News and Regulatory Updates

English reference page for medical device international registration, regulatory strategy, technical documentation, local representative requirements and post-market compliance.

English reference page for medical device international registration, regulatory strategy, technical documentation, local representative requirements and post-market compliance.

English reference page for medical device international registration, regulatory strategy, technical documentation, local representative requirements and post-market compliance.

The U.S. FDA Device Recall database has publicized a Philips Azurion correction involving 9 models and 4,304 units because some system computers may contain solid-state drives not documented in the Medical Device File. Philips Medical Systems Nederland B.V. issued an urgent customer letter on October 6, 2026; the FDA r

FDA/CDRH updated an Early Alert on November 3, 2026, for certain ButterflyBVM disposable bag-valve-mask resuscitators: 9 lots must be removed and 22 lots may remain in use with a pre-use device check. No serious injury or death had been reported as of November 2, 2026.

The EUDAMED UDI/Device module becomes mandatory on 28 May 2026, with 28 November 2026 as the registration deadline for existing devices whose first unit was placed before mandatory use and whose units are still being placed. AIMEILI outlines scope, exemptions and business impact.

FDA warned Chirp Innovations, LLC over promoting its K241509-cleared Chirp Halo TENS/EMS device for menstrual cramp relief, a major intended-use change requiring a new 510(k), and cited missing quality system and MDR procedures.

TGA's October 2026 digital scribe review found no supplier classified its product as a medical device, yet many products contain functions that likely meet the definition. Full translation plus AIMEILI analysis of the seven-function table, eight examples, CDSS exemption and business impact.

On 28 October 2026 the U.S. FDA published three recall numbers (Z-0208-2027, Z-0209-2027, Z-0210-2027) under event 99778 covering 900 Abiomed Impella controllers linked to four defect categories, including RFID firmware failure, sticking rotary push-buttons, controller start-up failure and a software fault producing ne

Health Canada has updated MDEL application form FRM-0292 and guidance GUI-0016, moving applications online, swapping Sections 4 and 5, replacing the senior official's handwritten signature with a position, name and date confirmation, and correcting the Phase 2 effective date to December 1, 2026. Foreign distributors se

FDA CDRH's FY 2027 device guidance agenda lists 13 A/B items and 4 in-development projects, with comments due November 30, 2026, under docket FDA-2012-N-1021.

MDCG 2026-4 rev.1 shifts EUDAMED SSCP/SSP upload responsibility from notified bodies to manufacturers, including translations, with legacy catch-up due by 27 March 2027.

FDA has announced a draft guidance on electronic submission templates for Investigational Device Exemption (IDE) applications, covering original IDEs, supplements, amendments and related submissions. Comments are due December 28, 2026. AIMEILI summarizes the notice, legal basis, timing and business impact for global de

On October 30, 2026, the U.S. FDA confirmed on its Medical Device Recalls and Early Alerts page that Instrumentation Laboratories (Werfen) has recalled four lots of the HemosIL AcuStar HIT-IgG(PF4-H) heparin-induced thrombocytopenia antibody assay and classified the action as the most serious type. Affected lots B40005

Singapore's HSA has issued Revision 15 of GN-15, adding a Premarket Submission Checklist to the Class B and Class C/D submission requirement tables, restricting which bodies may issue ISO 13485 certificates, and restating that reliance routes require the reference regulator's approved labelled use to be identical to th

On October 30, 2026, the U.S. FDA announced in the Federal Register the availability of a revised draft guidance, “Essential Drug Delivery Performance Characteristics for Devices Intended to Deliver Drugs and Biological Products,” which revises and replaces the July 1, 2024 draft on “Essential Drug Delivery Outputs,” r

On 21 October 2026, Brazil's National Health Surveillance Agency (ANVISA) opened a targeted consultation on expanding the use of the Medical Device Single Audit Program (MDSAP), with a submission deadline of 9 November 2026. The consultation feeds ANVISA's Regulatory Impact Analysis (AIR) and gathers cost and experienc

On 28 October 2026 the NMPA published its medical device approval certificate delivery notice covering 13 products, all approved on 27 October 2026 (9 domestic, 4 imported), including a Medtronic 3D cardiac electrophysiology mapping system and dual-energy ablation catheter, a Biosense Webster pulsed field ablation cath

On 30 October 2026 the U.S. FDA published four final device classification orders in the Federal Register, writing four previously De Novo-classified devices into 21 CFR 868.2378, 878.1830, 892.2085 and 868.1985 as Class II devices with special controls. Future similar devices can follow a 510(k) predicate route instea

On 29 October 2026, FDA CDRH issued an Early Alert for all Medline brand beds and accessories after Medline reported two deaths and 16 serious injuries. This article summarizes the timeline, scope, risks, use restrictions and compensation limits, followed by AIMEILI's regulatory interpretation and business impact.

On 27 October 2026 the UK MHRA refreshed both its list of devices holding an Exceptional Use Authorisation and its list of devices no longer covered. Several authorisations granted between September and October were extended, while others were closed because conformity had been restored. MHRA guidance states that an EU

ANVISA published enforcement measures on 23 October 2026 under resolutions RE 4.151/2026, RE 4.153/2026, RE 4.154/2026 and RE 4.157/2026, suspending Rota-Strip rapid tests manufactured from 9 February 2026, recalling three Precision Concepts Costa Rica products manufactured from 5 February 2026, and recalling BD Angioc

FDA’s October 20, 2026 update to Import Alert 89-04 adds small-bowel enteroscopes and ingestible capsule imaging systems made by Olympus in Japan, with 58 entries effective June 24, 2025, and 5 effective October 20, 2026. The alert detains new shipments without physical examination but does not require discontinuation

Health Canada has published Version 2 of GUI-0147, revising the criteria for adding devices to the exceptional importation list and introducing a 72-hour notification obligation when a designated device's foreign authorization changes or may no longer meet local legal requirements.

On 27 October 2026, FDA CDRH issued an Early Alert for the B. Braun Streamline Bloodline Set for Dialog+ (model SL-2010M2096) after a required solvent-application step was omitted during assembly, leaving dialyzer connector bonds insufficient. Three lots — A2600099, A2600128 and A2600136 — must be discontinued, quarant

On 27 October 2026, FDA published a draft guidance on electronic submission templates for IDE applications, jointly issued by CDRH and CBER. Comments are due 28 December 2026 under docket FDA-2026-D-11188. The draft describes existing eSTAR/PreSTAR resources only, is non-binding, and does not make PreSTAR mandatory for

On 19 October 2026 the MHRA updated its weekly Field Safety Notice list for 12–16 October 2026, covering 11 notices from 11 manufacturers, including Maquet anaesthesia systems, Philips Azurion interventional X-ray systems, the Medtronic Abre venous stent and Abbott i-STAT hs-TnI cartridges. Issue dates in the batch ran

TGA published a product correction for the KayserBetten Safe Surround Genie Bed care bed on 6 October 2026 and a Class III recall of one lot of Cook EchoTip Ultra ultrasound access needles from 20 October 2026. This article summarises the official records, classification logic and compliance checks for exporters.

On 6 October 2026 the UK Government confirmed that it accepts all 44 recommendations of the NHS clinician-led AI Commission, and MHRA opened applications for AI Airlock phase 3 in the same announcement. Three firm milestones follow: draft guidance on managing changes to AI-enabled medical devices by December 2026, a 20

Australia's TGA has completed its review of the Clause 14E exclusion for digital mental health tools. The exemption remains unchanged for now, with a regulatory options paper due for public consultation in 2026. Here is what the review found, what has not changed, and what manufacturers should prepare.

On 21 October 2026 the UK Government and MHRA confirmed indefinite recognition of CE-marked devices in Great Britain and extended the MDD transition to 31 December 2028, closing the six-month gap with the EU. UK Responsible Person, MHRA registration and PMS duties remain.

FDA announced NAIN on October 22, 2026, uniting CDER, CBER and CDRH expertise for neuroscience product development. The first project is the Alzheimer’s Prevention Accelerator. No submission pathways, device classifications or review timelines changed.

MHRA Device Safety Information DSI/2026/013 reports Nova Biomedical's recall and stop-shipment of specified StatStrip ketone test strip lots linked to repeated QC failures, with UK replacement stock expected to be unavailable for about four weeks. The notice sets lot handling, clinical prioritisation and distributor re

On 20 October 2026, FDA issued two early alerts concerning Cardinal Health Presource procedure packs that contain BD Alaris pump infusion sets already covered by a separate recall. Kit holders must quarantine inventory, apply warning labels and have clinicians remove and discard the affected sets, while distributors mu

FDA final guidance published October 21, 2026 (91 FR 66561) treats end-user output from sponsor-distributed prescription drug software as labeling, sets rules for device-connected and standalone software, and confirms Form FDA 2253 does not replace device authorization.

PMDA released a 29-page draft of review points for medical devices using generative artificial intelligence on 18 September 2026, with comments open until 17 March 2027; the English reference translation is for reference only.

FDA final order adds systems for detecting non-viral STI pathogens from home-collected specimens to 21 CFR 866.3385 as Class II with special controls; 510(k) clearance is still required.

ANMAT Disposición 6403/2026 establishes a unified application guide and certificate template for GMP certificates for foreign medical device and IVD manufacturing sites outside the MERCOSUR inspection framework, with ISO 13485 certification and ILAC/IAF accreditation-chain evidence as the compliance basis.

In its 20 October 2026 update to Class I recall event 99546, FDA recommends removing Nova Biomedical StatStrip Gen 2.0 hospital glucose meters from use and sale until a software update is available, after residual barcodes caused glucose results to be filed under the previous patient's record across 20,616 units.

HSA Singapore makes the MD-01 premarket submission checklist mandatory under GN-15 Rev 15. From 1 January 2027, incomplete applications are returned without a deficiency request or fee refund.

Health Canada's 16 October 2026 bulletin explains how SOR/2026-96 will be implemented: the exception importation framework is already in force, while new shortage and discontinuation reporting rules, including 5-calendar-day deadlines and reporting of all designated-device discontinuations, apply from 17 June 2027.

A Manchester Crown Court sentenced a 70-year-old defendant over P900 enteral feeding pumps and other devices supplied with invalid CE marks, following a ten-year MHRA investigation; the pumps have exited the UK and EU markets.

On October 20, 2026, FDA added two PCCP hypothetical case examples for a hospital-local sepsis alert system and continuously learning arrhythmia detection software, illustrating modification descriptions, protocols, impact assessments, acceptance criteria, deployment blocks, and audit trails. AIMEILI analyzes the regul

On October 20, 2026, FDA published 12 Class I recall records for Ventec Life Systems ventilators over an internal flow sensor cable connector that may detach, causing restart and interrupted ventilation. Event 99835; company notice issued September 17, 2026.

On 21 October 2026, the UK government confirmed it will legislate to recognise CE-marked medical devices certified under EU MDR and EU IVDR indefinitely in Great Britain, and align the transition for MDD-certified devices with the EU timeline ending 31 December 2028. UK Responsible Person, MHRA registration and post-ma

TGA's October 2026 digital scribe review found that none of the 12 substantively reviewed products was self-declared as a medical device, while eight contain functions likely to meet the definition. AIMEILI examines the CDSS exemption conditions, disclaimer claims and the compliance implications for sponsors.

On October 19, 2026, the U.S. FDA issued Import Alert 89-04 (DWPE) covering certain Olympus Medical Systems devices manufactured in Japan, followed by a Letter to Health Care Providers on October 20. The alert allows detention without physical examination at import for six device categories based on device quality syst

On 16 October 2026, the U.S. FDA published a Class 2 recall (Z-0191-2027) of Abbott's Amplatzer Amulet left atrial appendage occluder covering eight models and all lots and serial numbers. The action is a labeling-level recall driven by an IFU update that introduces a three-tier distance criterion (≤1.5 mm, 1.5–3.0 mm,

On 6 October 2026 the UK Government accepted all 44 recommendations from the National Commission into the Regulation of AI in Healthcare, and MHRA opened AI Airlock cohort 3. MHRA plans draft AI device change guidance by December 2026, a consultation on qualification and classification in 2027, and a full implementatio

FDA CDRH has published its FY 2027 guidance lists, including 17 items across the A-list, B-list, and under-development categories. Draft guidances on artificial intelligence device software lifecycle management and predetermined change control plans are priorities. Comments are due November 30, 2026.

On 9 October 2026, the US FDA issued an early alert for the Philips Lumify diagnostic ultrasound system, warning that iOS and Android apps may unexpectedly require re-registration of already registered probes, blocking scans where Wi-Fi or cellular signal is unavailable. As of 29 September 2026, Philips reported 8 seri

FDA has finalized the Class II classification of OTC infant pulse rate and oxygen saturation monitors in 21 CFR 870.2705, with special controls. Follow-on devices may use the 510(k) pathway with the De Novo device as a predicate.

In October 2026 the FDA classified Medline and AVID Medical convenience kit recalls as Class I, driven by BD ChloraPrep applicators contaminated with Aspergillus penicillioides. The corrective action changed from relabeling to destruction of the entire kit.

MHRA DSI/2026/014 advises that echinocandins such as caspofungin should be administered at least 6 hours after starting CRRT or changing a new polyacrylonitrile (PAN) membrane filter or circuit. CRRT should not be delayed. The UK position differs from EU PRAC advice to avoid PAN membranes.

On October 9, 2026, FDA added OTC infant pulse rate and oxygen saturation monitors to 21 CFR 870.2705 as Class II devices with seven special controls and no 510(k) exemption. AIMEILI reviews the requirements, predicate implications and business impact.

FDA issued an Early Alert on October 15, 2026, for four lots of Edwards' Commander M delivery system used with SAPIEN M3 after balloon ruptures during inflation; one death and one serious injury were reported as of October 5, 2026.

On October 5, 2026, FDA updated its Class I recall communication for BD Alaris infusion pump sets, adding affected products and replacing earlier performance data. Certain sets with closed male luer connectors, filters, check valves, Y-sites or microbore tubing perform below previously stated accuracy at flow rates und

The MHRA's 16 October 2026 update confirms that Great Britain still requires device-by-device MHRA registration through a UK Responsible Person, while Northern Ireland has moved to EUDAMED for all devices except custom-made devices from 28 May 2026. The guidance also flags closed DORS accounts for former authorized rep

On October 1, 2026, the U.S. FDA approved the Autus Size-Adjustable Valve, a surgically implanted pulmonary valve for pediatric patients with congenital pulmonary valve disease. Approved to Edwards Lifesciences and developed by Autus Valve Technologies Inc., it is the first heart valve designed to be enlarged after imp

On 14 October 2026 the MHRA published its 40-page Strategy 2030, setting out its regulatory direction for 2026–2030. Commitments relevant to medical devices include an MHRA AI and Digital Health Centre, a modern adaptive framework for AI as a Medical Device, device lifecycle identification and traceability, simpler Yel

On October 15, 2026, the FDA Center for Devices and Radiological Health issued an Early Alert on the Commander M delivery system used with Edwards Lifesciences' SAPIEN M3 transcatheter mitral valve replacement system. Affected lots are 67718561, 67804014, 67887043 and 67887044. Three reports of balloon rupture during i

On October 14, 2026, the U.S. FDA updated its communication pages for the AVID Medical and Medline convenience kit recalls, confirming Class I classification — the agency's most serious category. Both kit lines contain BD-recalled ChloraPrep skin antiseptic applicators, and the disposition requirement has escalated fro

Australia's TGA updated its public post-market review lists for ventilator, CPAP and BiPAP devices on 9 October 2026. PE-PUR foam cases for non-Philips sponsors have been finalised, while devices containing other foam materials remain under assessment with Conditions of Inclusion applied where evidence is insufficient.

On 1 September 2026, the UK government tabled three amendments to the Health Bill covering medicines and medical device regulation. The third would amend the Medicines and Medical Devices Act 2021 to provide powers for a future MHRA medical device licensing system. No immediate changes; parliamentary scrutiny and publi

On 10 August 2026, the UK MHRA issued Device Safety Information DSI/2026/007, requiring the immediate removal from use, cessation of supply and quarantine of six medical devices placed on the UK market without valid UKCA or CE certification under UK MDR 2002 or EU MDR 2017/745. The affected products — blood collection

On 24 August 2026, the UK MHRA issued Device Safety Information DSI/2026/009 requiring the withdrawal of NGPod handheld devices and sensors used to aid nasogastric tube placement. The manufacturer has ceased UK operations, and users must quarantine and destroy all devices. This article provides the full translated core

Australia's TGA has opened a supplementary public consultation on proposed amendments to the Poisons Standard for ethylene oxide, propylene oxide and epichlorohydrin. The three substances remain Schedule 7 with no exceptions; the applicant seeks an exemption for preparations below 0.002% (20 ppm). Comments close 26 Oct

On 9 October 2026, the UK MHRA issued Device Safety Information DSI/2026/013 concerning quality-control failures and a supply interruption affecting Nova Biomedical StatStrip ketone test strips, with replacement stock not expected for approximately four weeks. The alert sets out lot recalls and stop-ship measures, clin

On October 9, 2026, FDA published a final order (Docket No. FDA-2026-N-10994) classifying hematopoietic cell enrichment kits as Class II with special controls, codified at 21 CFR 866.6120. No 510(k) exemption has been granted, and the classification date applies retroactively to November 6, 2023.

FDA classified the HemosIL AcuStar HIT-IgG(PF-4) IVD reagent recall as Class I due to a possible invalid calibration curve or up to approximately 47% negative bias in patient samples. Affected lots B40005 and B38062; 434 units distributed across multiple U.S. states and countries. Includes AIMEILI regulatory interpreta

MHRA has issued DSI/2026/010 on cobalt-chrome modular neck hip prostheses, requiring healthcare providers to identify affected patients, offer clinical review, and consider blood metal testing and MARS MRI or ultrasound where indicated.

On September 25, 2026, the U.S. FDA classified Boston Scientific's recall of all Imager II Angiographic Catheters as Class I, the most serious category. The catheter tips were manufactured with stabilizer below the specified level, increasing the risk of tip degradation and detachment. As of July 16, 2026, the company

On 2 September 2026, the UK MHRA issued Device Safety Information DSI/2026/011 requiring all parenteral nutrition solutions to be administered through a filter with a pore size not exceeding 1.2 μm, with 0.2 μm preferred for lipid-free (aqueous) nutrition, and asked all PN product providers to state the filtration requ

On September 1, 2026, ANVISA published a list of recognized technical standards for medical devices, updated October 8, 2026. Compliance with recognized standards can reduce additional technical justification in the technical dossier, but recognition does not constitute approval, certification, or endorsement. No new c

On August 17, 2026, FDA published a Federal Register notice (Docket No. FDA-2025-N-6224) proposing to classify seven types of already marketed medical device accessories separately in Class I, decouple them from their parent device classifications, and exempt them from 510(k) premarket notification. This update summari

The FDA CDRH issued an Early Alert on October 9, 2026, for the Philips Lumify portable diagnostic ultrasound system due to a software defect that can require re-registration of previously registered probes, blocking scans until registration is completed via Wi-Fi or cellular signal. As of September 29, 2026, Philips re

On October 5, 2026, the U.S. FDA updated its correction notice for ICU Medical IV tubing sets (Event 99058). Discoloration and particulate reported in drip chambers were determined to originate from the PVC material itself, embedded in the chamber wall and unable to enter the fluid path. ICU Medical's July 28, 2026 fin

Australia's Therapeutic Goods Administration ran a public consultation from 13 August to 2 October 2026 on expanding its ability under section 61 of the Therapeutic Goods Act 1989 to disclose information about medical devices, particularly information generated during post-market reviews and investigations. As of verif

In September 2026, FDA's Center for Devices and Radiological Health (CDRH) published draft guidance on premarket submissions for software-controlled, teleoperated robotically-assisted surgical devices. The Federal Register notice of availability appeared on September 25, 2026 under docket FDA-2026-N-9505, with public c

MHRA Device Safety Information DSI/2026/012 (17 September 2026) confirms that co-channel RF telemetry interference in wireless cardiotocography (CTG) systems can cause a fetal heart rate to be displayed on another monitor, produce incorrect readings or cause signal loss, and sets expectations on channel separation, cli

MDCG position paper MDCG 2026-4 confirms that responsibility for uploading the Summary of Safety and Clinical Performance (SSCP, MDR) and the Summary of Safety and Performance (SSP, IVDR) to EUDAMED will move from notified bodies to manufacturers, with the new function planned for the EUDAMED production environment in

On 2 October 2026, the U.S. FDA updated its recall communication for the Draeger VentStar Resus Neo breathing circuit, formally classifying the action as a Class I recall — the most serious category. Affected model MP00310 (UDI 04048675422358) is a single-use infant breathing circuit for delivering respiratory gases to

In September 2026, the U.S. FDA classified the Spectra Medical Devices (Elevaris Medical Devices) recall of 0.9% Sodium Chloride Injection, USP, 10 mL flush ampules as a Class I recall. The root cause originated upstream at Huons Co., Ltd. in Korea, and the event triggered cascading corrections to convenience kits and

On October 6, 2026, FDA published four final device orders in the Federal Register: three De Novo-derived device types codified as Class II with special controls, and a 510(k) exemption for certain Class II clinical toxicology test systems, effective the same day.

Regulation (EU) 2026/1744 entered into force on 27 July 2026, deferring high-risk AI obligations to 2 December 2027 for Annex III systems and 2 August 2028 for Annex I embedded AI, including medical devices.

On 17 August 2026, the UK MHRA published National Patient Safety Alert NatPSA/2026/004/MHRA covering ResMed Astral 100 and Astral 150 ventilators and associated PCBA spares manufactured before October 2024. Electrolyte leakage from an internal supercapacitor can cause unexpected interruption of ventilation; eight requi

On October 1, 2026, FDA CDRH published its FY2027 list of proposed device guidances across an A List, a B List and an Under Construction list. Comments on the list or individual guidances are due November 30, 2026 under Docket FDA-2012-N-1021.

FDA's CDRH/DHCoE discussion paper on regulating generative AI-enabled medical devices proposes a two-axis risk framework and a capability assessment-based premarket pathway; comments are due October 19, 2026, under docket FDA-2026-N-7874.

On September 3, 2026, the U.S. FDA classified Boston Scientific's recall of the Infinion CX Lead as Class I, the most serious category. The recall covers two unused lead kits, with 1,081 serious injuries and no deaths reported as of May 27, 2026. This article provides the translated core content, regulatory interpretat

On September 11, 2026, the U.S. FDA classified Nova Biomedical's voluntary recall of StatStrip (Gen 2) hospital glucose meters as a Class I recall. A software synchronization and timing defect in barcode scanning can intermittently retain the previously scanned barcode, causing the current patient's glucose result to b

On September 23, 2026, FDA CDRH issued an Early Alert for React Health VOCSN ventilators because the internal flow sensor cable connector may partially or completely disconnect, interrupting communication with the IFT board and potentially causing device restarts and repeated System Fault 10 alarms. React Health notifi

Australia's TGA announced on 8 September 2026 amendments to the clinical decision support system exemption, effective 1 November 2026. The amendment clarifies the exemption boundary without changing its scope or adding requirements. Qualifying low-risk software may remain exempt, while artificial intelligence-enabled C

FDA granted PMA on October 1, 2026 for the Autus Size-Adjustable Valve, the first U.S. heart valve designed to grow with children and the first with polymer leaflets, plus AIMEILI analysis.

Commission Implementing Regulation (EU) 2026/977, published in the Official Journal on 5 May 2026, introduces uniform requirements for notified body conformity assessment under the MDR and IVDR — covering quotations, maximum time limits and "stop-the-clock" mechanisms, monitoring and annual publication of duration and

WHO formally launched prequalification assessment for medical devices on 25 September 2026, extending the programme beyond IVDs and male circumcision devices to cover male and female condoms, copper-bearing IUDs and computer-aided detection software for tuberculosis screening. The first assessment window opens on 1 Oct

On 16 September 2026, the UK MHRA published NatPSA/2026/005/MHRA on patient hoists and slings (all types), citing 22 fatal incidents from 1 January 2015 to 31 December 2025 and requiring five remediation actions by 16 September 2027. AIMEILI summarizes the alert, regulatory interpretation and business impact for global

Australia's Therapeutic Goods Administration has amended Schedule 2, Part 2 of the Therapeutic Goods (Medical Devices) Regulations 2002 by inserting clause 2.2, which classifies non-invasive devices containing only saline and intended to maintain or flush the lumen of another medical device as Class IIa. The rule appli

On September 24, 2026, the U.S. FDA classified Abiomed's Automated Impella Controller (AIC) recall as Class I, its most serious category, after failure of the purge flag within the purge pressure sensor assembly caused false 'Purge Disc Disconnected' or 'Purge Disc Not Detected' alarms. As of August 17, Abiomed had rep

On September 11, 2026, the U.S. FDA classified the Bravo CF capsule delivery device (Given Imaging Ltd.) as a Class 1 recall, recall number Z-3090-2026, Event ID 99626. Affected lots expire on or before October 20, 2027 (lots 64553F to 68912F); 127,416 units are in commercial distribution, with distribution including C

On August 19, 2026, FDA classified BMC Medical's Luna G3 APAP (LG3600) ventilator recall as Class I (Z-2979-2026). This article summarizes the timeline, affected devices, firmware failure mode, corrective action gaps, and AIMEILI's regulatory and business impact analysis for global medical device manufacturers, distrib

UK MHRA enforcement update: Manchester Crown Court sentenced Kenneth Harrison to a suspended prison term and an eight-year directorship ban over medical devices supplied with invalid CE marks; Medicina Limited awaits sentencing. Includes AIMEILI regulatory interpretation and business impact.

On 12 August 2026, Australia's Therapeutic Goods Administration (TGA) confirmed the suspension of the Corpuls 3 and Corpuls 3T defibrillators under paragraph 41GA(1)(b) of the Therapeutic Goods Act 1989, effective 25 August 2026 and expiring 25 November 2026. No new supply is permitted during the suspension, while devi

On 9 September 2026, the European Commission's Medical Device Coordination Group (MDCG) issued MDCG 2020-16 rev.5, the latest revision of its guidance on classification rules for in vitro diagnostic medical devices under Regulation (EU) 2017/746 (IVDR). The revision is limited to Rule 7 and clarifies the justification

On September 17, 2026, the U.S. FDA published a final order denying a petition to exempt radiology computer-aided detection and/or diagnosis devices and computer-aided triage and notification devices from 510(k) premarket notification. The device types remain subject to 510(k). Key dates: petition notice December 29, 2

FDA released draft guidance on electronic submission templates for PMAs on September 18, 2026, with comments due November 17, 2026. AIMEILI provides regulatory interpretation and business impact analysis for medical device stakeholders.

On August 10, 2026, MHRA published DSI/2026/007 requiring quarantine of six categories of medical devices supplied in the UK without valid UKCA/CE conformity markings or certification. The action is a market access compliance issue rather than a safety signal. This article translates the core content and provides AIMEI

On September 25, 2026, the U.S. FDA released draft guidance on robotically-assisted surgical devices (RASDs). The draft addresses nonclinical testing, clinical data, labeling, device description, comparison with marketed devices, accessories and compatible devices, teleoperation and control, kinematics, visualization,

FDA's March 2026 final guidance extends voluntary patient preference information (PPI) across the device total product life cycle, covering IDE, Breakthrough Device designation, PMA, HDE, De Novo and 510(k), and replacing the 2016 guidance.

UK MHRA and NHS England guidance of 29 July 2026 confirms that transcription-only, summarisation-only and documentation-only ambient voice functions are not medical devices, while diagnostic, therapeutic or autonomous clinical functions remain regulated under the UK MDR 2002.

MDCG position paper 2026-5 (July 2026) confirms that the same device may carry two UDI-DIs under two trade names, but both must be assigned by the manufacturer and linked to the manufacturer in EUDAMED and at the UDI issuing entity. Third parties may perform the operational steps, but legal responsibility cannot be tra

On 1 September 2026 the UK Government tabled three amendments to the Health Bill, with the MHRA publishing a parallel explanatory note. The amendments cover information-sharing powers, a mechanism for keeping regulations current, and an enabling power for a future medical device licensing regime in Great Britain. No re

TGA opened a public consultation on 13 August 2026 to amend Section 61 of the Therapeutic Goods Act 1989, seeking views on whether and what information about post-market device reviews or investigations should be disclosed publicly. The consultation closes on 2 October 2026.

On 1 September 2026 the NMPA held an expanded Party Leadership Group meeting to convey General Secretary Xi Jinping's important instructions, review the learning and education campaign on a correct view of political achievement, and plan to consolidate its outcomes. Includes AIMEILI's regulatory interpretation and busi

On August 31, 2026, the NMPA CMDE issued a notice to solicit public comments on the draft clinical trial technical review points for implantable brain-computer interface systems with electronic device cursor interaction control function. Feedback is due by September 14, 2026. AIMEILI provides regulatory interpretation

FDA CDRH issued an Early Alert on the NOxBOXi Nitric Oxide Delivery System and NOxMixer module due to an oxygen leak risk that may cause increased nitric oxide dose or treatment interruption. Includes full translation, UDI, serial number, corrective actions and AIMEILI regulatory interpretation for device manufacturers

On August 17, 2026, FDA CDRH issued an early alert stating that certain Medline convenience kits containing recalled BD ChloraPrep applicators pose a risk of Aspergillus penicillioides contamination. Affected lots, including item numbers 930480 and 930299, must be quarantined and the entire kit destroyed. This article

Health Canada announced on 18 March 2020 a free, expedited review of health product submissions and applications related to the diagnosis, treatment, mitigation or prevention of COVID-19. The notice also addresses clinical trials, the Special Access Program and review contact channels, with direct implications for regi

On July 22, 2026, the U.S. FDA announced the first participants selected for the TEMPO digital health device pilot — SonderMind, Limbic, Cadence and Dexcom — and confirmed it intends to exercise enforcement discretion for certain requirements covering behavioral health and early cardiometabolic products. Here is the fu

FDA CDRH has issued an Early Alert stating that CooperSurgical has recommended removing specific lots of INCA neonatal/infant nasal CPAP complete sets and replacement sets from use or sale because the flexible tubing may loosen or disconnect from the nasal prongs, causing loss of CPAP pressure and reduced patient oxyge

On August 24, 2026, Health Canada issued a formal notice on changes to the Medical Device Special Access Program (SAP) application process, introducing an accessible application form and a secure transmission tool, and confirming that from February 1, 2027 only the new form and the new submission method will be accepte

On August 19, 2026, the U.S. FDA authorized Vitestro's Aletta robotic blood draw device — the first standalone robotic device that draws blood from a patient's arm without manual operator intervention — via the De Novo pathway, with new special controls covering labeling, performance testing and clinical testing.

On April 3, 2025, FDA CDRH issued a discussion paper and request for comments on regulatory considerations for generative artificial intelligence-enabled medical devices, covering total product lifecycle oversight, transparency, performance monitoring, and human-machine teaming. The paper signals key compliance expecta

On August 17, 2026, the FDA issued a proposed notice under FDARA seeking to classify seven types of medical device accessories as Class I (general controls only): non-invasive blood pressure system accessories, ECG lead wires, ECMO accessories, ancillary power supplies for defibrillators, urological catheter plugs, rem

On June 8, 2026, the FDA issued a correction notice for specific Medline convenience kits containing ICU Medical pain management components and Huons bupivacaine hydrochloride in dextrose injection. This is a Class I recall, the most serious type. Continued use of uncorrected products may cause serious injury or death.

FDA's CDRH has published an introduction to its Patient and Caregiver Connection program, which systematically gathers patient and caregiver feedback on disease experience, device use and device-related trends to inform regulatory decisions. This article provides the full translated content plus AIMEILI's regulatory in

The World Health Organization has published a meeting report on pediatric drug optimization for sickle cell disease. This drug-sector report is not directly related to medical device registration, regulation, market access, quality systems, standards, recalls, safety, or post-market surveillance. It does not meet AIMEI

AIMEILI (Ameli), a brand of Beijing AIMEILI International Health Management Co., Ltd., supports medical device companies with international market access, regulatory information management, overseas market development and digital go-global management.

CMDE issued a public consultation on draft clinical trial technical review points for implantable brain-computer interface hand motor function compensation systems, with comments due August 19, 2026. The draft affects clinical trial design, endpoints, safety assessment and China registration strategy.

The World Health Organization has published a landscape review on per- and polyfluoroalkyl substances (PFAS) via oral ingestion and their health effects. The content falls within chemical safety and public health and is not directly related to medical devices; it therefore does not meet the admission criteria for AIMEI

Health Canada opened a consultation on July 27, 2026, on a draft update to the List of Recognized Standards for Medical Devices, with comments due September 25, 2026. Health Canada will also introduce year-round feedback and annual review for future list updates.

FDA CDRH Early Alert on certain Baxter Duo-Vent infusion sets due to potential air embolism risk, with affected product code, lots, recommended actions, and AIMEILI regulatory analysis.

The FDA is seeking comments by August 13, 2026 on certain non-device software functions excluded under the 21st Century Cures Act, including patient safety best practices, education, and competency. AIMEILI summarizes the scope, submission details, and implications for software-enabled medical device registration.

WHO has published the monograph from the 101st meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) on the safety assessment of arsenic as a food contaminant, updating toxicological data, dietary exposure estimates and dose-response analyses for inorganic and organic arsenic compounds. AIMEILI assess

FDA CDRH early alert: Abiomed recalls 14Fr low-profile introducer kits (1000434, 1000435) and Impella CP sets (1000413) over elevated thrombus risk, with AIMEILI regulatory analysis.

On July 9, 2026, China's National Healthcare Security Administration (NHSA) held its H1 2026 routine press conference. NHSA reported progress on high-value medical consumables price governance, including price reductions for 33 types such as defibrillators and heart valves; the launch of the seventh national organized

On July 2, 2026, NMPA approved the innovative product registration of Xinkainuo Medical Technology (Shanghai) Co., Ltd.'s Intracranial Stent for use with embolization devices in saccular wide-necked aneurysms of the anterior intracranial circulation. The approval highlights innovation-review pathways, technical documen

FDA CDRH has published a Frequently Asked Questions (FAQ) resource on market access for radiation-emitting electronic products, covering general requirements, records and reports, performance standards and certification, and import requirements for products such as diagnostic X-ray systems, laser products and microwave

Argentina's ANMAT has brought into force a simplified licensing regime under which manufacturers and importers of Class I and Class II medical devices and Class A and B in vitro diagnostics can obtain national sanitary authorization by submitting a sworn declaration through the Themis platform. The regime does not reli

Austria's Federal Office for Safety in Health Care (BASG) has issued a safety notice stating that several sexually transmitted infection (STI) self-tests sold via thuistest.shop and stdheimtest.de are intended for professional use only but were incorrectly promoted to lay users. Affected products include herpes, HPV, s

ISO published ISO 20417:2026 on 17 March 2026, replacing the 2021 edition. The standard sets general requirements for manufacturer-provided medical device information, including identification, labelling, packaging information, marking and accompanying documents. AIMEILI examines registration, technical documentation,

On 5 May 2026, the Danish Medicines Agency updated language requirements for medical device labelling and instructions for use. Devices placed on the Danish market must provide Danish labelling and IFU under MDR and IVDR, with clarifications on eIFU, software and service manuals, display and button symbols, and exempti

On 28 April 2026 the European Medicines Agency (EMA) launched a pilot giving manufacturers and notified bodies free expert panel support for breakthrough medical devices (BtX). The pilot runs in three phases through 2027; Phase Ia intake has closed, and the deadline for submitting a breakthrough status request brief in

On 22 June 2026 the Dutch Health and Youth Care Inspectorate (IGJ) published its inspection findings on transfers of benefit in the dental medical device sector: financial relationships between suppliers and dental professionals were not always sufficiently transparent, written agreements were sometimes absent and gift

Swissmedic confirms that from 1 July 2026 Swiss manufacturers, system and procedure pack assemblers and authorised representatives must register their devices, systems and procedure packs in the swissdamed UDI device module, with a transition period until 31 December 2026. The database is aligned with EUDAMED, and regi

On 25 June 2026, South Africa's SAHPRA updated its medical devices and IVD communication-to-industry page, consolidating more than 60 industry communications issued since 2020, covering RUO/IUO devices, e-IFU, licensing of outsourced activities, AI/ML-enabled devices, vigilance and establishment licensing.

On 10 March 2026 Singapore's HSA became the first national regulator worldwide to achieve WHO Maturity Level 4 for medical devices. Full translation of the announcement, plus AIMEILI analysis of registration strategy, technical documentation and post-market implications.

The European Commission has confirmed that four EUDAMED modules — Actor Registration, UDI/Device Registration, Notified Bodies and Certificates, and Market Surveillance — have been mandatory since 28 May 2026 under the transitional provisions of Regulation (EU) 2024/1860. This update summarises the official content and

Health Canada announced 537 drug and medical device authorizations over three months, including generic semaglutide, and introduced a Ministerial Trust Order to use selected foreign regulatory decisions for certain drug reviews, with consultations on priority review for certain Canadian-manufactured generics. AIMEILI a

On 8 May 2026, MHRA published draft pre-market requirements for medical devices and IVDs via the WTO notification portal and opened a consultation until 19 June 2026. The draft proposes a fast-track for devices approved in Australia, Canada and the US, mandatory implant cards and UDI, IMDRF-aligned IVD classification a

On July 20, 2026, NMPA Commissioner Huang Guo led a team to Xiong'an New Area and Handan, Hebei, to research grassroots drug regulation, TCM industry development and high-temperature drug quality and safety. Aimeili analyzes the compliance and registration implications for medical device companies.

FDA announced the first TEMPO pilot participant in July 2026 and issued detailed FAQs on manufacturer eligibility, the US-entity requirement, letters of intent, selection, enforcement discretion, and anticipated marketing authorization.

On 3 July 2026, the European Commission's Directorate-General for Health and Food Safety (DG SANTE) published new documents under its study supporting the monitoring of medical device availability in the EU market, including the 20th notified body survey and the 3rd economic operator survey. The update is closely linke

France's ANSM issued a user safety information notice on 7 July 2026 concerning the Sener Diagnostics Autoplak Advance automated bacteriology device, registered under reference R2619050, highlighting post-market safety actions and user notification for IVD laboratories.

ANSM issued safety information on July 7, 2026 concerning the bioMérieux Argene Enterovirus R-GENE reagent, reference R2619052, with implications for IVD performance claims, user notification, batch traceability and post-market safety correction.

Australia's TGA issued a safety alert on 9 July 2026 regarding performance concerns with the TouchBio Chlamydia and Gonorrhoea Test for self-testing (female use) and suspended its ARTG supply. The case highlights IVD self-test performance verification, labelling and post-market surveillance risks.

On 9 July 2026, the French agency ANSM published safety information on Boston Scientific's lot recall of the Rapid Refill Continuous Injection System (recall reference R2619855), with hospital pharmacies in France among the notified parties. The notice highlights recall management, lot traceability, post-market surveil

On June 30, 2026, NMPA issued two guidelines on classification determination and generic naming for brain-computer interface medical devices, effective on the date of release. The guidelines directly affect management attributes, classification, and registration pathways for BCI devices.

On July 1, 2026, NMPA announced the cancellation of 31 medical device registration certificates held by 14 companies, covering electronic stethoscopes, phototherapy units, IVD kits, patient monitors, bone screws, guidewires and other products. AIMEILI summarizes the official announcement and outlines the regulatory and

On 29 June 2026, the National Medical Products Administration (NMPA) approved the innovative "Intrasaccular Aneurysm Embolization System" of Beijing Taijie Weiye Technology Co., Ltd. for endovascular treatment of selected unruptured wide-necked bifurcation intracranial aneurysms. This article provides a full English tr

On 1 July 2026, NMPA approved Suzhou Wushuang Medical's ICM registration application, China's first domestically developed implantable cardiac monitor, filling a domestic gap. The approval highlights innovative-device review, classification, clinical evaluation and post-market requirements for cardiovascular implant co

China's NMPA convened its 2026 medical device regulatory system research project report meeting in Yantai, Shandong on 3 July 2026, reviewing interim results from 12 research projects across 6 areas—including production supervision, supervisory sampling and adverse event monitoring—led by 9 lead units from Beijing, Sha

On July 4, 2026, NMPA held the launch meeting for its Regulatory Science Innovation Research Base (Medical Devices and Cosmetics) and a medical device innovation seminar in Beijing. The meeting reviewed the base construction plan and four innovation cooperation platforms. AIMEILI summarizes the core announcement and ou

Health Canada announced on June 17, 2026, that Phase Two amendments to the Medical Device Establishment Licence (MDEL) modernization were published and will take effect on December 14, 2026. The amendments remove the MDEL requirement for foreign distributors selling through a licensed Canadian importer, clarify written

On July 7, 2026, FDA announced a public meeting to be held on August 5, 2026 on reauthorization of the Medical Device User Fee Amendments, covering proposed MDUFA recommendations for fiscal years 2028–2032 and their impact on device review fees, review resources and market-entry pathway planning.

PMDA updated its English SaMD page on July 6, 2026, consolidating review support and consultation information. AIMEILI examines evidence expectations and business impact for software medical device market entry in Japan.

FDA has classified the Abiomed Impella CP Sets with SmartAssist issue as a Class I recall, citing possible nonconformance and low perfusion pressure events at the start of a case. AIMEILI reviews the regulatory and business implications for manufacturers.

FDA classified the Hologic BioZorb Marker and BioZorb LP Marker recall as the most serious type of recall, citing implantable marker complications and patient risk. AIMEILI examines the regulatory and business implications for global device makers, distributors, CROs, and regulatory affairs teams.

FDA has classified the Insulet Omnipod Pods issue as a Class I recall because some Pod tubing may tear, causing insulin to leak rather than be delivered to the patient. The notice underscores post-market response expectations for infusion systems and other higher-risk devices.

The FDA has published correction information for North American Rescue first aid kits containing devices affected by the Trividia TRUE METRIX blood glucose monitoring system recall, together with AIMEILI's analysis of the post-market compliance and business implications for manufacturers.

FDA updated its Total Product Life Cycle Advisory Program (TAP) page on July 6, 2026. The voluntary TAP pilot aims to accelerate development and broaden patient access for safe, effective, high-quality medical devices of public health importance. AIMEILI provides regulatory interpretation and business impact for device

The U.S. FDA has classified Hamilton Medical's update to the instructions for use for certain coaxial breathing circuit sets as a Class I recall, citing expiratory valve diaphragm adhesion, obstructed expiratory flow and ventilation risk. AIMEILI reviews the post-market system implications and compliance actions for de

MHRA has extended the deadline for paying annual medical device registration fees to 31 July 2026, according to GOV.UK guidance. Manufacturers should review their MHRA accounts, fee structure and UK Responsible Person arrangements.

The Australian TGA has announced that certain medical devices supplied in Australia must meet UDI requirements from 1 July 2026, initially covering Class IIb and Class III high-risk devices and later expanding to other device categories and IVD products. AIMEILI examines the global shift toward life-cycle transparency

FDA's June 29, 2026 CDS software FAQ update clarifies when clinical decision support functions may fall outside medical device regulation and when FDA oversight may still apply. AIMEILI examines evidence expectations and business impact for SaMD and software device teams.

On June 26, 2026, the U.S. FDA updated its eMDR system enhancements plan, covering AEMS integration, country code rules, IMDRF adverse event code maintenance and test deployment arrangements for electronic reporting. The update signals a global shift from pre-market market access toward lifecycle-wide transparency, and

On June 25, 2026, FDA updated its medical device data integrity notification, reminding manufacturers and sponsors to carefully evaluate third-party testing laboratories and independently verify test data before submission. AIMEILI provides regulatory interpretation and business impact analysis.

On 22 June 2026, the FDA classified Abiomed's Instructions for Use update for Automated Impella Controllers as a Class I recall, citing a controller software error that can cause a restart under specific circumstances. AIMEILI reviews the regulatory interpretation and business impact for medical device manufacturers.

The FDA has announced a Town Hall on its final guidance for human factors information in medical device marketing submissions, emphasizing stronger evidence on human-machine interaction, usability engineering and use-related risk control. AIMEILI highlights the shift toward real-world use scenario review and recommends

The UK MHRA has opened a consultation on draft pre-market regulatory requirements for medical devices and IVDs entering the UK market, covering international regulatory recognition, UDI, implant cards, IVD classification, technical documentation retention, and product claim consistency.

On 6 May 2026, the IMDRF Quality Management System Working Group published a proposed document on the control of products and services obtained from suppliers and opened it for consultation. The document signals continued international regulatory focus on outsourcing, critical suppliers and quality management system ev

Health Canada's medical device guidance documents page, updated on 24 April 2026, lists the regulatory registration process and related application guidance, drawing attention to REP submission methods, application dossier management and licence application preparation. AIMEILI Regulatory Affairs explains why national

On 3 March 2026, IMDRF published the 2026 edition of its terminologies and codes for categorized adverse event reporting (AER). The update further advances global harmonization of post-market surveillance terminology and coding. This article summarizes the core content of the source document and sets out AIMEILI's regu

IMDRF released the Playbook for Medical Device Regulatory Reliance Programs on 26 February 2026. AIMEILI assesses the implications for global registration master files, technical documentation consistency and market access strategy.

On 11 February 2026, MFDS published English-language Medical Device GMP Regulations materials, highlighting quality system, manufacturing control and on-site compliance expectations for companies exporting to Korea.