Switzerland's Swissmedic: Med Dev Guidance on Export Certificates and Service Agreement
Saudi Arabia’s (SFDA): Requirements on Importation and Shipments of Medical Devices (MDS-REQ5)
UK MHRA: Med Dev Guidance on "Off-Label Use","Virtual Mfg." "Legal Requirements" & "Approved Bodies"
EC MDCG: Med Dev Guidance on Significant Changes regarding the Transitional Provision MDR
UK MHRA Guidance: Notifying MHRA on a Clinical Investigation for a Medical Device
ICH/USFDA Final Guidance: Q9(R1) Quality Risk Management
Singapore's HSA: Consultation on eCTD Implementation & Risk Classification on IVD
USFDA Guidance: Decentralized Clinical Trials for Drugs, Biological Products, and Devices
MHRA Guidance: Registration & Regulating Medical Devices in UK
Swiss Medic: Information sheet on Clinical Investigations with Medical Devices
IMDRF Guidance: CyberSecurity, Post-Market Surveillance, Personalized Medical Devices
USFDA Q&A: A Risk-Based Approach to Monitoring of Clinical Investigations
USFDA Guidance: Clinical Outcome Assessments Into Endpoints for Regulatory Decision
UK MHRA: MHRA Fees 2023 & Guidance on How to Draft a Direct Health Care Professional Communication
USFDA Med Dev: Marketing Submission Recommendations for Change Control Plan for AI/ML Enabled Device
USFDA MD Guidance: Cybersecurity-Refuse to Accept Policy for Cyber Devices & Related Systems
USFDA Guidance: General Considerations for Animal Studies Intended to Evaluate Medical Devices
UK MHRA: Guidance on Register Medical Devices to place on the Market
USFDA MD Guidance: Transition Plan for M.D Issued Emergency Use Authorizations Related to COVID-19
UK MHRA: MD Guidance on Crafting an Intended Purpose in the Context of SaMD