device>
You should carefully read the definition of a medical device and the "Guidelines on the Applicability of Programs to Medical Devices" and eliminate elements that could be considered medical devices as much as possible. These guidelines are also very useful as they contain a wealth of examples of cases that do not fall under the category of medical devices, such as the following:

• Health promotion and management for healthy people
• Simple recording, display, and transfer of data
• In-hospital work support
• Education and information provision

<Applicability of Hybrid Products Seen Through Scenarios>

• Scenario A (High possibility of remaining a non-medical device):
  • If the app's functionality is limited to recording blood glucose data obtained from a measuring device, displaying it in a time-series graph, or sending that data to a doctor by e-mail. This corresponds to the case of "simple recording, display, and transfer of data." In this case, the app is not considered a medical device, and it is highly likely that it will not affect the status of the measuring device itself as a medical device.
• Scenario B (High possibility of the whole being considered a new medical device):
  • If the app has a function that analyzes the fluctuation pattern of accumulated blood glucose levels with its own machine learning algorithm and presents the "probability of a hypoglycemic event occurring within the next 24 hours" as a score. This goes beyond mere data display and is interpreted as providing new medical information that contributes to "diagnosis (prediction)" and "prevention." In particular, if the algorithm is not disclosed (a black box), it is extremely likely that it will fall under the case of "risk analysis by a unique algorithm." In this case, based on the "integrated product" principle, the entire system, including the measuring device and the app, will be subject to a new approval/certification review as a new medical device different from the original measuring device. At that time, the risk class may also be set higher than that of the original measuring device.

<Points to Note>

• Even if a product has a function that can be used as a medical device, the situation may change significantly if it is not intended for use as a medical device. This is because the intended use is a crucial point in determining medical device applicability.
• If multiple medical devices are simply combined and are not inseparable, they may fall under the category of combination medical devices. In this case, a different pharmaceutical approval application process will be required. There is content that touches on combination medical devices, so please refer to that as well.

@K.Kamtiani

Medical Device Classification Guide

Combination Products, Combination Medical Devices, Kit Products, Kit Components, Assortment Products