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This resolution approves the Technical Regulation about the registration of medical products at ANVISA, including procedures for alteration, revalidation, and cancellation.

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How to fill out RESOLUTION RDC NO. 185, OF OCTOBER 22ND, 2001

01

Obtain a copy of RESOLUTION RDC NO. 185 from the official website or relevant authority.

02

Review the objectives and requirements outlined in the resolution.

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Gather necessary documentation that supports compliance with the resolution's guidelines.

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Complete the required forms or declarations specified in the resolution.

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Submit the completed documentation to the appropriate regulatory body.

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Keep a copy of all submitted materials for your records.

Who needs RESOLUTION RDC NO. 185, OF OCTOBER 22ND, 2001?

01

Manufacturers of health products including medical devices and cosmetics.

02

Importers and exporters of health products.

03

Healthcare professionals involved in the distribution and sale of regulated products.

04

Regulatory compliance teams within healthcare organizations.

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What is RESOLUTION RDC NO. 185, OF OCTOBER 22ND, 2001?

RESOLUTION RDC NO. 185, OF OCTOBER 22ND, 2001 is a regulatory framework established by the Brazilian Health Regulatory Agency (ANVISA) that governs the registration and regulation of cosmetic products and personal care items in Brazil.

Who is required to file RESOLUTION RDC NO. 185, OF OCTOBER 22ND, 2001?

Manufacturers, importers, and marketers of cosmetic products in Brazil are required to file RESOLUTION RDC NO. 185, OF OCTOBER 22ND, 2001.

How to fill out RESOLUTION RDC NO. 185, OF OCTOBER 22ND, 2001?

To fill out RESOLUTION RDC NO. 185, OF OCTOBER 22ND, 2001, stakeholders must provide detailed information about the cosmetic product, including its ingredients, safety data, labeling, and compliance with health regulations.

What is the purpose of RESOLUTION RDC NO. 185, OF OCTOBER 22ND, 2001?

The purpose of RESOLUTION RDC NO. 185, OF OCTOBER 22ND, 2001 is to ensure the safety, efficacy, and quality of cosmetic products available in Brazil, protecting consumer health.

What information must be reported on RESOLUTION RDC NO. 185, OF OCTOBER 22ND, 2001?

The information that must be reported includes the product formulation, labeling details, intended use, safety assessments, and any other data required by ANVISA to evaluate the product's compliance.

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