SaMD in Japan: Software as a Medical Device Regulatory Pathway

1. Key takeaways

Since November 25, 2014, Japan has explicitly included programs, and recording media for programs, within the scope of medical devices; programmable medical devices (SaMD) thereby became subject to approval, certification, or notification. For software vendors, three points are most easily overlooked: applicability is subject to a reverse exclusion clause, the registration-target manufacturing process is limited to design, and the package insert may be provided by electronic means. Each of these points reshapes the regulatory plan — the first decides whether the product is regulated at all, the second narrows the site registration scope, and the third changes how documentation is delivered.

• The inclusion of software in the medical device definition was completed by Act No. 84 of 2013, promulgated November 27, 2013, effective November 25, 2014.
• The basic policy on applicability was set out in Yakushoku Kanpatsu 1114 No. 5, November 14, 2014, applicable from November 25, 2014, with further examples to be added as necessary.
• Programs whose malfunction would have only a minor impact on human life and health are excluded from the medical device scope.
• For devices provided as programs, the registration-target manufacturing process is limited to design only.
• The package insert may be provided by electronic means where electromagnetic records accompany the device and users can easily access them.

2. Legal basis

The regulatory treatment of software as a medical device rests on the amended definition in the PMD Act, the MHLW policy notification on applicability, and specific provisions of the Implementing Rules. The key sources are as follows.

• PMD Act Article 2, Paragraph 4: the definition of medical devices; the inclusion of programmable medical devices was completed by Act No. 84 of 2013 (promulgated November 27, 2013, effective November 25, 2014).
• MHLW notification concerning the basic policy on the applicability of programs to medical devices, Yakushoku Kanpatsu 1114 No. 5, November 14, 2014; applicable from November 25, 2014, and stating that additional examples will be added where necessary.
• Implementing Rules, Article 114-8: for medical devices provided in the form of programs, the registration-target manufacturing process is limited to design.
• Implementing Rules, Article 225: provision of the package insert by electromagnetic means.
• PMD Act Article 63-2: the entries required in the package insert and related documents.
• Current statute: Act No. 145 of 1960.

3. Expert insights

Insight 1: The applicability judgment has one exception — programs whose impact from malfunction is minor are excluded.

While confirming that programs fall within medical devices, Yakushoku Kanpatsu 1114 No. 5 also provides that, where a malfunction or similar failure of a programmable medical device would have only a minor impact on human life and health, the program is excluded from the medical device scope. This is an exclusion rule based on the consequences of failure, which differs from the thinking applied to hardware devices, and it forms the dividing line between wellness applications and medical devices. The practical consequence is that every software product needs a documented applicability judgment, including an explicit analysis of what happens if the program fails and why that outcome is, or is not, minor. Leaving this analysis implicit invites disagreement with reviewers at exactly the moment when the product plan has already been fixed.

Insight 2: For software, the registration-target manufacturing process consists of design alone.

Article 114-8 of the Implementing Rules limits the registration-target process to design for devices provided in the form of programs. This contrasts with the multi-process list that applies to physical devices — principal assembly, sterilization, storage — and it means that the site registration scope for software vendors is comparatively concentrated. The concentration is an advantage, but only if it is planned deliberately: registering or preparing sites for processes that the law does not require adds cost and audit burden with no compliance benefit. The registration plan should therefore follow the statute exactly — design only — and the file should make clear that no other processes are performed on the product in Japan.

Insight 3: The package insert may be provided electronically, but subject to accessibility conditions.

Article 225 of the Implementing Rules allows the entries of the package insert to be provided by electromagnetic means where electromagnetic records accompany the programmable medical device and users can access them easily. This provision supports paperless delivery, but easy access is a verifiable condition, not an implementation choice left entirely to the vendor. The access path must work for the actual users of the device, remain stable across updates, and be demonstrable on request. A delivery scheme that meets the letter of the provision in a demo but fails in the field is a compliance defect waiting to be found, so the accessibility mechanism deserves design attention equal to that given to the software itself.

4. Practical recommendations

• Complete the applicability self-check before the project is initiated and keep it on record in writing. Focus on the exclusion clause: whether the impact of a malfunction on life and health is minor.
• Plan the registration-target process as design only. Avoid ineffective registration for assembly or sterilization processes that do not exist.
• Make the electronic delivery scheme for the package insert verifiable. Record the access paths, version management, and update mechanisms.
• Track updates to PMDA review priorities for software devices. Official guidance on algorithm verification, cybersecurity, and similar topics continues to be updated; recheck the current version before submission.

5. Verification checklist

• □ Has the applicability judgment been completed according to Yakushoku Kanpatsu 1114 No. 5 (November 14, 2014), including the exclusion clause?
• □ Has the registration-target manufacturing process been planned as design only (Article 114-8 of the Implementing Rules)?
• □ Does the electronic delivery of the package insert meet the easy access condition of Article 225 of the Implementing Rules?
• □ Has it been confirmed that programmable medical devices have been included in the medical device scope since November 25, 2014?
• □ Have the current PMDA guidance versions on software review priorities (algorithm verification, cybersecurity) been rechecked?

Legal 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 prepares J-GCP/J-QMS compliant dossiers, coordinates conformity assessments, and supports post-market vigilance obligations. Business enquiries: info@grzanglobal.com