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 are indicative
Actual timelines vary significantly. Query responses, resubmissions, and SFDA workload can extend review periods. Manufacturers should build sufficient lead time into market entry plans.
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.