Medical Equipment Regulations

Overview of Device Regulation | FDA

https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/overview-device-regulation

The basic regulatory requirements that manufacturers of medical devices distributed in the U.S. must comply with are: Establishment registration, Medical Device Listing, Premarket Notification...

Quality and Compliance (Medical Devices) | FDA

https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/quality-and-compliance-medical-devices

The FDA also recognizes that proper maintenance, repair, and servicing of medical devices is critical to maintaining the safe, effective, and reliable performance of devices used in …

Durable Medical Equipment (DME) Center | CMS

https://www.cms.gov/Center/Provider-Type/Durable-Medical-Equipment-DME-Center

The Centers for Medicare & Medicaid Services (CMS) recently issued a final rule that takes effect on February 28, 2022 and classifies non-implantable continuous glucose monitors …

Hospital Equipment Maintenance Requirements | CMS

https://www.cms.gov/Medicare/Provider-Enrollment-and-Certification/SurveyCertificationGenInfo/Policy-and-Memos-to-States-and-Regions-Items/Survey-and-Cert-Letter-14-07

• The equipment is a medical laser device; or • New equipment without a sufficient amount of maintenance history has been acquired. • Hospitals electing to …

Medical devices regulation basics - Therapeutic Goods …

https://www.tga.gov.au/medical-devices-regulation-basics

Medical devices - World Health Organization

https://www.who.int/health-topics/medical-devices

A medical device can be any instrument, apparatus, implement, machine, appliance, implant, reagent for in vitro use, software, material or other similar or related …

Regulatory guidance for medical devices - GOV.UK

https://www.gov.uk/government/collections/regulatory-guidance-for-medical-devices

Medical devices regulations: compliance and enforcement 26 February 2019 Guidance Virtual manufacturing of medical devices 3 February 2021 Guidance …

Regulating medical devices in the UK - GOV.UK

https://www.gov.uk/guidance/regulating-medical-devices-in-the-uk

Since 26 May 2021, the EU Medical Devices Regulation (Regulation 2017/745) (EU MDR) has applied in EU Member States and Northern Ireland. The in vitro …

HKWC Internet - Hospital Authority

https://www3.ha.org.hk/hkwc/

HKWC Internet. Home. Cluster Hospitals. HKWC Transplant Service. HKWC Hospitals & Institutions. Hospital Services. Public Private Interface (PPI) Community Health …

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