New Spanish Documentation Requirements for Argentina
New laws set to take effect in Argentina will require medical device manufacturers and importers to provide Installation, Maintenance and Service Manuals for their products only in Spanish to regulatory authority ANMAT, according to Emergo’s Buenos Aires contacts.
The new law, the Traceability System and Technical Aptitude Verification for Active Medical Devices in Health Institutions, applies to all active Class I, II, III and IV devices sold in Argentina. Foreign manufacturers and their importers (“holders”) will need to provide this documentation along with their medical device registration dossiers to ANMAT for review. Manuals for particular devices must also be provided to every Argentinean sanitary institution where those products are used.
Although the new law pertains only to Argentina in the near term, other member countries of the Mercosur South American trade bloc—Bolivia, Paraguay, Uruguay and Venezuela (State Members) as well as Chile, Colombia, Ecuador, Guyana, Peru and Suriname (Associate State Members) will likely adopt similar requirements for their respective medical device markets. (Brazil, Mercosur’s largest member, would presumably require such documentation in Portuguese.)
Previous iterations of the law had targeted only devices classified as Class II active or higher. Implementation of the new requirement in Argentina is expected to occur in early 2014.