WHO global benchmarking tool plus rev. VI+ ver. 1 - Laboratory Testing (LT)

Overview

The laboratory testing regulatory function is intended to ensure that the National Regulatory Authority (NRA) is able to assess the quality of medical products by performing quality tests on them in certain situations. For example, this testing can be a requirement to corroborate manufacturer’s test results as a part of the evaluation for marketing authorization or for a variation to a marketing authorization. Testing can be a requirement for lot release for certain products depending upon national regulations. Testing also may be needed for products for which there has been a complaint or a report or for products that are under investigation due to an adverse event. As part of the market surveillance function, laboratory testing is utilized for checking and confirming the quality of medical products placed on the market and for detecting substandard and falsified medical products. In order to do this product testing, the NRA must have access to suitable laboratories where these tests can be performed.