Global Medical Device Market Access Planner

Problem

Going global for medical devices is not just filing in one country. It is a path-planning problem shaped by product class, existing approvals, QMS maturity, and how target markets accept reference evidence. The order of market entry affects timelines, costs, and ongoing maintenance.

How It Works

The skill uses IMDRF regulatory convergence to break “prepare once, reuse across markets” into concrete planning steps:

• Confirm the product baseline: name, classification, existing CE, FDA 510(k), or NMPA approvals, manufacturer location, and ISO 13485 status.
• Rank target markets: EU, UK, US, Canada, Australia, Japan, China, Korea, Brazil, Saudi Arabia, Singapore, Malaysia, and Russia/EAEU, with expected timelines, core requirements, and reliance availability.
• Generate a route: for greenfield projects, it favors CE → MDSAP → TGA → FDA → Canada → ASEAN, using MDSAP audits, technical documentation, and UDI to reduce duplicate work.
• Estimate costs and reuse: Notified Body fees, annual establishment fees, QMS audits, registration testing, and post-market costs, with notes on markets that can serve as reference approvals.

Boundaries

Timelines and costs are planning estimates. Formal decisions still depend on the specific device class, clinical evidence, local rules, NB scheduling, authorized representatives, and labeling language. Some markets restrict reference certificates, local testing, or clinical data, so reliance pathways cannot be assumed automatically.