UK MHRA: Guidance on Register Medical Devices to Place on the Market
Health Canada: Guidance on Validation rules for Regulatory Transactions in the eCTD Format
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
UK MHRA: Guidance on Change of Ownership: Marketing Authorisation Process
Switzerland's SwissMedic: Guidance on Formal Requirements
USFDA Guidance: Real-Time Oncology Review (RTOR)
MHRA Guidance: Common Issues Identified during Clinical Trial Applications
USFDA Guidance: Submitting Patient-Reported Outcome Data, Clinical Trial Datasets & Documentation
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: Remote Interactive Evaluations of Drug Manufacturing & Bioresearch Monitoring Facilities
USFDA MD Guidance: Enforcement Policy for Non-Invasive Remote Monitoring Devices
USFDA Guidance: Benefit-Risk Assessment for New Drug and Biological Products
EMA Guidance: Procedural Advice for Orphan Medicinal Product Designation
UK MHRA Guidance: Apply for a Licence to Market a Medicine in the UK