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類別: QUALITY SYSTEMS
QMSR（品質管理體系法規）
更新的FDA法規（2026年生效），透過引用ISO 13485:2016取代品質體系法規（21 CFR 820）。QMSR消除了FDA QSR和ISO 13485之間的重複。
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
FDA’s Quality Management System Regulation (QMSR) modernizes device quality system requirements, aligning more closely with ISO 13485 while retaining FDA inspection authority.
PROCESS / STEPS
- Gap-assess current QSR procedures vs QMSR/ISO 13485 expectations.
- Update SOPs, training, and internal audits.
- Prepare inspection readiness under the new framework.
- Monitor FDA transition timelines and enforcement communications.
EXAMPLES
- Manufacturers already certified to ISO 13485 still need FDA-specific processes (e.g., certain reporting interfaces).
RELATED GUIDES & TOOLS
SOURCES
Track regulatory signals related to QMSR（品質管理體系法規） across 27 authorities in real time.
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