Jan 10 - 5:14
The new medical device regulations 745/2017 (MDR) and 746/2017 (IVDR) have introduced an entirely new assessment procedure. This is a crucial process and should be carried out by Notified Bodies. Notified Bodies: Legal...
Jan 9 - 7:24
Bangladesh has recently published updated requirements for the manufacturing, importation, distribution and sales of medical devices on their domestic market. The Scope of the Guidelines Contents The Scope of the...
Jan 8 - 6:21
The Medical Device Coordination Group (MDCG), an advisory body composed of the representatives of EU member states, issued guidance dedicated to cybersecurity issues. Scope of the Guidance Contents Scope of the...
Jan 7 - 3:39
The Government of Vietnam, at the proposal of the Minister of Healthcare, has published a decree amending and supplementing national medical device regulations. The proposed amendments aim to modify a wide scope of...
Jan 6 - 7:08
The National Administration of Drugs, Foods and Medical Devices (ANMAT), Argentina’s regulating authority in the sphere of medical device circulation, has recently issued the updated rules regarding the registration of...
