Japan Medical Device Regulations

We have assembled the following documents as a service to the medical device community. All were published by the Ministry of Health, Labour and Welfare (MHLW) or the Pharmaceutical and Medical Devices Agency (PMDA) and are in PDF format. If you find a newer version of a document or one that should be included, please marketing [at] emergogroup [dot] com (email us).

Major Regulations

• MHLW Ordinance #2 - Standards for Manufacturing and Quality Control - Tranlsation provided by BSI Japan K.K.
• 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 Notification #112 - List of Designated Controlled Devices subject to Product Certification (JAPANESE)
• MHLW Ordinance #135 - Standards for Post-market Safety Assurance (JAPANESE)
• MHLW Ordinance #136 - Role of MAH - Translation provided by BSI Japan K.K.
• MHLW Ordinance #169 - Quality Systems Regulations - Translation provided by BSI Japan K.K.
• MHLW Notification #252 - List of Registered Certification Bodies (JAPANESE)
• MHLW Notification #391 - Appointment of JAAME as Registered Certification Body (JAPANESE)

Specific Guidance Documents

• Handling of Applications for GMP Conformity Audit
• Handbook for Preparation of Summary Technical Documentation (STED)
• Guidance on Master File System
• Basic Principles of Biological Safety Evaluation

General Guidance Documents

• Quality Management System Inspections
• Q&A for the Handling of Clinical Trial Results on Medical Devices Obtained in Foreign Countries

Forms and Applications

• Application for Accreditation of Foreign Manufacturers
• Application for Marketing Approval for Medical Devices

Additional Information

• Handling Data from Foreign Clinical Studies