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Medical device testing in Brazil is now accepted by the OECD.

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.


How can I register my health product?

Como registrar o meu produto para saúde?

Licempre is a company specializing in the registration of health products, offering consultancy and advisory services to companies that seek to obtain the regularization of their products with competent authorities. With vast experience and knowledge in the area, Licempre has a team of highly qualified professionals who follow the entire registration process, from document analysis to obtaining the registration certificate. Our mission is to provide security and agility to our customers, ensuring that their products meet all legal requirements and are in compliance with current regulations.

By choosing Licempre to take care of the registration of your health products, you will have complete support, from the preparation of the necessary documents to the follow-up with the regulatory agencies. Our team is always up to date with regulations and industry requirements, ensuring an efficient and hassle-free process. Furthermore, Licempre offers a personalized service, understanding the particularities of each company and its products. Our goal is to simplify the registration process, providing all the necessary guidance and answering customer questions along the way.


Why do I have to register my product?

Por que preciso registrar o meu produto?

The regularization of health products is fundamental to guarantee the safety and quality of the products sold in the market. By obtaining registration, companies demonstrate their commitment to excellence and compliance, instilling confidence in consumers and regulatory bodies.

No matter the size of your company or the complexity of the product, Licempre is ready to assist you in all stages of registration. Our expertise and dedication make us the right choice for companies that seek agility, reliability, and positive results. If you need to register your health products and want to rely on a specialized company, contact Licempre.


We’re here to help you achieve regularization efficiently and securely, so you can focus on growing your business and meeting your customers’ needs.