Aptar Pharma said today that the European Medicines Agency approved its electronic nasal lockout device, e-Lockout. The device is the 1st and only fully-integrated electronic nasal drug delivery device to be approved by a European regulatory authority, according to the company. The e-Lockout device is a part of a multi-year development deal with Takeda Pharmaceuticals […]
Regulatory/Compliance
China regulators formalize procedures for medical device expert panel meetings
By Stewart Eisenhart, Emergo Group Regulators at the China Food and Drug Administration (CFDA) have published formal procedures for expert panel meetings held to discuss medical device registration issues, clarifying the process for Chinese market applicants. Get the full story here at the Emergo Group’s blog. The opinions expressed in this blog post are the […]
Medtech stories we missed this week: May 12, 2017
From Bioness’s new distribution deal to InBrace’s launch of new braces technology, here are 7 medtech stories we missed this week but thought were still worth mentioning. 1. Obalon receives approval to commercialize in Middle East Obalon Therapeutics announced in a May 11 press release that it has received regulatory approvals in select Middle East […]
Eurasian governments progress on unified device regulatory system
By Stewart Eisenhart, Emergo Group Regulators in five Eurasian countries report progress in efforts to establish a harmonized medical device market that would incorporate Russia, Armenia, Belarus, Kazakhstan and Kyrgyzstan. 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 […]
Ethicon touts new anti-infection suture guidelines
Johnson & Johnson (NYSE:JNJ) subsidiary Ethicon touted updated anti-infection suture guidelines from the Centers for Disease Control and Prevention, which recommend that healthcare professionals “consider the use of triclosan-coated sutures for the prevention of SSI [surgical site infection].” Ethicon Plus Sutures are the only globally available sutures coated with triclosan that stop bacteria commonly associated with […]
European medical device and IVD regulations officially published
By Stewart Eisenhart, Emergo Group The European Commission has officially published the Medical Device Regulations (MDR) 2017/745 and In Vitro Diagnostic Regulations (IVDR) 2017/746 on May 5, 2017 in the Official Journal of the European Union (OJEU). The MDR will replace the Active Implantable Medical Devices Directive (90/385/EEC — AIMD) and the Medical Devices Directive […]
Common audit problems: Publishing audit reports
By Stewart Eisenhart, Emergo Group In the final installment of Emergo’s blog series on medical device quality management system audit problems, we examine the audit report publication process and related challenges. 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 […]
China FDA clarifies device recall requirements
By Stewart Eisenhart, Emergo Group Chinese medical device market regulators have made reporting forms necessary for recall management available online. 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 or its employees.
Medtech stories we missed this week: May 5, 2017
From Biomerics’s $38.5 million expansion in Salt Lake City to new study results and partnerships, here are 7 medtech stories we missed this week but thought were still worth mentioning. 1. Biomerics opening new corporate HQ Biomerics announced in a May 1 press release that it is moving its corporate headquarters in Salt Lake City. The […]
FDA and NIH release final template for clinical trial protocols
By: Peter Marks, M.D., Ph.D. A little more than a year ago, FDA and NIH announced the availability of a draft template for investigators to use when organizing clinical trial protocols, which are essentially roadmaps for conducting a clinical trial. Today, we are excited to announce that the NIH-FDA Joint Leadership Council has issued a final […]
