A Webinar Presented by OFW Law and Davis, LLP
October 1, 2014, 1:00 p.m. EST
During this webinar, the first of four which OFW Law and Davis LLP are teaming up to present, attendees will learn about the regulatory requirements necessary to successfully and legally import and market a medical device in the U.S. and Canada. Topics will include, among others:
- Device classification schemes in the U.S. and Canada
- Marketing authorization mechanisms in Canada and the U.S.
- Manufacturing controls in both countries
- Canadian and U.S. labeling and promotional requirements and restrictions
- Reporting of adverse events in both countries
- Recordkeeping and reporting requirements imposed by both countries
The webinar will be approximately 40 minutes long with a Q and A session at the end. There is no cost to attend this webinar, but space is limited.
To register for the webinar, please visit www.cvent.com/d/14qf66.
To view or share this information as a PDF, please click here.
About the presenters:
Neil O’Flaherty is a principal at OFW Law, a Washington, D.C.-based law firm, where he has been practicing as a member of the firm’s Medical Device Practice Group for more than 23 years. Neil advises clients from around the world on a wide range of matters relating to the U.S. Food and Drug Administration’s (FDA) regulation of medical devices. Of particular relevance, Neil assists clients with labeling and promotional issues, the development of strategies to bring medical devices to market, pre-submission advocacy, adverse event reporting compliance and other postmarket requirements, and preparation of necessary regulatory filings.
Sara Zborovski is a partner in Davis LLP’s Toronto office and is a member of firm’s Life Sciences and Intellectual Property Groups. Sara assists companies in navigating the regulatory landscape imposed by Canada’s Food and Drugs Act, its related regulations, and their intersection with intellectual property issues. She advocates before all branches of Health Canada on behalf of the medical device, pharmaceutical, biotech, food and beverage, natural health product, and cosmetic industries. Sara works with clients to get products from idea to market while providing advice on approval and marketing strategies.
