Malaysia's Medical Device Authority: Guideline on Medical Face Mask and Respirator
Switzerland's Swissmedic: Med Dev Guidance on Export Certificates and Service Agreement
South Africa's SAPHRA: Updated Medicines Application Form Module 1.2.1
Saudi Arabia’s (SFDA): Requirements on Importation and Shipments of Medical Devices (MDS-REQ5)
USFDA Guidance: Pediatric Drug Development - Regulatory and Scientific Considerations
EMA Guidance: Good Practices for Industry for the Prevention of Human Medicinal Product Shortages
UK MHRA: Med Dev Guidance on "Off-Label Use","Virtual Mfg." "Legal Requirements" & "Approved Bodies"
USFDA Guidance: Testing of Glycerin & High Risk Drug Components & CBER Guidances on Blood Products
EC MDCG: Med Dev Guidance on Significant Changes regarding the Transitional Provision MDR
UK MHRA: Guidance on Qualified Person responsible for QPPV & PSMF
UK MHRA Guidance: Notifying MHRA on a Clinical Investigation for a Medical Device
South Africa's SAPHRA: Validation Template For ECTD Variation Applications, QOA & QIS
Swiss Medic: Guidance on Transfer of Marketing Authorisation
USFDA Guidance: Assessing User Fees Under the PDUFA of 2022
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
South Africa: Information Guideline and Quality and Bioequivalence guidelines Aligning with EMA/ICH
ICH/ USFDA Guidance: S12 Nonclinical Biodistribution Considerations for Gene Therapy Products
EMA Guidance: Pre & Post Authorisation for Users of the Centralised Procedure