FDA Updates Medical Device Establishments Inspection Processes and Standards

FDA released a final guidance on inspections of medical device establishments requiring reviewing processes and standards applicable to inspections of domestic and foreign device establishments
Accelerated Approval of Detection Reagents of Coronavirus in China

The Emergency Approval of Novel Coronavirus Nucleic Acid Detection Reagent has shown the NMPA accelerated approval of seven NAD Reagents in only four days before going to the market.
BRAZIL APPROVES IMPORTATION OF MEDICAL CANNABIS

ANVISA new regulatory framework creates a new class of products subject to health surveillance: Cannabis- based products.
ISO revises guidelines to address the risk management of medical devices

Overview: On December 18 of 2019, The International Organization for Standardization (ISO) presented their new and improved guidelines on medical devices ISO 14971, . The document instructs on the process of risk management for medical devices such as, software as medical devices, in-vitro diagnostic devices and other products which might defer medical devices classification under some […]