MDSAP
8 articles
NMPA GMP Announcement 107: Dual Release, Key-Person Gates, and the 1 November 2026 Clock
China NMPA GMP Announcement 107 operating guide: Order 53 manufacturing licenses vs 107 GMP, dual release, full-time key-person gates, and 1 November 2026.
Malaysia MDA Automated Re-Registration: MeDC@St 2.0+, July 2026 Switch & CN Trap
Operational guide to Malaysia MDA's Automated Re-Registration Route in MeDC@St 2.0+: six eligibility gates, CN-first sequencing, QMS whitelist, fees, and TAT.
Health Canada MDEL Phase 2: Foreign Distributor Exemption, Supplier Lists & GUI-0016
Operating guide to Health Canada MDEL Phase 2 (SOR/2026-110, GUI-0016 Dec 14 2026): keep-or-cancel, supplier lists, procedures, and CAD $5,519.
NSAI NB 0050 Medical Devices Divestment 2026: Stay vs Transfer Playbook
Playbook for NSAI NB 0050 clients on the 2026 divestment: confirmed facts, stay-vs-transfer tree, MDR Article 58, IVDR Article 53, MDSAP.
Pure Global AI: A Practical Workflow Guide for Medical Device Regulatory Teams
A vendor-neutral guide to Pure Global AI's regulatory databases, device and predicate agents, and evidence-first workpapers for risk, eSTAR, CAPA, QMSR, labeling, and post-market review.
MDSAP in 2026: Revised Audit Approach, TGA Migration, and Post-QMSR Value
A strategic evaluation of MDSAP in 2026: analyzing the February 2026 revised audit approach, the TGA mdsap.global migration, and a post-QMSR ROI decision framework.
Health Canada REP and CESG Digital Submissions for Medical Devices
Prepare for mandatory REP and CESG submissions for Class II-IV medical device licences, including IMDRF ToC format, XML templates, workflow changes, and April 2026 scope.
MDSAP Audit Preparation: Complete Guide for Medical Device Manufacturers (2026)
Everything you need to prepare for an MDSAP audit — the 2026 updated audit approach (AU P0002.010), QMSR alignment, step-by-step preparation checklist, costs, timelines, and common nonconformities.