Feb 20, 2018
South America
COFEPRIS, Agency that regulates food, medical devices and drugs in Mexico, has issued 288,000 import and export permits for products in the last 5 years. COFEPRIS recently signed an agreement with the Confederation of Associations of Customs Agents of the Mexican...
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Jan 10, 2018
South America
The National Health Surveillance Agency of Brazil, ANVISA, has proposed a new guideline for importation of products subject to sanitary surveillance. This effort has been made to ease importation burden and increase speed to market. ANVISA issues three hundred...
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Jan 10, 2018
South America
COFEPRIS, the decentralized division of the Department of Health in Mexico, is the governing body for medical devices and medicines. COFEPRIS has officially joined the Pharmaceutical Inspection Cooperation Scheme (PIC/S), which bridges the most important regulatory...
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Dec 12, 2017
South America
ANVISA recently introduced a new requirement for medical device manufacturers who will be conducting clinical investigations. Sponsors will need to submit Medical Device Clinical Dossier clinical (DICD). This resolution will be applicable to all clinical trials with...
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Nov 30, 2017
Europe
A harmonized standard is a European standard developed by the following recognized European Standards Organizations: CEN, CENELEC, or ETSI. Manufacturers and conformity assessment bodies use harmonized standards to demonstrate products or processes comply with the...
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