Worldwide Medical Device Regulatory Updates
As medical device quality assurance and regulatory affairs professionals, it can be challenging to stay on top of changes happening in our industry. Few people have the time to read lengthy articles these days and although many online newsletters exist, they are often packed with PR releases, ads or unrelated information. That is why we started this blog for QA/RA professionals in the medical device and IVD industry. The idea is to give you short updates on quality and regulatory topics that may be of interest to you.
Taiwan’s medical device market regulator has published significant new fee increases for various aspects of their device review and approval process. The increases are set to take effect July 1, 2015.
Based on data provided by the US Food and Drug Administration as well as Emergo consultants’ experience with medical device manufacturing clients seeking US marketing approval, seven major issues have been identified as the most common perennial causes for delayed premarket notification applications.
New draft guidance from the US Food and Drug Administration lays out appropriate uses of medical device clinical trial designs that allow for planned trial changes to be implemented based on accrued data while maintaining study validity and integrity.
Health Canada has released new information regarding common issues its reviewers found over the course of 2014 and early 2015 with higher-risk Medical Device License (MDL) applications that result in additional information requests to applicants.
Health Canada, the Canadian medical device market regulator, has announced changes to the Therapeutic Products Directorate’s List of Recognized Standards applicable to medical devices.
Medical device market regulators in the US have launched a new website to provide public access to their Global Unique Device Identification Database (GUDID) designed to store device labelers’ information about their products.
Hong Kong’s Medical Device Control Office (MDCO), the region’s medical device market regulator, has set up a voluntary listing and registration option for device distributors.
The US Food and Drug Administration’s Center for Devices and Radiological Health (CDRH) has identified 21 medical device product codes as candidates for reclassification from Class III to Class II as part of a broad review of pre- and post-market data collection processes.
Now that US medical device regulators have begun implementing their Unique Device Identification (UDI) system, many device manufacturers are questioning how best to comply with the new requirements in the most efficient manner possible. At Emergo, we’ve identified seven key (and common) issues firms should consider as they undertake their UDI compliance projects.
Although major news regarding new European medical device regulations remains forthcoming, European Commissioners have recently rolled out a new directive for devices using wireless components and reorganized their website so that manufacturers can more easily research laws and regulations beyond the Medical Device Directives that may also require compliance.