Medical Devices

Australia TGA Schedules UDI Information Session Ahead of 1 July 2026 Mandatory Deadline

Australia’s Therapeutic Goods Administration has confirmed that Unique Device Identification will be a legally mandatory requirement for high-risk and implantable medical devices from 1 July 2026, and is holding an online information session for clinical quality registries on 25 May 2026. Manufacturers, sponsors and registry operators should now finalise UDI implementation plans so that device data, systems and processes are ready in time to maintain compliance and support robust clinical outcome monitoring.

24 May 2026, 21:41tga.gov.auAustralia

Australia TGA Clarifies Import and Supply Rules for Cosmetic Injectables

Australia’s Therapeutic Goods Administration has issued a factsheet reminding health practitioners that only sponsors or their agents may import cosmetic injectable medicines and devices for commercial supply, and that parallel-imported or otherwise unapproved products are unlawful. The guidance signals heightened enforcement focus on cosmetic injector supply chains, so clinics and wholesalers should review sourcing, ARTG status and use of formal access pathways to avoid product loss, penalties and referral to professional regulators.

24 May 2026, 21:41tgacomms.health.gov.auAustralia

German Bundestag Holds First Reading of Bill to Strengthen Medical Registers

In May 2026 the German Bundestag held the first reading of a federal bill to create a Medical Registers Act and amend social security and implant register law, establishing a unified framework and new governance for more than 350 medical registries and their health data use. If adopted, this regime will formalise qualification and interoperability requirements, expand permitted reuse and linkage of registry data, and reshape compliance strategies for medical device and pharmaceutical firms that run or rely on clinical registries and real-world evidence.

24 May 2026, 21:17dserver.bundestag.deGermany

US FDA Issues Early Alert on Abiomed Automated Impella Heart Pump Controller Restart Risk

In May 2026, the US FDA issued an early alert on Abiomed’s Automated Impella Controller heart pump systems after discovering a software issue that can trigger brief controller restarts and loss of circulatory support for patients. Hospitals using these heart pumps must follow updated operating instructions, plan for backup support, and monitor for a software fix, as continued use carries a small but serious risk of injury or death.

24 May 2026, 21:11fda.govUnited States

US FDA Clears Biowy Multi-Chamber Freezing Bag Set (510(k) BK261343)

FDA has cleared Biowy Corporation’s Biowy Multi-Chamber Freezing Bag Set (510(k) BK261343) as substantially equivalent to a predicate device, enabling U.S. marketing from April 2026. This expands options for hematopoietic progenitor cell freezing and storage while reinforcing that manufacturers must maintain robust quality systems, labelling, reporting and identification controls for this device.

24 May 2026, 21:02fda.govUnited States

US FDA Class I Recall Of React Health VOCSN V+Pro Ventilators

In May 2026, the US FDA announced a Class I recall of React Health’s VOCSN V+Pro ventilators because a manufacturing defect can cause undetected oxygen leaks, reducing delivered oxygen and increasing fire risk. This forces hospitals and device managers to remove affected units from service immediately, substitute non-affected ventilators, and tighten recall and equipment risk controls for life-support devices.

24 May 2026, 20:52fda.govUnited States

US FDA Class I Recall of Omnicell i.v.STATION Sterile Syringe Label Stock

In May 2026, the US FDA classified as a Class I recall Omnicell’s sterile syringe label stock used with its i.v.STATION automated compounding systems after identifying a risk of unlabeled or mislabeled IV syringes. Hospitals and compounding pharmacies using these systems must urgently remove and return the affected label lots, switch to alternative labels, and reinforce pharmacist verification to prevent serious medication errors.

24 May 2026, 20:37fda.govUnited States

Australia TGA Updates Guidance on Application Audits for In‑Vitro Diagnostic Medical Devices

Australia’s Therapeutic Goods Administration has updated its guidance on how sponsors of in-vitro diagnostic medical devices should prepare technical documentation and evidence for ARTG application audits, adding references to the IMDRF Table of Contents and clarifying performance expectations as of May 2026. IVD sponsors and manufacturers should align their technical files, risk management, stability, and clinical and analytical performance evidence with this structure, and ensure labelling and advertising materials meet Australian legislative and advertising code requirements to minimise audit delays and approval risks.

23 May 2026, 19:38tga.gov.auAustralia

Australia TGA Issues User Guide for AusUDID Bulk UDI Upload Template

Australia’s TGA has issued a detailed user guide on using the Australian UDI Bulk Upload Template to submit up to 200 Unique Device Identification records at once into the AusUDID database. The guidance strengthens implementation of Australia’s UDI regime by clarifying roles, required data fields, editing rules, and portal steps so sponsors and manufacturers can scale compliant device data submissions efficiently.

23 May 2026, 19:37tga.gov.auAustralia

Australia TGA Publishes Guidance On Managing UDI Records With Multiple Sponsors

In May 2026, Australia’s Therapeutic Goods Administration issued guidance clarifying how sponsors must manage Unique Device Identification records in the AusUDID when the same medical device model is supplied by multiple sponsors. Sponsors must coordinate on shared device data, maintain their own sponsor-specific fields, and treat changes as formal corrections, reinforcing traceability, accountability, and compliance within Australia’s UDI regime.

23 May 2026, 19:37tga.gov.auAustralia

Australia TGA Publishes AusUDID Portal User Guide for Submitting UDI Records

Australia’s medicines regulator has issued a detailed user guide showing sponsors and manufacturers how to create, manage, correct and, where justified, delete Unique Device Identification records for medical devices in the AusUDID portal. This guidance strengthens implementation of the national UDI regime by clarifying system roles, record-keeping expectations, and portal workflows needed for reliable device traceability and future compliance management.

23 May 2026, 19:36tga.gov.auAustralia

Australia TGA Publishes UDI Consent Application Guide for Non-Compliant Medical Devices

In May 2026, Australia’s Therapeutic Goods Administration issued detailed guidance on how sponsors can seek consent to import, supply or export medical devices that do not meet UDI-related Essential Principles, including a streamlined pathway for UDI-only issues. This clarifies when reduced application fees will apply from 1 July 2026 and how to structure consent applications so companies can manage non-compliant inventory while staying aligned with Australia’s evolving UDI regime.

23 May 2026, 19:35tga.gov.auAustralia

Australia TGA Updates List of Licensed Therapeutic Goods Manufacturers

In May 2026, Australia's Therapeutic Goods Administration updated its list of licensed domestic manufacturers, granting 14 manufacturing licences while suspending 2 and revoking 8. These licensing decisions may affect supply chains and market access for therapeutic goods that rely on Australian manufacturers, so companies should verify whether critical contract manufacturing sites have gained or lost TGA licences and adjust quality and sourcing plans accordingly.

23 May 2026, 19:30tga.gov.auAustralia

Indonesia Implements Halal Certification Requirements for Medicines and Medical Devices

Indonesia has put in place a halal product assurance framework and specific rules for medicines, biological products, and medical devices, with mandatory halal certification for some medical products beginning to phase in from 2026. Exporters will need to adjust product design, materials, documentation, and quality systems to meet Indonesian halal requirements and track product-specific timelines to avoid disruptions to market access.

23 May 2026, 19:29farmalkes.kemkes.go.idIndonesia

EU Council Presidency Issues Cluster 4 Document on MDR/IVDR Simplification Proposal

The Council Presidency has tabled a non-public working document (ST 7254 2026 INIT) for cluster 4 examination of the EU proposal to simplify the MDR/IVDR framework and adjust related EMA and AI Act provisions, to be discussed at a 21 May 2026 Council meeting. This signals that negotiations on key elements of the medical devices simplification package are moving into detailed Council working-party scrutiny, but without yet creating new legal obligations or confirmed changes for manufacturers or healthcare providers.

23 May 2026, 09:10consilium.europa.euEuropean Union

China NMPA Publishes National Medical Device Supervision Sampling Results (Announcement No. 4, 2026)

China’s National Medical Products Administration has published Announcement No. 4 of 2026 releasing results from its national medical device supervision sampling programme. This underscores ongoing regulatory scrutiny of device quality in the Chinese market and the need for manufacturers and importers to monitor sampling results for potential issues affecting their products.

23 May 2026, 08:56nmpa.gov.cnChina

Delaware Senate Substitute Bill SS 1 for SB 269 Proposes Hearing Aid and Cochlear Implant Coverage Mandate

Delaware lawmakers are considering Senate Substitute 1 for SB 269, which would require health insurers and the state employee health plan to provide no-cost hearing aids, cochlear implants (including external sound processors), and related parts and services, with obligations applying to policies issued or renewed after 31 December 2027 if enacted. If adopted in substantially this form, the measure would materially expand mandated paediatric and family hearing coverage in Delaware, reshaping benefit design for insurers and large employers and potentially increasing demand for hearing devices and related clinical services.

22 May 2026, 18:58legis.delaware.govUnited States

East African Community Draft Standard DEAS 1352:2026 – Medical Kit Specification

Burundi, Kenya, Rwanda, Tanzania and Uganda have circulated a draft East African Standard (DEAS 1352:2026) that specifies detailed contents, packaging and labelling requirements for medical kits used where access to definitive care is delayed, with comments due by 19 July 2026. Manufacturers and operators supplying medical kits into these markets should assess how the proposed kit classifications, mandatory contents and labelling rules will affect product design, procurement specifications and future compliance obligations if the standard is adopted.

22 May 2026, 18:57members.wto.orgBurundiKenyaRwandaTanzaniaUganda

US FDA Updates Class I Recall and Safety Communication for TRUE METRIX Blood Glucose Monitoring Systems

The US FDA has updated its Class I recall notice and safety communication for Trividia Health’s TRUE METRIX blood glucose monitoring systems to reflect an updated May 2026 correction letter, while keeping its patient and provider recommendations unchanged. Manufacturers, distributors, and healthcare providers should ensure affected meters are identified, help users transition to alternative glucose monitoring where possible, and reinforce clear responses to E-5 error codes to reduce the risk of severe hypo- or hyperglycaemic events.

22 May 2026, 16:45fda.govUnited States

Estonian Medicines Agency Warns Of Possible Measurement Errors In Medtrum Glucose Monitoring Devices

In May 2026 the Estonian Medicines Agency issued a safety notice on Medtrum continuous glucose monitoring systems after discovering that certain sensors and transmitters can give inaccurate readings compared with finger-prick blood glucose values, with France, Portugal and Spain already suspending sales of the affected components. This creates immediate patient-safety and liability risks for manufacturers, distributors and healthcare providers using these CGM systems, making close monitoring of field performance, prompt incident reporting and readiness for potential corrective or recall actions essential.

22 May 2026, 12:13ravimiamet.eeEstoniaFrancePortugalSpain