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Global Certification Technical Update

May 2019

May 2019 Updates

Brazil

BRAZIL (ANVISA) – NOTIFICATION OF CLASS I MEDICAL DEVICES

Effective May 2, 2019

Brazil National Health Surveillance Agency (ANVISA) published RDC 270 / 2019 in the Brazilian Official Gazette. The new legislation deals with Class I medical devices (materials, equipment and IVD products). RDC 270/2019 amends RDCs 36 and 40/2015.

The regulation of Class I medical devices has been done through the cadastro process. Under the new Resolution, the lowest risk products will be regulated through notification as a simplified system in which there will be no prior technical analysis of the petitions. The publication of the notification is expected within 30 days following the notification’s application and the payment of the ANVISA fee. Only after the granting of the notification number can the product be industrialized or commercialized.

BRAZIL (ANATEL) – UPDATED TECHNICAL REQUIREMENT AND TESTING PROCEDURES FOR TELECOMMUNICATIONS EQUIPMENT

 Effective January 11, 2019

 National Telecommunications Agency (ANATEL) updated the list of Technical Requirements for Telecommunications Products, Category II. The scope of Category II equipment is not included in the definition of Category I, which uses radio spectrum for signal transmission (e.g. antennas, equipment with Wi-Fi interfaces, Bluetooth, etc.) The update also adds the requirements and procedure references for fixed, mobile and portable transceivers and transmitters.

 BRAZIL (ANATEL) – PUBLIC CONSULTATION Nº 6/2019

 Proposed date of entry into force: To be determined

 ANATEL is requesting comments and suggestions from the Brazilian society about revoking the antennas regulations, not being mandatory to certify Point to Point, Point to Multi-Point and Earth Station antennas.

Details of the public consultation can be viewed here:

https://sistemas.anatel.gov.br/SACP/Contribuicoes/TextoConsulta.asp?CodProcesso=C2209&Tipo=1&Opcao=andamento

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