INMETRO has issued a public consultation regarding the proposal for what they are calling a “New regulatory model for INMETRO”. The main goal, according to INMETRO’s director Gustavo Kuster, is to make Brazilian market safer for society and citizens and to create a less bureaucratic and more simple system. The action is a part of INMETRO’s new strategy aiming to simplify the process by creating rules that cover a wide range of products, following the example of the European Union.

Also according to director Gustavo Kuster, manufacturers will have more responsibilities as well as freedom to market their products. “It takes us up to seven years to implement new measures nowadays. The solution is to rethink the entire model. Our strategy is to simplify, that’s why it is important that the community takes part in the public audiences that will be open aiming to narrow the existent proposals and to make the simplest regulation process possible. This is one of the new government’s goals.”

Making it less bureaucratic helps to increase competitiveness among products (either locally manufactured or imported) marketed in Brazil. It is vital to help companies by making INMETRO’s certification process faster – he adds.

“We need a simpler and less prescriptive regulation, that allows innovation” – highlights the director.
Currently, INMETRO works with a framework that covers 684 items, including a wide range of medical devices, which represents only 10% of the products marketed in Brazil. Kruse points out that we need to modernize our present regulation rules by creating basic general principles that will ensure the safety and quality of all products. The goal is to cover 100% of the products traded in the national market.

All citizens and companies will have 60 days to answer seven questions that will contribute to the first step into the changing process. In order to participate and make suggestions, please check INMETRO’s website.

INMETRO is concerned about making the future transition to the new model as smooth as possible for manufacturers, certification bodies and the society. In due course, changes regarding all the regulated products and categories will be scheduled considering the proper time for everyone to adjust. We believe the current public consultation indicates INMETRO’s intentions of building this project with the participation of the parties involved.

DOMO Salute’s team will take active part in the process and keep you informed on the following projects and changes regarding INMETRO’s certification.
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DOMO Salute Team

Check INMETRO’s proposal (Portuguese)
Watch Gustavo Kuster’s invitation to take part on the public consultation (Portuguese)
Access to the public consultation (Portuguese)