Brazil ANVISA develops new regulations for custom-made medical devices

By Stewart Eisenhart, Emergo Group ANVISA, Brazil’s medical device market regulator, has issued a public consultation to establish new requirements pertaining to custom-made devices. 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 MedicalDesignandOutsourcing.com or its

Malaysian regulators extend medical device labeling requirement deadline

By Stewart Eisenhart, Emergo Group The Malaysian Medical Device Authority (MDA) is adding a three-year transition period for compliance to new medical device labeling rules. 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 MedicalDesignandOutsourcing.com or

Brazil ANVISA improves medical device registration review timeframes for 2018

By Stewart Eisenhart, Emergo Group Brazilian medical device regulator ANVISA has issued a performance report for the first half of 2018 showing small but consistent improvements in marketing application review times as well as higher volumes of applications submitted compared to mid-2017. Get the full story here at the Emergo Group’s blog. The opinions expressed

China FDA loosens documentation requirements for renewals, clinical trial applications

By Stewart Eisenhart, Emergo Group Chinese medical device market regulators have amended requirements for documentation related to registration renewals as well as clinical trial applications to simplify compliance. 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

Egypt CAPA expands medical device oversight regulations

By Stewart Eisenhart, Emergo Group Expanded medical device registration requirements in Egypt remain set to come into effect September 1, 2018, but affected companies should be familiarizing themselves now with new Central Administration of Pharmaceutical Affairs (CAPA) processes. Get the full story here at the Emergo Group’s blog. The opinions expressed in this blog post

Is your medical device affected by new EU regulations?

By Ronald Boumans and Stewart Eisenhart, Emergo Group Now that the European Medical Device Regulation (MDR) is widely available in draft form, manufacturers and other industry participants can more accurately predict key issues that will affect them—including how and whether the scope of the new regulations covers their devices. Get the full story here at

FDA proposes Class I designation for some medical device accessories

By Stewart Eisenhart, Emergo Group US medical device regulators have published a list of medical device accessories for which they are proposing classification as Class I devices. 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

UK MHRA issues new guidance for medtech and IVD companies in wake of Brexit

By Ronald Boumans, Emergo Group In early August 2018 the UK Medicines & Healthcare products Regulatory Agency (MHRA) issues three new guidance documents for medical device, IVD and related healthcare sectors to prepare for ramifications of Brexit. Get the full story here at the Emergo Group’s blog. The opinions expressed in this blog post are

Saudi Arabia updates clearance policy for medical device shipments

By Stewart Eisenhart, Emergo Group The Saudi Food and Drug Authority (SFDA) has published an update to its requirements for clearance of medical device shipments at Saudi ports of entry. 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

FDA increases medical device user fees in 2019

By Stewart Eisenhart, Emergo Group US Food and Drug Administration user fees for medical device registrations including 510(k) and Premarket Approval (PMA) applications will increase for the agency’s 2019 fiscal year at a much slighter rate than for 2018. Get the full story here at the Emergo Group’s blog. The opinions expressed in this blog

Analysis: Global medical device regulatory trends

By Evangeline Loh, Emergo Group In the past half year (January through June 2018), Emergo has observed data to support two global trends: Initiatives to enhance device tracking and traceability, and simplification of the regulatory process for the lowest-risk medical devices. Get the full story here at the Emergo Group’s blog. The opinions expressed in

China FDA adds more medical devices, IVDs to clinical trial exemptions list

By Teemo Chang and Stewart Eisenhart, Emergo Group The China Food and Drug Administration (CFDA) has drafted a new batch of medium- and high-risk medical devices and IVDs slated for exemption from clinical trial requirements in the country. Get the full story here at the Emergo Group’s blog. The opinions expressed in this blog post

Australia TGA to change Prostheses List publication schedule starting in 2019

By Stewart Eisenhart, Emergo Group The Australian Department of Health will begin publishing its Prostheses List of prosthetic medical devices more frequently starting in 2019 in an effort to address patient access and manufacturer reimbursement issues. Get the full story here at the Emergo Group’s blog. The opinions expressed in this blog post are the

China FDA accepting MDCO certificates from Hong Kong-based medical device registration applicants

By Stewart Eisenhart, Emergo Group The China Food and Drug Administration (CFDA) has begun recognizing certain certifications issued by the Hong Kong Medical Device Control Office (MDCO) for country-of-origin 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 necessarily

Swiss regulators to overhaul export certification system

By Stewart Eisenhart, Emergo Group Swissmedic, Switzerland’s medical device market regulator, will replace its current processes for issuing export certificates as well as manufacturing certificates with an online system in order to prevent delays and free up resources. Get the full story here at the Emergo Group’s blog. The opinions expressed in this blog post