Regulations database

Medical device regulations and regulatory updates. Updated 2026-09-09

Covers regulations and guidance, FDA product codes and recent 510(k) clearances.

282regulations and guidance
589update records
8tracked jurisdictions
7link-only jurisdictions
Medical device regulations only — no pharmaceuticals, food or cosmetics. Eight jurisdictions have official structured sources and are tracked continuously; the rest get bibliographic records and official links only.
Not legal advice. Pages state facts only.

Browse by country / region

China国家药品监督管理局 NMPA · in progress · tracked
United StatesFDA / CDRH
44 regulations · 318 updates
European Union欧盟委员会 / MDCG
172 regulations · 0 updates
United KingdomMHRA
36 regulations · 271 updates
CanadaHealth Canada
6 regulations · 0 updates
AustraliaTGA
12 regulations · 0 updates
JapanPMDA / 厚生労働省
11 regulations · 0 updates
KoreaMFDS
1 regulations · 0 updates
BrazilANVISA · in progress
SingaporeHSA · in progress
Saudi ArabiaSFDA · in progress
Hong Kong, China卫生署医疗仪器科 · in progress
Taiwan, ChinaTFDA · in progress
IsraelAMAR · in progress
RussiaRoszdravnadzor · in progress

Recent updates

DateJurisdictionTitle
2026-09-03United KingdomField Safety Notices: 24 to 28 August 2026
2026-09-02United KingdomFilters should be used during the administration of Parenteral Nutrition for patients in all care settings DSI/2026/011
2026-09-02United StatesDental Composite Resin Devices and Dental Curing Lights-Premarket Notification (510(k)) Submissions Guidances; Guidances for Industry and Food and Drug Administration Staff; Availability
2026-09-02United StatesDental Composite Resin Devices - Premarket Notification (510(k)) Submissions: Guidance for Industry and Food and Drug Administration Staff
2026-09-02United StatesDental Curing Lights - Premarket Notification (510(k)) Submissions: Guidance for Industry and Food and Drug Administration Staff
2026-09-01United KingdomMHRA regulatory reform amendments tabled in Government’s Health Bill
2026-08-31United StatesAgency Information Collection Activities; Proposed Collection; Comment Request; Medical Devices; Reports of Removals and Corrections
2026-08-28United KingdomMedical devices given exceptional use authorisations
2026-08-26United KingdomIncreased risk of wear and corrosion identified with certain cobalt chrome modular neck hip replacements
2026-08-26United KingdomCobalt-chrome modular neck hip replacements: risk of metal-wear effects and revision surgery (DSI/2026/010)
2026-08-26United StatesAgency Information Collection Activities; Proposed Collection; Comment Request; Allegations of Regulatory Misconduct Voluntarily Submitted to the Center for Devices and Radiological Health
2026-08-25United KingdomMHRA Safety Roundup: August 2026
2026-08-24United KingdomNGPod pH testing device: quarantine and dispose of all devices (DSI/2026/009)
2026-08-24United KingdomField Safety Notices: 17 to 21 August 2026
2026-08-24United StatesFood and Drug Administration Modernization Act of 1997: Modifications to the List of Recognized Standards, Recognition List Number: 066
2026-08-20United KingdomRectal catheters sold for personal use (gas and colic relievers): Do not use in infants, including for the treatment of colic, gas-related discomfort or constipation (DSI/2026/008)
2026-08-18United KingdomField Safety Notices: 13 to 17 July 2026
2026-08-18United KingdomField Safety Notices: 10 to 14 August 2026
2026-08-17United KingdomNational Patient Safety Alert: ResMed Astral 100 and 150 Ventilators: Potential for Patient Harm due to Unexpected Interruption of Ventilation Therapy (NatPSA/2026/004/MHRA)
2026-08-17United StatesMedical Devices; Classification of Accessories Distinct From Other Devices; Proposed List of Accessories Suitable for Class I; Request for Comments
2026-08-17United StatesGastroenterology-Urology Devices; Reclassification of Diagnostic Endoscopic Light Source Systems To Be Renamed Cystoscopic Systems Intended as an Aid for Detection of Bladder Cancer
2026-08-17United StatesHematology and Pathology Devices; Reclassification of In Situ Hybridization Test Systems for Use With a Corresponding Approved Oncology Therapeutic Product
2026-08-13United KingdomMagnetic resonance imaging equipment in clinical use: safety guidelines
2026-08-13United KingdomCOVID-19 test approval: how to apply
2026-08-12United KingdomClinical investigations for medical devices
2026-08-11United KingdomField Safety Notices: 3 to 7 August 2026
2026-08-10United KingdomMHRA advises quarantine of medical devices supplied without appropriate conformity markings
2026-08-10United KingdomDevices supplied without valid UKCA/CE conformity markings or certification: remove from use and place in quarantine (DSI/2026/007)
2026-08-10United StatesMolecular and Clinical Genetics Panel of the Medical Devices Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments-GRAIL, Inc. Galleri
2026-08-10United StatesRadiology Devices; Reclassification of Digital Breast Tomosynthesis System