FDA
The Food and Drug Administration (FDA) has published an information sheet guidance describing the regulatory aspects related to the Significant Risk and Nonsignificant Risk medical device studies. The document is intended to provide additional clarifications and...
Europe
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 According to the medical device regulations 745/2017 (MDR) and 746/2017...
Asia
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 provisions and cover numerous aspects related to the...
Uncategorized
ISO, the International Organization for Standardization, issued a new standard dedicated to the application of risk management to medical devices. Brief Overview of ISO standards ISO is an organization comprised of several national standards bodies. The...
Indonesia
The MoH in Indonesia has released SIKLARA- a medical device risk classification system that lines up with AMDD. This system aims to be more user friendly, as well as support registrants in determining medical device risk classes. Indonesia’s Device Risk Classification...
