Medical Device Definition under PMD Act Article 2, Paragraph 4

1. Key takeaways

Japan determines whether a product is a medical device by looking at its intended purpose and its effect on the structure or functions of the body, not by looking at whether it is hardware or software. Act No. 84 of 2013 explicitly brought programs, and recording media on which programs are recorded, within the scope of medical devices, applicable from November 25, 2014. For Chinese manufacturers, the qualification judgment must come before the route judgment: if the qualification is wrong, everything that follows is wrong, and the error propagates into classification, route, and dossier design alike.

• The definition turns on two groups of purpose elements, either of which is sufficient to bring a product within scope.
• Software products must be tested against the exclusion rule for program medical devices.
• Qualification and risk classification are two sequential steps, separated by the determination of the generic name.

2. Legal basis

The qualification analysis rests on the definitional provision of the PMD Act and on the ministry notification that addresses program products. Both are cited below with their full identifiers so that the judgment trail can be reconstructed later.

1. PMD Act Article 2, Paragraph 4: the definition of a medical device, covering products intended for the diagnosis, treatment, or prevention of disease in humans, or intended to affect the structure or functions of the human body.
2. PMD Act Article 2, Paragraphs 5 through 7: the designation authority for general medical devices, controlled medical devices, and highly controlled medical devices.
3. The notification of the Director of the Office of Surveillance and Narcotics, Pharmaceutical and Food Safety Bureau, on the basic understanding of whether programs qualify as medical devices, Yakushoku-Kanpatsu 1114 No. 5, dated November 14, 2014; the notification applies from the date of enforcement of Act No. 84 of 2013 (November 25, 2014).
4. The Act for the Partial Revision of the Pharmaceutical Affairs Law and Other Acts, Act No. 84 of 2013 (Heisei 25), promulgated November 27, 2013.

3. Expert insights

Insight one: the definition contains two groups of purpose elements, and satisfying either one suffices.

Article 2, Paragraph 4 of the PMD Act divides the purposes into diagnosis, treatment, or prevention of disease on the one hand, and effect on the structure or functions of the body on the other. This means that a product that is neither diagnostic nor therapeutic, but acts on the structure or functions of the human body, remains within scope. The most common misjudgment among Chinese manufacturers is to check only whether the product is used for diagnosis or treatment, and to miss the second group of elements altogether, thereby concluding too early that no registration is needed. The second group is especially relevant to products that support, move, measure, or process parts of the body without treating any disease, and those products are precisely the ones most likely to be caught late.

Insight two: a reverse exclusion exists for program medical devices.

Yakushoku-Kanpatsu 1114 No. 5, while confirming that programs qualify as medical devices, provides that program medical devices whose malfunction and similar events would have only a minor effect on human life or health are excluded from the scope of medical devices. This is an exclusion rule keyed to the consequences of failure rather than to a functional description, which makes its logic different from the analysis used for hardware instruments. A software product with a benign failure mode may therefore sit outside the regime entirely, but that conclusion must be demonstrated, not assumed, and the demonstration belongs in the written qualification record described below.

Insight three: qualification and risk classification are two separate steps.

First judge whether the product is a medical device; only then judge which class it belongs to. Between the two steps lies the determination of the generic name. Merging the two steps into a quick functional self-check table will miss cases where the Ministry of Health, Labour and Welfare has designated an item individually, and that omission surfaces late, when it is most expensive to correct. Keeping the steps separate also keeps the evidence trail clean, since each step has its own written record and its own source documents.

4. Practical recommendations

• Record the qualification conclusion in writing and file it. Document the basis of the judgment, including the definitional elements, the relevant notification provisions, and the functional description, for later use in generic name retrieval and PMDA consultation.
• Complete the qualification self-check for software products before the project is initiated. Focus on the exclusion clause: whether the effect of a malfunction on life and health is minor. This single point directly determines whether the approval or the certification route is even available.
• Send borderline products to PMDA consultation first. Where qualification is contested, obtaining a written position at the consultation stage is preferable to self-judging and carrying the risk of rejection later, because the consultation record also disciplines the rest of the dossier around the agreed reading.
• Watch for additional illustrative examples issued by the Ministry. Yakushoku-Kanpatsu 1114 No. 5 expressly states that further examples may be added as necessary, so the notification should be revisited on a regular schedule.

5. Verification checklist

• □ Has the product been checked against both groups of purpose elements in Article 2, Paragraph 4 of the PMD Act, rather than only the diagnostic and therapeutic uses?
• □ Have software products been checked against the exclusion clause for program medical devices?
• □ Is the qualification conclusion recorded in writing, with the notification number and date noted?
• □ Have the qualification judgment and the risk classification judgment been kept as two separate steps?
• □ Does every citation of the notification carry the full number (Yakushoku-Kanpatsu 1114 No. 5) and the date (November 14, 2014)?

Regulatory information verified as of October 29, 2026.

How GRZAN can help. GRZAN provides medical device and IVD registration, quality system, in-country representative and local testing support for the Japanese market. Our team manages PMDA submissions across Shonin/Todokede routes, coordinates J-QMS conformity, and supports post-market vigilance obligations. Business enquiries: info@grzanglobal.com