The QMN Weekly Bulletin
Medical Devices / Regulatory Affairs

Brazil Adopts Risk-Based Approach to Inspections

May 5, 2017
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Brazil’s National Agency for Sanitary Vigilance (ANVS) has introduced a risk-based approach to inspections for devicemakers.

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 a 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.

Classification is by type of company and device manufacturers can fall under any risk category depending on the product or products they make.

Companies are classified as:

  • High Risk Establishment: These companies have obligations prior to licensing, such as presentation of documents and records of previous inspections.
  • Low Risk Establishment: The manufacturer is exempt from pre-licensing requirements, for example, delivery of documents and records of prior inspections.
  • Information Dependent Risk: ANVS needs more information about the form or mode of operation of the company to determine if the activity is high or low risk.

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