Brazil’s ANVISA Proposes Extending Device Licenses to 10 Years

Brazil’s National Agency for Sanitary Vigilance is seeking industry comments on a proposal that would extend licenses for medical devices from five years to 10 years.

The move would cut costs for industry and also reduce bureaucratic layers at the regulatory authority.

Brazil recently introduced a risk-based approach to inspections for manufacturers and distributors of medical devices, and has engaged in numerous international initiatives aimed at regulatory convergence.

Previously, Brazilian companies seeking licenses had to first request on-site inspections from local health authorities, undergo inspections, and obtain inspection reports before applying for the mandatory federal license. Under the new, risk-based system, low-risk facilities will be exempt from certain pre-licensing requirements. Companies importing or distributing medical devices need to comply.

Foreign companies need to have a local representative to manufacture or distribute medical devices in Brazil.

The new risk-based system also streamlines Brazil’s rules for certifying good manufacturing practices. The system is similar to the European Medical Devices Directive 93/42/EEC, which assigns risk under four tiers. Low-risk Class I and II devices are exempt from certain pre-licensing requirements and require less technical data. High-risk devices have additional obligations prior to licensing, such as presentation of documents and records of previous inspections. Higher risk devicemakers need to provide a technical dossier that is based on the International Medical Device Regulators Forum standards.

Brazil also participates in the Medical Device Single Audit Program (MDSAP), which is on track for full implementation in 2019. MDSAP was devised to leverage regulatory resources into a single audit program so manufacturers do not face multiple inspections. The regulatory authorities currently participating in the MDSAP program are: Australia’s Therapeutic Good Administration; Brazil’s ANVISA; Health Canada; Japan’s Ministry of Health, Labor and Welfare; and the U.S. FDA.