Latest Articles
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China GMP inspections: outsourcing registrants from November 2026
Prepare for 1 November 2026 with a verified comparison of the registrant’s and manufacturer’s minimum inspection chapters, graded requirements and release responsibilities.
QMSR Warning Letters 2026: The ISO 13485 Records FDA Named
Four posted FDA warning letters cite ISO 13485:2016 Clause 7.1 and name the missing records. Pull those first, then management-review and audit reports.
ISO 14971 Risk Files: Evidence and Review
Use recall data, regulatory sources and worked examples to review risk controls and the evidence supporting release.
In-Country Representatives and Registration Holders: 2026 Guide
Who holds the file matters when a distributor changes. Compare local roles, handover documents, transfer conditions and the full annual cost before appointing a partner.
One Device, Three UDI Databases (2026): Build the US, EU and China Work Order
Shared identifiers need separate regulatory mappings. Use corrected database evidence, product-specific calendars and a scoped cost breakdown to plan the work.
Medical Device Technical File Compilation Cost (2026): Build, Buy, or Hybrid?
Technical-file quotes are incomparable until scope, writing, gap closure, reviewer responses, lifecycle maintenance, and authority fees are separated. This report combines public price lines, FDA workload data, EU survey evidence, and a break-even model to show when to build internally, buy a project, or use a hybrid team.
Medical Device Registration Verification 2026: What 15 National Public Data Files Actually Contain
A public register is not a market map. This workpaper names what one row means, which identity fields are filled, and where verification still needs in-country evidence.
Coronary Stent Global Market Access 2026: Class III Almost Everywhere
Coronary stents sit at the highest regulatory tier across major markets. This report maps four US regulatory objects, the PMA supplement lifecycle, eight market-access files, public register evidence, postmarket limits, government fees and a sequencing plan for manufacturers.
Surgical Robot Global Market Access 2026: One Platform, Eight Regulatory Files
Surgical robots do not follow one regulatory class or one reusable filing. This research report maps the public records across eight markets, showing how architecture drives FDA classification, why one platform becomes dozens of registration objects, where clinical evidence controls the schedule, and what government and in-country representation fees actually cost.
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