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MDCG Guidance: In-Vitro Diagnostic Medical Device Safety Reporting

The European Commission’s Medical Device Coordination Group (MDCG) released updated guidance "Safety reporting in performance studies of...

UK MHRA Guidance: Borderlines with Medical Devices & Other Products in Great Britain

The UK Medicines and Healthcare Products Regulatory Agency (MHRA) updated its guidance "Borderlines with Medical Devices & Other Products...

Switzerland's SwissMedic: Guidance on Export Certificates

On 3rd April, 2024 Switzerland's Swissmedic released an updated "Guidance on Export Certificates" and as part of its regulatory...

South Africa SAPHRA: Guideline For Professional Information For Human Medicines (Categories A and D) and Classification of Medical Devices and IVDs

Recently last week the South African Health Products Regulatory Authority (SAPHRA) released an updated "Guideline For Professional...

UK MHRA: Guidance on Regulation of devices in Northern Ireland & Apply for Manufacturer or Wholesaler of Medicines Licences

Earlier today (25 March 2025) UK's Medicines and Healthcare Products Regulatory Agency (MHRA) released updated guidance on "Apply for...