Regulatory

A manufacturer guide to EU MDR Article 1(8) and 1(9): classify integral ancillary devices, medicinal products, and administration devices with the four-scenario identity worksheet.

Mark whether one 510(k) device change still owes a new filing, is covered by a cleared 515C PCCP, or is documented without a 510(k).

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.

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.

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.

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.

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.

Evaluate whether a configurable EDC study build can reconstruct device models, firmware versions, deficiencies, and endpoint records for FDA and EU MDR trials.

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FDA August 2026 container closure systems draft guidance: device-constituent CCS vs packaging, 510(k)/PMA vs NDA, Section V.B.3, and Docket FDA-2026-D-7957.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 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.

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.

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.

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.

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.

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.

Navigate India's CDSCO MDSW guidance: SaMD qualification, Class A–D risk matrix, NSWS vs cdscomdonline portals, Algorithm Change Protocols, and MDR-2017 rules.

FDA DHT clinical investigation guide: investigational device vs remote measurement tool under 21 CFR 812, fit-for-purpose V&V, and August 2026 DDM status.

IEC 62353 in-service electrical safety testing: manufacturer IFU duties, IEC 60601-1 type test differences, CMS S&C 14-07 major repair rules, and NFPA 99.

Manufacturer ISO 80369 conversion guide: route-specific particular parts, FDA recognition transition windows through Dec 17, 2028, and 510(k) change forks.