IVDR Transition: Australia and Switzerland Align With the European Union In recent years, both Australia and Switzerland have taken significant steps [...]
FDA Finalises Guidelines on Off-Label Communications in the U.S. For Medical Devices and Drugs On January 6, 2025, the FDA published [...]
Vigilance on Medical Devices: Update of MDCG Guidelines 2023-3 Rev.2 Vigilance on Medical Devices is a key activity to ensure patient [...]
The Commission Launches a Public Consultation and a Call for Input for the Assessment of the Regulatory Environment The European Commission [...]
UK: Guidelines for Post-market Surveillance of Medical Devices Published On January 15, 2025, the Medicines and Healthcare products Regulatory Agency (MHRA) [...]
USA: FDA Publishes Draft Guidelines for the Development and Management of Medical Devices With Artificial Intelligence In January 2025, the US [...]
19/12/2024 As of January 1, 2025, the Hong Kong Medical Device Division (MDD) is applying new rules for renewal applications for [...]
19/12/2024 On November 22, 2024, the Philippine Food and Drug Administration (FDA) issued the new Administrative Order No. 2024-0015 to update [...]
19/12/2024 On November 26, 2024, the Medical Device Coordination Group (MDCG) published MDCG Guide 2024-14, a key document for contact lens [...]
22/11/2024 The European Commission has recently published a document entitled 'Q&A Obligation to inform in case of interruption or discontinuation of [...]
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