In the United States, according to the Medical Device Reporting: Electronic Submission Requirements (eMDR), the Food and Drug Administration (FDA) requires [...]
The White Paper “Factsheet for Manufacturers of in vitro Diagnostic Medical Devices” explores the in vitro Diagnostic Medical Devices Regulation [...]
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 [...]
The White Paper “Medical Devices Labelling: instructions for use” explains, from the regulatory point of view, what are the labelling [...]
On 15 February 2021, the European Commission published the “Management of Legacy Devices in EUDAMED” document to explain how legacy devices [...]
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. [...]
In order to increase the availability of certain Medical Devices in contrast to the COVID-19 health emergency, on January 15, 2021 [...]
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