Brazil Medical Device
Showing 1–16 of 18 results
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Brazil’s Anvisa : Good Manufacturing Practice Certification for Medical Devices in Brazil
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Brazil’s Anvisa: Compliance Assessment Requirements for Equipment required by the Health Surveillance
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GENERAL REQUIREMENTS FOR PRODUCT CERTIFICATION (RGCP)
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GOOD MANUFACTURING PRACTICES OF MEDICAL DEVICES AND IN-VITRO DIAGNOSTIC PRODUCTS FOR IMPORTERS, DISTRIBUTORS, AND STORAGE COMPANIES
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INSPECTION PROCESSES AND REQUIREMENTS TO VERIFY THE GOOD MANUFACTURING PRACTICES OF MANUFACTURERS OF ACTIVE PHARMACEUTICAL INGREDIENTS, HEALTH PRODUCTS OF RISK CLASS III AND IV AND MEDICINES
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INSPECTION PROGRAMS AND ADMINISTRATIVE PROCEDURES TO GRANT OF GOOD MANUFACTURING PRACTICES CERTIFICATE TO MANUFACTURERS OF MEDICAL DEVICES LOCATED OUTSIDE THE BRAZILIAN TERRITORY AND MERCOSUR
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NORMATIVE INSTRUCTION DESCRIBES THE CLASSIFICATION OF RISK OF CADASTRO AND REGISTRO REGISTRATIONS FOR IN VITRO DIAGNOSTIC PRODUCTS
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PROVISIONS ON THE IMPORT, COMMERCIALIZATION AND DONATION OF USED AND REFURBISHED HEALTHCARE PRODUCTS
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RDC No. 36/2015 RESOLUTION ON THE RISK CLASSIFICATION, THE SYSTEMS OF NOTIFICATION CONTROL, REGISTRATION AND LABELING REQUIREMENTS AND INSTRUCTIONS FOR USE FOR IN VITRO DIAGNOSTIC DEVICES AND THEIR INSTRUMENTS
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REGULATIONS FOR CLINICAL TRIALS WITH MEDICAL DEVICES IN BRAZIL
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REGULATORY REQUIREMENTS FOR GOOD MANUFACTURING PRACTICES (GMP) FOR MEDICAL DEVICES AND IN-VITRO DIAGNOSTICS IN BRAZIL
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REGULATORY REQUIREMENTS FOR NOTIFICATION AND REGISTRATION OF CLASS I AND CLASS II MEDICAL DEVICES IN BRAZIL
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RULES FOR PROVIDING INSTRUCTIONS FOR USE OF HEALTHCARE PRODUCTS IN NON-PRINTED FORMATS
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TECHNICAL NOTE ABOUT THE NEED FOR SUBMISSION OF CLINICAL TRIALS FOR THE PURPOSES OF REGISTRATION OF HEALTH EQUIPMENT AND MATERIALS
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TECHNICAL NOTE ON HEALTH PRODUCTS LABELING INFORMATION
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TECHNICAL REGULATION: ESSENTIAL REQUIREMENTS FOR SAFETY AND EFFICACY OF MEDICAL DEVICES
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