Japan Medical Device Regulations
We have assembled the public documents below as a service to the medical device community. Although we do our best to ensure that these documents are the latest versions, things change. If you would like to suggest a document for inclusion or we have included an outdated version, please let us know. All documents were published by the Ministry of Health, Labour and Welfare (MHLW) and are in PDF format unless otherwise noted
- Application for Accreditation of Foreign Manufacturers (ENGLISH)
- Guidance on Master File System (ENGLISH)
- Handling Data from Foreign Clinical Studies (ENGLISH)
- MHLW Notification #112 - List of Designated Controlled Devices subject to Product Certification (JAPANESE)
- MHLW Notification #252 - List of Registered Certification Bodies (JAPANESE)
- MHLW Notification #391 - Appointment of JAAME as Registered Certification Body (JAPANESE)
- MHLW Notification #71 - Revised List of Specially Designated Installation Medical Devices (JAPANESE)
- MHLW Notification #78 - Specially Controlled, Controlled, & General Medical Devices (JAPANESE)
- MHLW Notification #83 - Partial Amendment of Specially Controlled Medical Devices (JAPANESE)
- MHLW Notification #85 - List of General (Class I) Devices Requiring Manufacturing and Quality Control (JAPANESE)
- MHLW Ordinance #135 - Standards for Post-market Safety Assurance (JAPANESE)
- MHLW Ordinance #136 - Role of MAH (ENGLISH) - Provided by BSI Japan K.K.
- MHLW Ordinance #169 - Quality Systems Regulations (ENGLISH) - Provided by BSI Japan K.K.
- MHLW Ordinance #2 - Standards for Manufacturing and Quality Control - (English) Provided by BSI Japan K.K.
- Quality Management System Inspections (ENGLISH)
