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In order to access the Brazilian market, medical devices have to be notified or registered with ANVISA, depending on their risk class. With RDC No. 423/2020, the Brazilian regulator has recently eliminated the Cadastro pathway for the registration of Class II medical devices and IVDs. This was a considerable reduction of the registration requirements for the manufacturers of these devices. The process of registration in Brazil can be very burdensome because certain products are subject to additional certification requirements, depending on their characteristics. Most electro-medical devices, independent of their risk class, have to be certified by the National Institute of Metrology, Standardization and Industrial Quality (INMETRO). Following the trend towards simplifying some regulatory hurdles in Brazil, Ordinance No. 384/2020 has introduced significant changes for manufacturers of devices that require INMETRO certification and will reduce the effort to obtain and maintain this certification.

The new ordinance was published on 18 December 2020 and took effect 10 days later. It included a transition period for certificates issued under previous ordinances. Existing certificates issued under Ordinance No. 54/2016 will have to be reviewed and revised, based on the new ordinance, during the next maintenance audit, once the transition period of six months has passed. Existing certificates issued under the repealed Ordinance No. 350/2010 (and issued before 30 April 2018) may be audited and renewed until the certificate expires.

Depending on when your INMETRO certificate was issued and based on the specific ordinance, the next maintenance audit will already use the new, eased requirements. Ordinance No. 384/2020 has introduced the following changes to the INMETRO certification process:

  • On-site inspections: The new ordinance changes the requirement for on-site inspections, which will no longer be required for all certification procedures. Whether an on-site audit will be required will be based on previous audits, including under MDSAP or ISO 13485. Should the auditing entity decide that an on-site audit is unnecessary, the certification will be based on a desktop audit.
  • Test reports: The new ordinance changes how recent test reports must be: for small and medium-sized equipment, test reports may be older than two years, while for large equipment, test reports may be older than four years. Test reports must reflect the current version of the device to be certified/under review. Changes to the device lead to new testing unless the manufacturer can provide a rationale as to why changes to the device do not justify further testing.
  • Duration of validity: The new ordinance changes the expiration of certificates, since they no longer expire. Maintenance audits have to be performed regularly (every 15 months or annually).

The changes reduce the burden on medical device manufacturers, particularly regarding the requirements for the actuality of test reports. To avoid unnecessary testing, we recommend checking the current certificates and using the applicable transition period to plan and adapt your renewal processes.

PORTARIA Nº 384, DE 18 DE DEZEMBRO DE 2020 (DIÁRIO OFICIAL DA UNIÃO, 18.12.2020).