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REGULATORY UPDATES IMDRF Stakeholders Meeting Braslia, Brazil, March - PowerPoint PPT Presentation

Apr 22, 2023 •379 likes •473 views

REGULATORY UPDATES IMDRF Stakeholders Meeting Braslia, Brazil, March 2016 ANVISA Brazil Regulatory Updates Resolution ANVISA Normative Instruction n 04 (24/09/2015) - Update of technical standards (ISO/IEC) regarding mandatory

  1. REGULATORY UPDATES IMDRF Stakeholders Meeting Brasília, Brazil, March 2016 ANVISA Brazil

  2. Regulatory Updates Resolution  ANVISA Normative Instruction nº 04 (24/09/2015) - Update of technical standards (ISO/IEC) regarding mandatory certification of electromedical equipments. - Aim: to improve marketing control, intending reduction of risks to user / patient. 2

  3. Regulatory Updates Resolution  RDC ANVISA nº 52 (27/11/2015) - Sets registration requirements for HIV self-testing products with screening purposes. 3

  4. Regulatory Updates Law  Law nº13.202 (09/12/2015) - Updates fees for regulatory activities. 4

  5. Regulatory Updates Resolution Resolution RE n. 3454, published on  December 16 th 2015  Allows ANVISA to use MDSAP regulatory audit outcomes from BSI Group America Inc. to issue the Anvisa´s GMP certificate. Resolution RE n. 80, published on  January 11 th 2016 Allows ANVISA to use MDSAP regulatory audit  outcomes from TUV SUD America Inc. to issue the Anvisa’s GMP certificate. 5

  6. Regulatory Updates Resolution  Portaria INMETRO nº 54 (01/02/2016) - Approves the improvement of Conformity Assessment Requirements for equipments under Health Surveillance System. 6

  7. Regulatory Updates Resolution  RDC ANVISA nº 64 (02/24/2016) - Aligns biological safety requirements for tattoo inks to the ISO 10993 requirements. 7

  8. THANK YOU! Leandro Rodrigues Pereira General Manager Office of Medical Devices ANVISA Brazil 8

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