Korea Food and Drug Administration improves software medical device import procedures

[식품의약품안전처 로고. ] On the 22nd, the Ministry of Food and Drug Safety announced on the 22nd that it has implemented a notification of “medical devices excluding standard customs clearance information” that has reasonably improved regulations by excluding “software medical devices” from the subject of standard customs clearance preliminary information that must be passed every… Continue reading Korea Food and Drug Administration improves software medical device import procedures

Occlutech Atrial Flow Regulator (AFR) Receives Breakthrough Status

Occlutech, a private company Announcing today that the US Food and Drug Administration (FDA) has approved the Breakthrough Device designation status for atrial fibrillation devices. Also known as the Atrial Flow Regulator (AFR), it is used in heart failure (HF) patients with normal left ventricular compression (HFpEF) or low-rate left ventricular compression. (HErEF) Heart failure… Continue reading Occlutech Atrial Flow Regulator (AFR) Receives Breakthrough Status

U.S. states report adverse reactions to vaccination and food pharmacy launches investigation_Modena

Original Title: The State of the United States reports adverse reactions to vaccination Many states report adverse reactions to vaccination On December 19, local time, according to the US “Capitol Hill” report, the US Food and Drug Administration (FDA) is investigating allergic reactions after vaccination with Pfizer’s new crown vaccine. Pete Marks, director of the… Continue reading U.S. states report adverse reactions to vaccination and food pharmacy launches investigation_Modena

Ministry of Food and Drug Safety’Caught’ an Unlicensed Manufacturer and Distributor of 10 Million Health Masks

【Youth Daily】 The Ministry of Food and Drug Safety arrested Mr. B, the representative of A company, on charges of manufacturing and selling unlicensed health masks in violation of the’Pharmaceutical Affairs Act’ by exploiting social confusion that became unstable due to’Corona 19′ It was announced on the 29th that it was sent to the prosecution.… Continue reading Ministry of Food and Drug Safety’Caught’ an Unlicensed Manufacturer and Distributor of 10 Million Health Masks