The laboratory testing regulatory function ensures that the National Regulatory Authority can assess the quality of medical products by conducting quality tests in various situations. This may include verifying a manufacturer’s test results and performance claims during the marketing authorization process or during variations to an existing authorization.

Testing may also be required for lot release of certain products, based on national regulations and for products subject to complaints, adverse event investigations or reports. As part of market surveillance, laboratory testing helps confirm the quality of products on the market and detects substandard or falsified products. It is a key regulatory function, supporting the efficacy, safety and quality of medical products throughout their life cycle.

Data from these tests are critical for regulatory actions and public health interventions. National quality control laboratory personnel are responsible for conducting investigations, performing quality control analyses using appropriate methods and equipment, and generating technical reports to inform regulatory decisions.