MedDeviceGuide — IVD & Medical Device Knowledge Base
Is This Reagent an ASR or a Finished IVD?
Mark whether one US reagent SKU is still an ASR under 21 CFR 864.4020 and 809.30, an RUO or IUO shipment, a general-purpose reagent, or a finished IVD with performance claims.
Does This US IVD Study Need an IDE, an IND, or Neither?
How to determine whether a US IVD clinical protocol qualifies for 21 CFR 812.2(c)(3) exemption, requires an abbreviated or full IDE, or falls under 21 CFR Part 312 IND rules.
Which Combination-Product 4.4 Path Still Applies After QMSR?
A practical 21 CFR 4.4 worksheet for combination product facilities after QMSR: how to verify eligibility, separate-facility rules, and current ISO 13485 or drug CGMP streamlining clauses.
Combination Product Safety Reports: Which Clock, Which System, Which Applicant?
A practical 21 CFR Part 4 Subpart B worksheet mapping applicant identity, 4.102 baselines and add-ons, statutory reporting clocks, and electronic routing between FAERS, eMDR, and VAERS.
Changing Device Distributors: Who Keeps Complaint and Traceability Files?
A medical device RA/QA guide to records custody when changing distributors: who keeps complaint and traceability files under US, EU, and Canadian post-market rules.
Device Label Translation: Reconciling Units, Symbols, and Released Versions
How medical device RA/QA teams reconcile units, ISO symbols, and released versions across translation cycles before artwork issuance under FDA QMSR 820.45 and EU MDR GSPR 23.
Incomplete Supplier Change Notices: A Device QA Triage Guide
When a supplier change notice omits affected lots, dates, or technical details, device QA must hold unverified product, issue an evidence request, and halt close-out until facts are verified.
MedDeviceRepair: Keeping Loaner Exchanges Traceable When Serial Numbers Change
A three-asset chain-of-custody crosswalk for medical device loaner exchanges: preserve serial traceability across removal, placement, and return without slot-level record overwrites.
Outsourced Device Testing: What Raw Data Must Your Contract Deliver?
A signed summary is not the deliverable. What protocols, complete reports, raw data, and archive terms medical device manufacturers must contract for premarket evidence and QMSR compliance.
VetMedGuide: Building a Useful Veterinary Device Field-Feedback Form
A manufacturer intake worksheet for veterinary analyzer complaints: separate instrument observation, species and matrix, clinic QC evidence, and unsupported causality.
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.
EClinCloud EDC for Device Studies: Linking Versions, Deficiencies and Endpoints
Evaluate whether a configurable EDC study build can reconstruct device models, firmware versions, deficiencies, and endpoint records for FDA and EU MDR trials.
HSA GN-21 R7 Change Notification: 6Aii/6Aiii Approval, Two-CN Cap, & August Clock
Singapore HSA GN-21 Revision 7 change notification guide: when 6Aii/6Aiii SMDR updates require approval, the two-active-CN cap, and the 1 August 2026 clock.
FDA 2026 Container Closure Draft: Device-Constituent CCS, 510(k), & October Clock
FDA August 2026 container closure systems draft guidance: device-constituent CCS vs packaging, 510(k)/PMA vs NDA, Section V.B.3, and Docket FDA-2026-D-7957.
MDCG 2026-4: Who Uploads SSCP and SSP to EUDAMED, the Handover, and 2027 Clocks
MDCG 2026-4 EUDAMED SSCP and SSP upload guide: NB interim duties, manufacturer handover in October 2026, Article 32 vs 29(4), and the 27 February 2027 clock.
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.
Philippines FDA Advisory 2026-1007: CPR Validity, 120-Day Clock & CMDN/CMDR
Operational guide to FDA Advisory 2026-1007: CPR validity during renewal, RA 9711 IRR 120 days, customs proof, CMDN/CMDR 90-day filing, and fee suspension.
India G.S.R. 743(E): Outsourced Sterilization Labels, 14 Feb 2027 Clock & Ninth Schedule
Guide to CDSCO G.S.R. 743(E) Medical Devices Second Amendment Rules 2026: Rule 44(p) label prefixes, 14 Feb 2027 clock, Ninth Schedule fees, and loan licences.
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.
ISO 20417:2026 Guide: FDA Rec# 5-149, July 1 2029 DoC Window & ISO 15223-1
Operational guide to ISO 20417:2026: FDA Rec# 5-149 complete recognition, the July 1 2029 DoC transition window, ISO 15223-1, 21 CFR 801, and EU MDR GSPR 23.