Brazilian INMETRO Risk Management, Auditing Requirements Updated to Reflect IEC 60601 Changes
Brazilian regulators have updated INMETRO certification requirements for electrical medical devices to align more closely with the third edition of the IEC 60601 standard, impacting both existing and future certificate holders.
According to a new ordinance, Ordinance 54/2016 (link in Portuguese), the new INMETRO certification requirements reflect IEC 60601 3rd Edition’s heavier focus on risk management and performance. For manufacturers whose devices require INMETRO certification, this update in turn means greater scrutiny of their risk management processes and procedures in order to obtain and renew those certifications.
Furthermore, foreign manufacturers will be required to affix the INMETRO seals on their products prior to importation to and distribution in Brazil.
Certification request changes
Under Ordinance 54/2016, additional documentation will be required from INMETRO certification applicants. Additional documentation includes risk management summaries as well as user manuals translated into Portuguese.
During initial INMETRO evaluations, applicants have had to provide test reports, and this remains the case under Ordinance 54/2016. A new testing report requirement under this ordinance pertains to “large-sized equipment.” For large medical devices falling into this category, defined in Ordinance 54/2016, test reports may not be more than four years older than the date of acceptance of an applicant’s INMETRO certification contract.
Other longstanding test report requirements remain in place, as well.
INMETRO certification and maintenance audits
Brazilian certification bodies or accredited organizations will conduct INMETRO audits on manufacturers’ risk management files, quality management systems and production processes. Furthermore, audits will also be performed on INMETRO certification applicants’ Brazil Registration Holder (BRH) in-country representatives.
Following INMETRO certification, maintenance audits will be carried out at manufacturers’ sites annually, no more than 15 months following issuance of certification.
Transition to the new INMETRO Ordinance
Medical device firms currently holding INMETRO certification based on previous requirements laid out in Ordinance 350/2010 will have to update their compliance to Ordinance 54/2016 at their next certificate renewal or when they need to make changes to their certifications.
All new must accord with Ordinance 54/2016. Furthermore, all certifications must come into compliance with Ordinance 54/2016 six months after the ordinance’s publication. The ordinance was published February 1, 2016, so the effective date is August 1, 2016.