1 Brazil Medical devices regulatory systems at country level World Bank income group: Upper middle income Legal Legal framework: Yes Authorizing legislation: Law No. 6,360 (23 Sept. 1976) Cadastro Procedures, RDC 24/2009 (2009) Clinical Trials, RDC 10/2015 (2015) 03/03/2015&jornal=1&pagina=73&totalArqui vos=140. Classification and Registration Requirements for Medical Products, RDC 185/2001 (2001) http://. Technical regulation on in-vitro diagnostic products, RDC 206/2006 upload/ Field Action Requirements, RDC 23/2012 (2012) legislacao/2012/52604 Post-market surveillance, RDC 67/2009 c52e168846bc0a466faa84/RDC+67-2009+ Guidelines: N/A.
2 Notes: Brazil is a member of Mercosur: MERCOSUR/GMC/RES. N 72/98: Reglamento T cnico Requisitos Esenciales de Seguridad y Eficacia de los Productos M dicos Resoluciones/ES/Res_072_098_RT_Req-Esenc _Seg-Eficacia_Prod-M%C3%A9dicos_Acta%20. MERCOSUR/GMC/RES N 37/96: Registro Armonizado de Productos Medicos http://www. National Regulatory Authority National Regulatory Authority present: Yes Name: Brazilian Health Surveillance Agency Responsibilities of the NRA: N/A. Medical device definition Medical device defined: Yes Text: A medical device is a healthcare product, such as equipment, devices, materials, articles, or systems for medical, odntological, or laboratory use or application, intended for prevention, diagnosis, treatment, rehabilitation, or anti-conception and that does not use pharmacological, immunological, or metabolic means to fulfil its main function in human beings, but have its functions assisted by such means.
3 RDC 185/2001, Annex I. In vitro diagnostic medical device (IVD) defined: N/A. Text: N/A. Medical device classification Classification: Yes Categories: Class I, II, III, and IV. RDC 185/2001, Part 2. Classification rules: Yes Classification rules details: Classification rules are contained in Annex II of RDC 185/2001. Essential principles Essential principles: Yes June 2015 - April 2016. Details: Law No. 6,360 (23 Sept. 1976) Art. 16. Conformity assessment Conformity assessment bodies: N/A. Details: N/A.
4 Pre-marketing / procedure: N/A. Reliance Reliance: N/A. Details: N/A. Jurisdictions: N/A. WHO Region of the Americas Brazil Clinical investigation Clinical investigation controls: Yes Details: RDC 10/2015 details clinical trial controls, including applications for permission to conduct trials as well as adverse event reporting. Registration and listing Registration of establishment: Yes Details: Law No. 6,360 (23 Sept. 1976) Art. 2. Listing of medical devices: Yes Details: Healthcare products must be registered with ANVISA.
5 RDC 185/2001, Part 3. Import controls Import controls: N/A. Details: N/A. Post market controls Post Market Surveillance: Yes Details: The registration-holder must designate at least one professional within the company to be responsible for post-market surveillance. RDC 67/2009, Art. 5. Inspection (QMS): Yes Details: Health surveillance measures shall enclose any product herein addressed, including those exempt from registration, as well as healthcare products, establishments of manufacture, distribution, storage, sales, and vehicles for product transportation.
6 Law No. 6,360 (23 Sept. 1976), Art. 68, Art. 69. Enforcement: Yes Details: ANVISA may suspend or cancel registration of medical devices in certain cases. RDC. 185/2001, Part 5. Adverse event reporting: Yes Details: The registration holder must notify the National System of Health Surveillance (SNVS) of any adverse events. RDC 67/2009, Art. 8. Field safety corrective action monitoring: Yes Details: Manufacturers are obliged to initiate a field action as soon as possible when there are sufficient indications that a Health product does not meet essential safety or efficacy.
7 The registration-holder must issue an alert message as soon as possible on the problem, the product, and the risks related to the problem. The manufacturer may also send an alert message to ANVISA. for broad circulation. The registration-holder must also notify ANVISA about any field action within specified timeframes. RDC 23/2014. Advertising: N/A. Details: N/A. Labelling: Yes Details: Information on labels and instructions for use must be written in Portuguese. RCD. 185/2001, Annex Limitations: these data reflect a limited view and do not capture what may currently occur within Member States or how they implemented the data.
8 Complete verification of the data may not be immediately possible and inaccuracies may linger. Mis-categorization or non-capture of a country's regulatory framework is possible due to translation and interpretation.