CBDL | Bibliotecas – CBDL – Câmara Brasileira de Diagnóstico Laboratorial

Bibliotecas

RDCs

RDC_37-2015-Labeling rubber latex medical devices

RDC_39-2013- Administrative Procedures for GMP, Good Distribution and Storage Practices

RDC_67-2009-Post-market Surveillance applicable to registration holders of health products

RDC_102-2016- Procedures for the Transfer of Registrationof Products

RDC_183-2017- CBPF Brazil and Mercosul

RDC_551-2021_Medical device registration

RDC_579-2021-Used and Refurbished Medical Devices

RDC_591-2021-UDI Unique Medical Devices Identification system

RDC_665-2022-GMP_IvD

RDC_15-2014-Requirements for proof of GMP for registration processes of healthcare products

RDC_16-2013-Technical Regulation for Good Manufacturing Practices of Medical Devices and In Vitro Diagnostic Devices

RDC_23-2012-Compulsory Execution and Notification of Field Action by Registration holders

RDC_36-2015-Registration Risk classification,cadastro&registro control systems, labeling, instructions for use, IvD&instruments

Decretos

Decree_8077-2013_Health Surveillance of products subject to sanitary license

Outros

IN_3-2015-IvD-RDC_36-2015

IN_4-2012-Establishes rules for providing instructions for use of healthcare products in non-printed formats

Law_6.360-1976-Health Surveillance Standards

Law_6.437-1977-Sanitary Violations and Sanctions

Ordinance_118-2015-INMETRO - Guidelines & Criteria for compliance evaluation