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類別: SAFETY SURVEILLANCE
市場監督
主管部門為驗證市場上的醫療器材符合適用法規而進行的活動。根據EU MDR，成員國主管部門進行主動和被動的市場監督。
Last reviewed 2026-08-05 · Reviewed by MedFlux Editorial Board · Editorial policy
Expanded process notes below are currently maintained in English; the short definition above is localized. See our editorial policy.
WHEN IT APPLIES
Market surveillance is the set of activities by competent authorities (and manufacturer post-market systems) to ensure devices on the market remain compliant and safe—distinct from, but related to, manufacturer PMS.
PROCESS / STEPS
- Authorities inspect, sample, and enforce; manufacturers must cooperate and respond to requests.
- Manufacturers run PMS/vigilance to detect issues early and support authority actions.
- Field safety corrective actions and recalls are coordinated under national rules.
- Keep distribution records to support rapid market actions.
EXAMPLES
- An EU competent authority market surveillance inspection may review technical documentation sampling and vigilance files.
RELATED GUIDES & TOOLS
SOURCES
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