By Stewart Eisenhart, Emergo Group The South Korean Ministry for Food and Drug Safety (MFDS) has established new regulations for registration of IVD products in order to improve oversight of these devices’ safety and quality, according to the agency. Get the full story here at the Emergo Group’s blog. The opinions expressed in this blog […]
Emergo Group
South Korea trade group, Emergo partnered for medical device RA/QA support
By Stewart Eisenhart, Emergo Group The Korea Medical Devices Industrial Cooperative Association (KMDICA), a South Korean medical device industry association, has partnered with global regulatory consulting firm Emergo by UL to provide European market compliance support to the group’s more than 500 member companies. Get the full story here at the Emergo Group’s blog. The […]
FDA ends medical device Alternative Support Program
By Stewart Eisenhart, Emergo Group The US Food and Drug Administration’s medical device oversight division has ended reporting exemptions for some manufacturers and made more report data publicly available in an effort to boost transparency and better monitor product safety. Get the full story here at the Emergo Group’s blog. The opinions expressed in this […]
European Commission warns on supply disruptions due to MDR, IVDR
By Stewart Eisenhart, Emergo Group A new factsheet from the European Commission advises healthcare providers and institutions to prepare for possible shortages of some medical devices and IVDs in the event that manufacturers do not meet compliance deadlines for the Medical Devices Regulation (MDR) and In-vitro Diagnostic Medical Devices Regulation (IVDR). Get the full story […]
Brazil ANVISA modifies custom-made medical device regulations
By Stewart Eisenhart, Emergo Group Brazilian medical device market regulator ANVISA recently discussed revisions to planned requirements for custom-made devices with Emergo by UL consultants prior to finalization and official publication of the new rules. Get the full story here at the Emergo Group’s blog. The opinions expressed in this blog post are the author’s […]
LRQA to withdraw European Notified Body medical device and IVD manufacturers services
By Ronald Boumans, Emergo Group UK-based Notified Body Lloyd’s Register (LRQA) plans to withdraw European Notified Body (NB) services for medical device and IVD manufacturers later in 2019. Get the full story here at the Emergo Group’s blog. The opinions expressed in this blog post are the author’s only and do not necessarily reflect those […]
European regulators assign UDI issuing agencies
By Ronald Boumans, Emergo Group The European Commission has designated four organizations as Unique Device Identification (UDI) Issuing Agencies to support medical device and IVD manufacturers comply with new regulatory requirements. Get the full story here at the Emergo Group’s blog. The opinions expressed in this blog post are the author’s only and do not […]
Global medical device regulatory trends
By Evangeline Loh, Emergo Group In our third global medical device regulatory update on global trends (November 2018 through May 2019), we share more updates on our previously identified themes. Get the full story here at the Emergo Group’s blog. The opinions expressed in this blog post are the author’s only and do not necessarily […]
Human factors and usability investment considerations for medtech companies
By Mark Tavano, Emergo Group Embedding human factors engineering (HFE) and usability studies early in medical device design and development cycles can yield benefits beyond regulatory compliance for manufacturers. Get the full story here at the Emergo Group’s blog. The opinions expressed in this blog post are the author’s only and do not necessarily reflect […]
Chinese authorities update regulatory guidelines
By Stewart Eisenhart, Emergo Group China’s National Medical Product Administration (NMPA) has clarified various technical review and information guidelines related to medical device registration and approval. Get the full story here at the Emergo Group’s blog. The opinions expressed in this blog post are the author’s only and do not necessarily reflect those of MassDevice.com […]
India regulators list risk classifications for 12 notified medical devices
By Stewart Eisenhart, Emergo Group The Indian Central Drugs Standard Control Organization (CDSCO) has set risk classifications for 12 products scheduled for notification and regulation as medical devices starting April 1, 2020. Get the full story here at the Emergo Group’s blog. The opinions expressed in this blog post are the author’s only and do […]