BYTEC passes ANVISA audit


BYTEC was audited by the Brazilian Health Regulatory Agency (ANVISA) according to the demands of GMP and passed this without divergences. BYTEC is thereby an accredited producer for the audited product line.

Background information:

Good manufacturing practices (GMP) are the practices required in order to conform to the guidelines recommended by agencies that control authorization and licensing for manufacture and sale of food, drug products, and active pharmaceutical products. These guidelines provide minimum requirements that a pharmaceutical or a food product manufacturer must meet to assure that the products are of high quality and do not pose any risk to the consumer or public.

Good manufacturing practices, along with good agricultural practices, good laboratory practices and good clinical practices, are overseen by regulatory agencies in the United States, Canada, Europe, China, and other countries.

Registration and licensing of medical devices by the ANVISA in Brazil
In Brazil, medical devices are controlled by the Agência Nacional de Vigilância Sanitária (ANVISA). The Brazilian regulatory and classification patterns of medical devices are similar those of the European MDD 93/42/EEC.