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19 posts tagged with "japan"

Foreign Manufacturer Accreditation (FMA) — 5-Year Renewal Cycle

japan 📅 key dates

Accreditation of Foreign Medical Device Manufacturers

japan 🔄 reform tracker

Advanced Efforts in Medical Device Review

japan 🔄 reform tracker

Master File System for Medical Devices

japan 🔄 reform tracker

Medical Device QMS and GMP Inspection Program

japan 📋 regulatory changes

Ministerial Ordinance on Good Clinical Practice for Medical Devices

japan 📋 regulatory changes

Ministerial Ordinance on Good Laboratory Practice for Nonclinical Safety Studies of Medical Devices

japan 📋 regulatory changes

Ministerial Ordinance on Standards for Quality Assurance for Medical Devices (GQP)

japan 📋 regulatory changes

Public Comments on Medical Device Regulations

japan 💬 consultations

Regenerative Medical Products Approval and Review Process

japan 📋 regulatory changes

Regulations for Buildings and Facilities of Pharmacies

japan 📋 regulatory changes

RS General Consultation for Medical Devices

japan 💬 consultations

Software as a Medical Device Regulatory Pathway

japan 📋 regulatory changes

Medical Device Review System and MDSAP

japan 🔄 reform tracker

Ministerial Ordinance on Good Clinical Practice for Medical Devices

japan 📋 regulatory changes

Ministerial Ordinance on Good Laboratory Practice for Nonclinical Safety Studies of Medical Devices

japan 📋 regulatory changes

Ministerial Ordinance on Standards for Quality Assurance for Medical Devices (GQP)

japan 📋 regulatory changes

Regenerative Medical Products Regulation

japan 🔄 reform tracker

Software as a Medical Device (SaMD) Regulation

japan 🔄 reform tracker