RAGB

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In order to assist your company on products registration with ANVISA (National Agency of Health Surveillance), RAGB provides qualified and experienced professionals who will take care of the whole bureaucratic part of the processes. This service involves updated specialists according to the constant changes of legislation and internal processes of ANVISA, and will guide your company since its required documents compilation until the publication on the Official Gazette of the Union. RAGB still counts on the service of processes renovation of registrations.<br />
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Our Services:<br />
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1- PRODUCTS FOR HEALTH (CORRELATIONS)<br />
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1.1 – Registration of medical usage equipment and items;<br />
1.2 – Registration of In-Vitro Diagnosis products;<br />
1.3 – Registration of family of products for health;<br />
1.4 - Notification / Registration of products;<br />
1.5 – Renovations of registration;<br />
1.6 - Petitions/Changes;<br />
1.7 – Technical translations;<br />
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Services available for the following category of products:<br />
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Products for Health – (Correlations)<br />
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• Sets, reagents and inputs destined to diagnosis;<br />
• Medical-hospital equipment and materials;<br />
• Equipment for image diagnosis;<br />
• Dental equipment;<br />
• Hemotherapeutic and laboratory diagnosis equipment;<br />
• Radio-isotopes for in-vivo diagnosis;<br />
• Radiopharmakons and radioactive products used in diagnosis and therapy.<br />
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Equipment of health usage – classifications grades I and II subject to registration (IN N. 07/2010)<br />
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Electrical equipment under Health Surveillance regime including their parts and accessories:<br />
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• Ones destined to esthetics and embellishment, and having as functioning way the application of energy or substances in a potentially dangerous way, considering the nature and place of application of the energy or substance;<br />
• Ones destined to medical, physiotherapeutic and dental usage, that are connected to electrical wired or have an internal source of energy, and that provide direct contact with the patient:<br />
• Apparatus for disinfection of medical products; (and/or sterilization)<br />
• Apparatus for sterilization of products for embellishment or esthetics;<br />
• Apparatus for sterilization of medical products;<br />
• Freezer and refrigerators for blood bags, human biological tissues, organs destined to transplants in humans and fluids to be managed in the human body;<br />
• Centrifuge for blood bags;<br />
• Processor of blood components; <br />
• Heater for blood bags;<br />
• Surgical Microscope;<br />
• Software that provides processing of medical images;<br />
• Automatic equipment for diagnosis in-vitro as: biochemical analyzer, glucose measurer, etc.;<br />
• Active applicator of medicines such as insulin applicator, hormones applicator, etc.;<br />
• Reprocessor of hemodialyzers;<br />
• Surgical pneumatic motor.<br />
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Electrical equipment under Health Surveillance regime including their parts and accessories:<br />
<br />
• Ones destined to esthetics and embellishment, and having as functioning way the application of energy or substances in a potentially dangerous way, considering the nature and place of application of the energy or substance;<br />
• Ones destined to medical, physiotherapeutic and dental usage, that are connected to electrical wired or have an internal source of energy, and that provide direct contact with the patient:<br />
• Apparatus for disinfection of medical products; (and/or sterilization)<br />
• Apparatus for sterilization of products for embellishment or esthetics;<br />
• Apparatus for sterilization of medical products;<br />
• Freezer and refrigerators for blood bags, human biological tissues, organs destined to transplants in humans and fluids to be managed in the human body;<br />
• Centrifuge for blood bags;<br />
• Processor of blood components; <br />
• Heater for blood bags;<br />
• Surgical Microscope;<br />
• Software that provides processing of medical images;<br />
• Automatic equipment for diagnosis in-vitro as: biochemical analyzer, glucose measurer, etc.;<br />
• Active applicator of medicines such as insulin applicator, hormones applicator, etc.;<br />
• Reprocessor of hemodialyzers;<br />
• Surgical pneumatic motor.<br />
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COSMETICS AND HYGIENE AND PERFUME PRODUCTS<br />
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2.1 – Registration of cosmetics grade II;<br />
2.1 – Notification of cosmetics grade;<br />
2.3 – Certificate of free sale;<br />
2.4 – Renovation of registration grade II;<br />
2.5 - Petitions/Changes;<br />
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Cosmetics, toiletries foot<br />