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Timelines

Timelines

⚠️ Important Update – Changes to WHO’s Prequalification of IVD Assessment Procedure (from 2026)

Starting in 2026, WHO will introduce a new prequalification assessment procedure. The performance evaluation will no longer be part of the prequalification assessment and will become a separate procedure.

The information on this webpage reflects these upcoming changes. If you have any questions, please email WHO’s Prequalification of IVDs team at diagnostics@who.int.

WHO Prequalification Assessment Timelines and Processes

 

Overview

Both WHO and applicants must complete applicable steps in the prequalification assessment and post-prequalification change assessment processes within defined deadlines.

These timelines apply to all applications received on or after 1 January 2026.

WHO Target Review Deadlines

Assessment Type

WHO Target Review Time

Full Assessment270 calendar days
Abridged Assessment100 calendar days

These timelines include WHO’s time to:

  • Review the dossier (full or abridged)

  • Inspect manufacturing site(s)

  • Review product labelling

  • Communicate the prequalification listing decision

Note: The pre-submission form review and dossier screening stages are used to confirm the completeness of an application. They are not part of the assessment and therefore have no associated timelines for WHO or the applicant.

WHO also aims to complete:

  • Dossier screening rounds within 30 days

  • WHOPAR drafting within 30 days (after prequalification listing)

 

Applicant response timelines 

Response timelines are specified in all official WHO correspondence to manufacturers.

WHO provides several support mechanisms to help applicants understand requirements and meet timelines.
For assistance, contact  diagnostics@who.int 

 WHO review begins after payment of required fees. The dossier review, site inspection, and labelling review occur in parallel.

Assessment stage
Maximum time allowed (calendar days) in which to provide a response
WHO time Manufacturer response time
Dossier review component [1]
Dossier review90 days N/A
CAP submission (CAP1, CAP2)N/A30 days per round
CAP review (CAP1, CAP2)60 days per roundN/A
Dossier amendment submissionN/AAs agree with WHO
Dossier amendments review60 days N/A
Manufacturing site(s) inspection [2]
Stage 1 inspection30 daysN/A
Stage 1 additional information submissionN/A30 days 
Additional information review30 daysN/A
Scheduling of Stage 2 inspectionUp to 180 days from acceptance by WHO for assessmentUp to 180 days depending on availability of the manufacturer
Stage 2 inspection3–4 days 3–4 days
Inspections report30 daysN/A
CAP submission (CAP1, CAP2)N/A30 days
CAP review (CAP1, CAP2)30 daysN/A
Labelling review component
Labelling review60 daysN/A
Revised labelling submissionN/A30 days
Revised labelling review30 daysN/A
Prequalification decision after all assessment components complete
Prequalification decision and website listing (if accepted)10 days N/A

[1] Commences once dossier screening complete letter sent to manufacturer

[2] Commences with the receipt of QMS documents in the dossier

 

Like the full assessment, WHO’s review starts after fees are paid. The abridged dossier review, site inspection and labelling reviews occur in parallel.

Assessment stage
Maximum time allowed (calendar days) in which to provide a response
WHO time Manufacturer response tim
Abridged dossier review [3]
Abridged dossier review60 days N/A
CAP/Dossier amendment submissionN/A30 days
CAP / Dossier amendment review30 daysN/A
Manufacturing site inspection [4]
Information package review30 daysN/A
Additional information submissionN/A30 days 
Additional information review30 daysN/A
Scheduling of Stage 2 inspectionUp to 180 days from acceptance by WHO for assessmentUp to 180 days depending on availability of the manufacturer
Stage 2 inspection3–4 days 3–4 days
Inspections report30 daysN/A
CAP submission (CAP1, CAP2)N/A30 days
CAP review (CAP1, CAP2)30 daysN/A
Labelling review
Labelling review30 daysN/A
Revised labelling submissionN/A30 days
Revised labelling review30 daysN/A
Prequalification decision after all assessment components complete
Prequalification decision and website listing (if accepted)10 days N/A

[3] Commences once dossier screening complete letter sent to manufacturer

[4] Commences with the receipt of the information package

 

Stage 
Maximum time allowed (calendar days) in which to provide a response
WHO review time
Manufacturer response time
Change request screening (S1)30 daysN/A
Submission of additional information (if applicable)N/A30 days
Screening of additional information (S2)30 daysN/A
Assessment (R1 review)60 daysN/A
Response to R1 review (if applicable)N/A30 days
R2 review60 days N/A
Final response to R2 review (if applicable)N/A30 days
R3 review (if applicable)60 days N/A

Requesting time extension

Manufacturers may request deadline extensions during prequalification or changes assessment. Requests must be:

  • Submitted in writing by the manufacturer’s authorized contact before the deadline. See In Vitro Diagnostics Key Contacts for relevant person(s) to contact.
  • Accompanied by a justification.

If more time is required than WHO allows, the applicant may be asked to withdraw and reapply later.
 

Assessment stage
Maximum extension allowed
Dossier review (including CAP & amendments6 months
Labelling review 2 months
On-site inspection (inspections scheduling, stage1 inspection, stage 2 inspection6 months
Change assessment for prequalified IVDs6 months

 

Failure to comply with deadlines

Failure to comply with deadlines without prior notice or justification will result in termination of the application.

If WHO determined that the necessary amendments or actions cannot be completed within the allowable time, WHO may recommend withdrawing the application from the process.