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.
US medical device regulators have notified registrants that production changes to a commonly used sterilization product from DuPont will likely not warrant new 510(k) or Premarket Notification (PMA) filings from device manufacturers.
An Australian government task force has begun work to recommend changes to the country’s healthcare funding processes that if implemented could impact how some medical device providers are reimbursed.
The Health Sciences Authority, Singapore’s medical device market regulator, has published a new risk classification tool for medical devices and IVDs.
Brazilian medical device market regulator ANVISA has published a new list of technical standards to which some electrical medical devices and IVDs must comply in order to obtain INMETRO certification in the country.
Emergo’s latest podcast covers medical device registration requirements for Mexico, Latin America’s second-largest device market behind Brazil.
DIGEMID, Peru’s medical device market regulator, has published amendments to the country’s law covering pharmaceutical and device regulatory requirements that better reflect guidelines of the International Medical Device Regulators Forum, or IMDRF.
The US Food and Drug Administration has begun forming a new Patient Engagement Advisory Committee (PEAC) to improve communications with patients and users on various clinical and regulatory issues involving medical devices.
The New Zealand government is in the midst of completely overhauling its regulatory system for medical devices following cancelled plans for a joint regulatory system with Australia.
Of the thousands of medical device manufacturers assisted by Emergo each year, most are based in North America, Europe and Japan, and will spend whatever it takes to enter those same markets. For most firms, markets such as the US, Canada, Europe and Japan offer the highest potential return on investment in terms of meeting regulatory requirements and commercializing their devices in those regions.
Along with recent major changes to medical device registration and quality system requirements in Brazil, regulators in that country have also significantly reformed oversight of in vitro diagnostic devices.