Register and Certifications
IBRAMED has the certifications and registers required by the competent bodies to commercialize its products, both in Brazil and abroad (USA), and the certifications of the quality management system. (MS).
ANVISA – Agência Nacional de Vigilância Sanitária – National Agency of Sanitary Vigilance is an autarchy affiliated to the Ministry of health whose objective is to control and regulate the Sanitary area of services and products, both nationally and the imported products arriving in Brazil. IBRAMED, as a medical device manufacturer, is within the Competence encompassed by ANVISA and complies with the requirements defined by it. Is registered under the number IBRAMED 103603-1 with ANVISA.
FDA – Food and Drug Administration – is the regulating body of the United States responsible for the control of food (both human and animal), dietary supplements, medication (human and animal), cosmetics, medical equipment, biological material and derivatives of human blood. IBRAMED complies with the requirements of this body. Its registration number is 03026070.
All IBRAMED equipment have the INMETRO – Instituto Nacional de Metrologia, Qualidade e Tecnologia – National Institute of Metrology, Quality and Technology seal of approval. To receive the seal, the equipment goes through conformity tests according to their type in laboratories accredited by it.
NBR ISO 13485 is also a norm of the quality management system (QMS), specifically directed to medical area companies and establishes requirements which encompass phases from development to post-sales service.