At the end of 2020 INMETRO published Ordinance 384, which came into force on December 28th.

The new regulation replaces Ordinance 54/2016 with new requirements for conformity assessment for equipment under health surveillance, establishing more clearly the competence of Certfication Bodies and ANVISA.

Amongst the main changes, we highlight:

– The certification body can now review the results of previous audit reports, performed according to MDSAP or ISO 13485, for example, and determine whether the test routine reports can be attested through document analysis, a desktop audit, or if an on-site audit will be required in order to comply with the test routine reports requirements.

– In case the device hasn’t been updated or altered after testing, there is no longer a requirement related to the issuance date of the report. Up to the publication of the new Ordinance, INMETRO certifiers could only accept 2 years old test reports for small and medium-sized equipment, and 4 years old test reports for large equipment.

– According to the new Ordinance, in some cases manufacturers are not obliged to insert INMETRO’s seal at the origin, being now allowed to insert the seal in Brazil, before marketing the devices. Also concerning INMETRO’s seal, in some cases for disposables and/or non-sterile devices, the seal can now be attached to the packaging only, and not the device itself.

In addition, the new Ordinance 384/2020 instated that INMETRO certificates, issued under the new regulation, will not expire after 5 years (as the previous Ordinance 54/2016). The certificates will require maintenances to be carried out properly every 15 months.

It is worth mentioning that the new Ordinance defines applicable requirements that must be met to allow the new possibilities to apply.

During the next 6 months, maintenance process, audits and recertifications can still be carried out through Ordinance 54/2016, however, they must be revised according to Ordinance 384/2020 on the next maintenance. For existing certificates issued according to Ordinance 350/2010 though, maintenance process and audits can be performed according to Ordinance 350/2010 until the end of the 5 year’s certificate validity.

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DOMO Salute Team