Informativos

QC CERT Informs: INMETRO – Ordinance No. 384 (12/18/2020)

22/12/2020

Inmetro published on 12/18/2020 the new Ordinance  N. 384.

It will bring some changes in the conformity assessment process of Equipments under the Health Surveillance Regime (Anvisa).

The new regulation will take effect on 12/28/2020, revoking the following Ordinances:

  • N. 350 (09/06/2010)
  • N. 54 (02/01/2016)
  • N. 544 (11/24/2016)

The transition of certificates already issued by the previous Ordinances to the new Ordinance must occur within a maximum of 06 months, counting from the effective date (12/28/2020).

Feel free to contact the QC CERT Team regarding any questions you might have.