Complaints Handling by WHO
WHO will investigate any complaint concerning a prequalified in vitro diagnostic (IVD) that is communicated to WHO by end users or by manufacturers. (Product complaints can be submitted by completing a product complaint form. (See WHO guidance document on post-marketing surveillance for IVDs.) First, it will notify the manufacturer and, depending on the nature of the complaint, may also notify national regulatory authorites, other relevant authorities of any interested WHO Member State and/or interested UN agencies of the complaint.
WHO reserves the right to use, publish, issue, share with with relevant authorities of WHO Member States as well as with UN agencies and other relevant intergovernmental organizations, and/or make publicly available (taking into account the need to protect commercially-sensitive information) any outcomes, reports and/or results — whether in draft or final form and whether positive or negative — of:
- any investigation relating to a complaint concerning any product and/or prequalified product: product complaints can be submitted by completing a product complaint form
- any field safety corrective action
- any WHO Notices of Concern, WHO Notices of Suspension or WHO information notices for users
- any field safety notices issued by the manufacturer
- any confidential information to which WHO may gain access in the course of any of the foregoing.
WHO will review the investigation conducted by the manufacturer to ensure that it complies with scientific principles and is in accordance with international guidance and standards. WHO reserves the right to request a special inspection to verify that correction and corrective actions have been implemented.