Apr 29, 2020

In Brazil over the last two months, the National Health Surveillance Agency (ANVISA) has issued a series of Resolutions and announcements directly pertaining to the COVID-19 pandemic and the need for critical medical supplies.

New Regulations streamline processes and temporarily lift requirements

ANVISA published RDC 346/2020, establishing temporary Brazil Good Manufacturing Practice (B-GMP) certification procedures for health products related to the COVID-19 outbreak.

RDC 348/2020 establishes the criteria for the expedited registration of medicines, biological products, and IVDs indicated for COVID-19. Per the Resolution, IVDs intended for the diagnosis of COVID-19 must still comply with the provisions in RDC No. 36/2015. The lack of any performance study or data must be justified with technical methods that will allow for the assessment of the reliability and effectiveness of the product. Unless accompanied by completed real-time studies, the maximum shelf-life that will be approved for any device is six months.

RDC 349/2020 lays out rules for expedited registration of personal protective equipment (PPE), ventilators, and other medical devices indicated for the prevention or treatment of COVID-19. The expedited registration allows for exemption from B-GMP certification by leveraging an MDSAP or ISO 13485 certificate. Eligible devices will also be exempt from Brazilian Compliance Assessment System (SBAC) certification and will be subject to simpler documentary requirements. Per the Resolution, relevant devices must still comply with the other provisions in RDC No. 185/2001 and RDC No. 40/2015. Any deficiency in registration requirements must be justified with technical methods that will allow for the proper evaluation of product safety and effectiveness.

Another effect of RDC 349/2020 is to authorize the use of surgical masks, FFP2, and N95 respirators with a Certificate of Approval from the Ministry of Economy for use in health services, without requiring additional authorization from ANVISA throughout the validity of the Resolution (120 days).

RDC 355/2020 temporarily suspends deadlines for ANVISA procedures, including review timelines for medical device and IVD petitions, as well as manufacturers' deadlines for the submission of documents. Deadlines pertaining to vigilance and field safety actions were not modified as part of this Resolution, which is valid for 120 days from issuance.

RDC 356/2020 temporarily exempts manufacturers and importers of the following products from registration, Operating License (AFE) requirements, and other health authorizations:

  • Surgical masks;
  • Respirators;
  • Goggles and face shields;
  • Disposable hospital gowns, caps, and props; and
  • Valves, circuits, and respiratory connections.

RDC 356/2020 was accompanied by a guidance document in Q&A format, providing details on the exemption of certain low-risk devices and PPEs from regulatory requirements.

RDC 366/2020 establishes the application requirements for importing IVDs relating to the diagnosis and treatment of COVID-19.

RDC 375/2020 stipulates that clinical trials for class III and IV priority medical devices relevant for combating COVID-19 will now be submitted as Notifications, without the need for a Clinical Trial Dossier (DICD). Notifications must be submitted through ANVISA's Electronic Petitioning System

Learn how other device markets are responding to COVID-19.

ANVISA reaches out to medical device companies about expedited approvals

ANVISA announced on March 12 that applicants can request priority review of products intended for the diagnosis of COVID-19 and other agents that cause respiratory infections.

A further announcement was issued on March 20 regarding prioritization of submissions related to COVID-19. Operating License (AFE) applications from importers and industries who intend to carry out activities related to products for the diagnosis, prevention, and treatment of COVID-19 will be prioritized upon request (through e-mail) by the applicants.

ANVISA published a FAQ guidance on March 25 to clarify the procedures for expedited approval and prioritization of IVDs used to counter COVID-19.

Learn more about Brazilian medical device regulations at Emergo by UL:

Author

  • Timothy Herr

Related