China
15 articles
China Volume-Based Procurement (VBP) for Medical Devices: Price Cuts & Strategy
Guide to China's NHSA volume-based procurement (VBP) for medical devices: round history, price cuts, provincial alliances, and multinational strategy.
Why FDA or CE Clearances Fail to Register Aesthetic Devices in China, Korea, and Brazil
A deep regulatory analysis of aesthetic device classification and registration pathway divergence across the US, EU, China, South Korea, and Brazil, mapping sequencing strategies and all-in costs.
Why One FDA/CE Clearance Opens Far Fewer CGM Markets: The Global Class-Divergence Map
A comprehensive cross-market analysis of continuous glucose monitor (CGM) classification, clinical trial requirements, and reimbursement gates across the US, EU, China, Japan, and Canada.
US Medical Device Imports Teardown: Why Mexico — Not China — Is America's #1 Source
A data-driven teardown of US medical device imports using the CEPII BACI dataset, analyzing the difference between core devices and the PPE/consumables basket.
China Medical Device Distributor and CSO Compliance Audit Checklist
Operational audit checklist for China medtech distributors, CSOs, and clinical application specialists to meet hospital reception and anti-bribery standards.
China Medical Device Sales Representative Compliance: 2026 Guide
Will China's 2026 Medical Representative Management Measures apply to medtech field teams? Learn how device and IVD firms should prepare for upcoming rules.
China NMPA Device Registration: 14,187 Approvals, Import Mix, and Foreign Wins
A data-driven analysis of China's NMPA medical device registry database. Discover approval volumes, import vs. domestic splits, and strategic pathways for foreign device makers.
NMPA Flight Inspections: Preparing for China's Unannounced Audits Under Order 14
A regulatory guide to China NMPA flight inspections under Decree No. 14. Understand unannounced triggers, inspector powers, and GMP readiness for manufacturers.
IVD Registration Compared: FDA 809, EU IVDR, China, Brazil & India
Side-by-side legal-text comparison of IVD registration: FDA 21 CFR Part 809, EU IVDR 2017/746, China SAMR Decree 48, Brazil RDC 830/2023, India MDR 2017 — classes, pathways, who reviews.
QMS/GMP Compared: FDA QMSR, Brazil RDC 665, Mexico NOM-241 & China
Legal-text comparison of medical device quality systems: FDA 21 CFR Part 820 (QMSR), Brazil RDC 665/2022, Mexico NOM-241-SSA1-2025, and China Order 53 — scope, certification, and audit.
UDI & Labeling Compared: FDA 801/830, EU MDR, Mexico NOM-137 & China
Legal-text comparison of medical device UDI and labeling: FDA 21 CFR Parts 801 & 830, EU MDR Article 27/Annex VI, Mexico NOM-137-SSA1-2025, and China Order 6/2014 — carriers, databases, and language.
Asia-Pacific Medical Device Registration: Market Comparison and Entry Strategy (2026)
Compare medical device registration across APAC markets — China, Japan, South Korea, Australia, Singapore, India, ASEAN — including timelines, fees, reliance pathways, and strategic entry order.
Medical Device Post-Approval Change Management: FDA, EU MDR, and Asian Markets (2026)
When device modifications require new regulatory submissions in the US, EU, Korea, Japan, and China — FDA special 510(k), PMA supplements, EU MDR significant changes, and Asian pathways.
Medical Device Regulatory Consulting Hourly Rates by Region (2026)
Benchmark medical device regulatory consulting rates by region and consultant tier, with cost drivers and budgeting guidance for registration projects in major markets.
China NMPA Medical Device Registration: The Complete Guide for Foreign Manufacturers
How to register medical devices with China's NMPA — classification, documentation, clinical requirements, testing, timelines, costs, and practical guidance for market entry.