WHO global benchmarking tool plus rev. VI+ ver. 1 - Market Surveillance and Control (MC)

Overview

Market surveillance and control function plays a crucial role in assuring medical products consumer safety since its objective is to ensure compliance of the products placed on the market with pre‐set criteria for quality, safety and efficacy (i.e., verify compliance with marketing authorization and good practices guidelines). Market surveillance and control function activities are primarily concerned with four themes: control of import activities, prevention and detection of and response to substandard and falsified medical products, market surveillance program for monitoring the quality of medical products throughout the supply chain, and (4) control of promotional, marketing and advertising activities. The aforementioned activities may or may not be undertaken by a single entity (e.g., organization, division, or department). 

A general limitation to one of the market surveillance and control function activities exists in countries where advertisement is not allowed or is restricted to specific medical products (e.g. over‐the‐counter medical products). However, in all cases, control of marketing and promotional materials (i.e., in its wider meaning that includes promotion to healthcare professionals) will always apply.