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.
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.
New draft guidance from the US Food and Drug Administration proposes Good Clinical Practice (GCP) compliance for accepting medical device clinical data from studies conducted in foreign countries, and also outlines criteria the agency uses for accepting such data as part of medical device premarket registration submissions.
The Taiwan Food and Drug Administration (TFDA) plans to implement significant changes to its registration and approval system for medical devices, according to Emergo consultants in Taipei.
Medical device market regulators in Malaysia have set rules for a fast-track registration process available for some medical devices between April 10 and June 30, 2015.
Malaysia’s Medical Device Authority, responsible for overseeing the country’s medical device market, has published new draft guidance on post-market surveillance regulatory audits for manufacturers authorized to sell their products there.
US medical device market regulators are launching a new expedited market access program for select high-risk devices targeting life-threatening diseases or ailments.
The International Medical Device Regulators Forum (IMDRF) has published new guidelines for how software developers whose products are considered medical devices may be affected by quality management system regulations that currently apply to more conventional device manufacturers.