Anvisa, the Brazilian health surveillance agency, updated its regulations on clinical trials for medical devices to speed up the process.

"Clinical trials, which are necessary for the development of new medicines and health products, will gain more agility in the country," said Anvisa in a press release to announce resolution RDC 10 of 2015 that sets out guidelines to carry out trials for Class III and IV devices, updating regulations that date back to 2008.

"[The resolution] adopts a harmonized regulatory model with the main international agencies, considering the aspects of technical documentation submission and good clinical practice as well as offering higher quality and administrative efficiency for the evaluation of clinical trials in scope of Anvisa," the federal agency added.

With faster evaluation of research applications, Brazil is looking to attract more of this type of studies, which help the country by transferring knowledge and resource, said Anvisa.

"A greater number of clinical trials being conducted in the country also brings greater possibilities for Brazilian citizens to have a chance to participate in drug trials and have access to products still in development phase," the agency said.

The med-tech sector has long been waiting for these rules, said Marcelo Brisolla, country managing director of Emergo Group (Austin, Texas) in Brazil.

"We've had a long time without the regulation," he said. "We expect that we can improve the clinical trials in Brazil," Brisolla added.

Brazil's regulatory landscape is increasingly dynamic and rules are frequently changing. This creates a concern, said Brisolla.

"The rules are not enough to create a legal certainty [that brings] a stable ambience for companies to work here," he said.

"We expect to improve this legal environment, so companies could start doing more clinical trials in Brazil and we expect shorter times to do it," said Brisolla. "This is what we expect, and Anvisa as well. We'll be better than in the past when you had to wait a long time without answers and it was complicated."

With these new rules, companies willing to conduct clinical trials in the Latin American country should have an easier time deciding how to present their dossiers.

"[Anvisa] defined a deadline to analyse the dossiers, they have the deadline of 90 days to analyze [dossiers] for class III and class IV devices," Brisolla said.

"In the past [the problem] was the long time that Anvisa had to analyse the dossiers, it could take up to one year [or even] year and a half [to get a response from the agency]," Brisolla said. "It was so complicated and [there were no] specific rules."

To introduce these changes, Anvisa held public consultations 2014, which included the participation of the Brazilian clinical research sector. According to Anvisa, key players in the sector submitted 641 comments during the discussion of the project´s draft.

The federal agency is taking significant steps to cut red tape. Almost one year ago, Anvisa´s backlog for studying dossiers for med-tech registration processes in the Latin American country was quite substantial and only for class III and IV devices, there were 299 processes pending review. (Medical Device Daily, Apr. 3, 2014; Aug. 11, 2014).

However, dossiers submitted under the new rules will be screened through different legal teams inside Anvisa.

"This is through a different channel," said Brisolla. "It will not have impact on the applications of registration [of new med-tech products]," he added and remarked that the group that will analyse these dossiers is a different one from the one that processes the registrations. "It is another area," he said.

The new regulation is in line with the Latin American country´s investment in research and development,

"By 2015, the Brazilian Ministry of Health plans to invest $1.5 billion in research of new drugs, treatments, vaccines, and devices," wrote in a 2012 publication John Andrews and Eduardo Pizolato, director of regulatory affairs for the Americas for Chiltern International (Slough, UK), and the company´s regulatory affairs officer for Brazil at Chiltern Pesquisa Clínica (Sao Paulo, Brazil), correspondingly.