In June 2021, the Medical Device Coordination Group (MDCG) published the Q&A Guide to answer some of the most significant questions [...]
On 8 July 2021 an amendment to the Regulation on Medical Devices MDR (EU) 2017/745 was published in the Official Journal [...]
One month has passed since the date of full application of the MDR Regulation (EU) 2017/745 for Medical Devices and there [...]
The Australian Therapeutic Goods Administration (TGA) has issued guidelines for the reclassification of Medical Devices and relative temporary arrangements. TGA reclassifies [...]
The Kingdom of Saudi Arabia (KSA) has officially introduced the new Medical Devices Regulation, which is expected to come into effect [...]
The regulatory regimes of the Old Continent are undergoing great change: the scenario is fairly heterogeneous and far from a standardization [...]
UPDATE 31/05/2021 Since 26 May 2021, with the full application of the Medical Device Regulation MDR (EU) 2017/745 and in the [...]
On 1 May 2021 the Medical Devices Act entered into force, replacing the previous regulatory framework for Medical Devices in Taiwan. [...]
The Medical Device Coordination Group (MDCG) has recently published some useful guidance on Medical Devices to provide information and support to [...]
From January 2021 new requirements have come into force to obtain the EAC Certificate (EurAseC Conformity), which is essential for commercializing [...]
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