Brazil proposed Requirements for blood glucose monitoring systems Brazilian Health Regulatory Agency (Anvisa) proposed Normative Instruction establishes the parameters of the Technical Norm ISO 15197: 2013 - In vitro diagnostic test systems - Requirements for blood glucose monitoring systems for self-testing in managing diabetes mellitus, as requirements to be adopted and observed by the manufacturers of self-test instruments for glucose and its consumables for registration purposes, changes and revalidation of registration with Anvisa. The items of the Technical Dossier provided in art. 29 of the Resolution of the Collegiate Board of Directors - RDC 36 of 26 August 2015, applicable to the instruments for glucose self-test and its consumables must be met through the inclusion of reports prepared according to the analytical performance evaluation chapter of the Standard Technique ISO 15197: 2013. The reports prepared, cited in article 2, shall be presented within a maximum period of 180 (one hundred and eighty) days after the publication of this Normative Instruction. Product registrations that do not demonstrate compliance with the requirements of ISO 15197: 2013 will be cancelled. In the event that the Technical Standard indicated in this Normative Instruction be replaced by an updated version, the updated version will be required according to the transition period recommended by the text of the updated Technical Standard. Failure to comply with the Technical Note requirements within the established deadline will result in the cancellation of the registration of the product in question. Product covered: Self-test instruments for glucose and its consumables HS code: 9027 Proposed date of adoption: NA Proposed date of entry into force: NA Final date for comments: NA | 
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