Research and development of medical technology, a vital sector of this multi-billion industry is limited to just a few countries around the globe where adequate financial resources and industry professionals are available. Worldwide, both public and private sector medical care systems import these new technologies and given this dynamic, the medical industry must communicate highly complex information in hundreds of languages to a vastly diverse international audience. This specialized information must be communicated in a way that is consistent with the OEM manufacturer’s documentation but also customized to comply with the importing country’s regulations. Translation is a crucial part of the distribution chain.
The United States Food and Drug Administration (USFDA) plays a highly participative role in setting medical regulatory standards around the world. Most recently an amendment to the agency’s policy on Human Subject Protection (21 CFR Parts 807, 812, and 81) specifically related to the acceptance of data from clinical studies performed outside of the United States for Medical Devices has been proposed. Under the current law the FDA will accept studies begun on or after November 19, 1986, submitted in support of a pre-market approval conducted outside of the United States if the data is found to be valid and the study was performed and compliant with the World Medical Association’s “Declaration of Helsinki” or the local laws of the research entity’s host country. Under this proposed new regulation the FDA will accept studies submitted in support of a pre-market approval only if the FDA is satisfied that the data presented are certified as scientifically valid and that the rights, safety and welfare of human subjects have not been violated. This regulation also encourages applicants to meet with FDA officials prior to the submission of an application that will be based solely on non-US clinical data. As advanced clinical research is routinely conducted outside of the US and taking into account the complexity of complying with these regulations and the risks involved, this work must be done by a translator experienced in the field of medical devices who is supported by a project manager that is knowledgeable about the regulatory environment of the target market.
As technologies continue to evolve, regulation of medical devices is in a constant state of flux. As well, government regulatory requirements mandate that medical devices comply with strict quality standards but there is good news – the general trend is towards standardization. International standards for medical devices are covered by ISO standards ICS 11.100.20 and 11.040.01. Additionally the requirements of each country may vary slightly. This series will examine the specifics of 3 major markets in Latin America. We’ll begin with a closer look at the regulatory environment in the blue-chip market of Brazil.
Brazil is an economic powerhouse on the Latin American continent as well one of the world’s fastest growing economies. According to industry figures, the global medical devices market was worth $266 billion in 2011(cit.) with Latin America accounting for $14.1 billion of that figure, with Brazil representing 30% of that figure .Brazil alone is expected to reach $8.4 billion in 2015.
Brazil is also a regional leader in medical device research and development. Medical devices in Brazil are regulated by the Agência Nacional de Vigilância Sanitária (ANVISA) whose medical device classification schemes are similar to those found in the European MDD 93/42/EEC. However, they are not completely identical. Europe divides medical devices into Class I, IIa, IIb and III, whereas Brazil uses class I, II, III and IV. These classifications are based on risk to the human body, with the lowest number classifying the device as low risk and the higher numbers representing a greater risk. It is vitally important to know the correct classification of your medical device prior to starting the ANVISA registration process. The multi – phase process of approval for medical devices begins with the determination of the device’s class or category and in the case of an electrically powered device, the National Institute of Metrology Standardization and Industrial Quality (INMETRO), Brazil’s electrical safety commission’s certification may be required.
Clinical trials in Brazil are well respected for their high ethical standards which are comparable to internationally recognized benchmarks. The overall process, however, is lengthy and requires several independent reviews for similar processes which are considerably redundant. Within the next 2 years the Ministry of Health has projected that 1.5 Billion USD (cit.) will be spent on clinical trials in Brazil. This figure is greater than the total investment made in the past 4 years combined. Regulatory entities are discussing changes in the approval process as outlined in “Resolution 346“. This regulation references the process of multi-centered research and aims to streamline the process to allow summarized information to be submitted all at once by a single ethics committee. At this stage, all relevant information regarding the device’s functionality, related clinical research, case studies and a purpose statement must be presented for approval to ANVISA in the Portuguese language. A local translation agency familiar with this process and the Brazilian market is a key element to ensure accurate information is presented, accepted and expeditiously approved. Depending on device classification Brazil may also require certification of general safety criteria according to Brazilian Good Manufacturing Practices (BGMP). Required quality audits are performed which may reduce exposure to the risk of costly litigation in the case of manufacturing defects as well as ensure product safety and integrity. Currently, these audits are performed by ANVISA every 2 years and require a self-audit to be submitted each alternate year. Proposed legislation that will likely pass in the near future will allow Good Manufacturing Practice audits performed outside of Brazil to be recognized and accepted by ANVISA.
Lastly, and of utmost importance, is the need to secure an experienced distributor that has the ability to promote and sell your product in the Brazilian marketplace. This critical link is imperative to ensure a high level of market penetration of the device. It is best to look for an experienced local distributor well-versed in marketing, logistics, distribution chain, local customs and language as well as the tributary procedures of Brazil’s government tax agency known as “Receita Federal”. To resolve these complex matters it’s essential that they are performed in Portuguese. An adept localization team can contribute to the overall level of success of your commercialization efforts. Win & Winnow Communications localization professionals are highly experienced in translation and localization for medical device regluation in Latin America. Contact us for an assessment of your needs.