How do you prepare a Japanese clinic for a 立入検査?

Under article 25 of the 医療法, the prefecture or the city or ward 保健所 may enter a clinic and inspect its staff, hygiene, premises, 診療録 and books. Readiness means the 開設届, the staff, the 診療録 and the safety and cybersecurity files match what the clinic actually does, every day.

What the law lets the 保健所 do

The governor, the mayor of a city with its own 保健所 or the head of a special ward may order a clinic to report, and may send staff in to inspect its staff, its cleanliness, its premises and its 診療録, 帳簿書類 and other items.¹ Where the authority suspects a breach, it may also order documents produced and inspect the 開設者's office.¹ MHLW's 要綱 sets an inspection of every hospital in principle once a year, and the yearly notice asks authorities to inspect clinics as the need arises.²³ Refusing or obstructing the inspection carries a fine of up to ¥200,000.¹

What MHLW tells inspectors to look at

The June 2025 notice asks inspectors to check that incidents reach the safety committee and lead to improvements shared across the facility, that personal data is handled under the APPI and the PPC and MHLW guidance, and that fees for disclosing records are reasonable.³ It asks for close checks of the 開設者 and the non-profit rule at clinics offering 美容外科 and other 自由診療.³ The 要綱 adds cybersecurity, asking that the clinic's checklist is filled in and that the incident contact chart is shown.² In FY2023, cybersecurity was the item hospitals met least often, at 91.1%.⁴

1. Reread the 開設届. Check that the 管理者, the doctors, the rooms and the hours still match what was filed.
2. Check the posted notice. The 管理者, the doctors and their hours posted inside the clinic, as article 14-2 requires.
3. Read five 診療録 cold. Look for an entry for every consultation, written without delay, with its author and time.
4. Walk the safety file. The safety guideline, training records, incident reports, infection control and the medicines lead.
5. Answer the cybersecurity checklist. Every item marked yes, or a target date in this fiscal year for each no.
6. Close leavers' accounts. No account open for anyone who has left, as the checklist asks.

1. Month ______ Checked by ______
2. 開設届 still accurate ______ Changes notified on ______
3. 診療録 read ______ Gaps found ______
4. Incidents reviewed ______ Improvements shared on ______
5. Cybersecurity checklist items open ______ Target dates ______
6. Actions, owner and date ______

Copy template

What a clinic is likely to be asked for

Questions

Does the 保健所 announce a 立入検査 in advance?

Article 25 sets no notice period, and MHLW asks authorities to coordinate with the clinic. Readiness works best as the clinic's everyday state, whatever the date.

What happens when an item is not met?

The authority tells the 開設者 or 管理者 and gives guidance to correct it, which may include an improvement plan.

Are clinics inspected every year?

Hospitals are, in principle. MHLW asks authorities to inspect clinics as the need arises, and to check new clinics after their 開設届.

Sources

1. 1e-Gov法令検索, Digital Agency, 2026医療法 (Medical Care Act), Act No. 205 of 1948Read source
2. 2Ministry of Health, Labour and Welfare, 2025医療法第25条第１項の規定に基づく立入検査要綱, revised June 2025, 医政発0627第７号Read source
3. 3Ministry of Health, Labour and Welfare, 2025令和７年度の医療法第25条第１項の規定に基づく立入検査の実施について, 医政発0627第９号, 27 June 2025Read source
4. 4Ministry of Health, Labour and Welfare, 2026医療法第25条に基づく病院に対する立入検査結果 (令和５年度), published 29 May 2026Read source
5. 5Ministry of Health, Labour and Welfare, 2026令和8年度版 医療機関・薬局におけるサイバーセキュリティ対策チェックリスト, June 2026Read source

Written by the wai team from Ministry of Health, Labour and Welfare, with the prefectures and public health centres guidance, checked on 16 October 2026. This is guidance, not legal advice. Neither MHLW nor any prefecture or public health centre endorses wai or any software.