Singapore HSA implements major medical device regulatory changes

By Stewart Eisenhart, Emergo Group Medical device market regulators in Singapore have begun enforcement of key regulatory changes affecting areas such as low-risk devices, telehealth products and quality system requirements starting June 1, 2018. Get the full story here at the Emergo Group’s blog. The opinions expressed in this blog post are the author’s only

FDA plans fast-track development and marketing program for medical devices that treat opioid addiction

Stewart Eisenhart, Emergo Group Medical device regulators at the US Food and Drug Administration have initiated a new campaign to support development and commercialization of novel devices aimed at pain treatment and opioid addiction. Get the full story here at the Emergo Group’s blog. The opinions expressed in this blog post are the author’s only

FDA takes cautious approach to new regulations for OEM and third-party device servicers

Joel Domanowski, Emergo Group The U.S. FDA has cited insufficient evidence regarding public health concerns to warrant new regulatory requirements for original equipment manufacturers (OEM) and third-party servicers of medical devices, but will take less formal steps to ensure safety and effectiveness of these entities’ products and services. Get the full story here at the

Brazil Anvisa changes market pathway for low-risk medical devices

By Stewart Eisenhart, Emergo Group Brazilian medical device regulators have approved plans to amend registration requirements for low-risk devices to more closely align with International Medical Device Regulators Forum (IMDRF) recommendations. 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

FDA clarifies multiple-function medical device oversight policy

Stewart Eisenhart, Emergo Group New guidance from the U.S. Food and Drug Administration addresses premarket authorization requirements for multiple-function products with at least one function that qualifies as a medical device. 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

Eudamed completes actors module testing

By Ronald Boumans, Emergo Group On April 12, 2018, 20 representatives of stakeholders from industry and European Competent Authorities (CAs) had the opportunity to test the first Eudamed module. This module will be used for entering actor data. Get the full story here at the Emergo Group’s blog. The opinions expressed in this blog post

Health Canada launching new unit for digital health technology licensing

By Stewart Eisenhart, Emergo Group Medical device regulators at Health Canada are developing a more targeted oversight approach for digital health technologies such as mobile medical applications. 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

What Brexit withdrawal means for MDR implementation in the U.K.

Ronald Boumans, Emergo Group Negotiators discussing how the U.K. will leave the European Union have reached a draft Withdrawal Agreement about the Brexit transition period. The transition will start on March 29, 2019 and will end on December 31, 2020. Instead of 12 months from now, there are 21 months to prepare. This is still

HFES conference to host workshop on risk analysis for summative usability tests

Kate Jablonski, Emergo Group A workshop session at the 2018 International Symposium on Human Factors and Ergonomics in Health Care will provide insights into conducting residual risk analyses for summative usability tests for medical devices. Get the full story here at the Emergo Group’s blog. The opinions expressed in this blog post are the author’s

China CFDA proposes regulatory framework for 3D-printed medical devices

Stewart Eisenhart, Emergo Group Medical device market regulators at the China Food and Drug Administration (CFDA) have published new guidance proposing registration requirements for devices produced via 3D printing or additive manufacturing. 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

MDSAP certification expanded for Brazilian, South American medical device companies

By Stewart Eisenhart, Emergo Group Brazilian medical device market regulator ANVISA has officially extended applicability of the Medical Device Single Audit Program (MDSAP) to domestic manufacturers as well as other companies based in South America. Get the full story here at the Emergo Group’s blog. The opinions expressed in this blog post are the author’s

Indian CDSCO releases FAQ on medical device rules

By Stewart Eisenhart, Emergo Group The Central Drugs Standard Control Organization (CDSCO), India’s medical device market regulator, has published a new Frequently Asked Questions (FAQ) document to clarify industry questions regarding the country’s new medical device oversight system. Get the full story here at the Emergo Group’s blog. The opinions expressed in this blog post

Regulatory changes a top concern for medtech companies in 2018

Changing regulatory environments are a top concern for medtech industry professionals in 2018, according to a recent survey from Emergo Group (Austin, Texas). According to the survey, 68% of industry senior managers and executives said that changing regulatory environments is one of the biggest challenges their companies face. Europe is currently going through major regulatory

FDA plans 2018 update for global UDI database

By Stewart Eisenhart, Emergo Group The US Food and Drug Administration will soon implement updates to its Global Unique Device Identification Database, or GUDID, based on feedback and requests from medical device 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

Eudamed accessibility for medical device regulators outside of Europe

By Ronald Boumans, Emergo Group The European Commission is considering extending access to the Eudamed medical device database to non-European regulators to boost sharing of device safety information, potentially creating a new global data exchange standard for the industry. Get the full story here at the Emergo Group’s blog. The opinions expressed in this blog