Nov 30, 2017
Asia
The Chinese Food and Drug Administration (CFDA) is the regulatory body in China that oversees the safety and efficiency of foods, pharmaceuticals, medical devices, and cosmetics. The CFDA recently issued regulations to enforce record-keeping of clinical trial...
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Apr 11, 2017
Case Study
When your cherished distributor fails to meet sales targets, you may be inclined to end the relationship and swiftly move to a new distributer. Only if things were so simple. Tribulations related to distributor fallout are a common problem confronted by most medical...
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Apr 6, 2017
Africa
You don’t ask your sales team to offer you regulatory guidance. So why do you rely on your distributor to handle all your regulatory burden? First of all, it’s not so simple to register medical device abroad. Access to customers sometimes requires...
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Priya Bhutani, CEO of RegDesk, was cited as “a woman changing the Face of tech in Philadelphia” in the Philadelphia Business journal. 15 women changing the face of tech in Philadelphia Michelle Caffrey, Reporter – Philadelphia Business Journal Dec...
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Mar 17, 2016
Africa
General Context UDI is a Unique Device Identifier in the form of a unique number or alphanumeric code. It consists of plain text and AIDC (only readable via machine) Issued by an FDA-accredited issuing agency. UDI is granted for 3 years and can be renewed upon...
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