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ANVISA’S measures on medical devices during the Covid-19 Pandemic

Date: 03/17/2020

Covid-19: Prioritizing IVD products

Last Thursday (03/12/2020) ANVISA published an update regarding IVD products for Covid-19 diagnosis aiming to speed products regularization and the offer of diagnostics.

ANVISA will prioritize the analysis of all processes related to products for Covid-19 diagnosis and other agents that cause respiratory infections.

The measure aims to expand access to IVDs and support health professionals in identifying positive cases.

Brazil has declared public health emergency through the Ministry of Health.

Alternatives to GMP certification: RDC Nº 346/2020

Last Friday (03/13/2020) ANVISA published RDC Nº 346/2020, which defines extraordinary and temporary criteria and procedures for GMP Certification, for the purposes of registration and post-registration changes to active pharmaceutical ingredients, medicines and medical devices, due to the international public health emergency of the new Coronavirus.

Under the terms of the new Resolution, temporary and emergency use of information from Foreign Regulatory Authorities is allowed to replace Health Inspections carried out by ANVISA. According to the Resolution, Foreign Regulatory Authority members of the MDSAP (Medical Device Single Audit Program) are the ones entitled to share information for certifications related to medical devices.

In addition, while the Resolution is in force (180 days), the emergency use of remote inspection mechanisms will be temporary allowed, replacing the on-site sanitary inspection for purposes of obtaining GMP Certification. Remote inspections are carried out by means of videoconferencing technologies and data transmission to verify compliance with the GMP. Moreover, remote inspections replace the need for inspectors to be physically present at the productive plant.

Good Manufacturing Practices Certifications granted under the terms of the Resolution will be valid for two years, counting from the publication date in the Brazilian Official Gazette (DOU).

The alternative and temporary certification mechanisms described in the Resolution apply only to petitions submitted prior to the publication of this Resolution, with the exception of the request for GMP certification for medicines or medical devices intended for control, diagnosis, prevention or treatment of  the new Coronavirus OR essential products to maintain life, when the availability is threatened by shortages (imminent or installed) in the national market motivated by reason proven to be linked to the new Coronavirus.

It is important to highlight that the Resolution can be renewed for equal and successive periods of 180 days in case inspections by ANVISA are still unviable due to the pandemic.

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

DOMO Salute Team

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