Central & South America

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

Peru Unveils Update to Device Registration Requirements

Peruvian health officials have amended regulations related to medical devices in a move that could prove beneficial for foreign and domestic manufacturers. Read More

Industry Protests Higher Fees at Brazil’s ANVISA

Industry reacts as ANVISA hikes fees for the first time. Read More

Japan, Brazil Look for Common Ground on Device Regulations

The Japan External Trade Organization and that country’s Pharmaceuticals and Medical Devices Authority are looking to enhance ties with Brazil’s Agência Nacional de Vigilância Sanitária on medical products regulations. Read More