January 2023 Medical Device and IVD News Update
This month we'll look at working with the FDA on recalls, steps to an effective medical devices FDA 483 response, the latest update on the delay to EU MDR transition timelines by the European Commission, and more.
Working With the FDA on Medical Device Recalls
Ashley Kelleher, Senior Medical Device and IVD Consultant, talks about working with the FDA on medical device recalls at Informa’s recent Product Recalls and Complaints Conference. She covered recall requirements and what the FDA expects as well as how to navigate interactions with the FDA. Her expert advice on the procedures you need in place prior to the initiation of any recall will allow the recall process to proceed in an efficient manner.
Ten Steps to an Effective Medical Devices FDA 483 Response
If you are a medical device manufacturer and receive an FDA inspection, chances are you will be issued an FDA 483 List of Inspectional Observations at the conclusion of the inspection. Effectively responding to the observations cited on the FDA 483 may be the difference between receiving a Warning Letter and not receiving a Warning Letter.
Read our latest whitepaper “Ten Steps to an Effective Medical Devices FDA 483 Response” by Robert Ruff, Executive Director at NSF and ex-FDA field investigator and CDRH compliance officer.
European Commission Puts the Delay to EU MDR Transition Timelines to the Vote
The MedTech industry is facing huge problems in implementing the EU MDR with capacity constraints and bottlenecks with notified bodies. Additional challenges like manufacturers not being sufficiently prepared for the changes in the regulation, post Covid-19 pandemic impacts on clinical investigation and on-site audits and the conflict in Ukraine effecting global supply chains is not helping either. These challenges are hurting the most important stakeholders; the patients and users of these medical devices.
The European Commission published its proposal paper on the transition provisions for medical devices and in vitro diagnostic medical devices on January 6, 2023, it sets out the new transition deadlines and is a must read for the MedTech industry. Find out what this means for you.
Market Approval of Medical Devices in LATAM
The market for medical devices in Latin America (LATAM) is one of the largest in the world and healthcare in this region heavily relies on technologies developed abroad. These two characteristics make the LATAM market very attractive to manufacturers from the US and European Union. However, entering the market and navigating the constantly evolving regulatory landscape poses a challenge to many businesses. Our keynote gives you an overview on recent regulatory changes and explores basic requirements for product registration in Brazil (ANVISA), Mexico (COFEPRIS), Colombia (INVIMA) and Argentina (ANMAT). Apart from learning about the pros and cons of working with local subsidiaries, distributors or consultants, you will also understand the advantages of performing clinical investigations in these countries
Spotlight on Training
Understanding Top Management Responsibilities for Medical Device Quality Management SystemsThis course is designed to efficiently focus on top management obligations relative to FDA’s Quality System Regulation and ISO 13485:2016. This course does not simply focus on the requirements of the regulation and standard but provides insight into the expectations of the framers of those documents through discussions of the preamble to the quality system regulation, and TC 210 guidance relative to ISO 13485:2016.
Medical Device Regulatory Requirements: Five-Course MDSAP Bundle
This 10-hour course bundle provides a comprehensive overview of the medical device regulatory requirements for all five countries currently participating in the MDSAP program, a requirement for all manufacturers utilizing audits.
MDSAP Countries include: Australia, Brazil, Canada, Japan and the United States. (Each of the five courses can also be purchased individually.)
Learn what it takes to bring a product to market in each MDSAP-participating country and keep it there. We introduce the Medical Device Single Audit Program (MDSAP) and cover pre- and post-market requirements, and explain how each country utilizes MDSAP in its regulatory framework.
Our global medical device experts ensure content is up to date, highly interactive and designed with a visual learner in mind. These courses offer one-of-a-kind training developed by device experts and former regulators from around the globe. We provide English translations of regulations that are very difficult to locate, specifically Brazil and Japan.
Competency assessments provide documented evidence for the training requirements of ISO 13485, the international quality management system standard for medical devices.