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.
The Indian Drugs Controller General’s office has launched a new task force to review processes and procedures currently in place at the Central Drugs Standards Control Organization (CDSCO) in order to boost efficiencies in how medical devices and drugs are
Canadian regulators have updated their list of recognized standards pertaining to medical devices, affecting manufacturers applying to Health Canada for Medical Device Licenses (MDL).
The Australian Department of Health has published additional details on the government’s plan to allow domestic medical device manufacturers to leverage CE Marking for faster registration in their home market.
The Australian government under Prime Minister Tony Abbott has proposed allowing domestic medical device manufacturers to register their “routine” products in the country using CE Marking certificates from European Notified Bodies.
As many mobile medical application developers are aware, Apple has amended its App Store Review Guidelines to forbid apps available through the firm’s HealthKit framework from storing users’ health data on the iCloud virtual server.
The US Food and Drug Administration has published final guidance on cybersecurity controls manufactures should build into their medical devices in order to ensure proper safety and functionality—and to meet premarket review
Argentina’s medical device market regulator ANMAT has published its latest schedule (link in Spanish) of annual maintenance fees for both new and renewed registrations.
For existing medical device registrations, ANMAT has set the following fees:
Health Canada regularly publishes performance data with respect to Medical Device License applications (Class 2-4); however, the data publically available for Medical Device Establishment License (MDEL) applications has generally been limited. To gain a better understanding of MDEL applications, Emergo's Vancouver office contacted Health Canada under Canada’s Access to Information Act
Mexico’s medical device market regulator COFEPRIS has issued new guidance on its technovigilance reporting program (link in Spanish) for medical device manufacturers commercialized in the country.