Apr 14, 2016
The Agencia Nacional de Telecomunicacoes (ANATEL) in Brazil has updated its labeling regulations for wireless products, including some medical devices.
Resolution 662 (link in Portuguese) amends the previous resolution 242 from Nov. 2000. This affects all wireless products that fall under ANATEL’s scope.
The primary changes to labeling requirements are as follows:
1) The Certification number (homologation) and the manufacturer’s identification number have changed. There are now five numbers each. The new labeling format is, for example, HHHHH-AA-FFFFF, where:
2) ANATEL has removed the EAN number and bar code requirement for their labels.
ANATEL allows products with limited space for the logo and approval identification code to place these markings on the user manual and optionally on the product packaging. Affected medical device manufacturers should check whether their devices are in fact considered small enough for this exemption.
Although major news regarding new European medical device regulations remains forthcoming, European Commissioners have recently rolled out a new directive for devices using wireless components and reorganized their website so that manufacturers can more easily research laws and regulations beyond the Medical Device Directives that may also require compliance.
Brazilian regulators have updated INMETRO certification requirements for electrical medical devices to align more closely with the third edition of the IEC 60601 standard, impacting both existing and future certificate holders.