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QSS will be attending Florida's International Medical Device Expo (Fime) From July 27-29th
QSS is a global consulting regulatory compliance firm headquartered near Toronto; their regulatory experts will be in Miami, FL from July27-29th to answer all your questions regarding Medical Device licensing with FDA & Health Canada.
FIME is the largest medical trade exhibition in the Western Hemisphere, serving the entirety of the North, Central, and South American regions. FIME's primary focus is across four medical industry sectors: technology, products, supplies, services, and equipment. The show provides a strong business platform to more than 700 exhibitors from more than 45 countries, including country pavilions to showcase their cutting-edge device innovations and solutions.
It is very important to understand the Regulatory Classification basics of your medical devices as they vary by perceived risk and product type. Medical device manufacturers selling internationally need to familiarize themselves with the applicable regulations within the Canadian market.
Kalpna Mistry the Regulatory Project Specialist at Quality Smart Solutions said this regarding the importance and distinction of an MDL & MDEL: "A medical device license (MDL) is required for Class II, III, and IV medical devices in Canada. A medical device establishment license (MDEL) is issued to manufacturers of Class I devices and importers/distributors of all device classes (I-IV). The MDL demonstrates product approval whereas the MDEL demonstrates establishment approval."
Quality Smart Solutions is a Health Canada and FDA compliance solutions provider, having served over 1,400 clients and completed over 130,000 services over the past 16 years. We offer regulatory advice and support related to securing your medical device license. We can help you by responding to potential information requests, keeping your license updated, and reviewing your device labels. If you are looking to get your MDL or MDEL or need help renewing your medical license we make your job effortless.
Quality Smart Solutions is headquartered near Toronto, Ontario. For more information, visit https://qualitysmartsolutions.com/
Phone Number: 1-866-396-5144
Page Updated Last on: Jun 13, 2022