← Advanced Medical Technology Association
USTRNonrulemakingUSTR-2019-0012

National Trade Estimate Report on Foreign Trade Barriers

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Advanced Medical Technology Association filings
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Advanced Medical Technology Association filed 1 comment on this docket between Nov 4, 2019 and Nov 4, 2019. 47 other organizations filed here. The comment window closed 2462d ago.

What Advanced Medical Technology Association filed (1)

Nov 4, 2019· Advanced Medical Technology Association (AdvaMed)· USTR-2019-0012-0017

The 2019 NTE appropriately included the following language regarding Brazil - Conformity Assessment Procedures for Medical Devices Conformity Assessment Procedures for Medical Devices Under Ordinance 54/2016, INMETRO established a two-year validity period for product test reports (four years in the case of large equipment) and a five-year validity period for certifications, resulting in frequent product re-testing and re-certification. The ordinance also requires the application of a compliance identification mark prior to importation into Brazil. This language should remain and AdvaMed recommends that the following language be added: At the time of this submission, INMETRO has issued draft Ordinance 259/2019 to rectify 54/2016, altering but not lessening the negative trade impact of these overtly trade restrictive and Brazil-unique conformity assessment requirements. We also submit the following general comment regarding Brazilian TBT obligations: Brazil continues to present critical challenges for U.S. manufacturers in the lack of international alignment of its technical regulations including those for conformity assessment. Most Brazilian regulatory agencies have not fully and formally implemented the WTO/TBT agreement requiring the use of international standards as a basis for technical regulations developed within their respective rulemaking processes. In addition, under Brazils conformity assessment system, INMETRO publishes the requirements for conformity assessment programs required by other sector-specific regulatory agencies, but INMETRO is not familiar with the technical criteria for the various sectors, does not send technical experts to attend the international meetings of the sector regulators and standardizers, and does not conduct regulatory impact assessment in its rulemaking resulting in many Brazil-unique conformity assessment requirements. While INMETRO has announced plans to overhaul the management of its conformity assessment program covering hundreds of products, at the time of submission for this report, the overly trade restrictive system remains in place.

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