South Korea Update: Release of IVD Clinical Performance Testing Institutions and More
South Korea’s regulator MFDS announced several regulatory changes that medical device manufacturers who do business in the country should review.
Guide to US FDA Requirements for Novel and Innovative Medical Devices
This white paper covers the US FDA regulations for manufacturers of novel and innovative medical devices and technologies.
US FDA and MDSAP Inspections for Medical Device Manufacturers
Prepare for US FDA and MDSAP inspections and help meet compliance with our expert guide.
European Notified Body Survey Shows Uptick in MDR, IVDR Applications
Data from the European Commission shows increase in Notified Body activities around MDR, IVDR applications and certifications through June 2023
Update: Brazil Registrations and Foreign Medical Device Regulators
RDC 741/2022 was released in August 2022 to acknowledge that the regulator in Brazil, ANVISA, would leverage registrations from foreign regulatory agencies for identical devices.
Overview of Japan IVD Registration
In this on-demand webinar, our Emergo by UL expert will outline the latest insights into Japan IVD registration.
Consultation to Extend Brazil GMP Certificate Validity for MDSAP Submissions
Medical devices marketed in Brazil must be made by a manufacturer who is QMS compliant with the Brazil Good Manufacturing Practice (RDC 665/2022 and RDC 497/2021).
RAPS Convergence 2023: Until We Meet Again Next Year
Since RAPS Convergence 2023 concluded, we're still celebrating its success. The exhibit halls percolated with the fervor of discussions.
EC adopts exceptions to contact lenses and UDI-DI assignment
The European Medical Devices Regulation (Regulation 2017/745, MDR) requires each specific model of a device to have its own unique UDI-DI. Since contact lenses come in a broad variety, this would require manufacturers to assign a great number of UDI-DIs.
Thailand FDA and Singapore HSA Regulatory Reliance Program
The Thai FDA has recognized the Singapore Health Sciences Authority as a reference regulatory agency to expedite registration of medical devices.