How to determine if a product is a medical device
*Please note that the majority of references are in Japanese. This is due to accuracy and a significant lack of official documents available in English.
*Communication with regulatory authorities and other organizations is mostly in Japanese. Also, given the subtle nuances and business customs that are hard for non-Japanese to grasp, I recommend you to secure a local Japanese partner such as DMAH.
1. Definition of Medical Devices
Definition of Medical Device (Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices, Article 2, Paragraph 4)
The term "Medical Device" as used in this Act means an instrument or apparatus (excluding regenerative medicine products) intended for the diagnosis, treatment, or prevention of diseases in humans or animals, or intended to affect the structure or functions of the body of humans or animals, and which is specified by a Cabinet Order.
This definition can be broken down as follows:
2. Key Points for Determination
A comprehensive judgment is made based on the purpose of use and the degree of risk.
"Whether a specific program falls under the category of a medical device under the Act is determined based on whether the program's purpose of use and degree of risk fall under the definition of a medical device, based on the product's labeling, explanatory materials, advertisements, etc., provided by the manufacturer or distributor."
Guidelines on the Applicability of Programs as Medical Devices, MHLW, https://www.pmda.go.jp/files/000240233.pdf
Purpose of Use
The most important criterion is the purpose for which the manufacturer or distributor places the product on the market. Regulatory authorities determine the "purpose of use" based on the claims (indications/effects) made on the product's label, instruction manual, advertisements, website, etc.
Example: Even with the same EMS device, if the purpose is "to train muscles," it is a general good, but if it claims a medical effect such as "improvement of muscle atrophy," it becomes a medical device.
Risk to the Human Body
Devices are classified into classes according to their degree of risk.
Regarding the Applicability of Programs as Medical Devices (Basic Concepts), MHLW, https://www.pmda.go.jp/files/000273985.pdf
3. How to Make an Assessment
Check if the product seems to qualify as a medical device based on its definition, purpose of use, etc.
If there are similar products, check whether they are classified as medical devices.
For SaMD, check the flowcharts and case studies in the "Guidelines on the Applicability of Programs as Medical Devices."
https://www.pmda.go.jp/files/000240233.pdf
If time permits, also check the following regarding JMDN (Japan Medical Device Nomenclature):
Check if there is an applicable name in the list of JMDN.
Check the websites or package inserts of similar products to find their JMDN.
If the product fits the definition of that JMDN, it is highly likely to be a medical device.
What is a "JMDN"?
It is a kind of "classification name" for grouping medical devices according to their characteristics and uses. Knowing the JMDN helps to understand the device's class and the rules that must be followed.
JMDN Search (PMDA), https://www.std.pmda.go.jp/stdDB/index.html
Q&A on Determining the Applicability to JMDN of Medical Devices, https://www.std.pmda.go.jp/stdDB/Data/RefStd/Std_etc/H290929_0000000_01.pdf
4. Useful Reference Materials for Determination
5. Consulting with the Authorities
Ultimately, confirm with the regulatory authorities.
The contact point differs depending on whether it is a medical device or software as a medical device.
List of consultation counters for medical device applicability (PMDA)
https://www.pmda.go.jp/files/000225620.pdf
Medical Devices
Prefectural Pharmaceutical Affairs Divisions
Software as a Medical Device (SaMD)
Centralized Consultation Service for SaMD (Comprehensive Consultation for Medical Device Programs)
Centralized Consultation Service for SaMD (PMDA)
https://www.pmda.go.jp/review-services/f2f-pre/strategies/0011.html
6. How to Prepare for a Consultation
When consulting with regulatory authorities, it is recommended to organize the following information in advance and prepare it as materials in Japanese to obtain an accurate response. Communications/Meetings are done in Japanese, so you should bring a Japanese speaking person, ideally someone with Japanese regulatory knowledge with you.
*Communication with regulatory authorities and other organizations is mostly in Japanese. Also, given the subtle nuances and business customs that are hard for non-Japanese to grasp, I recommend you to secure a local Japanese partner such as DMAH.
1. Definition of Medical Devices
Definition of Medical Device (Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices, Article 2, Paragraph 4)
The term "Medical Device" as used in this Act means an instrument or apparatus (excluding regenerative medicine products) intended for the diagnosis, treatment, or prevention of diseases in humans or animals, or intended to affect the structure or functions of the body of humans or animals, and which is specified by a Cabinet Order.
This definition can be broken down as follows:
- Purpose of Use: Intended to be used for the "diagnosis, treatment, or prevention of diseases" in humans or animals, or to "affect the structure or functions of the body."
- Form: Instruments and apparatus, dental materials, medical supplies, sanitary articles, and programs (software) and their recording media.
- Designation by Cabinet Order: Even if the above requirements are met, the product must be specifically designated by a Cabinet Order.
2. Key Points for Determination
A comprehensive judgment is made based on the purpose of use and the degree of risk.
"Whether a specific program falls under the category of a medical device under the Act is determined based on whether the program's purpose of use and degree of risk fall under the definition of a medical device, based on the product's labeling, explanatory materials, advertisements, etc., provided by the manufacturer or distributor."
Guidelines on the Applicability of Programs as Medical Devices, MHLW, https://www.pmda.go.jp/files/000240233.pdf
Purpose of Use
The most important criterion is the purpose for which the manufacturer or distributor places the product on the market. Regulatory authorities determine the "purpose of use" based on the claims (indications/effects) made on the product's label, instruction manual, advertisements, website, etc.
Example: Even with the same EMS device, if the purpose is "to train muscles," it is a general good, but if it claims a medical effect such as "improvement of muscle atrophy," it becomes a medical device.
Risk to the Human Body
Devices are classified into classes according to their degree of risk.
Regarding the Applicability of Programs as Medical Devices (Basic Concepts), MHLW, https://www.pmda.go.jp/files/000273985.pdf
3. How to Make an Assessment
Check if the product seems to qualify as a medical device based on its definition, purpose of use, etc.
If there are similar products, check whether they are classified as medical devices.
For SaMD, check the flowcharts and case studies in the "Guidelines on the Applicability of Programs as Medical Devices."
https://www.pmda.go.jp/files/000240233.pdf
If time permits, also check the following regarding JMDN (Japan Medical Device Nomenclature):
Check if there is an applicable name in the list of JMDN.
Check the websites or package inserts of similar products to find their JMDN.
If the product fits the definition of that JMDN, it is highly likely to be a medical device.
What is a "JMDN"?
It is a kind of "classification name" for grouping medical devices according to their characteristics and uses. Knowing the JMDN helps to understand the device's class and the rules that must be followed.
JMDN Search (PMDA), https://www.std.pmda.go.jp/stdDB/index.html
Q&A on Determining the Applicability to JMDN of Medical Devices, https://www.std.pmda.go.jp/stdDB/Data/RefStd/Std_etc/H290929_0000000_01.pdf
4. Useful Reference Materials for Determination
- What kinds of medical devices are there? (PMDA), https://www.pmda.go.jp/safety/consultation-for-patients/on-devices/qa/0016.html
- Regarding the Applicability of Programs as Medical Devices (Basic Concepts), MHLW, https://www.pmda.go.jp/files/000273985.pdf
- Q&A on Determining the Applicability to JMDN of Medical Devices, https://www.std.pmda.go.jp/stdDB/Data/RefStd/Std_etc/H290929_0000000_01.pdf
- Let's investigate the applicability to medical devices (JAAME), https://www.jaame.or.jp/program/investigate.html
- Case Studies on Determining the Applicability of Programs as Medical Devices (PMDA), https://www.pmda.go.jp/files/000251980.pdf
5. Consulting with the Authorities
Ultimately, confirm with the regulatory authorities.
The contact point differs depending on whether it is a medical device or software as a medical device.
List of consultation counters for medical device applicability (PMDA)
https://www.pmda.go.jp/files/000225620.pdf
Medical Devices
Prefectural Pharmaceutical Affairs Divisions
Software as a Medical Device (SaMD)
Centralized Consultation Service for SaMD (Comprehensive Consultation for Medical Device Programs)
Centralized Consultation Service for SaMD (PMDA)
https://www.pmda.go.jp/review-services/f2f-pre/strategies/0011.html
6. How to Prepare for a Consultation
When consulting with regulatory authorities, it is recommended to organize the following information in advance and prepare it as materials in Japanese to obtain an accurate response. Communications/Meetings are done in Japanese, so you should bring a Japanese speaking person, ideally someone with Japanese regulatory knowledge with you.
- Product Name and Overview: What the product is and what functions it has.
- Purpose of Use and Target Users: Who will use it, in what situations, and for what purpose.
- Operating Principle/Algorithm: A technical explanation of how it functions.
- Input/Output Information: What information is input and what information is output.
- Investigation of Similar Medical Devices: Information on the existence and classification of similar products already approved in Japan and overseas.
- Drafts of Advertisements/Promotional Materials: Website mockups, brochure drafts, etc., showing the intended claims and advertisements.
- Regarding Consultation on the Applicability of Medical Devices (PMDA), https://www.pmda.go.jp/files/000225620.pdf
- PMDA Centralized Consultation Service for SaMD (Application method/forms), https://www.pmda.go.jp/review-services/f2f-pre/strategies/0011.html