Brazilian Presidential Decree Opens Door To Less Stringent GMP Certification Requirements For Foreign Firms
This article was originally published in The Gray Sheet
New decree opens door to more lenient good manufacturing practice certification requirements than are currently imposed on international medical device manufacturers seeking to gain market entry in Brazil.
You may also be interested in...
FDA is strongly encouraging manufacturers to participate in the Medical Device Single Audit Program, set to launch in a pilot phase by June. An agency official points to strong global incentives, particularly for firms pursuing the Brazil and Canada markets.
Irish device maker Covidien has set up a joint venture with Changzhou Kangdi to capture the value segment in China’s vast lower-tier market.
Covidien acquired a privately held manufacturer of electrosurgical generators based in Ribeirao Preto, Brazil, and established a joint venture with a manufacturer of open stapler products based in Kiangsu Province in China, to access patients who can’t afford top-tier hospitals in those countries.