17 November 2020, WHO launch of global strategy for cervical cancer elimination
WHO Division of Access to Medicines and Health Products develops guidance, norms and standards to support cancer screening, diagnosis, and treatment, including: vaccines, in vitro diagnostic medical devices (IVDs), medical devices, and medicines. These health products are used throughout the health care system in primary care, hospitals, laboratories.
Today, we present the following WHO information product developed by the WHO Department of Regulation and Prequalification to support Member States to strengthening their capacities towards cervical cancer elimination:
WHO guidance on post-market and market surveillance of medical devices including IVDs.
This document provides an overview of proactive and reactive procedures for post-market surveillance that manufacturers of IVDs will implement. The guidance emphasizes reactive post-market surveillance through collecting and evaluating feedback, and any required actions to correct and prevent recurrence. It also provides an overview of the market surveillance activities that are the responsibility of National Regulatory Authorities. Users are provided with simplified tool to report their feedback on use of medical devices
WHO guidance on post-market and market surveillance of medical devices including IVDs will be available soon. If you would like to receive the guidance, please send an email to Ms. Anita Sands sandsa@who.int with copy to rapidalert@who.int
WHO will issue a policy brief that is specific for post-market and market surveillance for cervical cancer screening, diagnosis and treatment programmes.
Please click here to access the draft guidance
