Life Sciences & Healthcare - updated on Mar 25 at 09:48 am
INMETRO NO LONGER REQUIRES COMPULSORY CERTIFICATION FOR CERTAIN HEALTH PRODUCTS
The National Institute of Metrology, Quality and Technology (INMETRO) published, on March 23, 2020, the Ordinance No. 102/2020, suspending for 12 months (from the date of its publication) the compulsory certification issued by the Institute, determined by the following technical rules:
i. Ordinance No. 332, of June 26, 2012, which establishes technical standards for “Surgical Gloves and Non-Surgical Gloves made of Natural Rubber, Synthetic Rubber and Synthetic Rubber Mixtures”;
ii. Ordinance No. 123, of March 6, 2015, which establishes technical standards for "Protection Gloves Against Biological Agents, Not Subject to the Health Surveillance Regime, made of Natural Rubber, Synthetic Rubber, Mixtures of Natural and Synthetic Rubber, and Polychloride Vinyl”; and
iii. Ordinance No. 561, of December 23, 2014, which establishes technical standards for “Personal Protective Equipment – Facial Particulate Filter”.
The Compulsory Certification is the conformity assessment mechanism that is necessary for obtaining the Compliance Identification Seal (in Portuguese: Selo de Identificação de Conformidade) by INMETRO.
With the suspension of compulsory certification, companies that manufacture the above-mentioned products may choose not to obtain the certificates, if they keep records of compliance with the technical standards for each product.
Therefore, INMETRO seeks to contribute to the adequate supply of these products in the market.