Updated on July 2nd 2020: INMETRO published, on the 30th of June, Ordinance nº 225 which extended the terms and temporary procedures for Conformity Assessments, due to the international public health emergency resulting from the new Coronavirus. The Ordinance extends the possibility of remote audits until December 31st 2020, as well as explains the terms for companies that are going or went through, maintenance or recertifications processes during the pandemic. 

INMETRO published, on the 27^th of March, Ordinance nº 111, regarding extraordinary and temporary procedures for Conformity Assessments, due to the international public health emergency resulting from the new Coronavirus.

The Ordinance establishes alternative conditions for Product Certification Bodies (CBs) to carry out Conformity Assessment activities in manufacturing plants located in countries affected by the coronavirus epidemic (COVID-19), including Brazil.

The Ordinance is only applicable for processes initiated between January 1^st 2020 and June 30^th  2020. For maintenance or recertifications processes, the regulation is effective only if the maintenance/expiration date of the certificate or registration is within the informed period.

For maintenance and recertification processes, the CB shall perform a risk analysis based on the records of the latest internal audits, top management´s critical analysis and complaints handling, as well as the history of non-conformities in testing. After the analysis, the CB may take the decision to postpone the maintenance or recertification audit.

In the event of the postponement, the Audit must necessarily be carried out within a maximum period of 6 (six) months, counting from the date on which the decision is registered by the CB. Alternatively, based on the risk analysis and considering the existence of adequate conditions, the CB may decide to perform a remote audit.

In the case of remote auditing, the initial, maintenance or recertification audit activity may be performed, at the CB’s discretion, dismissing the need for in house audit or scheduling a subsequent in house audit to confirm the certification. If the risk analysis does not support the audit’s postponement or if the operating conditions of the factory do not support the performance of remote auditing, the certificate must be suspended.

Regarding testing and test reports, Ordinance 111 gives the possibility for tests to be performed by the manufacturer in 1st or 3rd party laboratories accredited in Brazil or abroad, within the scope of the ILAC Mutual Recognition Arrangement (ILAC MRA), regardless of the lab acceptance criteria provided in the medical device specific Conformity Assessment Requirements.

Regardless of the extraordinary conditions, technical requirements provided for in the regulations published by INMETRO must continue to be complied with by manufacturers.

Follow us on social media to get an update on the top news regarding the Brazilian regulatory system.

DOMO Salute Team