Purchasing & Supplier Controls

RDC 752/2022 requires that manufacturers control purchased products and services that affect device quality. Key requirements:

• Maintain an approved supplier list with qualification criteria;
• Evaluate and select suppliers based on their ability to meet quality requirements;
• Define purchasing requirements clearly (specifications, standards, quality requirements);
• Conduct incoming inspection of purchased materials and components; and
• Re-evaluate suppliers periodically.

For importers: the foreign manufacturer is the primary "supplier." ANVISA requires importers to audit or otherwise verify foreign manufacturer compliance with GMP requirements (see GMP for Importers).

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Official sources

Verify all information against official ANVISA sources before making regulatory decisions.