Medical Device Keyword Index

Guidance for Industry- Keyword Index to Assist …

https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices/application-information/guidance-documents/guidance-industry-keyword-assist-manufacturers-class-medical-devices.html

The Keyword Index to Assist Manufacturers in Verifying the Class of Medical Devices is intended to assist manufacturers in confirming the classification of medical device products after application of the Classification Rules for Medical Devices set out in Schedule 1 of …

Classify Your Medical Device | FDA

https://www.fda.gov/medical-devices/overview-device-regulation/classify-your-medical-device

There are two methods for accomplishing this: go directly to the classification database and search for a part of the device name, or, if you know the device panel (medical specialty) …

How to Determine if Your Product is a Medical Device | FDA

https://www.fda.gov/medical-devices/classify-your-medical-device/how-determine-if-your-product-medical-device

Applications for Medical Device Investigational Testing …

https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices/application-information/guidance-documents/investigational-testing-authorizations-guidance/guidance-document.html

2.1 Abbreviations and definitions. 2.1.1 Abbreviations. CTA. Clinical Trial Application (drugs …

Guidance documents – Medical devices - Canada.ca

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

Keyword Index to Assist Manufacturers in Verifying the Class of Medical Devices [2006-09-14] Application for a Medical Device Licence Amendment for a Private …

Classify Your Medical Device | FDA

https://cacmap.fda.gov/medical-devices/overview-device-regulation/classify-your-medical-device

For Class III devices, a premarket approval application (PMA) will be required unless your device is a preamendments device (on the market prior to the passage of the medical …

September 12, 2006 NOTICE

https://www.canada.ca/content/dam/hc-sc/migration/hc-sc/dhp-mps/alt_formats/hpfb-dgpsa/pdf/md-im/keyword_motscles2-eng.pdf

The Medical Device Keyword Index is an alphabetical listing of words which appear in the short descriptors for medical device groups identified by the Medical Devices Bureau. It …

Dow Jones U.S. Select Medical Equipment Index

https://www.spglobal.com/spdji/en/indices/equity/dow-jones-us-select-medical-equipment-index/

This index tracks the performance of companies in the medical equipment subsector. These companies are manufacturers and distributors of medical devices such …

Guidance Document - Labelling of In Vitro Diagnostic …

https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices/application-information/guidance-documents/guidance-document-labelling-vitro-diagnostic-devices.html

a medical device or a product subject to Section 3.1 of the Medical Devices Regulations that is intended to be used in vitro for the examination of specimens derived …

Health Canada Offers Guidance on Use of Medical Device …

https://www.fdanews.com/articles/88574-health-canada-offers-guidance-on-use-of-medical-device-keyword-index

Health Canada Offers Guidance on Use of Medical Device Keyword Index. October 5, 2006. Health Canada has published a revised keyword index aimed at …