How do you open a clinic in Japan, with a 開設届 or a 開設許可?

A physician who has completed clinical training opens the clinic and files a 開設届 with the prefecture or the city or ward 保健所 within 10 days, under article 8 of the 医療法. Anyone else, a 医療法人 included, needs a 開設許可 before opening, under article 7.

Which route your clinic takes

The 医療法 defines a 診療所 as a place where a doctor practises with no inpatient beds or with 19 beds or fewer.¹ A 臨床研修等修了医師 who opens a clinic notifies the authority within 10 days of opening, while anyone who is not, a company or a 医療法人 included, applies for permission before opening.¹ The authority is the prefectural governor, or the mayor of a city that runs its own 保健所, or the head of a Tokyo special ward.¹ A 開設許可 is granted when the premises and staff meet the ministry's ordinance and the prefecture's rules.¹

What the 保健所 asks for

The 開設届 states the 開設者's address and name, with the clinical training certificate shown or copied, and the clinic's details set out in the enforcement regulation.² A Tokyo 保健所 asks a physician to bring floor plans showing each room's use and area before building work starts, to file 2 copies within 10 days of opening, and to attach licences, land and building certificates, the lease and X-ray room drawings where there is X-ray equipment.³ Its staff then visit to check the clinic against the filing, and hand back the stamped copy on the spot when everything matches.³ A Tokyo 法人 clinic obtains its 開設許可 before opening and then files its notice within 10 days.⁴

MHLW tells authorities that notified clinics sometimes differ on site from what was filed, and asks them to check promptly after each 開設届 that the address, premises, 管理者 and staff match, along with infection control, accident prevention and the non-profit rule.⁵

1. Decide the route. A physician's own clinic files a 開設届. A 医療法人, a company or anyone else applies for a 開設許可 first.
2. Check the area. Since 1 April 2026, a clinic without beds in a designated 外来医師過多区域 gives 6 months' notice, once the prefecture has designated the area.
3. Consult the 保健所 early. Bring floor plans with each room's use and area before building work starts.
4. Name the 管理者. A 臨床研修等修了医師 who manages this clinic only, unless the governor permits otherwise.
5. Collect the attachments. Licences, the clinical training certificate, the career history, land and building certificates, the lease and plans.
6. Open and file. File the 開設届 within 10 days of opening, and host the 保健所's on-site check.
7. Diary what follows. Changes notified as the law requires, and a 廃止届 within 10 days if the clinic closes.

1. Prefecture or city ______ 保健所 ______
2. Route 開設届 ______ 開設許可 ______
3. 開設者 ______ 管理者 ______ Training certificate no. ______
4. Pre-consultation with plans on ______
5. 外来医師過多区域 checked on ______ Result ______
6. Opening date ______ 開設届 filed on ______
7. On-site check on ______ Stamped copy received ______

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Two local steps in Tokyo and Osaka

Article 30-18-6 lets a prefecture designate an area with more outpatient doctors than it needs, and a clinic without beds opening there notifies the governor 6 months before opening.¹ The Tokyo Metropolitan Government says the rule took effect on 1 April 2026, and that as of April 2026 it was still deciding which areas to designate.⁶ Osaka Prefecture asks a new general clinic for a letter of intent on cooperating with local care, filed with the 開設届 or within 10 days after it.⁷ Japan counted 105,702 general clinics at the end of July 2026, 37,940 opened by individuals and 48,704 by 医療法人.⁸

Questions

Can a 医療法人 open a clinic with a 開設届?

No, the 開設届 route is for a physician who has completed clinical training. A 医療法人 applies for a 開設許可 before opening.

Who receives the 開設届 in Tokyo's 23 wards?

The head of the special ward, through the ward's own 保健所, because the 医療法 gives the ward that role for clinics.

Is there an on-site check after a 開設届?

Yes. A Tokyo 保健所 visits to check the clinic against the filing, and MHLW asks every authority to check newly notified clinics promptly.

What happens if a clinic opens late after a 開設許可?

The governor may revoke the permission when a clinic does not start work within 6 months of it without good reason.

Sources

1. 1e-Gov法令検索, Digital Agency, 2026医療法 (Medical Care Act), Act No. 205 of 1948Read source
2. 2e-Gov法令検索, Digital Agency, 2026医療法施行規則 (Ordinance for Enforcement of the Medical Care Act)Read source
3. 3Tokyo Metropolitan Government, Bureau of Public Health, 2026個人開設の診療所, 多摩府中保健所Read source
4. 4Tokyo Metropolitan Government, Bureau of Public Health, 2026診療所・歯科診療所の開設について, 多摩立川保健所Read source
5. 5Ministry 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
6. 6Tokyo Metropolitan Government, Bureau of Public Health, 2026外来医療計画, 外来医師過多区域における事前届出Read source
7. 7Osaka Prefectural Government, 2026診療所開設後の地域医療への協力に関する意向書の提出について (概要)Read source
8. 8Ministry of Health, Labour and Welfare, 2026医療施設動態調査 令和８年７月末概数, published 30 September 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.