Timelines for Medical Devices
Both WHO and applicants must complete applicable steps in the prequalification assessment and post-prequalification change assessment processes within defined deadlines.
WHO Target Review Deadlines
Assessment Type | WHO Target Review Time |
|---|---|
| Full Assessment | 270 calendar days |
| Abridged Assessment | 100 calendar days |
WHO's target review times (270 days for full assessment; 100 days for abridged) represent elapsed calendar time from the start of formal assessment. These targets include all WHO review activities (dossier review, site inspection, labelling review) conducted in parallel and communication of the prequalification listing decision. Time during which WHO is awaiting a manufacturer's response (e.g., CAP submission, revised labelling) pauses the clock and are not included within these targets. Similarly, if a manufacturer requests and is granted a deadline extension, this also pauses the clock.
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 | Manufacturers response time | |
| Dossier review component [1] | ||
| Dossier review | 90 days | NA |
| CAP submission (CAP1, CAP2) | NA | 30 days per round |
| CAP review (CAP1, CAP2) | 60 days per round | NA |
| Dossier amendment submission | NA | As agree with WHO |
| Dossier amendment submission | 60 days | NA |
| Manufacturing site(s) inspection | ||
| Stage 1 inspection | 30 days | NA |
| Stage 1 additional information submission | NA | 30 days |
| Additional information review | 30 days | NA |
| Scheduling of Stage 2 inspection | Up to 180 days from acceptance by WHO for assessment | Up to 180 days depending on availability of the manufacturer |
| Stage 2 inspection | 3-4 days | 3-4 days |
| Inspection report | 30 days | NA |
| CAP submission (CAP1, CAP2) | NA | 30 days |
| CAP review (CAP1, CAP2) | 30 days | NA |
| Labelling review component | ||
| Labelling review | 60 days | NA |
| Revised labelling submission | NA | 30 days |
| Revised labelling review | 30 days | NA |
| Prequalification decision after all assessment components complete | ||
| Prequalification decision and website listing (if accepted) | 10 days | NA |
[1] Commences once dossier screening complete letter sent to manufacturer
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 | Manufacturers response time | |
| Abridged dossier review component [2] | ||
| Abridged dossier review | 60 days | NA |
| CAP / Dossier amendment submission | NA | 30 days |
| CAP / Dossier amendment review | 30 days per round | NA |
| Manufacturing site(s) inspection | ||
| Information package review | 30 days | NA |
| Additional information submission | NA | 30 days |
| Additional information review | 30 days | NA |
| Scheduling of Stage 2 inspection | Up to 180 days from acceptance by WHO for assessment | Up to 180 days depending on availability of the manufacturer |
| Stage 2 inspection | 3-4 days | 3-4 days |
| Inspection report | 30 days | NA |
| CAP submission (CAP1, CAP2) | NA | 30 days |
| CAP review (CAP1, CAP2) | 30 days | NA |
| Labelling review component | ||
| Labelling review | 30 days | NA |
| Revised labelling submission | NA | 30 days |
| Revised labelling review | 30 days | NA |
| Prequalification decision after all assessment components complete | ||
| Prequalification decision and website listing (if accepted) | 10 days | NA |
[2] Commences with the receipt of QMS documents in the dossier
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Manufacturers may request deadline extensions during prequalification or changes assessment. Request must be:
- Submitted in writing by the manufacturer's authorized contact before the deadline. See 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 (calendar days) in which to provide a response |
WHO review time | Manufacturers response time |
| Dossier review (including CAP & amendments) | 6 months |
| Labelling review | 2 months |
| On-site inspection (inspection scheduling, stage 1 inspection, stage 3 inspection) | 6 months |
| Change assessment for prequalified MDs | 6 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.