Learn how QR Group’s Brazil GMP Quality System Compliance service secures GMP certification of foreign manufacturers for registration of class III and IV devices
With a focus on quality system compliance, QR Group offers specialized support for GMP certification with ANVISA, essential for international manufacturers of class III and IV medical devices.
What is quality system compliance?
Quality system compliance involves evaluating and adapting the Quality Management System (QMS) of manufacturers as required by ANVISA (RDC 665/2022) or in the context of the MDSAP.
Why is this strategic?
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Cause and effect: without the GMP certificate, the registration of class III/IV devices is not accepted by ANVISA.
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Clarification: the inspection can be done on-site or based on an MDSAP audit.
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Emphasis: With full compliance, the registration process moves forward more efficiently, avoiding rework and delays.
How QR Group operates
a) Evaluation of the QMS
We perform a complete internal audit at the manufacturer to map gaps and comply with ANVISA.
b) Implementation of improvements
Personalized suggestions for corrective and preventive actions to align the QMS with Brazilian requirements.
c) Support during inspections
Technical follow-up during ANVISA’s on-site inspection or in the presentation of MDSAP reports, with support to the Registration Holder in Brazil (BRH).
Target audience
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Brazilian importers and distributors seeking to register class III or IV devices.
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Foreign manufacturers without structure in Brazil, who need to obtain GMP certification.
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Companies that need regulatory certainty to operate effectively in the Brazilian market.
QR Group masters the quality system compliance process, ensuring that foreign manufacturers obtain the GMP certification required by ANVISA for registration of class III/IV devices.
Source: QR Group
