ANVISA NEW REGULATION FOR POST-APPROVAL CHANGES TO MEDICAL DEVICES: RDC 340/2020
On March 3, 2020, Anvisa published a new regulation “RDC 340/2020” that classifies the changes made to approved medical devices in Brazil, into three categories based on the level of risk .
FDA New Policy on Emergency Use Authorization (EUA) of In Vitro Diagnostics of Coronavirus
On February 2020, FDA issued a Policy that allows CLIA certified high-complexity testing laboratories to use their validated diagnostic tests to detect the SARS-CoV-2 virus in specimen while they are preparing for EUA submission to FDA.
NMPA Emergency Approval of Imported Medical Devices in China: What this means for Foreign Manufacturers
The Coronavirus outbreak in China has led to an extraordinary demand of some medical devices. The NMPA (Chinese health authority) started granting emergency approval to some imported medical device, provided that they meet certain regulatory and quality standards.
FDA Draft Guidance on Performance Criteria for Safety and Performance Based Pathway for Soft Daily Wear Contact Lenses
On March 4, 2020, US FDA published a new draft guidance to allow manufacturers of eligible daily wear soft (hydrophilic) contact lenses to use new performance criteria pathway to support substantial equivalence instead of a direct comparison of the performance of their device to that of a predicate device during 510(K0 submission
PMDA Approach to Artificial Intelligence (AI) based Medical Devices
PMDA has adapted emerging technologies such as AI based medical devices and has reviewed the registration process to make it more efficient.
Brazil’s ANVISA successful implementation of the Medical Device Single Audit Program (MDSAP)
Brazil implements successful Medical Device Single Audit Program (MDSAP) and shows exciting results for the future of international inspection.