Local production of quality and safe essential in vitro diagnostics and WHO PQ, WHO EUL and ERPD processes
February 23 & 24, 2021 from 12h to 15h30 (CET Geneva)
The Local Production and Assistance Unit (LPA) with strong support from the Prequalification IVD Assessment team and the Incidents and Substandard/Falsified Medical Products team from the Regulation and Prequalification Department in WHO Headquarters is organizing a special workshop that is intended for interested IVD manufacturers located in low- and middle- Income countries (LMIC) who wish to better understand the international medical device quality management system standard ISO 13485:2016, risk management standard ISO 14971:2019, and WHO guidance.
For some manufacturers who intend to produce priority medical products for WHO PQ of in vitro diagnostics, Emergency Use Listing (EUL) (e.g. COVID-19 devices), or Expert Review Panel for Diagnostics (ERPD), meeting WHO PQ requirements can be challenging. In addition, global initiatives to ensure harmonized regulation of in vitro diagnostics (IVDs) and other medical devices have resulted in changed regulatory requirements at national, regional, and global levels, which may be difficult to interpret. WHO’s LPA Unit helps LMIC manufacturers to understand and implement WHO PQ requirements and international standards through specialized PQ related technical assistance, capacity building and training workshops.
This training is intended for IVD manufacturers, medical device associations, Ministries of Health, and National Regulatory Agencies’ officials.