Regulatory Blog

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