This one-hour webinar provides an overview of FDA regulations and requirements for imports of medical devices. Presenters will discuss how FDA defines and regulates a medical device, as well as what requirements FDA imposes when importing a medical device<\/p>\n
The Presentation Will Cover the Pathway to Legally Market a Medical Device in the US, Including:
\n– How to Determine if Your Product is a Medical Device
\n– How to Find Your “Product Code” and Device Class
\n– How to Determine the Requirements to Import Your Device Class Into the U.S.
\n– How to Register a Medical Device With the FDA
\n– Who Needs a U.S. Agent
\n– How to Perform Due Diligence on Your Manufacturer Registration and Listing Information
\n– What Premarket Submissions are Required for Specific Products
\n– Labeling Requirements (Including UDI) when Importing Medical Devices
\n– “Top 10 Tips When Importing Medical Devices”
\n– Best practices for Responding to Enforcement Actions<\/p>\n
Presenters:
\n– Jennifer Diaz
\n– Denise Calle<\/p>\n
Who Should Attend:
\n– Importers
\n– Customs Brokers
\n– Regulatory Affairs Professionals
\n– In-house Legal Counsel
\n– Product Development Managers
\n– Consultants
\n– Others Interested in FDA<\/p>\n
Eligible for 1 CCS\/MCS NEI Credit
\n– Input your NCBFAA NEI ID number at the time of registration to receive credit<\/p>\n","protected":false},"excerpt":{"rendered":"
This one-hour webinar provides an overview of FDA regulations and requirements for imports of medical devices. Presenters will discuss how FDA defines and regulates a medical device, as well as what requirements FDA imposes when importing a medical device The Presentation Will Cover the Pathway to Legally Market a Medical Device in the US, Including: – How to Determine if Your Product is a Medical Device – How to Find Your “Product Code” and Device Class – How to Determine the Requirements to Import Your Device Class Into the U.S. – How to Register a Medical Device With the FDA – Who Needs a U.S. Agent – How to Perform Due Diligence on Your Manufacturer Registration and Listing Information – What Premarket Submissions are Required for Specific Products – Labeling Requirements (Including UDI) when Importing Medical Devices – “Top 10 Tips When Importing Medical Devices” – Best practices for Responding to Enforcement Actions Presenters: – Jennifer Diaz – Denise Calle Who Should Attend: – Importers – Customs Brokers – Regulatory Affairs Professionals – In-house Legal Counsel – Product Development Managers – Consultants – Others Interested in FDA Eligible for 1 CCS\/MCS NEI Credit – Input your NCBFAA NEI ID number at the time of registration to receive credit<\/p>\n","protected":false},"featured_media":6513,"comment_status":"open","ping_status":"closed","template":"","meta":[],"product_brand":[],"product_cat":[900],"product_tag":[],"class_list":{"0":"post-5802","1":"product","2":"type-product","3":"status-publish","4":"has-post-thumbnail","6":"product_cat-fda-101","8":"first","9":"instock","10":"virtual","11":"sold-individually","12":"purchasable","13":"product-type-simple"},"yoast_head":"\n