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.
New draft guidance from the US Food and Drug Administration proposes Good Clinical Practice (GCP) compliance for accepting medical device clinical data from studies conducted in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Malaysia’s Medical Device Authority, responsible for overseeing the country’s medical device market, has published new draft guidance on post-market surveillance regulatory audits for manufacturers authorized to sell their products there.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.
The comment period for new Health Canada guidance on the regulator’s program for providing healthcare professionals access to unlicensed medical devices under qualifying circumstances will end in late May 2015.
New guidance from the US Food and Drug Administration explains the role of specialized advisory panels in medical device regulatory issues including classification and marketing authorization determinations.
Canadian medical device market regulator Health Canada will start accepting electronic as well as hard copies of some Medical Device License (MDL) application forms starting April 1, 2015, and will also require separate fee forms to be submitted either electronically or via hard copy with application forms starting on that same date.
Pakistan’s Drug Regulatory Authority has issued new medical device and in vitro diagnostic (IVD) regulatory requirements, the Medical Devices Rules, 2015, that have gone into effect.