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Medical Device

Best PracticesFDA IssuesImportMedical Devices

Does Your Medical Device Have a Unique Device Identification (UDI)?

posted by Jennifer Diaz June 14, 2017 0 comments

We’ve previously kept you informed on how to determine whether your product is regulated as medical device by the U.S. Food and Drug Administration (FDA) and how to register your medical devices with the Agency. On June 2, 2017, FDA issued a letter to Device Labelers of certain classes informing of extended compliance dates for UDI requirements. Today we are providing more information on medical device labeling requirements – specifically the new Unique Device Identification (UDI) requirement. Continue Reading

Best PracticesFDA IssuesImportMedical DevicesU.S.CustomsUncategorized

WHAT DO CONTACT LENSES, DENTAL FLOSS, AND PACEMAKERS HAVE IN COMMON?

posted by Jennifer Diaz June 12, 2017 0 comments

Medical DevicesOne might naturally think of a product like a defibrillator as a medical device, but in our business, we find many companies unsure if its products are, in fact, medical devices.

The following is the first of a two part series which you may use as a helpful guide to get you through the medical device maze. First is a description of what medical devices are, and helpful hints so that you may identify if your product is regulated as a medical device. Second is a brief overview of FDA’s regulation of medical devices. The second part of the series will discuss the classes of medical devices, and the FDA registration process.

What is a Medical Device? Continue Reading

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Calling Medical Device Importers Attending U.S.’s TOP Medical Show, FIME

posted by Jennifer Diaz July 29, 2015 0 comments

If you import medical devices into the U.S. (or want to), FIME is the trade show for you. Last year, FIME surveyed attendees and received feedback that 52,890 FIME attendees were interested in 25 categories of medical device products. FIME is the #1 Medical Show, and the #1 Medical Trade Fair – and takes place from August 5-7, in my home town, at the Miami Beach Convention Center. Since 2010, I have had the privilege to be a speaker at FIME and had some of the
largest groups of attendees to discuss compliance with the FDA, and how to resolve typical FDA and CBP issues.  

I’m thrilled to say I’m speaking again this year. My topic is “How to Effectively Resolve Typical U.S.
Food and Drug Administration (FDA) and U.S. Customs and Border Protection (CBP) Issues for Medical Devices”. 

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Best PracticesFDA IssuesImport AlertMedical DevicesSpeaking

Jennifer Diaz Teaches Two Medical Device Seminars at FIME

posted by Jennifer Diaz August 1, 2014 0 comments
FIME

I’m pleased to be back for my fourth year teaching at FIME! For those of you that don’t know, FIME was rated the #1 medical show in the USA by Successful Meetings Magazine. FIME runs from August 6-8, 2014 at the Miami Beach Convention Center.  You still have limited time to register to attend the conference and my seminars! Continue Reading