DUBLIN–(BUSINESS WIRE)–The “Tougher
Import Rules for FDA Imports in 2018” conference has been added
to ResearchAndMarkets.com’s offering.
The course covers detailed information about the roles and
responsibilities of the various parties involved with an import
operation and how to correct the weakest link(s) in the commercial
chain. The course will include tips on how to understand FDA’s thinking,
negotiate with the FDA and offer anecdotal examples of FDA’s import
What happens when your product is detained? FDA will begin a legal
process that can become an expensive business debacle. You must respond
fully within short timeframes. This is not the time for you to be on a
learning curve. You need to have a plan in place and know what you are
The FDA is steadily increasing the legal and prior notice information
requirements. If you do not know what those requirements are and you
initiate a shipment, your product is figuratively dead in the water. You
must be accurate with the import coding information and understand the
automated and human review process. If not, you can expect detained
shipments. CBP is implemented a new “Automated Commercial Environment”
computer program that changes import logistics and information reporting
for FDA regulated products. Your shipment may be stopped before it is
even loaded at the foreign port.
When products are refused, you have different options. Some options may
cost more than others. For example, your product can be seized and
destroyed by the government. You may be fined if you do not act in a
timely manner. These are common problems that become prohibitively
expensive. You should know how to avoid common problems or at least how
to mitigate the cost by using established and effective business
Learn how to deal with common problems, such as returns for repair,
importing QC samples, and investigational products.
On a positive note, the FDA is implementing the Voluntary Qualification
Importer Program under the FDA Food Safety and Modernization Act. One
other perk is that FDA offers export certificates, for a modest fee,
which may give you a competitive advantage in foreign markets. In some
cases, a FDA export certificate is required by foreign governments.
Finally, the new EU Medical Device Regulation will change how FDA
manages foreign inspections and in your favor.
For more information about this conference visit https://www.researchandmarkets.com/research/vtxcvq/2_day_course?w=4
Laura Wood, Senior Manager
E.S.T Office Hours Call 1-917-300-0470
For U.S./CAN Toll Free Call
For GMT Office Hours Call +353-1-416-8900