FDAnews Device Daily Bulletin
Medical Devices / Regulatory Affairs

Brazil Begins Risk-Based Assessment for Sanitary Manufacture Licensing

May 5, 2017

Brazil’s National Agency for Sanitary Vigilance (ANVS) has introduced a risk-based approach to health inspection for manufacturers and distributors of medical devices based on degree of risk.

Previously, all Brazilian companies seeking sanitary 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.

While the classification system applies mainly to domestic device manufacturers, the agency cautions that anyone importing or involved in warehousing and distribution of medical devices will need to be aware of the new system for sanitary risk assessment. The new system streamlines Brazil’s rules for certifying sanitary manufacturing practices for nearly every type of economic activity—from food processing to making instruments for radiology or other medical imaging.

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