ACTIVE MEDICAL DEVICES
IMPLANT MEDICAL DEVICES
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Medical Device

Modern health care  across all continents depends on the use of sophisticated devices for patient care and cure. Unlike drugs the  primary mode of action of devices is not pharmacological, immunological or metabolic. 
Manufacturing or Marketing of medical devices are controlled by regulatory authorities in each country. The major medical device markets are USA, Europe, India, China, Canada, Russia, Brazil.

  • US FDA's Centre for Devices and Radiological Health (CDRH) is responsible for regulating firms who manufacture, repackage, relabel, and/or import medical devices sold in the United States

More information about Medical Device clearance process and Establishment Registration and listing Refer here.

  • European Regulations covering 28 member countries and 5 Candidate countries relating to the safety and performance of medical devices following below directives.

EU Medical Device Regulation (MDR) was published on 5th May 2017. MDR will replace the EU's current current medicla device directive (93/42/EEC) and Active Implantable Medical Device Directive ( 90/385/EEC) with a 3 year transitional period.

Our one-stop shop approach offers a wide range of services designed to help export of medical devices to  USA and Europe fast.

In search of Medical Device Consulting service or for any clarification customers can fill our contact form, we are happy to help you.

INDIA -Bangalore
+ 91 994 591 2081
Phone / Viber / WhatsApp


USA -Chicago
+1 630 696 1293
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enquiry@i3cglobal.com

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