Our team has compiled a few important news from the past days concerning medical device’s regulation and the Brazilian regulatory system: 

Field safety correction action information is now submitted to ANVISA by electronic system

Since the 22th of July manufacturers must submit field safety correction action information via ANVISA’s electronic system – called Solicita. Before that, the information was submitted to ANVISA by e-mail or hard copies.

Field safety correction actions are actions taken by manufacturers and medical devices’ registry holders to reduce the risk of adverse events and other incidents related to products marketed in Brazil.

By making all the information electronic ANVISA aims to organize the documentation received by the agency, give transparency to the actions taken and better manage the work flow.

QMI-SAI Canada new Notified Body recognized by ANVISA to perform MDSAP Audits

ANVISA recently (August 6) published the Resolution RE Nº 2.138, DE 5 DE AGOSTO DE 2019 granting QMI-SAI Canada Limited the status of notified body able to perform MDSAP on-site audits for medical devices’ manufacturers.

ANVISA is a member of the IMDRF and along with four other countries – Australia, Canada, Japan and the United States – compose the MDSAP participating regulators.

BGMP (Brazilian Good Manufacturing Practices) inspection requests for foreign manufacturers must be applied by a Brazilian Registration Holder, who will also be the holder of the certificate issued by ANVISA.

INMETRO is working on reducing the average time to issue Import Permits

INMETRO is working alongside with Global Alliance for Trade Facilitation and developing a project to reduce the deadline to issue Import Permits from 5 to 2 days by automating 70% of the requests. The results will start to show by the end of the year, informs INMETRO.

INMETRO gets through approximately 200 thousands of processes requesting Import Permits every year.  Low risk products’ Permits will be issued by an automatized, simple process which will allow INMETRO’s specialists to focus on high-risk products – improving the safety for importers and consumers. The risk level will be periodically reevaluated.

The action is a part of INMETRO’s effort to propose a new regulatory model aiming to create a less bureaucratic and more simple system.

INMETRO’s new Ordinance makes the approval of  measuring  instruments faster

INMETRO’s Ordinance 302/2019 published by the end of June has altered the procedures that must be taken in order to approve measuring instruments such as  blood pressure meters and clinical thermometers.

Before, the manufacturer or importer had to open a process with INMETRO, submit the instrument for INMETRO’s lab evaluation, wait for INMETRO´s reply, then send the instrument to an accredited lab and wait approximately 3 months for  the lab  to provide a test report to be evaluated by INMETRO. Waiting time could be up to 145 days.

Now, the company can submit the sample directly to the lab and the report, issued by the accredited lab, can be submitted directly to INMETRO thus making the process up to 3 months faster. The changes increase the process predictability and efficiency making it easier for the manufacturer to plan his entrance in the market.

INMETRO also published, on July 15th, the Ordinance 336/2019 concerning measuring instruments. Manufacturers and importers of certain measuring instruments can now obtain authorization to issue a declaration of conformity  instead of the initial verification that needs to be done to every instrument before they can be marketed in Brazil. Before the ordinance, the initial verification could only be carried by Brazilian Metrology and Industrial Quality Bodies.

Follow us on social media to get an update on the top news regarding the Brazilian regulatory system.

DOMO Salute Team