IMDRF To Test Improved Program For Exchanging Info On Medical Device Incidents, Finalizes Strategic Plan For 2020
This article was originally published in SRA
Executive Summary
The International Medical Device Regulators Forum has finalized a pilot project that will test improvements it has made to a program that allows national competent authorities to exchange information on medical device incidents. It has also finalized a number of documents to support the implementation of other IMDRF projects, including its single audit program1.
You may also be interested in...
Medical Device Regulations In Latin America And The Way Forward
Akhila Krishnan reviews the different regulatory requirements for medical devices in five Latin American countries and discusses how harmonization initiatives will make things easier for manufacturers in this guest column.
EU Regulatory Assessors Get AI Boost In Reaching Scientific Decisions
The European Medicines Agency is training scientific staff working for the European medicines regulatory network in how to use a new AI-powered search engine that allows them to easily retrieve information on regulatory precedents.
EMA Hopes New Requirement Will Make Companies Stick To Their Filing Plans
An additional form that marketing authorization applicants must now complete during the pre-submission stage emphasizes the importance of companies providing accurate information on their intended submission date.