FDA GUDID and AccessGUDID Procurement Verification Guide: DI Fields and Premarket Cross-Checks
Use FDA GUDID and AccessGUDID to verify device identity, then cross-check authorization and establishment registration in separate FDA databases.
Research archive
China & Global Biomed
Source-backed biomed industry news, regulation, clinical development, medtech, import/export platforms, and market signals. Not medical advice.
Tongue-Swab Tuberculosis Diagnostic Accuracy: Evidence Appraisal of a Multicenter Study and Public Health Deployment Boundaries
A 689-participant study found 84.1% tongue-swab sensitivity versus a composite reference and 99.7% specificity. Review the evidence limits.
FDA Establishment Registration Verification Guide
Verify FDA establishment registration and device listing with this 4-step CDRH database audit workflow for medical device exporters and buyers.
国家药监局第21号公告UDI实施解读：2027二类器械与一类IVD赋码、数据库上传及医保代码对接（已纳入医保代码数据库的产品适用）
2026年第21号公告规定2027年6月1日起全部二类器械及一类IVD须具备UDI并完成数据库上传；已纳入医保代码数据库的产品须完成医保代码对接。本文深度解读合规要求与四大误区。
FDA Foreign Drug Establishment Registration Guide
FDA foreign drug establishment registration: timing, site DUNS, U.S. agent and importers, annual renewal, SPL filing and approval boundaries.
FDA Labeler Code Checklist for Foreign Companies
FDA labeler code checklist covering DUNS, SPL submission routes, the 30-day update scope, and conditional two-year deactivation.
FXR0906 Clinical Trial China: Fosun Evidence Check
FXR0906 clinical trial China: what Fosun reported about NMPA clinical-trial approval, what remains unknown about Phase 1, and evidence boundaries.
FDA Global Generic Drug Affairs: Overseas Team Guide
What FDA Global Generic Drug Affairs does and does not do: Generic Drug Cluster, PSA pilot, and ANDA submission boundaries for overseas teams.
FDA Drug Registration and Listing: A Pre-Workshop Compliance Map for Manufacturers
FDA drug registration and listing compliance map: current SPL, EDRLS, and 510(j)(3) duties, plus the future 12-digit NDC timeline.