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 […]
Emergo Group
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 […]
Proposed medical device regulatory changes to Order No. 650 in China
By Teemo Chang and Stewart Eisenhart, Emergo Group The Chinese government has issued draft changes to the country’s medical device regulatory framework that would allow easier market access for foreign 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 […]
How medtech can prepare for the consequences of a “Hard Brexit”
By Ronald Boumans, Emergo Group On July 5, the Dutch Ministry of Health organized an informative meeting for the medical field about the possible impact the UK’s exit from the European Union (EU), Brexit, might have. This is considered a very important issue that may impact many aspects of the Dutch – and European – […]
9 trends in medical device user interface design
By Valerie Ng and Jon Tilliss, Emergo Group As the influence of technology in our everyday lives continues to grow, the standard for aesthetically pleasing and contemporary user interface (UI) designs in the healthcare space continues to evolve. Get the full story here at the Emergo Group’s blog. The opinions expressed in this blog post […]
South Korea changes guidelines for medical device cybersecurity management
By Stewart Eisenhart, Emergo Group In a sign that medical device market regulators are moving toward a uniform approach to cybersecurity risk management, the South Korean government has published new guidelines referencing the UL 2900 cybersecurity standard as well as US Food and Drug Administration recommendations. Get the full story here at the Emergo Group’s […]
Key questions for the role of post-market surveillance in European MDR
By Mark Leimbeck, Emergo Group Manufacturers are beginning to take action with respect to the European Medical Device Regulation (MDR), including the Regulation’s new approach to post-market surveillance, or PMS. 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 […]
MDR and IVDR publication requirements for user information on medical device manufacturer websites
By Ronald Boumans, Emergo Group Section 23.1 of Annex I of the Medical Devices Regulation (EU) 745/2017 (MDR) and section 20.1 of Annex I of the In-Vitro Diagnostic Medical Devices Regulation (EU) 746/2017 (IVDR) pertain to requirements that looks quite simple: If the manufacturer has a website, it must publish the user information (label, instructions […]
Saudi regulators revise medical device shipment requirements
By Stewart Eisenhart, Emergo Group The Saudi Food and Drug Authority (SFDA) has published revised requirements for clearing imported medical devices 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 reflect those of DrugDeliveryBusiness.com […]