Central & South America

ARTICLES

Brazil’s ANVISA Proposes Extending Device Licenses to 10 Years

Brazil’s National Agency for Sanitary Vigilance is seeking industry comments on a proposal that would extend licenses for medical devices from five years to 10 years. Read More

Brazil Adds Ireland as MDSAP Accredited Auditor

Brazil’s National Surveillance Agency has added Ireland’s standards authority to its list of accredited organizations to perform quality management system audits under the Medical Device Single Audit Program. Read More

Brazil Begins Risk-Based Assessment for Sanitary Manufacture Licensing

Brazil’s National Agency for Sanitary Vigilance (ANVS) has introduced a risk-based approach to health inspection for manufacturers and distributors of medical devices based on degree of risk. Read More

ANVISA Medical Device Importation Process Moves to All Electronic

Brazil’s ANVISA has switched over to a wholly electronic submission system for importation of devices. Read More

Olympus Reaches $646M Settlement Over FCPA, Kickback Investigations

Olympus will cough up a total of $646 million to settle two investigations for making illegal payments to doctors and hospitals in the U.S. and Latin America. Read More

Companies Take Aim at Zika With New Tests

With Zika poised to strike in more and more countries, companies are responding by developing new tests that can identify the virus. Read More

ANVISA Easing Industry Burden With New Requirements for Devices, IVDs

Brazil’s ANVISA has issued new regulations defining registration requirements for medical devices and in vitro diagnostics that likely will require industry to revise technical documents by Oct. 26. Read More

Brazilian Officials Eye Further Trade with Iran, Including Medical Devices

Following the international thawing of relations with Iran, Brazil’s Ministry of Development, Industry and Foreign Trade and Brazilian Trade and Investment Promotion Agency conducted a prospective trade mission to that country, with medical devices and hospital equipment being one of the areas of focus. Read More

INVIMA Updates GMP Resolution for External Orthopedic Devices

Colombia’s Instituta Nacional de Vigilancia de Medicamentos y Alimentos has updated regulations governing the sanitary requirements related to laboratories developing external orthopedic prosthetics and orthotics. Read More

Brazil, French Officials Meet to Strengthen Transparency

Officials from the Agência Nacional de Vigilância Sanitária met with health and economic representatives from France last week to discuss the economic regulation of medical products and pricing models in Brazil. Read More