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Brazilian Presidential Decree Opens Door To Less Stringent GMP Certification Requirements For Foreign Firms

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.

Medical device manufacturers can expect to see changes in Brazil’s regulatory environment, which has long stifled the industry, with the issuance of a new presidential decree governing medical products and services.

Presently, foreign companies that wish to sell their products in Brazil are required by law to attain a good manufacturing...

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