Step 1 of 4 · Classify phase

Classify

Determine the correct regulatory classification for your medical device across different markets. MedTech-AI provides guidance on EU MDR/IVDR classification (Class I, IIa, IIb, III), FDA classification (Class I, II, III), and classification systems in Canada, Australia, Japan, China, and more.

Understand classification rules, risk categories, and intended use definitions. Learn how device features, invasiveness, duration of contact, and therapeutic purpose affect classification. Get clarity on borderline products and combination devices.

Accurate classification is critical—it determines your regulatory pathway, conformity assessment requirements, and time to market.

Classify capabilities

  • EU MDR/IVDR classification rules (Class I, IIa, IIb, III)
  • FDA device classification and product codes (Class I, II, III)
  • Health Canada Medical Device Classification (Class I-IV)
  • TGA Australia classification (Class I, IIa, IIb, III, AIMD)
  • PMDA Japan classification and approval categories
Example: "How do I classify a non-invasive blood glucose monitor?" → Likely Class IIa under EU MDR (Rule 5: monitoring physiological process) and Class II under FDA.
Step 2 of 4 · Register phase

Register

Navigate regulatory pathways for device registration across global markets. MedTech-AI provides step-by-step guidance on conformity assessment procedures, notified body selection, clinical evaluation requirements, and technical documentation standards.

Understand CE marking requirements under EU MDR, FDA 510(k) clearance and PMA approval processes, Health Canada licensing, TGA Australia registration, and pathways in Japan, China, South Korea, and other key markets.

Access information on registration fees, timelines, required testing (biocompatibility, electrical safety, EMC), quality management system requirements (ISO 13485), and post-market surveillance obligations.

Register details

  • EU: CE marking under MDR/IVDR with notified body conformity assessment
  • USA: FDA 510(k) clearance, PMA approval, or De Novo classification
  • Canada: Health Canada Medical Device License (Class II-IV)
  • Australia: TGA inclusion in ARTG (Australian Register of Therapeutic Goods)
  • Japan: PMDA approval (Shonin) or certification pathways
Example: Class IIb device in EU requires notified body conformity assessment (Annex IX or X), technical documentation, clinical evaluation, and post-market surveillance plan.
Step 3 of 4 · Price phase

Price

Develop optimal pricing strategies for medical devices across different markets. MedTech-AI provides guidance on pricing mechanisms, reference pricing systems, value-based pricing approaches, and market-specific pricing dynamics.

Understand how reimbursement systems influence pricing decisions—from DRG-based hospital payments to fee-for-service models. Learn about price negotiations with payers, volume-based discounting, and bundled payment arrangements.

Access benchmarking data on device pricing by category, competitive pricing analysis frameworks, and strategies for demonstrating value to justify premium pricing.

Price details

  • Free pricing vs. regulated pricing markets
  • Reference pricing systems and international price comparisons
  • Value-based pricing and outcomes-based agreements
  • Cost-plus pricing, competitive pricing, and value-based pricing models
Example: Germany allows free pricing for medical devices, but prices are negotiated with hospitals and insurers. France uses reference pricing with fixed tariffs for certain device categories.
Step 4 of 4 · Reimburse phase

Reimburse

Secure reimbursement for your medical device across healthcare systems. MedTech-AI provides comprehensive guidance on reimbursement pathways, coding systems (CPT, HCPCS, ICD-10-PCS), and payer coverage policies.

Understand reimbursement mechanisms—from DRG add-on payments and new technology codes to separate device reimbursement and bundled payments. Navigate Medicare coverage determination, private payer policies, and international reimbursement systems.

Learn how to prepare reimbursement dossiers, demonstrate clinical and economic value, engage with payers, and secure favorable coverage decisions that enable market access and adoption.

Reimburse details

  • USA: Medicare coverage (NCD, LCD), DRG add-on payments, new technology codes
  • Germany: NUB (Neue Untersuchungs- und Behandlungsmethoden) applications
  • UK: NICE Medical Technologies Guidance and commissioning decisions
  • France: CNEDIMTS evaluation and tariff inclusion (LPP list)
  • Japan: Shinkisei (innovation) premium and C2 pricing for new devices
Example: For a novel surgical device in the US, pursue DRG new technology add-on payment (NTAP) while seeking permanent CPT code assignment for long-term reimbursement.