UK MHRA: Guidance on Register Medical Devices to Place on the Market
Australia TGA: Clinical Evidence Guidelines
Swiss Medic: Biosimilar Authorisation Guidance
South Africa's (SAPHRA): Questions And Answers Licensing Of Medical Device Establishments
USFDA MD Guidance: Notifying FDA of a Permanent Discontinuance, 506J Guidance & Computational Model
Switzerland's SwissMedic: Guidance on Formal Requirements
MHRA Guidance: Common Issues Identified during Clinical Trial Applications
USFDA MD Guidance: Enforcement Policy for Clinical Electronic Thermometers
USFDA Guidance: Supplements for Approved Premarket Approval or Humanitarian Device Exemption
TGA Guidance: General Dossier Requirements
UK MHRA: Guidance on Software and Artificial Intelligence (AI) as a Medical Device
USFDA MD Guidance: Enforcement Policy for Non-Invasive Remote Monitoring Devices
USFDA MD Guidance: Submission of Premarket Notifications for Magnetic Resonance Diagnostic Devices
USFDA MD Guidance: AST System Devices, Technical Considerations & Electronic Submission Template
USFDA MD Guidance: Cybersecurity-Quality System Considerations & Content of Premarket Submissions
EC Q&A Guidance: Questions & Answers: Clinical Trials Regulation
EMA Guidance: Pre-Authorisation Procedural Advice for Users of the Centralised Procedure
MHRA MD Guidance: Innovative Devices Access Pathway (IDAP) & How to Notify Clinical Investigation
USFDA Guidance: Conduct of Clinical Trials of Medical Products During Major Disruptions
USFDA Guidance: Regulatory Considerations for Prescription Drug Use-Related Software