INMETRO is a general term for the Brazilian National Metrology, Standardization and Industrial Quality Association, which is a national accreditation body and standards development organization in Brazil, which regulates the INMETRO-certified product and certification process. INMETRO certification system compulsory and voluntary certification, electronic medical equipment is a mandatory certification of the product. In addition to the fact that the thermometer must be certified by the INMETRO authorities, other live medical devices must be accredited to INMETRO's accredited third party (eg SGS OCP 0040) for product registration to the Brazilian Health Authority (ANVISA) after obtaining the INMETRO certificate.

Brazil INMETRO certification standards of the latest developments

Laws and regulations relating to INMETRO certification are available in three sections: Nr. 350, Resolution RDC 27 and NormativeInstruction IN 09. Ord 350 is issued by INMETRO, which specifies the requirements and procedures for INMETRO certification (factory review, product testing, document review, annual supervision and auditing), and provides that the product certification must be accompanied by the INMETRO logo and affixed with INMETRO approved Tripartite institutions (OCP) signs. RDC 27 rules to supplement the requirements of product certification, provides for electrical and electronic medical products must obtain INMETRO certificate. Ord350 is expected to be updated in 2014, and IN9 is a new regulations, since December 26, 2013 release has been effective, and replaced the original IN3.

How to deal with Brazilian INMETRO certification regulations

The new regulations IN9 are actually a standard list that specifies the criteria that need to be met when the product is certified. In other words, the company can prepare the test report for INMETRO certification according to IN9. (1) Some new standards, such as IEC80601-x, IEC61010-2-101 and some ISO standards; (2) the standard listed in IN9 is large, as compared to the previous standard list IN3, IN9. Most are three editions. It can be seen that Brazil has proposed the implementation of the three version of the standard, but whether mandatory, the current is mainly to see the local laboratory has the qualifications of the standard, if the Brazilian laboratory to obtain the standard three edition qualification, The standard is mandatory, the Brazilian laboratory will be gradually within this year to obtain all the standard three edition qualification. In addition, it is worth noting that if any of the special criteria on the list applies to your product, it means that INMETRO certification is mandatory; the test report provided by the enterprise must be within 2 years and is qualified (ILAC , EA, IAAC).