ANVISA Publishes Database for Clinical Investigations into Medical Devices

Overview

The National Health Surveillance Agency (ANVISA) has announced the launch of a database aimed at clinical investigations related to medical devices. This initiative represents an important milestone in the health sector, promoting greater transparency, efficiency and safety in research carried out in Brazil.

Introduction

The main objective of the database is to gather information on clinical studies conducted in the country, creating a centralized platform for registering, consulting and monitoring these trials. It is designed to benefit researchers, manufacturers, health professionals and the population itself, offering essential data on the safety and efficacy of new medical devices.

Principal Features

Registration of Studies:

All clinical investigations of medical devices must be recorded in the system, guaranteeing traceability and compliance with regulatory standards.

Public Consultation:

Manufacturers, researchers and the general public will have access to information on ongoing or completed clinical studies, promoting greater transparency.

Monitoring:

The database will allow ANVISA to monitor the progress of investigations in real time, identifying potential risks and ensuring compliance with regulations.

Benefits for the Health Sector

Transparency:

Public access to information strengthens the confidence of the population and health professionals in medical devices.

Agility:

The centralized system facilitates the submission and review of studies, optimizing time for approval and execution of research.

Innovation: With more organized data, Brazil is positioning itself as a more attractive environment for developers and manufacturers of medical devices, stimulating technological advances in the sector.

Impact on Medical Device Regulation

The launch of this database reinforces ANVISA’s commitment to responsible, evidence-based regulation. It also contributes to aligning Brazil with international practices, strengthening the control and safety of medical devices used in the country.

Conclusion

ANVISA’s clinical research database is a fundamental step towards ensuring greater transparency and quality in the development of medical devices in Brazil. The initiative is an invitation to collaboration between all players in the health sector, promoting innovation and safety for the Brazilian population.

The clinical investigational data for the Brazilian market is welcome and coincides with the release of clinical investigational data in Europe. In Europe, the Clinical Investigation Reports (CIR) were published in the European CIRCABC (November 30).

In addition, Health Canada now makes clinical information available on Class III and Class IV medical devices (Public Disclosure of Clinical Information).

The actions of these regulators indicate recognition of the importance of disclosing this investigational clinical data.

GRP Brazil

If you are interested in registering your products in Brazil, GRP is ready to help. Our team of experts can simplify the process of registering products in Brazil and make it easier to schedule meetings with Anvisa more efficiently.

GRP can act as your local Agent & Register your product in U.S

Contact our team today to Inquire!

 Email: info@globalregulatorypartners.com

Telephone : (+1) 781-672-4200

References

Learn more about Anvisa. For the link, click here

About Global Regulatory Partners

Global Regulatory Partners Inc, (GRP) is an American company that provides regulatory affairs, clinical, quality and safety services to medical devices, pharmaceutical, cosmetic and Food Supplement companies globally.

GRP headquarters is located in Massachusetts USA and its main affiliates are located in China, Japan, Brazil, Mexico and South Korea. GRP helps many life science companies register their products in different countries in compliance with local regulations. 

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