Understand the Medical Device Registration Process at ANVISA
Ensuring access to the Brazilian market requires a detailed regulatory process, especially in the registration of medical devices with ANVISA. QR Group’s registration service was developed to facilitate this journey, ensuring compliance, agility, and strategy for companies that want to operate safely in the health sector.
Complying with regulatory requirements involves more than simply submitting a petition. It requires technical knowledge, mastery of regulations, and a strategic approach to avoid rework, minimize risks, and accelerate product entry into the market. QR Group acts as a bridge between companies and ANVISA, taking care of each step of the process with precision, from the analysis of the device’s risk classification to the final filing of the petition. All this within a technical planning that considers the requirements of RDC 751/2022 and other applicable standards, according to the size of the product and its intended use.
Strategic Steps for Successful Registration
With the medical device registration service, QR Group analyzes technical documentation, prepares and reviews regulatory dossiers, and defines the most appropriate strategy for each type of device. This avoids unnecessary notifications and significantly increases the predictability of the process. The result is a faster and safer entry into the Brazilian market, with time savings and cost reductions for companies.
Solutions for National and International Companies
Foreign companies, startups in the medical sector, importers and distributors who wish to register their products in Brazil find in this service a complete solution in line with local requirements. This includes the technical translation of documents, electronic submissions via Datavisa and monitoring of regulatory requirements, always with specialized technical support at each stage of the process.
QR Group combines technical knowledge, regulatory experience and commitment to public health to transform complex processes into accessible solutions. If your goal is to register a medical device in Brazil efficiently and compliantly, this is the ideal solution.
Contact the QR Group team and learn how to register your medical device quickly, safely and in full compliance with ANVISA.
Source: QR Group
