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8 posts tagged with "fda"

ASEAN AMDD Harmonisation — Class A/B/C/D Classification Framework

philippines 🔄 reform tracker

Medical Device Act (RA 9711) and CDRRHR — Philippine Regulatory Framework

philippines 📋 regulatory changes

ASEAN AMDD Harmonisation and Common Submission Dossier Template (CSDT)

thailand 🔄 reform tracker

Medical Device Act B.E. 2562 (2019) — Thailand's Modern Device Regulatory Framework

thailand 📋 regulatory changes

FDA Medical Device Regulatory Framework — FD&C Act and CDRH

united-states 📋 regulatory changes

FDA QMSR compliance date — 21 CFR Part 820 aligned with ISO 13485

united-states 📅 key dates

QMSR — Quality Management System Regulation Transition from QSR (21 CFR Part 820)

united-states 📋 regulatory changes

UDI System — Unique Device Identification Requirements (21 CFR Parts 801 and 830)

united-states 📋 regulatory changes