The new Technovigilance Manual improves health regulation to meet the challenges posed by new technologies and the speed with which reality is changing.
The speed with which technologies evolve and are incorporated by the various segments of production and services sectors, greatly impacts our daily lives and even contributes to the constant changes in our habits.
In the health field, we have also experienced important changes that have affected the health care provided to the population, either by the introduction of new products for prevention, diagnosis, and treatment of the most diverse health conditions, or by the way these technologies are incorporated by health systems.
Thus, at the same time that we experience their benefits, we are faced with concerns about their safety and efficacy – pillars that are directly related to the with the current regulatory framework – and cost-effectiveness.
In other words, the transformation provoked by the innovation of technology, combined with to the regulatory frameworks and public policies, requires a reformulation in the process post-use monitoring process.
Monitoring is faced with different realities that require the improvement of post-marketing surveillance of products whose technology is already consolidated and incorporated, as well as the need to advance in the perspective that products with new technologies are (or will be) marketed in Brazil. We are talking about Technovigilance.
WHAT IS TECHNOVIGILANCE?
Technovigilance is the system for surveillance of adverse events and technical complaints of health products in the post-marketing stage, in order to recommend the adoption of measures that ensure the protection and promotion of the population’s health. Technovigilance aims at post-marketing health safety of health products (Equipment, Materials, Medical and Hospital Articles, Implants and Products for Diagnostic Use “in-vitro”)
ABOUT THE NEW TECHNOVIGILANCE MANUAL
The Manual values historical aspects of sanitary surveillance and techno-surveillance in Brazil and in the world, and describes practices adopted nowadays.
The new Technovigilance Manual is divided into 7 sections, addressing the following topics:
Section 1 - National Health Surveillance System
History of the development of sanitary surveillance in Brazil and the creation of Anvisa, presenting the legal and technical framework related to sanitary surveillance and medical device.
Section 2 - Technovigilance as a Public Health Practice
Summarizes the main regulatory frameworks and consolidates Technovigilance as a public health practice, which is being improved both nationally and internationally context.
Section 3 - Processes Relevant to Technovigilance
Details the processes relevant to techno-surveillance, including: legal and regulatory framework for medical devices; recommendations that have been incorporated over the past decade; certification of medical devices; and scenarios for expanding the analytical capacity of these products.
Section 4 - Technovigilance as a Strategy for Patient Safety
Expands the concept of patient safety as a national public policy; addresses and restructures the guidelines for healthcare institutions regarding the processes of acquisition, use and disposal of medical devices and clinical engineering; the role of health services in the safe use of products; technovigilance as a pathway to manage risks.
Section 5 - Technovigilance in Companies
Awareness of companies for being responsible for managing their products; importance of risk management throughout the product life cycle; and brings a model of post-marketing monitoring process with active search of data and information.
Section 6 - Implantable Products
Specificity and challenges of implantable products: indications, failures, complications, risks, adverse events, rules and recommendations regarding technovigilance on orthopedic and cardiac implantable devices
Section 7 - Innovative Products
Information on the use of innovative technologies and guides best practices regarding custom-developed devices.
It is expected, with the update of the Manual, to demonstrate that post-market surveillance of medical devices will be effective if it involves regulatory authorities, manufacturers, health services, health care professionals, and patients or users; and that despite advances, there are still many challenges in this field of public health, including the importance of informative and educative reporting of technical complaints and adverse events.
To learn more about the Technovigilance Manual 2021, please access the link here (available only in Portuguese).
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, and Mexico. GRP helps many life science companies register their products in different countries in compliance with local regulations.