Post-prequalification requirements

Medical devices that meet WHO prequalification requirements are listed in the WHO List of Prequalified MDs.  After Prequalification, manufacturers of prequalified MDs must

• Fulfil prequalification commitments

• Conduct post-market surveillance

• Maintain compliance with relevant WHO Technical Specifications series/Technical report series documents

• Report any changes to the product after prequalification

• Pay an annual fee

• Allow routine and non-routine manufacturing site inspections

These requirements are described in detail in “WHO’s prequalification procedure for medical devices”, (see guidance section).

In addition WHO will undertake follow-up/surveillance inspections as part of post-qualification activities. Further information can be found on the WHO inspections service webpage.