The Universal Language of Risk
Medical device regulation worldwide is built on one principle: risk. Higher risk → tighter controls. Below is how three major markets apply it.
USA (FDA)
Three tiers from low (Class I) to high (Class III) risk.
EU (MDR)
Four classes with added granularity in mid-risk tiers.
Vietnam (MoH)
Four-class, risk-based system from A (lowest) to D (highest).
The Four Pillars of Compliance
Intended Purpose
Defines classification and the regulatory pathway.
Quality Management
ISO 13485 as the global QMS baseline.
Risk Management
Per ISO 14971, identify and mitigate risks.
Technical Documentation
Evidence your device is safe and performs as intended.
Market Entry Routes
Core principles align, but the journey differs between USA and EU. These flows outline the main routes.
USA (FDA) Pathway
EU (MDR) Pathway
Sourcing Hub to Global Market
Dual focus: comply locally for manufacturing, then align to target export market. ISO 13485 is the bridge.
(ISO 13485 Certified QMS)
(MoH MA License for Class C/D)
(Meet FDA / EU MDR Requirements)
Technical File Burden
Total effort varies. This stack visualizes relative rigor across core components for submissions.
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