Project FNS/USP: Brazilian Internalization of Technical Standards in the Sector of Health Products

On December, 2008, a project was agreed upon between the National Health Fund and the São Paulo University, known as “Brazilian Internalization of Technical Standards in the Health Products Sector”. The Project aimed mainly the consolidation of the adoption of Technical Standards both in use and the production of health products in Brazil.

The obtainment of results on this Project demanded an effective performance, both on the national and the international scope of the Brazilian Dental-Medical-Hospital Committee (CB-26) and the Brazilian Association of Technical Standards (ABNT), from this point, mentioned on this text as ABNT/CB-26.

This performance along with the regulatory bodies producers of Technical Standards abroad, intended for the production of Brazilian Technical Standards by ABNT/CB-26 to be concomitant with the international normative production, both on IEC and ISO. Hence, this Project also intended to enable the important, necessary and late performance of Brazil with the International Electrotechnical Commission (IEC) and the International Standards Organization (ISO), international organizations that produce Technical Standards used by ABNT/CB-26 as a reference for the production of its normative texts. It is paramount to highlight that the ABNT Technical Standards are used as Reference Standards throughout the regulatory process of a few health products, for example, in the certification of medical equipment by the Brazilian System of Conformity Evaluation (SBAC) by INMETRO, that certificate being a demand in the registration process of medical equipment with ANVISA.

Project OPAS/ABIMO: Project of Internalization of International Medical Standards in the Health Products Sector

During the first semester of 2010, the link with the Health Ministry (MS) and the Pan-American Health Organization (OPAS) began in order to obtain resources, with the purpose of continuing the project that started between the National Health Fund (FNS) and the São Paulo University (USP). In November of that same year, the agreement was signed between OPAS/ABIMO.

The main goal of the OPAS/ABIMO Project is to establish the use of national technical Standards from international normative documents, which will be applicable to health products. In addition, the Brazilian performance along with the international standardization organs, collaborating on the elaboration of those international documents, will promote, in the future, the internalization and adoption of technical standards in the processes of industrialization and use health product users.

In order to reach that normative standard, a few activities will be executed, they are:

– The analysis, translation and upgrading of normative texts based on international or foreign standards.
– Participation in international meetings to defend the Brazilian position against standard projects being elaborated.
– Dissemination of information regarding national and international normative processes.
– Consolidation of the normative culture in manufacturing and post-market.
– Restructuring of CB-26 adopting IEC and ISO molds.
– Expansion of certification and registration processes to other health products.
With this project ABIMO intends to promote an equal competition between the great manufacturers of medical-hospital products, as well as promote the quality improvement on those products.