Understand how GMP inspection impacts the registration of medical devices and how QR Group facilitates the compliance process.
ANVISA requires that a Good Manufacturing Practices (GMP) Inspection be carried out at the facilities of manufacturers of risk class III and IV medical devices, whether national or international, as part of the process for product registration. In this article, we explain how this inspection works and how QR Group, a healthcare regulatory specialist, can help your company ensure compliance and registration clearance in an agile and efficient manner.
Impacts of ANVISA’s GMP Inspection on the Registration of Medical Devices
For medical devices of risk class III and IV, the GMP Inspection carried out by ANVISA is a mandatory step in the registration process. ANVISA performs this inspection at the manufacturer’s facilities to ensure that the required quality and safety standards are met. If Good Manufacturing Practices are not followed correctly, the device may be rejected, directly affecting access to the Brazilian market.
What are Good Manufacturing Practices (GMP)?
Good Manufacturing Practices (GMP) are a set of standards and guidelines that guarantee the production of high-quality medical devices, with strict process control. They ensure that products are manufactured in accordance with international standards, maintaining their safety and effectiveness. GMP covers everything from production management to quality control, preventing failures that could compromise the device’s performance.
The Importance of GMP Compliance
Failure to comply with GMP can lead to the production of medical devices that do not meet the safety and efficacy requirements set forth by ANVISA. This not only compromises product quality, but also puts patients’ health at risk. Therefore, following GMP is crucial to ensure that devices meet market and regulatory expectations, minimizing risks and ensuring continued market access.
How QR Group Ensures Fast and Efficient Compliance
QR Group is a specialist in medical device regulation and has extensive experience in helping companies comply with ANVISA requirements. With a team of qualified professionals, QR Group offers internal audit and regulatory consulting services to ensure that your company is ready for GMP inspection and registration clearance. Our efficient and technical approach allows you to reduce risks and comply with all requirements, accelerating the regularization process.
If your company manufactures medical devices and needs to prepare for ANVISA’s GMP Inspection, contact QR Group to ensure that your compliance process is fast, safe and efficient.
Source: QR Group
