Regulatory
408 articles
21 CFR Part 4: Combination Product cGMP Quality Systems for Drug-Device Manufacturers
How drug-device combination product manufacturers implement quality systems under 21 CFR Part 4 — streamlined approach, QMSR update, design controls, stability, and EU MDR Article 117.
FDA 510(k) Fees: MDUFA V User Fee Schedule and Total Cost Breakdown
Complete guide to FDA 510(k) user fees for FY 2026 under MDUFA V, including the $26,067 standard fee, $6,517 small business fee, $11,423 establishment registration, waivers, and total project cost.
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.
Veterinary Medical Device Regulation: FDA CVM, EU Gaps, and Global Strategy
How veterinary medical devices are regulated under FDA CVM, EU frameworks, and key global markets. Covers classification gaps, 510(k) exemptions, off-label use, and market entry strategy.
FDA Prior Knowledge Framework for Cell and Gene Therapy: Draft Guidance June 2026
FDA's June 2026 draft guidance on reusing CMC, nonclinical, and clinical prior knowledge to accelerate gene therapy development, and its interaction with the Plausible Mechanism Framework.
UK MHRA International Reliance Pathway: Draft Regulations 2026 Analysis
MHRA's draft Medical Devices Regulations 2026: International Reliance Pathway for US, Canada, and Australia approvals, IVD reclassification, PCCPs for AI software, and what manufacturers must prepare.
Australia ARTG Sponsor Map: Who Controls Market Access for 63,000 Devices?
Analysis of Australia's ARTG reveals 3,377 sponsors managing 63,131 device listings — top 10 sponsors control 22%, and Emergo Australia represents 375 overseas manufacturers.
Bahrain NHRA: 3 ARs Hold 55% of Devices — Small GCC Market Channel Lock-In
Bahrain NHRA device database analysis: 62 ARs manage 1,491 devices, top 3 hold 55%, all tracked licenses expired, and manufacturer-AR lock-in is high. GCC channel strategy implications.
Canada MDALL Class III/IV Analysis: US Companies Hold 48% of High-Risk Listings
US companies hold 48% of Canada's 57,000 Class III/IV MDALL listings. Median device age is 9.7 years and 49% of devices are over a decade old. Full data analysis.
FDA 510(k) Exemptions for Unclassified Devices: June 2026 Guidance Update
FDA's June 5, 2026 guidance adds five unclassified device product codes to the 510(k) exemption list. Covers all 13 codes, enforcement policy, remaining obligations, and next steps.
KIMES 2026: 977 Exhibitors, 78% Korean, Surgical Leads — Korea Export Push
KIMES 2026 exhibitor analysis: 977 companies, 78% Korean, surgical devices lead at 259 exhibitors, 94% export-ready. China tops international pavilion with 81 companies.
Korea MFDS: J&J, Medtronic, Stryker Dominate High-Risk Device Imports
Korea MFDS data shows 13,117 licence holders manage 273,672 registrations. Top 20 holders control 14.4%. US firms dominate Class III/IV imports at 30.4%.
Malaysia MDA: 2,462 Establishments, 23% Expiry Cliff, J&J at 58% Renewal
Malaysia MDA 49,198-row device dataset reveals 2,462 establishments with top-20 concentration at 18.7% and 11,438 devices expiring by end 2027. Data-driven establishment selection insights.
Medical Device Cybersecurity Is Now a Procurement Gate: 2026 Hospital Buying Data
RunSafe's 2026 Index: 56% of hospitals reject devices over cybersecurity, 35% won't buy without an SBOM, and 84% include security in RFPs. What manufacturers must do now.
Mexico COFEPRIS Registration Holders: 5,286 Holders and the 2024 Volume Surge
Analysis of Mexico's 16,473 COFEPRIS registrations reveals 5,286 holders, 60% single-registration, diagnostics dominance at 37%, and a 2024 record peak.
Qatar's 2,623 Implantable Devices: 62% in 20 Suppliers, Lebanese Lock-In
Qatar MoPH implantable device register: 2,623 devices, 171 suppliers, top 20 control 62%. Lebanese distributor dominance and single-supplier manufacturer lock-in analyzed.
Saudi SFDA AR Concentration: 1,608 ARs, 35% in 20 Hands, 13,700 Expiry Cliff
Saudi SFDA 56,737-row device database: 1,608 ARs, top-20 concentration at 35.4%, and 13,717 devices expiring 2026-2027. Data-driven AR selection insights.
UAE EDE: 10 Suppliers Control a Third of All Medical Device Registrations
UAE EDE data shows 10 suppliers control 33.7% of 4,793 medical device registrations. Cigalah, Pharmatrade lead. US tops country of origin at 16%. Dubai holds 63.5% of registrations.
FDA 510(k) Application: Submission Components and Format Requirements
Every section of an FDA 510(k) application explained — cover sheet, indications for use, device description, SE discussion, testing, labeling, software, and the eSTAR template structure.
FDA 510(k) K-Number: How to Decode It, Find It, and Use It for Regulatory Intelligence
What the 510(k) K-number means, how the format encodes the year and sequence, and how regulatory professionals use K-numbers for predicate research, competitor tracking, and submission management.