HEALTH PRODUCTS
Health products are classified according to the intensive risk they represent to the health of the consumer, patient, operator or third parties, in Classes I, II, III or IV. For class a different procedure applies.
Before the start of operations, health product companies must be duly authorized by health authorities, which includes (i) Operating License issued by the Local Sanitary Surveillance and (ii) Company Operating Authorization (AFE) granted by ANVISA.
We serve your company in different states of Brazil.
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Some of our services in Health Products:
for companies:​
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Operating License; Authorization and Renewal of Company Operation (AFE), for industry, importer, distributor, storage and transport of Health Products (Correlatos); ​
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Alteration/Expansion/Reduction of Activities in the Operating License and in the Company Operating Authorization (AFE);
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General changes such as Corporate Name, Technical Responsible, Legal Responsible, address changes, etc., in the Company's Operating Permits (AFE).
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For the products:
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Registration of Medical, Hospital and Dental Materials;
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Registration of Medical-Hospital Equipment, Dental Equipment, Electronic Equipment, Image Diagnosis Equipment, Hemotherapy and Labor Diagnostic Equipment;
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Registration of Sets, Reagents and Supplies intended for Diagnostics and radioisotopes for use in in vitro Diagnostics;
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Health Product Family Registration;
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Registration of Health Products;
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Renewal and amendment of Health Product Registration;
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Certification of Good Manufacturing Practices/Storage and Distribution of Medicines.