BRAZIL'S ANVISA UPDATES MEDICAL DEVICE REGULATIONS DURING COVID-19 PANDEMIC.

Overview

Anvisa’s updated regulation RDC 379/2020 provides requirements for medical device manufactures and identifies devices eligible for priority importation. Anvisa points out that it was only updated due to the extraordinary circumstances but will only remain in effect for 180 days and may be renewed while the public health emergency is recognized by the Ministry of Health.

RESOLUTION OF THE BOARD OF DIRECTORS – RDC Nº 379 OF APRIL 30, 2020

Automatic Approval of import licensing:

Via the Integrated Foreign Trade System (Siscomex) the following medical devices will have automatic approval for importation into Brazil.

  • The import of surgical masks;
  • goggles;
  • facial protectors or face shield;
  • N95,
  • PFF2 or equivalent respirators;
  • valves;
  • circuits;
  • respiratory connections and disposable hospital clothing

Automatic Approval of import Requirements:

  • These products are exceptionally and temporarily exempted from the Company Operating Authorization (AFE), notification to Anvisa as well as other health authorizations.
  • This regulation does not exempt the manufacturer and importer from complying with the other requirements applicable to the sanitary control of medical devices and the applicable technical standards; and from carrying out post-market controls, and from comply with post-market regulations.
  • These products may be imported from any country as long as the manufacturer or importer guarantees their origin, quality, safety and efficacy.
  • Products manufactured or imported may be submitted to analytical quality monitoring by the National Network of Sanitary Surveillance Laboratories (RNLVISA).
  • Companies must ensure the traceability of products manufactured or imported and allow the identification of those responsible for marketing.

medical devices not regulated by ANVISA:

  • It is allowed to import medical devices essential to the combat of COVID-19, new and not regulated by Anvisa, as long as they are regulated and commercialized in a jurisdiction member of the International Medical Device Regulators Forum (IMDRF), by public and private bodies and entities, as well as health services, when similar devices regulated at Anvisa are not available for commerce. For this type of import, the importer must attach a Responsibility Term signed by the legal responsible.
  • The importing company must have Anvisa’s operating authorization for the related import activity.
  • The company holding the product registration must issue a Declaration authorizing the import. It is forbidden to import these products regularized at Anvisa without this Declaration.
  • Importers of diagnostic kits must send a sample of at least 100 units of each imported lot for analysis by the National Institute of Quality Control (INCQS) within a maximum period of 5 (five) days from the date of release of the load.

 medical devices donation:

  • It is permitted to receive, in donation, medical devices essential for combating COVID-19, new, regularized and marketed in jurisdiction member of the International Medical Device Regulators Forum (IMDRF), by public bodies and entities; and public and private health services.
  • When the products do not meet the requirement of regularization and marketing in the jurisdiction of a member of the IMDRF, the person responsible for the donation, prior to import, must request prior authorization from Anvisa.
  • The request must be accompanied by the technical file and the specifications of the product, country of origin and manufacturer.

About Global Regulatory Partners:

Global Regulatory Partners Inc, (GRP) is an American company that provides regulatory affairs, clinical, quality and safety services to medical devices and pharmaceutical companies globally. GRP headquarters is located in Massachusetts USA and its main affiliates are located in China, Japan, Brazil, Mexico and Argentina. GRP helps many life science companies register their products in different countries in compliance with local regulations.

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