Clinical Decision Support Software Exemption Notification Form

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Closing date for consultation on publishing GMP inspection outcomes

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Deadline for medical device sponsors to complete transition from EU MDD to EU MDR for ARTG inclusion

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Increasing Transparency of Good Manufacturing Practice (GMP) Inspection Outcomes

australia💬 consultations

M2M HL7 SPL Testing Completion Confirmation Form

australia📋 regulatory changes

Medical Devices Transitioning from EU MDD to EU MDR - Sponsor Notification and Obligations

australia📋 regulatory changes

Accreditation of Foreign Medical Device Manufacturers

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Advanced Efforts in Medical Device Review

japan🔄 reform tracker

Master File System for Medical Devices

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Medical Device QMS and GMP Inspection Program

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Ministerial Ordinance on Good Clinical Practice for Medical Devices

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

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

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Public Comments on Medical Device Regulations

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Regenerative Medical Products Approval and Review Process

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Regulations for Buildings and Facilities of Pharmacies

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RS General Consultation for Medical Devices

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Software as a Medical Device Regulatory Pathway

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Consultation on Medical Device Regulations

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Medical Device Authority Enhanced Market Surveillance Program

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