Brazil: update on Compliance Assessment Requirements for Medical Electrical Equipment

The Compliance Assessment Requirements for Medical Electrical Equipment under Sanitary Surveillance Regime (established in Portaria Inmetro no 350, from September 06, 2010) have been updated and are present in Ordinance No. 54, published by INMETRO on February 1, 2016, and is in effect since May 1, 2017.

The the new Ordinance was created as a response to the recent update of the IEC 60601 Standard (now in its third edition), and establishes product safety processes based on the recommendations of the IEC.

The main points are:

- Processes dealt before April 30, 2017, may be initiated and completed under the Ordinance No. 350.

- Processes initiated under the Ordinance No. 350 will have until April 30, 2018 to be completed. If the process is not completed by this deadline, the process should be restarted according to Ordinance No. 54.

- There will be certificates based on Ordinance No. 350 until April 30, 2023, if the process meets the above item.

- Processes dealt after of May 1, 2017 may only be conducted according to Ordinance No. 54.

- Renewal of certification process should be updated to Portaria 54 in the event of recertification.

- The factory audit will take into consideration, in addition to the items of Quality System (ISO 13485), the items related to Risk Management through analysis of the Risk Management File, safety criteria based on the series of standards IEC 60601, including usability assessment, eco-responsible projects, and software.

Considering the above, there will be a leveling of the projects, so that the processes are always carried out in a way that ensures that security risks are minimized or if possible avoided.