RegDesk Regulatory Roundup

Dec 27, 2020

Kazakhstan: New Importation and Exportation Rules

The National Center for Expertise of Medicines and Medical Devices (NDDA), a Kazakhstan`s body responsible for the premarket assessment of medical devices, has published an official announcement about the implementation of the new importation and exportation rules for...

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...

RegDesk Regulatory Roundup

Kazakhstan: New Importation and Exportation Rules

Increased Fees for FDA Issued Medical Device Exportation Certificates

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