Abridged Assessment of an IVD

An in vitro diagnostic (IVD) submitted for WHO prequalification may already have received stringent regulatory approval. Full assessment for prequalification could therefore entail duplication of effort. However, although prior regulatory approval may provide a level of assurance relating to the product's quality, safety and performance in countries where it is approved, this may not be the case in other jurisdictions, including resource-limited settings. In such cases an abridged assessment may be appropriate, the aim of which is to avoid duplication of effort and reduce the time taken to prequalify a product and focusing on aspects where WHO prequalification assessment brings added value.

WHO will review the pre-submission form and supporting documentation to determine whether the product qualifies for an abridged prequalification assessment. Products that do not qualify for abridged prequalification assessment will require a full prequalification assessment.

Decision to abridge prequalification assessment

The prequalification pre-submission form submitted by the manufacturer will:
  • provide information on the product submitted for prequalification
  • identify the regulatory version submitted for prequalification
  • enable WHO to determine the differences between existing regulatory versions of the product.

WHO will determine:

  • whether there is acceptable evidence of prior stringent assessment and approval for the product submitted for prequalification
  • whether the product is eligible for abridged assessment.

In order to be considered acceptable for abridged assessment, the product must meet the requirements for market entry in the respective regulatory jurisdiction. See the table below. If the regulatory version submitted for WHO prequalification differs from the version that underwent regulatory review by a founding member (i.e. Australia, Canada, Japan, USA or the European Union), of the Global Harmonization Task Force, WHO will compare the key differences between the stringent regulatory version and the regulatory version submitted for prequalification, specifically, differences in: product description; intended use; test procedure; labelling and instructions for use; quality management system; design; manufacturing site; key suppliers; verification/validation studies; and/or lot release criteria. Provided no substantial differences are observed, the product will be eligible for abridged prequalification assessment.

Regulatory authority Acceptable evidence
European Union European Commission (EC) Full Quality Assurance Certificate
EC Production Quality Assurance Certificate
EC Type-Examination Certificate
Health Canada Medical Device License and summary report for a Class IV IVD
CMDCAS-issued ISO 13485 Certificate
Therapeutic Goods Administration (TGA), Australia TGA Licence for Manufacture
TGA Issued ISO 13485 Certificate
AUST R Number
TGA Full Quality Assurance Certificate
TGA Type-Examination Certificate
TGA Production Quality Assurance Certificate
Japan Ministry of Health (JMHLW), Labour and Welfare JMHLW Minister’s Approval
JMHLW License for Manufacturer (seizo-gyo-kyoka)
JMHLW Recognised Foreign Manufacturer (gaikoku seizo-gyosya nintei)
US Food and Drug Administration Premarket Approval Process letter or Biologics License Application license

Note: In some cases, a product may have multiple regulatory versions and associated approvals and more than one of the different types of evidence specified "Acceptable evidence" column of the table above. Each of these approvals may support different aspects of the WHO requirements, further facilitating the abridged prequalification assessment. Therefore, it is important for the manufacturer to submit to WHO all available evidence of previous stringent regulatory approvals.

If the product successfully meets the WHO prequalification requirements, a summary of the product dossier review will be included in the WHO prequalification public report. This report may also include manufacturer’s commitments to prequalification to resolve findings from the manufacturing site inspection relating to the technical documentation.

Components of abridged assessment

Abridged assessment consists of:

  • performance evaluation including operational characteristics
  • manufacturing site inspection of abridged scope
  • labelling review.

Performance evaluation

Independent verification of its performance and operational characteristics is essential for any IVD submitted for prequalification. It also allows WHO to verify performance and operational characteristics that are considered essential for use in resource-limited settings. The data obtained complement the verification and validation data submitted by the manufacturer in the product dossier. Manufacturers can choose between performance evaluation organized by WHO and carried out by a specified WHO Collaborating Centre, or a designated laboratory. In the latter case, the manufacturer must both organize the evaluation and cover its cost.

Inspection of abridged scope

If a product qualifies for such an inspection, the manufacturer will not have to submit full quality management system documentation for a Stage 1 audit. But it will be requested to submit an information package that will assist WHO in preparing for the manufacturing site(s) inspection. The on-site inspection time will be limited and calculated for selected product(s) and key processes for that site.

Labelling review

Product labelling is reviewed as part of the pre-submission form, performance evaluation and inspection of manufacturing site(s).