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Brazilian Regulators Establish Criteria for Marketing of Unregistered Medical Devices

EMERGO KEY POINTS:

  • New Brazilian regulations list criteria for importing unregistered medical devices and health products into the country to address public health issues.
  • Qualifying devices and products must be requested by the Brazilian Ministry of Health; requests are then reviewed by ANVISA.

Brazil ANVISA RDC 203/2017 for importation of unregistered medical devicesANVISA, Brazil’s medical device market regulator, has published new regulations for allowing importation of devices that have not undergone full premarket registration into the country in order to meet public health needs.

The new regulation, RDC 203/2017 (link in Portuguese), covers criteria and processes for importing devices intended for Brazilian public health programs. The country’s Ministry of Health must first request acquisition of such products and verify that they meet at least one of the following criteria in order to qualify for use without ANVISA registration:

  • Device is unavailable domestically in Brazil; therapeutic alternatives are also unavailable;
  • Device is necessary to help address a public health emergency on a national or international level;
  • Product is a vaccine listed under the National Immunization Program
  • Devices or products donated from international organizations or agencies.

In addition, devices imported based on RDC 203/2017 criteria should have undergone pre-qualification by the World Health Organization; or, the device importer must provide proof of valid registration in a country whose market regulator belongs to the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH), as well as valid good manufacturing practice certification from the product’s country of origin.

Once a qualifying device or product has been requested by the Ministry of Health, ANVISA will review the request and accept or reject it anywhere from within 48 hours to 10 days. The regulator will also manage technical complaint and adverse event monitoring of such devices once they enter the Brazilian market.

RDC 203/2017 will go into effect 180 days following publication.

Related Brazilian medical device regulatory resources from Emergo:

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