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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.
Canadian medical device market regulator Health Canada will stop accepting hard copies of some Medical Device License (MDL) application forms starting April 1, 2015, and will also require a separate fee forms to be electronically submitted with application forms starting on that same date.
Pakistan’s Drugs Regulatory Authority has issued new medical device and in vitro diagnostic (IVD) regulatory requirements, the Medical Devices Rules, 2015, that have gone into effect.
The US Food and Drug Administration has released final guidance on how manufacturers of reusable medical devices should validate instructions for these products.
South Korea’s medical device market regulator, the Ministry of Food and Drug Safety (MFDS), will begin requiring clinical data for dozens of medical devices in January 2016 that currently can avoid such requirements if their equivalence to predicate devices already on the South Korean market can be shown.
Regulatory Authorities are challenged to keep their markets open and to ensure that patients have proper access to devices while at the same time keeping non-compliant, possibly dangerous devices away from their populations. To achieve this they need to use risk control strategies. Authorities that are rethinking their approaches to risk management could consider a three-tier system:
US medical device regulators at the Food and Drug Administration have issued correcting amendments to their post-market electronic Medical Device Reporting (eMDR) requirements to eliminate any disparities between those rules and their Unique Device Identification (UDI) system.
A new medical device nomenclature system launched and enforced by Russian regulators is causing challenges for registrants due to incomplete and missing codes, as well as more stringent requirements for grouping products together in the same registration.
ANVISA, Brazil’s medical device market regulatory agency, has published new requirements for conducting clinical testing of devices in the country.
A new report commissioned by the US Food and Drug Administration recommends a seven-year, multi-step implementation project in order to establish a nationwide postmarket surveillance system for medical devices.