Brazil – Inmetro Decree 102/2020 Suspending the Mandatory Certification of Hospital Medical Supplies Due to COVID-19 Epidemic

​The Inmetro Decree No 102/2020, considering the need to maintain an adequate supply of medical hospital supplies to face the coronavirus pandemic (COVID-19), in order to facilitate its rapid manufacture or import and distribution throughout the country is suspending the mandatory certification of the following: – Surgical Gloves and Non-Surgical Procedure of Natural Rubber, Synthetic Rubber and Synthetic Rubber Mixtures, established in Inmetro Decree No 332, of June 26, 2012; – Protective Gloves Against Biological Agents, Not Subject to the Health Surveillance Regime, Natural Rubber, Synthetic Rubber, Mixtures of Natural and Synthetic Rubber, and Polyvinyl Chloride, established in Inmetro Decree No 123, of March 6, 2015; – Personal Protection Equipment (PPE): Particles Filtering Mask, established in Inmetro Decree No 561, of December 23, 2014. Except for certification, which is now voluntary, the requirements set out in the referenced Decrees, must continue to be met by suppliers. If the supplier chooses not to certify the product, it must keep records of the fulfillment of the expected technical requirements, through tests carried out in a laboratory accredited by Cgcre/Inmetro or by a member of the mutual recognition agreements of the International Laboratory Accreditation Cooperation – ILAC, or another criteria to be determined by the Anvisa (National Health Surveillance Agency) or the Special Secretariat for Social Security and Labor of the Ministry of Economy (PPE Regulatory Body). The Inmetro Decree No 102/2020 is valid after March 23rd 2020 and the mandatory certification requirement is suspended for 12 months.