Important Update: Licensing Regime for Class C & D Non-Notified Medical Devices […] Important Update: Licensing Regime for Class C & D Non-Notified Medical Devices Read More »
Artificial Intelligence & Machine Learning (AI/ML): FDA Guideline On Predefined Change Control Strategy Artificial Intelligence & Machine Learning (AI/ML): FDA Guideline On Predefined Change Control Strategy Read More »
MDR Extension Effect on Medical Device Sale in UK: MHRA Update MDR Extension Effect on Medical Device Sale in UK: MHRA Update Read More »
MDCG 2023-2 Guidance: European Regulators Clarify MDR and IVDR Standard Fees MDCG 2023-2 Guidance: European Regulators Clarify MDR and IVDR Standard Fees Read More »
The EC Supports The Extension Proposal of Transition Period for Legacy Devices. The EC Supports The Extension Proposal of Transition Period for Legacy Devices. Read More »
Gujarat FDCA Issuing Registration Certificate to Medical Device Manufacturers. Gujarat FDCA Issuing Registration Certificate to Medical Device Manufacturers. Read More »
EU MDCG 2022-18 : Extended Timeline for Legacy Device Compliance EU MDCG 2022-18 : Extended Timeline for Legacy Device Compliance Read More »
EU Proposes Extensions of MDR Transition Period EU Proposes Extensions of MDR Transition Period Read More »
The US FDA Has Updated Its Guidance On Identifying And Responding To Deficiencies (FDA Deficiency Guidance) The US FDA Has Updated Its Guidance On Identifying And Responding To Deficiencies (FDA Deficiency Guidance) Read More »
MDCG 2022-16 guidance on EU Authorized Representative Requirements MDCG 2022-16 guidance on EU Authorized Representative Requirements Read More »
