APAC Medtech Approvals, 2026 H1: Filing and Clearance Volumes by Quarter
Filings grew every quarter while approvals fell twice. Registry counts by pathway, with live figures and grounded citations.
Executive summary
Across the first half of 2026, device filings in the APAC registries grew in every quarter while approvals fell twice. The gap is not a slowdown in review capacity: median time-to-decision held flat. It is a mix shift — a larger share of filings entered pathways that clear in the second half.
168 Q4 filings
37 Q3 approvals, the low point
61 Q4 approvals, recovered
203 days novel pathway median
Filings vs approvals
Where the gap sits
| Pathway | Filings | Median days |
|---|---|---|
| Standard clearance | 312 | 148 |
| Expedited | 96 | 61 |
| Novel pathway | 151 | 203 |
The novel pathway carries the growth and the wait. Its 203-day median puts every Q2 filing on a clearance clock that lands in Q4 — which is exactly where the approvals curve recovers.
References
- 510(k) Premarket Notification database, H1 2026 extract FDA 510(k) grounded
- Global Unique Device Identification Database, device registrations GUDID grounded