Brazilian GMP rule change might speed market entry
This article was originally published in Clinica
Executive Summary
Brazil’s medical devices regulator, ANVISA, has issued a consultation (No 50 of 12 November 2013) that would make it easier and faster for medical devices from foreign manufacturers to reach the market. The national regulator is proposing to allow companies to submit device products for registration if they can prove they have filed for GMP certification, rather than having to show proof of actual certification.