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Notified Bodies and Conformity Assessment in the EU
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...
MDCG Releases Guidance on Cybersecurity
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...
Vietnam Amends Medical Device Regulations – 2019
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...
Argentina Updates Medical Device Registration Rules
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...