Brazil – New Brazil INMETRO ordinance eases inspection and documentation requirements

In Brazil, a new ordinance was published by the National Institute of Metrology, Standardization and Industrial Quality (INMETRO), providing updated conformity assessment standards and documentation requirements. INMETRO certification is an additional registration prerequisite for most electro-medical devices subject to IEC 60601, along with some other device types such as hypodermic needles, breast implants, surgical gloves, and syringes. INMETRO Ordinance No. 384/2020 (link in Portuguese) was issued last month and became effective on December 28, 2020. This represents the most notable change since Ordinance No. 54/2016 went into effect more than four years ago…