ISO 22441 Beyond the U.S.: How VHP Sterilization Now Navigates EU MDR, Health Canada, TGA, and PMDA

ISO 22441:2022 is on the FDA consensus list. Notified Bodies in Europe are formally certifying VHP processes against it. Health Canada, TGA, and PMDA accept the framework. For any company with a global device portfolio, VHP validation done once to ISO 22441 now travels farther than it ever has.