The national health surveillance agency modified the requirements for manufacturers and importers of needles, syringes and equipos – materials used in medical procedures and hospital.
In 360 days, the registration of these products shall be compulsory in Brazil. The measure was published in the Official Gazette of the day 07/02.
based on national and international technical standards, resolutions DRC 3/4/2011 2011, DRC and DRC 5/2011 set out the minimum requirements of the identity and quality to the needles, syringes and equipos. Before, these products were registered in Anvisa
only.
manufacturers and importers must meet the new requirements established by the Agency. Among the requirements for obtaining/> record of these materials, is the obligation of submission of the certificate of good manufacturing practices (GMP), issued by the Agency, and certification of conformity Inmetro.
More information, visit www.anvisa.gov.br/>
