Lo scorso Novembre 2020, il Medical Device Coordination Group (MDCG) ha pubblicato la linea guida MDCG 2020-16 “Guidance on Classification Rules [...]
Short time to May 26, 2021 which is the date of full implementation of the Medical Devices Regulation MDR (EU) 2017/745. [...]
Last August 2020 the Medical Device Coordination Group (MDCG) published the document MDCG 2020-15 “MDCG Position Paper on the use of [...]
On 16 October 2020 the Center for Devices and Radiological Health (CDRH) of FDA published the list of guidelines it intends [...]
On 18 September 2020, the National Health Surveillance Agency of Brazil (ANVISA) published the Resolution RDC n. 423/2020 declaring the elimination [...]
In September 2020 FDA published some “Final Guidance Document” for companies operating in Medical Devices field. Latest FDA strategic guideline Published [...]
FDA has published fee schedule for the 2021 fiscal year (FY 2021) from October 1, 2020 through September 30, 2021, providing [...]
In recent days, the United States has registered record data on Coronavirus infections. Over 500 thousand cases in one week. The [...]
As already happened for the Medical Devices Regulation MDR (EU) 2017/745, the European companies are mobilizing to request the postponement of [...]
On September 3, 2020, the Indian Central Drugs Standard Control Organization (CDSCO) published the “Notice regarding classification of non notified medical [...]
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