China Medical Device Market Entry Checklist for International Manufacturers

Product and evidence readiness

• Stable intended use, models and configurations
• Manufacturing sites and quality-system scope
• Existing registrations and marketing history
• Technical, performance and clinical evidence
• China labeling, language and claims plan

NMPA pathway readiness

Confirm the likely classification, applicant and representation structure, testing and clinical-evaluation questions, dossier gaps, translation needs and responsible specialists. Treat early estimates as planning inputs, not approval guarantees.

Commercial route readiness

• Target departments, users and purchasing route
• Distributor or direct operating model
• Import, inventory and service responsibilities
• Pricing assumptions and reimbursement or tender questions
• Training, complaint and post-market handoffs

Decision gates before launch

Define the evidence required to move from assessment to registration, from registration to partner appointment, and from pilot launch to wider investment. Each gate should have an owner, budget and stop condition.