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Internal audits and
supplier inspections
Get ready to register your medical devices.
Understand how Anvisa’s
GMP inspection works
In order to register risk class III and IV products, ANVISA must carry out a Good Manufacturing Practices Inspection at the manufacturer’s premises, whether national or international. This inspection is mandatory before registration can be granted.
What are Good Manufacturing Practices?
GMP is one of the main mechanisms for ensuring the quality of a medical device. It ensures that products are consistently produced and controlled to the appropriate quality standards for their intended use and registration requirements.
Failure to comply with GMP can lead to the manufacture of a medical device that does not meet the appropriate quality standards, compromising the safety and efficacy of the product.
Understand how Anvisa’s GMP inspection works
In order to register risk class III and IV products, ANVISA must carry out a Good Manufacturing Practices Inspection at the manufacturer’s premises, whether national or international. This inspection is mandatory before registration can be granted.
What are Good Manufacturing Practices?
GMP is one of the main mechanisms for ensuring the quality of a medical device. It ensures that products are consistently produced and controlled to the appropriate quality standards for their intended use and registration requirements.
Failure to comply with GMP can lead to the manufacture of a medical device that does not meet the appropriate quality standards, compromising the safety and efficacy of the product.
Why is it important to have GMP certification?
ANVISA requires GMP certification for the distribution of class III and IV medical devices, requiring an Inspection
How can QR Consulting help you in this process?
QR Consulting carries out inspections prior to the ANVISA audit at manufacturers’ facilities with the aim of verifying compliance with the requirements of RDC 665/2022 – Good Manufacturing and Control Practices.
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A structure dedicated to the development of your business.
A structure dedicated to the development of your business.
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