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 [...]
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 [...]
The Medical Device Coordination Group (MDCG) published the document MDCG 2021-3 Q&A “Questions and Answers on Custom-Made Devices” to provide clarifications [...]
Last month, the Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) announced the new electronic Biocompatibility Assessment [...]
Recently, the Turkish Medicine and Medical Devices Authority ("TITCK") made amendments to the Regulation on sales, advertising and promotion of Medical [...]
In the notification published on 5 February 2021 in the Official Gazette, the India’s Ministry of Health and Family Welfare (MoHFW) [...]
The Thai Food and Drug Administration (Thai FDA) has issued new rules on classification and registration of Medical Devices and IVDs. [...]
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