Medical device testing in Brazil is now accepted by the OECD.June 30, 2023
Boosting the economy and international trade through scaling up Mutual Acceptance of Laboratory Data (MAD).
The National Institute of Metrology, Standardization and Industrial Quality (Inmetro), through the General Coordination for Accreditation (Cgcre), recently announced a significant achievement: the expansion of its scope of adherence to the acts of the Organization for Economic Cooperation and Development (OECD) related to the Mutual Acceptance of laboratory data (MAD). This new achievement is excellent news for the medical device sector, such as prosthetics and pacemakers, as well as for Brazilian testing facilities recognized by Good Laboratory Practices (GLP).
From now on, tests performed at these Brazilian facilities, using OECD methodologies and by GLP, will be accepted by OECD member countries, as well as by non-member countries that have full adherence to the Acts, such as Brazil. This expansion of the scope of mutual acceptance of data represents an important milestone, as it boosts international trade and strengthens confidence both in exporting Brazilian products and in importing products from other countries.
One of the main advantages of this process is the avoidance of double testing, which significantly reduces the time and costs involved in certifying medical devices. Furthermore, the mutual acceptance of data also helps to avoid non-tariff barriers to trade, facilitating the entry of Brazilian products into international markets. This means medical device manufacturers will be able to rely on a more efficient and streamlined process to obtain the necessary certification, resulting in benefits for both businesses and consumers.
Currently, the General Coordination for Accreditation (Cgcre) has 50 testing facilities recognized by Good Laboratory Practices (BPL) in various scopes. These facilities play a key role in ensuring the quality and safety of products, contributing positively to the country’s economy. Expanding the scope of adherence to OECD acts further strengthens the credibility of these facilities and their ability to deliver reliable and accurate results. It is important to highlight Brazil’s history of adherence to OECD Acts. In May 2011, the country, through Inmetro, obtained full adherence related to the Mutual Acceptance of Data (MAD) following Good Laboratory Practices (GLP) for agrochemical products and industrial chemical substances. Subsequently, in February 2015, the scope was expanded to include veterinary products, feed additives, cosmetics, pharmaceuticals, sanitizers, wood preservatives, and remediators. This achievement now extends to medical devices, providing even greater scope for mutual acceptance of data.
Licempre is proud to offer specialized consultancy and advisory services to companies wishing to obtain certification for their medical devices according to OECD and Good Laboratory Practice (GLP) requirements. Our team of specialists is ready to assist in the certification process, guaranteeing the compliance and regularity of devices in the national and international markets. With the expansion of mutual acceptance of OECD data, Brazil strengthens its position as a country committed to product quality and safety, promoting a favorable environment for international trade. This achievement is evidence of the country’s continued progress in its pursuit of excellence and compliance with international best practices.
Inmetro, through the General Coordination for Accreditation (Cgcre), remains committed to promoting the quality and safety of products in the Brazilian market, while seeking integration and international recognition. The expansion of the scope of adherence to OECD acts is an important step in this direction, benefiting both companies and consumers and contributing to the sustainable development of the country.
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