Change Notification Medical Device

Deciding When to Submit a 510(k) for a Change to an …

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/deciding-when-submit-510k-change-existing-device

Almost from the enactment of the Medical Device Amendments to the Federal Food, Drug, and Cosmetic Act (the FD&C Act) in 1976, the Food and Drug Administration (FDA or the Agency) has attempted...

Is a new 510(k) required for a modification to the device?

https://www.fda.gov/medical-devices/premarket-notification-510k/new-510k-required-modification-device

HSA | Notify changes to registered medical devices

https://www.hsa.gov.sg/medical-devices/change-notification

Changes may be grouped and submitted as one CN application for medical device listings based on the following guidelines: Multiple changes in one dossier for a …

Change Control Process : An Overview of the …

https://www.qualitymeddev.com/2021/01/29/change-control/

In general, when a legally marketed device subject to 510 (k) requirements is significantly changed or modified in design, components, method of manufacture, or intended use, a new premarket notification …

Guidance for the Interpretation of Significant Change of a …

https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices/application-information/guidance-documents/guidance-document-interpretation-significant-change-medical-device.html

Jan 20, 2011

Change Notification - Medical Device Authority (MDA)

https://portal.mda.gov.my/industry/medical-device-registration/change-notification.html

Any change to a registered medical device is linked to the principles of safety and performance and the ability of the regulatory framework to manage the …

HSA | Guidance documents for medical devices

https://www.hsa.gov.sg/medical-devices/guidance-documents

Annex 3 to GN-21 R4.9 Guidance on Change Notification for Registered MD(2022 Apr) 20 KB; Change Notification applications arising from the EU MDR/IVDR …

Reporting Changes to the Notified Body - BSI Group

https://www.bsigroup.com/meddev/LocalFiles/en-IN/Events/UK-Consultants-Day-2015/BSI-md-consultants-day-reporting-changes-to-your-notified-body-presentation-UK-EN.pdf

Steps for the Notified Body to assess change Clause 5.4 – Particular Examples: Design Built-in control mechanism Operating principles Design specifications Software Materials …

MDR Significant Changes for Medical Devices - BIOREG …

https://bioregservices.com/blog/mdr-significant-changes/

Notified Bodies will verify changes and their implementation for devices other than Class I, at audits or upon change notification submissions. In addition, the Notified Body will determine whether an …

Notification of Substantial changes - TUV

https://www.tuv.com/content-media-files/master-content/global-landingpages/medical-device-testing-and-auditing/(s)cn_product-assessment-(ms-00368701).docx

Nomenclature: significant change and substantial change can be used interchangeably For requirements and guidance related to sign ificant changes please refer to MDR …