Class I, II, and III Medical Devices distributed in the United States must carry a Unique Device Identifier, or UDI, per the Food and Drug Administration (FDA). The compliance dates for this regulation began as early as September 2015 for Class III Medical Devices with ongoing benchmarks over subsequent years for other levels of devices. The FDA estimates the Initial cost of compliance will be 1% – 8% of company revenue and the average implementation time to meet the US requirements is 6 months. In addition Medical Device Manufacturers will have to comply with coming device data standards from other international regulatory authorities for every country in which they are selling devices.
Coridian offers a full UDI compliance
solution that guides our clients through both understanding the UDI rules and
also provides the services to help them achieve successful implementation of
their UDI compliance project from labeling and verification to GUDID data
submission.Let Coridian help you
comply. Fill out the form on the right, call 952-227-9147 or email us at udi@coridian.com
The 9/24/16 deadline for Class II Submissions has passed! Did you miss the deadline? Compliance is not optional, contact us today at udi@coridian.com for all you GUDID submissions and UDI labeling needs!
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Class I, II, and III Medical Devices distributed in the United States must carry a Unique Device Identifier, or UDI, per the Food and Drug Administration (FDA). The compliance dates for this regulation began as early as September 2015 for Class III Medical Devices with ongoing benchmarks over subsequent years for other levels of devices. The FDA estimates the Initial cost of compliance will be 1% – 8% of company revenue and the average implementation time to meet the US requirements is 6 months. In addition Medical Device Manufacturers will have to comply with coming device data standards from other international regulatory authorities for every country in which they are selling devices.
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