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MHLW compliance hub

MHLW guides

Each guide answers one question a provider in Japan asks about MHLW, from the official sources it cites. There are 7 guides across 7 topics, last checked on 16 October 2026.

The depth of an inspection readiness review, written from Japan's own laws, MHLW's notices and the PPC's guidance. Japan counted 105,702 general clinics at the end of July 2026, and every one answers to its 保健所. Each guide ends with how wai does the work.

Updated .

A man in a dark suit walking across a sunlit stone atrium, a tall tree growing inside under a wall of glassOpeningHow do you open a clinic in Japan, with a 開設届 or a 開設許可?A woman working on a tablet at a long oak counter in a quiet townhouse room, tall sash windows and an arrangement of flowers in the afternoon sunInspectionHow do you prepare a Japanese clinic for a 立入検査?A medical director alone at a long pale stone table in a vast bright clinic, reviewing a single bound document, tropical green beyondDocumentsWhich documents and policies does a clinic in Japan need?A physician in a white coat seated in a sculptural chair in a quiet consulting suite, reading and signing a note on a tabletRecordsHow must a Japanese clinic write and keep the 診療録?Two colleagues talking at a wall of windows high above a city park and skyline in the afternoonSecurityWhat does MHLW's security guideline ask of a clinic in Japan?

More guides

  1. 16 Oct 2026How does the APPI apply to patient data in a Japanese clinic?Privacy
  2. 16 Oct 2026How should a Japanese clinic record and report incidents?Incidents

How the guides map to the MHLW framework

The hub sets out the 5 headings MHLW works to, and the guides take them one task at a time.

The 5 headings on the MHLW hub

  1. Opening a clinic, 開設届 or 開設許可, 5 requirements on the hub. A clinic opened by a physician who has completed clinical training is notified within 10 days of opening. Anyone else, a 医療法人 included, needs permission before opening.
  2. The 管理者 and the people, 5 requirements on the hub. Every clinic is managed by a physician who has completed clinical training, who supervises the staff and posts who practises when.
  3. Medical safety and cybersecurity, 5 requirements on the hub. The 管理者 must keep a written safety guideline, train staff, run incident reporting and infection control, and take the cybersecurity measures MHLW sets.
  4. The 診療録, 5 rules on the hub. A doctor writes the 診療録 without delay after every consultation, and the clinic's 管理者 keeps it 5 years. An electronic record must stay authentic, readable and preserved.
  5. Patient data under the APPI, 6 rules on the hub. A patient's medical history is 要配慮個人情報. The clinic posts its purposes of use, protects the data, reports serious leaks to the PPC and discloses the record on request.

The 7 topics the guides are filed under

  1. Opening, 1 guide and about 9 minutes of reading. Opening a clinic, 開設届 or 開設許可.
  2. Inspection, 1 guide and about 8 minutes of reading. 立入検査 readiness.
  3. Documents, 1 guide and about 9 minutes of reading. Documents and policies.
  4. Records, 1 guide and about 8 minutes of reading. The 診療録.
  5. Security, 1 guide and about 9 minutes of reading. The security guideline 第7.0版.
  6. Privacy, 1 guide and about 9 minutes of reading. Patient data under the APPI.
  7. Incidents, 1 guide and about 8 minutes of reading. Incidents and reporting.

Questions about the MHLW guides

Which MHLW guide should I read first?

Start with Opening a clinic, 開設届 or 開設許可, the first guide on this page, about 9 minutes of reading, filed under Opening. The other 6 each stand on their own, so take them in the order your own preparation needs.

How do these guides relate to the MHLW hub?

The MHLW hub sets out the 5 headings MHLW works to and how wai evidences each one. Each guide goes one level down, to a single task, with steps to follow, a template to copy, answers to common questions and the sources behind it.

How current are the MHLW guides?

Every guide shows the date its facts were checked against the official sources it cites. All 7 were checked on 16 October 2026, the same date the hub shows beside its Updated line.

Are the MHLW guides legal advice?

They are guidance, not legal advice, written from what MHLW publishes, with a link to the source for each fact. Neither MHLW nor any prefecture or public health centre endorses wai or any software, and the inspection result for your organisation is decided by the prefecture or public health centre.

How do I request a demo for MHLW?

Request a demo from this page and it reaches the wai team with MHLW already named, so the call starts from MHLW rather than a general tour. You can also write to team@wellnessa-i.com.

The hub

  1. MHLWWhich clinic software fits Japan's 医療法 and APPI?Hub

See wai on your own diary, notes and inbox.

Fifteen minutes on video, in Japanese or English, on your own clinic's records.

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