Agência Nacional de Vigilância Sanitária www.anvisa.gov.br FUNCTION OF STANDARDS Regulatory requirements & state of the art principles – Regulator’s Perspective.

Apresentação em tema: "Agência Nacional de Vigilância Sanitária www.anvisa.gov.br FUNCTION OF STANDARDS Regulatory requirements & state of the art principles – Regulator’s Perspective."— Transcrição da apresentação:

1 Agência Nacional de Vigilância Sanitária www.anvisa.gov.br FUNCTION OF STANDARDS Regulatory requirements & state of the art principles – Regulator’s Perspective Japan – September 2015 Fábio Pereira Quintino IMDRF MC

2 Agência Nacional de Vigilância Sanitária www.anvisa.gov.br Regulators Mission “Establish and implement policies to promote and protect public health...”

3 Agência Nacional de Vigilância Sanitária www.anvisa.gov.br Anvisa Within the Federal government Stablished by Law - 1999

4 Agência Nacional de Vigilância Sanitária www.anvisa.gov.br REGULATION FIELDS Medicines Medical devices Pesticides Cosmetics Tobacco Advertisement Ports, airports and borders Laboratórios International affairsSNVS coordination Sanitizer Official Laboratories Foods Health Service Pharmacovigilance Blood, Tissues and e organs

5 Agência Nacional de Vigilância Sanitária www.anvisa.gov.br Overview of the Regulatory Scheme Premarket Activities Postmarket Activities GMP Certification MD Registration/ Notification Clinical Evidence Third Part Certification/ Evaluation Establishment Authorization Registration/ Notification Amendments Registration Renewal Monitoring Programs Postmarket surveillance (Technovigilance)

6 Agência Nacional de Vigilância Sanitária www.anvisa.gov.br How standards have been adopted at Anvisa? Two ways: Compulsory Non compulsory

7 Agência Nacional de Vigilância Sanitária www.anvisa.gov.br Compulsory way Anvisa has given regulatory status to certain standards for some medical devices. Resolution – Inclusion of the device on the Brazilian System of Conformity Assessment (SBAC, in portuguese. Coordinated by INMETRO.)

8 Agência Nacional de Vigilância Sanitária www.anvisa.gov.br Compulsory way Examples:  Male condom  Surgical and procedural gloves  Syringes  Needles  Infusion disposables  Silicon Breast implant  Electromedical equipment  Hip implant (under discussion)

9 Agência Nacional de Vigilância Sanitária www.anvisa.gov.br Non Compulsory way As a tool to provide safety and effectiveness evidence of a wide range of products routinely submitted for approval

10 Agência Nacional de Vigilância Sanitária www.anvisa.gov.br Challenges to improve the use of international standards for regulatory purposes Built standards in a risk oriented basis Have parameters and acceptance criteria set, based on safety and efectiveness Keep it as simple as reasonable possible

11 Agência Nacional de Vigilância Sanitária www.anvisa.gov.br Thank you!