Brazil’s Anvisa publishes guide about cyber security in medical devices
Anvisa publishes Guide 38/2020, “Principles and Practices of Cyber Security in Medical Devices”. The document is intended for anyone interested in ensuring the safe use of medical devices and will be useful for users of such equipment, patients, manufacturers, distributors, health services and researchers in the area of safety
Brazil’s Anvisa Announces New Medical Device Regulations
On September 18,2020 Brazil’s Anvisa published the RDC no. 423/2020 which deals with the extinction of the registration and migration of medical devices of risk class II to the notification regime.
China’s NMPA issues Guideline for changes of Raw Material in Passive Medical Device Products.( No. 33 2020)
China’s NMPA issued a guidance (No 33. 2020) on May 19, 2020 to provide a guideline and systematic approach for risk analysis of raw material changes in passive medical device products .
Brazil’s Anvisa Registration Requirements for COVID-19 Rapid Test
On May 14, 2020 Brazil’s Anvisa published information on the requirements of the registration of the rapid tests for COVID-19 in Brazil.
The FDA Ventilator Requirements for EUA
To face the increase demand of ventilators and other respiratory devices in USA due to the COVID-19 pandemic, US FDA released a new guidance on the FDA expedite review of new ventilator under the Emergency Use Authorization (EUA) program.
Japan’s MHLW Allows Online IRB Meetings for Coronavirus Trials
Japan’s MHLW issued on April 1, allowing institutional review board (IRB) meetings to be held online or via emails when urgent deliberations are needed to decide whether to approve clinical trials for COVID-19.
The FDA Introduces the Coronavirus Treatment Acceleration Program (CTAP)
The FDA introduces the Coronavirus Treatment Acceleration Program (CTAP) to expedite the development of safe and effective life saving treatments against Coronavirus.
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.
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.
ANVISA -RDC 305/2019- Regulation for Custom-Made Medical Devices
On October 2019, Anvisa published its formal regulations for custom-made medical devices “RDC 305/2019. “
US FDA Expands the Abbreviated 510 (k) Program to Well-known Medical Devices by — Implementing a Safety and Performance Based Pathway
The FDA expands the concept of the Abbreviated 510(k) pathway for certain well understood device types, using the Safety and Performance Based pathway.