Our Blog

Never miss a thing! The latest regulatory news and updates are always on our feed.

Slider
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...
FDA Publishes Order Regarding 510(k) Exemption
The Food and Drug Administration (FDA), the authority responsible for the regulation of medical device circulation in the US, has issued an order excluding certain Class I and Class II medical devices from obligatory...