Industry News

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.

CMS-1850-P proposed SaMS policy: status indicator O1, Table 61 vs Table 62, CLFS-to-APC rate mismatch, and the August 31, 2026 comment deadline.

MHRA and NHS England 2026 guidance on ambient voice technology (AVT): 9-example medical device qualification tree, Class I vs IIa, DCB0129, and UKCA strategy.

Playbook for NSAI NB 0050 clients on the 2026 divestment: confirmed facts, stay-vs-transfer tree, MDR Article 58, IVDR Article 53, MDSAP.

Data-driven regulatory dossier of Teleflex (NYSE: TFX): ~440 FDA 510(k)s, multi-country registration counts, Arrow Class I recalls, and the 2025 $2.03B divestiture.

Israel's MOH register lists 28,821 medical devices — 91.8% imported, the US/Germany/China supply 53.6%, and 2,111 importers (IRHs) hold the licence layer.

Japan's PMDA database lists ~88,900 approved medical devices held by 2,796 MAHs; the top 50 MAHs hold 40.8%, and a 2021 cluster reflects the e-IFU/UDI mandate.

Vietnam's MOH register holds 108,658 valid registrations across 21,871 applicants; new filings tripled in 2022 under Decree 98. Highly fragmented (HHI 16).

Analysis of Taiwan's TFDA medical device register shows 52,726 active devices. 74.1% are imported (US 22.6%, Germany 9.5%), Class II dominates at 52.9%, and top 10 applicants hold 14.5%.

Analysis of the UK MHRA device register shows 22,554 registered devices. UK manufacturers hold 33.5%, IVD accounts for 37.7%, and the top 10 manufacturers hold 13.1% of registrations.

3,510 FDA Class I device recalls since 2006, led by Medtronic, Boston Scientific and Teleflex. Catheters and ventilation devices drive a sharp post-2020 rise.

Analysis of 14.4M FDA MAUDE adverse event reports (2020–2025) shows diabetes devices account for over half of all events. Death reports rose 63% from 2020 to 2024.

Analysis of Singapore's medical device register shows 20,599 approved devices across 859 registrants. Top 20 registrants hold 35.5%, while US product owners hold 37.9% of all devices.

Analysis of 175,149 FDA 510(k) clearances shows foreign applicants exceed US ones since 2021. China leads non-US at 19.1%, top 50 applicants hold under 10%.

FDA establishment data shows 59.7% of 24,795 registered facilities are foreign. China leads with 4,753 establishments and contract manufacturing dominates.