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How to surf LATAM's regulatory issues, perspectives from Brazil

Article-How to surf LATAM's regulatory issues, perspectives from Brazil

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Brazil has gained international visibility in the health control of medical devices with the development of governance practices and a regulatory model.

Brazil represents the largest medical device (MD) market in South America and thus, it is a much sought-after destination for several manufacturers around the world, with commercial interest in launching their products.

According to the Brazilian Alliance of Innovative Health Industry (ABIIS), edition 45 of the Economic Bulletin, in the accumulated period from January to December 2023, the US was the main country of origin of Brazilian imports of MDs, of which Brazil purchased $879 million — or 17.2 per cent of the 5,101 billion in MD imports. Countries like Germany (15.8 per cent) and China (11.4 per cent) were also important product suppliers for Brazil.

The Bulletin also states that the US was the main supplier of MDs for Brazil in 11 market segments. In another five segments, China is the main supplier. In the IVD reagents segment, Germany appears as a relevant player.

The Brazilian National Health Surveillance Agency (ANVISA) regulates all health-related products. It is mandatory to have a local legal representative for product liability, and the local legislation classifies the MDs depending on the nature of the application or operation and the intrinsic risk they pose to the health of the patient, operator or third parties involved. The definition of the need for safety and efficacy documents is entirely related to the classification of the product, depending on its nature and risk class.

MDs are classified into four risk classes (RDC 751/2022 DMs; RDC 830/2023 IVDs) that differ in classification rules considering whether the product is active in terms of action or energy conversion; whether it is invasive or non-invasive in terms of applicability; and in relation to the length of stay with the patient, whether it is transient, short or long-term. For higher-risk MD (classes III/IV), the presentation of clinical studies to prove efficacy and safety is mandatory.

On the other hand, products that fall into risk classes I/II undergo a simplified notification process, and the presentation of clinical studies, in this case, is only required when the product is considered innovative in design, raw material or indication for use. In the current days, there are still challenges for foreign manufacturers to enter the Brazilian market, and this includes local-specific certifications such as INMETRO (National Institute of Metrology, Quality and Technology); integration of Brazil’s local requirements into the R&D stages and Clinical Evaluation for innovative and risk class III/IV products.

Another challenge is to face the long line for license approval. For implantable and orthopedics products, for example, the timeline for approval can take around 12 months. For other products (equipment and IVD) the scenario is more favorable, with shorter timelines (around three to six months).

Globalization and the fast advancement of new technologies have presented a major challenge to all regulators around the world. According to ANVISA, the volume of submissions along with the complexity of documentation (complex and diverse studies) for analysis, as well as an increase in external demands, and the shortage of human resources has been a constant challenge faced by the General Management of Technology and Health Products (GGTPS), prolonging the estimated time to complete the submissions’ analyses.

In the last two decades, Brazil gained international visibility in the health control of MD, developing governance practices and promoting arrangements in the regulatory model to align with the global convergence scenario. To support this mindset, ANVISA’s Strategic Plan developed for the period from 2024 to 2027 has priorities related to the Agency's essential responsibilities and to face the challenges and needs of a future that is already present in Brazil's health regulation.

As defined within the Strategic Objectives, obtaining recognition as an international reference health authority is one of the agencies’ priorities. The Strategic Plan also mentions that, in an era of global healthcare public partnerships, regulatory agencies have sought the alignment with global dynamics of interdependence and regulatory trust practices (reliance) for products and health services, facilitating the approval of medicines, vaccines and MDs.

Several actions are already implemented and in force, facilitating the approval processes for the registration of MDs imported into Brazil. Regarding Good Manufacturing Practices Certification, ANVISA has already implemented two initiatives:

1. Brazil is part of the Medical Device Single Audit Program (MDSAP) that allows manufacturers of MDs to hire an Auditing Body, authorized within the scope of MDSAP, and carry out a single audit that will cover the relevant requirements of Participating Regulatory Authorities. It replaces the necessity of an audit performed by ANVISA in manufacturing units of MDs.

2. The validity of the Certificate of Good Manufacturing Practices issued by ANVISA for MD manufacturers granted through MDSAP was extended from two to four years, through the publication of the RDC 850/2024.

With regards to the MDs submissions, ANVISA published the IN 290/2024, which establishes the process to leverage authorization from an Equivalent Foreign Regulatory Authority (AREE). It applies only to Class III/IV MDs and IVDs, which are subject to a more complex regulatory process in Brazil. The AREEs include the following — Australia Therapeutic Goods Administration (TGA), Health Canada, FDA and Japan Ministry of Health, Labor and Welfare (MHLW) — bringing many expectations of positive impacts as it establishes the optimized procedure for the review and decision of submissions for registration of MDs.

With this approach, ANVISA expects to have a simplification of submission analysis and better use of the workforce. These improvements are already adding value to the MDs area and the expectation is to have a 30 per cent decrease in the timeline for the risk class III/IV license approvals.

In conclusion, it is quite clear that ANVISA is aware of the existing challenges. On the other hand, their improvements show that the Agency will not spare efforts to be an innovative and reliable health authority to the whole world. Stepping into Brazil’s market has its complexities, it can be challenging, however, Brazil is the largest MD market in Latin America, therefore, persistence will prove itself to be worth all the effort.

Laura Baroni

Laura Baroni is the Regulatory Affairs Analyst at Vera Rosas Group in Brazil. She will be speaking at the “Main Regulatory Issues for LATAM — How to Surf LATAM's Regulatory Issues” session on June 20 at 11am.

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