INMETRO postponed the implementation of the Ordinance 54 that replaces the Ordinance 350. The implementation date is expected to be in 2017. The contents of this new legislation were already made public when it was published months ago.

This new Ordinance will introduce new requirements and will inevitably make requirements more demanding. Here are some examples of the proposed changes included in the withdrawn document:

  • Only companies established in Brazil will be entitled to be applicants of certification;
  • Existing test reports cannot be older than 2 years (or 4 years if case they refer to large equipment example, MRI and Tomography);
  • One set of test reports can only be valid for one manufacturing location. If multiple assembling locations receive kits supplied according to the design center they will be treated as different families and will require separate laboratory tests.
  • The scope of factory evaluations is increased with the inclusion of other requirements that must be verified on-site (see details below):
    • ISO 13485 (Ordinance 54 – Annex B – table 8)
    • RDC/ANVISA n° 16/2013 (Ordinance 54 – Annex B – table 9)
    • ISO 14971 (Ordinance 54 – Annex A – table 2)
    • IEC 60601-1-6 (Ordinance 54 – Annex A – table 4)
    • ABNT NBR IEC 62366/2010 (Ordinance 54 – Annex A – table 5)
    • IEC 60601-1-9 (Ordinance 54 – Annex A – table 6)
    • IEC 62304 (Ordinance 54 – Annex A – table 7)
    • Routine tests that must be performed on 100% of the units that will have the INMETRO mark:
      • grounding (clause 8.6);
      • measurement of leakage current (clause 8.7);
      • dielectric strength test (clause 8.8, non-destructive); and
      • the functional tests are specified by the manufactured and agreed with the OCP
      • Inclusion of new devices manufactured at a location that is already under surveillance will require an extra visit.

The requirements above may change as INMETRO is rewriting the legislation for expected publication next year.

UL will keep you posted about this topic.