RegDesk Regulatory Roundup

Sep 17, 2015

5 Medical Labeling Requirements In Brazil

Here are steps for proper device labeling in Brazil: The Brazilian Consumer protection code requires that product labeling should provide the consumer with accurate, concise and easily readable information. about the product’s quality, quantity, composition,...

Increased Fees for FDA Issued Medical Device Exportation Certificates

Aug 20, 2015

North America

Increased Fees for FDA Issued Medical Device Exportation Certificates

The FDA has announced an increase in fees for assessing and exporting medical devices. The FDA Export Reform and Enhancement Act of 1996 enables manufacturers to request that the FDA issue a certification stating that their device meets certain requirements within 20...

How the 4.2% Medical Device User Fee Increase Impacts You

Aug 3, 2015

North America

How the 4.2% Medical Device User Fee Increase Impacts You

The Food and Drug Administration has announced that it will be increasing the fee rates and payment procedures for medical device user fees by 4.2%. What is the Medical Device User Fee? Originally established in 2002 by the Medical Device User Fee and Modernization...

Research Shows Your Device Is Likely at Risk of Being Compromised

Jul 14, 2015

North America

Research Shows Your Device Is Likely at Risk of Being Compromised

Recently a wide range of X-ray and computerized tomography technology were discovered to be acutely vulnerable. According to researcher Scott Erven, an unnamed organization exposed intelligence on over 68,000 systems, causing alarm. Erven noted that passwords to such...

Advancements in New EU Medical Device Legislation

Jun 23, 2015

Europe

Advancements in New EU Medical Device Legislation

Last Friday, after a three year gridlock, the Council of the European Union came to an agreement on the reworking of regulatory legislation on medical devices and in vitro diagnostics which will impact both manufacturers and regulatory authorities. The European...