Japan Medical Device GCP: Ordinance No. 36 of 2005 Compliance

1. Key takeaways

The compliance baseline for medical device clinical trials in Japan is the Medical Device GCP Ordinance (MHLW Ordinance No. 36 of 2005, last amended by MHLW Ordinance No. 128 of 2016), which is separate from the GCP ordinance governing drug trials. For overseas trial data to be accepted in Japan, the sponsor must show that the standard the trial followed is equivalent to, or stricter than, Japanese GCP. The ordinance therefore serves a dual role: it is the implementation standard for trials conducted in Japan, and it is the benchmark line against which the comparability of foreign trial data is judged. Dossiers that ignore this dual role routinely attract deficiency questions that a well-structured equivalence mapping would have prevented.

• Device trials and drug trials in Japan are governed by two separate ordinances; mixing their document systems creates structural mismatches.
• Device trial design has its own characteristics, including operator learning curves and the effect of device iterations on outcomes.
• Overseas data are accepted only if the standard followed is equivalent to or stricter than Japanese GCP, judged against Ordinance No. 36 of 2005.
• The ordinance was last amended in 2016; citations must reference the current version of the text.
• Endpoints and sample size should be aligned with reviewers at the PMDA consultation stage, before submission.

2. Legal basis

The sources below define both the conduct requirements for device trials in Japan and the legal basis for requiring clinical evidence in approval review.

• Ordinance on the standards for conducting clinical trials of medical devices, MHLW Ordinance No. 36 of 2005 (Heisei 17) (title: Ordinance on the Standards for the Conduct of Clinical Trials of Medical Devices).
• Last amendment: MHLW Ordinance No. 128 of 2016 (Heisei 28).
• PMD Act Article 23-2-5, Paragraph 2: the judgment of quality, efficacy and safety in approval review, which constitutes the legal source of the clinical documentation requirements.
• PMD Act Article 80-2 (notification of clinical trial protocols) and the related provisions of the Implementing Rules — these concern the notification system for drug clinical trials; the conduct requirements for device clinical trials are governed separately by the Medical Device GCP Ordinance.
• Current statute: Act No. 145 of 1960; Act No. 84 of 2013 (promulgated November 27, 2013, effective November 25, 2014).

3. Expert insights

Insight 1: Device GCP and drug GCP are two ordinances — do not mix them.

Drug clinical trials and medical device clinical trials in Japan are governed by different ordinances. Device trials have their own characteristics in trial design, endpoint selection, and sample size justification — for example, the operator learning curve and the influence of device iterations on results. Applying a drug GCP document system to a device trial will be identified during review as a structural mismatch: the procedural documents, monitoring approach, and data handling conventions that suit drug studies do not map onto the questions a device trial must answer. The correction is not cosmetic; it requires rebuilding the trial framework around device-specific considerations, which is far easier to do before the trial starts than after a deficiency letter arrives.

Insight 2: The ordinance is the benchmark line for judging the comparability of overseas data.

One of the premises for accepting an overseas trial is that the standard it followed is equivalent to, or stricter than, Japanese GCP. The reference object for that judgment is precisely MHLW Ordinance No. 36 of 2005. When preparing overseas trial documentation, companies should therefore map their trial conduct against the ordinance clause by clause and explain equivalence for each clause, including how any differences are handled. A clause-level equivalence table turns a vague claim of international compliance into a verifiable argument, and it gives reviewers a direct route to conclude that the foreign data can stand alongside — or in place of — Japanese trial data.

Insight 3: The ordinance underwent its final amendment in 2016 — version control matters.

The final amendment of this ordinance is MHLW Ordinance No. 128 of 2016. When companies cite clauses or build their quality system documents, they must confirm that the text relied upon is the current version, not an older one. Version drift is a quiet but real risk: internal procedures drafted years ago may paraphrase superseded wording, and a review that cross-checks citations against the current statutory text will flag the discrepancy. A simple control — verifying every citation against the current text on e-Gov and recording both the ordinance number and the amendment number — keeps the document system aligned with the law as it stands.

4. Practical recommendations

• Build the clinical trial system documents on the current version. Base citations on the current text on e-Gov, noting both the ordinance number and the amendment number.
• Attach an equivalence comparison table to overseas trial documentation. Explain clause by clause the correspondence to MHLW Ordinance No. 36 of 2005 and how differences are handled.
• Complete ethics and institutional procedures before trial initiation. The ethics review of each participating institution and any required prior procedures should be finished before subject enrollment.
• Align the protocol and the statistical plan in advance. Endpoints and sample size should reach a shared understanding at the PMDA consultation stage, reducing post-submission additions.

5. Verification checklist

• □ Are the system documents based on the current version (MHLW Ordinance No. 36 of 2005, last amended by Ordinance No. 128 of 2016)?
• □ Does the overseas trial documentation include an equivalence comparison table against Japanese GCP?
• □ Have the ethics review and prior procedures of each participating institution been completed?
• □ Were the trial endpoints and sample size aligned at the PMDA consultation stage?
• □ Has the direct application of a drug GCP document system to the device trial been avoided?

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