SFDA Review Timelines
Approximate timelines by device class
SFDA review timelines depend on the device class, the completeness and quality of the technical file, and SFDA workload. The following are indicative timeframes:
| Step | Timeframe |
|---|---|
| Completeness check | 30–60 days from submission |
| Invoice issued and payment | Typically 7–14 days after check |
| Technical review (Class A) | 30–90 days |
| Technical review (Class B) | 60–120 days |
| Technical review (Class C) | 90–180 days |
| Technical review (Class D) | 120–240 days |
| Total (typical): Class A | 2–4 months |
| Total (typical): Class B | 3–6 months |
| Total (typical): Class C/D | 6–12+ months |
These timelines are indicative only. Actual timelines vary significantly based on query complexity, resubmission cycles, and SFDA workload. Manufacturers should build a safety margin of at least 2–3 months beyond the maximum indicative timeline into their market entry plans to account for unexpected delays.
Factors affecting review duration
- Completeness of the technical file — incomplete submissions are a major cause of delay
- Timeliness of query responses — late or incomplete answers extend the clock
- Device complexity — novel or innovative devices require more review time
- Number of bundled items — large device groups (up to 50 items) may take longer
- SFDA workload — periods of high submission volume can extend timelines
Query response timelines
When the SFDA issues a deficiency letter, the AR or manufacturer must respond within the timeframe stated in the query. Failure to respond within the timeframe may result in application withdrawal.