How to Determine if Your Product Is a Medical Device in Japan

A practical guide for English speakers on how to judge whether a product qualifies as a “medical device” under Japan’s PMD Act. It covers the legal definition, how the purpose of use and degree of risk drive the decision, how to check the JMDN and device class, special rules for software (SaMD), worked examples (CYBERDYNE HAL and Apple Watch), what to do when a product is not a medical device, and how to consult the authorities. It also notes points relevant to entering Japan from overseas.

⚠️ Before you start

① English materials are scarce. Most official Japanese-government materials (PMDA, MHLW, etc.) are Japanese-only or machine-translated; the Japanese original prevails. References here are tagged (Japanese) / (English) / (Japanese / English).

② Authorities and public support are largely Japan-focused and in Japanese. Official communication is mostly in Japanese, and many public-sector programs target Japanese companies, so some resources cited here may not apply to overseas companies. Check with each organization in advance whether they can support you in English and/or accept overseas companies.

③ So secure a Japan-based partner in advance — for example, a local Japanese speaker or an agent such as a DMAH (Designated Marketing Authorization Holder) — before entering the Japanese market.

Contents

1. Definition of Medical Devices
2. Key Points for Determination
3. How to Make an Assessment (JMDN and Device Class)
4. Special Rules for Software (SaMD)
5. Worked Examples (HAL and Apple Watch)
6. If Your Product Is a Medical Device: Who Acts in Japan?
7. If Your Product Is NOT a Medical Device
8. Consulting with the Authorities
9. How to Prepare for a Consultation
10. Reference materials in English
11. Reference materials in Japanese
12. Related JPRO Pages

1. Definition of Medical Devices

Put simply, whether a product is a medical device comes down to whether it falls within the legal definition. In recent years the authorities have compiled guidelines, notices, and case studies, so you can now make a reasonable preliminary judgment yourself by referring to them.

Definition of Medical Device (PMD Act, Article 2, Paragraph 4): A “medical device” means an instrument or apparatus, etc. (excluding regenerative medicine products) that is intended for the diagnosis, treatment, or prevention of diseases in humans or animals, or that is 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.

References:

• Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices (医薬品、医療機器等の品質、有効性及び安全性の確保等に関する法律 / 昭和35年8月10日法律第145号), e-Gov, laws.e-gov.go.jp (Japanese)
• Regarding the Applicability of Programs as Medical Devices — Basic Concepts (プログラムの医療機器該当性について（基本的な考え方）), MHLW, 000273985.pdf (Japanese)
• English translation of the Act (provisional; only the Japanese text has legal effect — Act No. 50 of 2015 version, later amendments not reflected): PMD Act, Japanese Law Translation Database, japaneselawtranslation.go.jp (English)

2. Key Points for Determination

For both physical devices and software (SaMD), the approach is the same: 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.”

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 for the same EMS device, if the purpose is “to train muscles,” it is a general good (zakka); 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 (see Section 3).

References:

• Guidelines on the Applicability of Programs as Medical Devices (プログラムの医療機器該当性に関するガイドライン), MHLW, 000240233.pdf (Japanese)
• Regarding the Applicability of Programs as Medical Devices — Basic Concepts (プログラムの医療機器該当性について（基本的な考え方）), MHLW, 000273985.pdf (Japanese)

3. How to Make an Assessment (JMDN and Device Class)

A practical sequence:

• Check whether 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 (look at their websites and package inserts).
• For SaMD, check the flowcharts and case studies in the “Guidelines on the Applicability of Programs as Medical Devices” (プログラムの医療機器該当性に関するガイドライン) (000240233.pdf (Japanese)).
• If time permits, also check the JMDN (Japan Medical Device Nomenclature):
  • Check whether there is an applicable name in the JMDN list.
  • 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”?

A JMDN is a kind of “classification name” for grouping medical devices according to their characteristics and uses. Knowing the JMDN helps you understand the device’s class and the rules that must be followed. For details, see how to confirm the JMDN of a medical device.

• JMDN Search (一般的名称検索 / PMDA), std.pmda.go.jp (Japanese); English version: Standards for Medical Devices in Japan, std.pmda.go.jp/…/index_en.html (English)
• Q&A on Determining the Applicability to JMDN of Medical Devices (医療機器の一般的名称への該当性判断に関する質疑応答集（Q&A）について), H290929_0000000_01.pdf (Japanese)

Device class (Class I–IV)

Once a product is a medical device, it is assigned to one of four risk-based classes, and the regulatory route differs by class:

• Class I (general medical devices): lowest risk — self-notification (todokede).
• Class II (controlled medical devices): low risk — third-party certification (for devices with a certification standard) or approval (shonin).
• Class III / IV (specially-controlled medical devices): medium to high risk — approval (shonin) by the Minister (PMDA review).
• Some devices are additionally designated as “specially-controlled maintenance medical devices” (tokutei hoshu kanri iryokiki).

For details and concrete examples, see Classification of Medical Devices. For products that combine medical-device and non-medical-device functions, see medical device classification for combined products and Combination Products, Combination Medical Devices, Kit Products, Kit Components, Assortment Products.

4. Special Rules for Software (SaMD)

For software/programs, the same purpose-of-use + risk logic applies, but two rules often surprise newcomers:

There is no “Class I” SaMD

A program that — even if it malfunctions — poses almost no risk to human life or health (i.e., a program equivalent to a Class I general medical device) is excluded from the scope of medical devices under the law. In other words, the lowest-risk software does not become a “Class I medical device”; it simply falls outside the definition.

• Reference: Guidelines on the Applicability of Programs as Medical Devices — “Basic concept of applicability” (プログラムの医療機器該当性に関するガイドライン（令和5年3月31日改正）「該当性の基本的考え方」), revised March 31, 2023, MHLW, mhlw.go.jp (Japanese)

Programs distributed integrally with a physical product

“A program that is distributed integrally with a tangible product is judged for medical-device applicability as a single product, including the tangible part.” In other words, when software is bundled with hardware as one product, the whole product is assessed together.

• References: Regarding the Applicability of Programs as Medical Devices — Basic Concepts (プログラムの医療機器該当性について（基本的な考え方）), MHLW, 000273985.pdf (Japanese); Partial amendment to the Guidelines (プログラムの医療機器該当性に関するガイドラインの一部改正について), 000252002.pdf (see p.5) (Japanese)

5. Worked Examples (HAL and Apple Watch)

Example 1 — Physical product: CYBERDYNE HAL® (Hybrid Assistive Limb®)

A good example of an almost identical device that is intentionally split into a non-medical and a medical version depending on the purpose of use and claims. HAL is a wearable device that reads bioelectric signals on the skin surface and assists the wearer’s intended movement.

• HAL® Lumbar Type for Care Support / Pro (HAL自立支援用下肢タイプ Pro) – CYBERDYNE — non-medical device. It does not aim to treat disease; its purpose is “to assist weakened muscle movement to make sitting, standing, and walking easier.” This does not fall under the PMD Act definition of “medical device.” (Japanese)
• HAL Medical Lower Limb Type (JP model) (HAL医療用下肢タイプ JPモデル) – CYBERDYNE — medical device. It targets patients with specific diseases (slowly progressive neuromuscular diseases with reduced walking function) and aims to improve walking function. The medical version was approved as a medical device after clinical trials demonstrated improvement in walking function. (Japanese)
  • Package insert: HT010910A-U01_R3.pdf (Japanese)
  • Review report (PMDA): PMDA review report (Japanese)

The websites and product wording also differ between the two versions — a useful model when designing your own positioning.

Example 2 — Software: Apple Watch

On a single device, “medical-device programs” and “non-medical programs” coexist. Comparing them makes SaMD applicability easier to understand.

Functions that ARE medical devices

• ① ECG app — Class II controlled medical device. Approval No. 30200BZI00020000 (home-use electrocardiograph program). The user wears the watch at rest and touches the Digital Crown for ~30 seconds to obtain a single-channel ECG resembling Lead I; the app classifies it as sinus rhythm or possible atrial fibrillation and notifies the user. Why it qualifies: it performs medical inference and clearly aims to contribute to early detection of disease.
• ② Irregular rhythm notification — Class II controlled medical device. Approval No. 30200BZI00021000 (home-use heart-rate monitor program). It periodically samples pulse data in the background and, after repeated detections suggestive of atrial fibrillation, notifies the user. Why it qualifies: it autonomously acquires, analyzes, classifies, and conditionally notifies, aiming to detect signs of a specific arrhythmia and prompt the user to seek care.
• ③ Sleep apnea notification — Class II controlled medical device (approved September 2024). Approval No. 30600BZI00017000; JMDN name “home-use body-motion information analysis program” (JMDN code 71132002). Using accelerometer-derived body-motion data, it estimates breathing disturbances during sleep and, over a 30-day window, notifies the user of possible moderate-to-severe sleep apnea. Why it qualifies: multi-stage medical inference aimed at screening for moderate-to-severe sleep apnea.

Functions that are NOT medical devices

• ④ Heart-rate display — measures and displays/graphs pulse (bpm). Not applicable: it only records/displays/graphs values without judging the presence of disease or prompting a medical visit. (Distinct from ②, a separate program aimed at detecting disease signs.)
• ⑤ Blood Oxygen (SpO2) “wellness” — Apple explicitly limits this to general fitness/wellness, not a medical purpose. Not applicable. Note: if redesigned to judge disease risk and recommend a medical visit, it would likely become a medical-device program.
• ⑥ Sleep tracking — estimates sleep stages and visualizes sleep quantity/quality. Not applicable: it does not diagnose/detect a specific disease. (Distinct from ③.)
• ⑦ Steps / calories / activity — fitness/wellness “exercise management.” Not applicable.
• ⑧ Wrist skin temperature — displays temperature trends only; Apple states it is not intended for medical diagnosis. Not applicable.
• ⑨ High/low heart-rate alerts — notifies when a user-set threshold is crossed. Not applicable, because the threshold is chosen by the user and the program does not run its own medical algorithm to judge a specific disease. Gray zone: if changed to judge a specific disease via a medical algorithm and recommend a visit, it could approach the medical-device-program boundary.

These cases illustrate the core principle: within one device, classification turns on the purpose of use, the claims made, and whether the function detects disease signs / prompts a medical visit. For positioning strategy, see Medical Device vs Non-Medical Device.

6. If Your Product Is a Medical Device: Who Acts in Japan?

(This page is about applicability, so the following is only a brief pointer — not a full procedural guide.)

This is the same legal framework for Japanese and foreign companies — except that a company without a base in Japan cannot itself hold the marketing authorization or perform the domestic procedures. If your product is a medical device, you will need a domestic actor (a Marketing Authorization Holder) and, typically, a DMAH (Designated Marketing Authorization Holder); manufacturing sites overseas also need to be registered (Foreign Manufacturer registration), and Class II-and-above products require conformity with the QMS Ordinance. These are procedural matters beyond the scope of this applicability page. For details, see DMAH: Designated Marketing Authorization Holder – Summary Ver.

7. If Your Product Is NOT a Medical Device

“Not a medical device” does not mean “unregulated.” Depending on its claims and form, a product may instead fall under quasi-drugs, cosmetics, general goods (zakka), or health foods, each with very different rules. Designing your claims to stay outside the medical-device definition (or to fit a different category) is a legitimate strategy, but you must then comply with that category’s rules.

• Cosmetics and Quasi-Drugs
• Medical Device vs Non-Medical Device (positioning)
• Guidance for non-medical services
• Therapeutic Orthoses and Assistive Devices
• Case study — taking a non-medical-device product to market as a medical device overseas: Learning from the Case of PARO

8. Consulting with the Authorities

Ultimately, confirm with the regulatory authorities. The contact point differs depending on whether the product is a (physical) medical device or software as a medical device.

• List of consultation counters for medical-device applicability (医療機器の該当性に関する相談窓口一覧 / PMDA): 000225620.pdf (Japanese)
• Medical devices → Prefectural Pharmaceutical Affairs Divisions (都道府県薬務主管部局相談窓口一覧). List (JFMDA): prefectural counter list (PDF) (Japanese)
• Software as a Medical Device (SaMD) → Centralized Consultation Service for SaMD — Comprehensive Consultation for Medical Device Programs (SaMD一元的相談窓口（医療機器プログラム総合相談）), PMDA: pmda.go.jp (Japanese)

Note: PMDA does not itself decide whether an individual product is a medical device; for a formal determination, the route is in practice via a Japan-resident MAH (J-MAH). For how to make the most of consultations, see PMDA consultation and the free MEDISO free consultation service.

9. How to Prepare for a Consultation

When consulting the authorities, prepare the following in advance (as materials in Japanese) to get an accurate answer. Meetings are mostly conducted in Japanese, so bring a Japanese speaker — ideally someone with Japanese regulatory knowledge.

• Product name and overview: what the product is and what it does.
• Purpose of use and target users: who uses it, in what situations, and for what purpose.
• Operating principle / algorithm: a technical explanation of how it works.
• Input/output information: what is input and what is output.
• Investigation of similar medical devices: 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 advertising.

Reference URLs:

• Regarding Consultation on the Applicability of Medical Devices (医療機器の該当性に関する相談に当たって / PMDA), 000225620.pdf (Japanese)
• PMDA Centralized Consultation Service for SaMD — application method/forms (SaMD一元的相談窓口（申込方法・様式）), pmda.go.jp (Japanese)

10. Reference materials in English

For readers who want sources they can read directly in English (note: each English page is a machine-assisted translation, attachments are often untranslated, and the Japanese original prevails):

• PMD Act — English translation (provisional; Act No. 50 of 2015 version, later amendments not reflected), Japanese Law Translation Database, japaneselawtranslation.go.jp (English)
• Regulations and Approval/Certification of Medical Devices, PMDA, pmda.go.jp/english (English)
• Software as a Medical Device (SaMD), PMDA, pmda.go.jp/english (English)
• Revision of Japanese Medical Device QMS Requirements (incl. English translation of the QMS Ordinance), PMDA, pmda.go.jp/english (English)
• Frequently Asked Questions (FAQ; incl. “who determines device applicability”), PMDA, pmda.go.jp/english (English)
• Invest Japan / Life Science sector, JETRO, jetro.go.jp (English)

11. Reference materials in Japanese

The following are useful primary sources and case studies available in Japanese. Many are referenced inline above; they are gathered here for convenience. (For documents that also have an English version, see Section 10.)

• What kinds of medical devices are there? (医療機器にはどんなものがあります。/ PMDA), pmda.go.jp (Japanese)
• Regarding the Applicability of Programs as Medical Devices — Basic Concepts (プログラムの医療機器該当性について（基本的な考え方）), MHLW, 000273985.pdf (Japanese)
• Guidelines on the Applicability of Programs as Medical Devices (プログラムの医療機器該当性に関するガイドライン), MHLW, 000240233.pdf (Japanese)
• Partial amendment to the Guidelines on the Applicability of Programs as Medical Devices (プログラムの医療機器該当性に関するガイドラインの一部改正について), 000252002.pdf (Japanese)
• Case Studies on Determining the Applicability of Programs as Medical Devices (プログラムの医療機器該当性判断事例について / PMDA), 000251980.pdf (Japanese)
• Case Studies on Determining the Applicability of Programs as Medical Devices (プログラムの医療機器該当性判断事例について / MHLW), mhlw.go.jp (Japanese)
• Q&A on Determining the Applicability to JMDN of Medical Devices (医療機器の一般的名称への該当性判断に関する質疑応答集（Q&A）について), H290929_0000000_01.pdf (Japanese)
• JMDN Search (一般的名称検索 / PMDA), std.pmda.go.jp (Japanese)
• Let’s investigate the applicability to medical devices (医療機器への該当性を調べよう / JAAME), jaame.or.jp (Japanese)
• Explanatory handbook on the Guidelines for the Applicability of Programs as Medical Devices, v1.0 (プログラムの医療機器該当性ガイドラインに関する解説書（医機連編）第1.0版), JFMDA, handbook (PDF) (Japanese)
• Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices (医薬品、医療機器等の品質、有効性及び安全性の確保等に関する法律 / 昭和35年8月10日法律第145号), e-Gov, laws.e-gov.go.jp (Japanese)

12. Related JPRO Pages

• DMAH: Designated Marketing Authorization Holder – Summary Ver.
• How to confirm the JMDN of a medical device
• Classification of Medical Devices
• Medical device classification for combined products
• Combination Products, Combination Medical Devices, Kit Products, Kit Components, Assortment Products
• Cosmetics and Quasi-Drugs
• Medical Device vs Non-Medical Device (positioning)
• Guidance for non-medical services
• Therapeutic Orthoses and Assistive Devices
• Overseas Expansion of Non-Medical Device Products as Medical Devices: the Case of PARO
• Comparison of Medical Device Definitions: Japan, US, & EU
• IVD, LDT, RUO
• PMDA consultation
• MEDISO free consultation service