Learn how to obtain the GMP certification required to register Class III and IV medical devices with ANVISA with the help of QR Group.
To market Class III, Class IV or IVD medical devices in Brazil, it is essential that foreign manufacturers obtain Good Manufacturing Practices (GMP) certification from ANVISA. This process is crucial to ensure regulatory compliance and product safety. QR Group, specialized in health product regulation, offers practical solutions to facilitate the certification and registration process with ANVISA.
Impacts of GMP Certification on Medical Device Registration
For Class III, IV and IVD medical devices, ANVISA requires international manufacturers to have GMP certification. This certification, which attests to compliance with good manufacturing practices, is a fundamental requirement for marketing authorization in Brazil. The certification process includes an on-site inspection or the evaluation of audit reports, depending on the regulatory agreement between countries, such as the MDSAP (Medical Device Single Audit Program).
Obtaining the GMP Certificate is essential to ensure that products meet the rigorous quality and safety standards required by ANVISA. Without this certification, registrations will not be approved and the marketing of medical devices will not be permitted.
How QR Group Facilitates the Compliance Process
QR Group offers a specialized service to help Brazilian importers and distributors obtain the GMP certification required for the registration of Class III and IV medical devices. The company acts as a facilitator of the ANVISA petitioning process, ensuring that all requirements are met quickly and effectively.
In addition, QR Group offers full support to Brazilian Registration Holders (BRH), who must submit B-GMP inspection requests on behalf of foreign manufacturers. The company also provides guidance on the evaluation of the audit report according to the MDSAP model, streamlining the certification process and ensuring compliance with Brazilian standards.
Benefits of Working with QR Group
By counting on QR Group’s support, foreign manufacturers and Brazilian distributors can accelerate the certification process and ensure that medical devices are in full compliance with ANVISA requirements. This not only facilitates access to the Brazilian market, but also minimizes the risk of delays and rejections, ensuring that products reach the public quickly.
If you are a medical device manufacturer and want to ensure compliance with ANVISA, contact QR Group. Our expertise in GMP regulation and certification facilitates your process of entering the Brazilian market.
Source: QR Group
