Brazil - who.int

1 BrazilWorld Bank income group: Upper middle incomeLegal Legal framework: Ye sAuthorizing legislation: Law No. 6,360 (23 Sept. 1976) Cadastro Procedures, RDC 24/2009 (2009) Clinical Trials, RDC 10/2015 (2015) Classification and Registration Requirements for Medical Products, RDC 185/2001 (2001) Technical regulation on in-vitro diagnostic products, RDC 206/2006 Field Action Requirements, RDC 23/2012 (2012) Post-market surveillance, RDC 67/2009 +67-2009+ : N /ANotes: 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 MERCOSUR/GMC/RES N 37/96: Registro Armonizado de Productos Medicos Regulatory AuthorityNational Regulatory Authority present: Ye sName: Brazilian Health Surveillance Agency of the NRA: N /AMedical device definitionMedical device defined: Ye sText.

2 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. RDC 185/2001, Annex vitro diagnostic medical device (IVD) defined: N /AText: N /AMedical device classificationClassification: Ye sCategories: Class I, II, III, and IV. RDC 185/2001, Part rules: Ye sClassification rules details: Classification rules are contained in Annex II of RDC 185 principlesEssential principles: Ye sDetails: Law No.

3 6,360 (23 Sept. 1976) Art. 16 Conformity assessmentConformity assessment bodies: N /ADetails: N /APre-marketing / procedure: N /ARelianceReliance: N /ADetails: N /AJurisdictions: N /AMedical devices regulatory systems at country level June 2015 - April 2016 WHO Region of the AmericasClinical investigationClinical investigation controls: Ye sDetails: RDC 10/2015 details clinical trial controls, including applications for permission to conduct trials as well as adverse event and listingRegistration of establishment: Ye sDetails: Law No. 6,360 (23 Sept. 1976) Art. 2 Listing of medical devices: Ye sDetails: Healthcare products must be registered with ANVISA.

4 RDC 185/2001, Part controlsImport controls: N /ADetails: N /APost market controlsPost Market Surveillance: Ye sDetails: The registration-holder must designate at least one professional within the company to be responsible for post-market surveillance. RDC 67/2009, Art. (QMS): Ye sDetails: 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. Law No. 6,360 (23 Sept. 1976), Art. 68, Art.

5 : Ye sDetails: ANVISA may suspend or cancel registration of medical devices in certain cases. RDC 185/2001, Part event reporting: Ye sDetails: The registration holder must notify the National System of Health Surveillance (SNVS) of any adverse events. RDC 67/2009, Art. safety corrective action monitoring: Ye sDetails: 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. The registration-holder must issue an alert message as soon as possible on the problem, the product, and the risks related to the problem.

6 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 : N /ADetails: N /ALabelling: Ye sDetails: Information on labels and instructions for use must be written in Portuguese. RCD 185/2001, Annex : these data reflect a limited view and do not capture what may currently occur within Member States or how they implemented the data. 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.