{"id":1957,"date":"2011-01-04T00:54:15","date_gmt":"2011-01-04T00:54:15","guid":{"rendered":"http:\/\/www.eisnersafety.com\/eisnersafetycom\/?p=1957"},"modified":"2011-01-04T00:54:15","modified_gmt":"2011-01-04T00:54:15","slug":"med-dvcs-e-labeling-health-canada-tpds-interpretation","status":"publish","type":"post","link":"https:\/\/eisnersafety.com\/eisnersafetycom\/2011\/01\/04\/med-dvcs-e-labeling-health-canada-tpds-interpretation\/","title":{"rendered":"Med Dvcs E-Lableing: Health Canada TPD’s Interpretation"},"content":{"rendered":"

On November 9, 2010 Health Canada’s Therapeutic Product Directorate (TPD) issued an interpretation of the <\/span>Medical Devices Regulations<\/span><\/em> (<\/span>Regulations<\/span><\/em>) with respect to electronic labeling (e-labeling) of certain medical devices sold or imported into Canada. \u00a0This interpretation only covers products for professional use and not products sold to the general public.<\/span><\/p>\n

Per the Interpretation issued \u00a0e-labelling refers to the information required by section 21(1) of the <\/span>Regulations<\/span><\/em> (Medical Devices Regulations – SOR\/98-282)\u00a0that would ordinarily be found in the directions for use. Per the notice: <\/span><\/p>\n

“The directions for use may include a surgeon’s instruction manual, operator’s manual, or user’s manual. At this time, the only acceptable electronic media in which to present information to satisfy the labeling requirements of section 21(2) of the <\/span>Regulations<\/span><\/em> are those described below.<\/span><\/p>\n

Electronic labelling may be provided on Compact Disc (CD) or Digital Video Disc (DVD), accompanying the device at the time of sale and\/or delivery….The CD\/DVD must be packaged with or accompany the device in a manner that alerts the user to its purpose. The information provided on CD\/DVD should be easily navigable.<\/span><\/p>\n

For the following two categories of devices…, this information may, in the alternative, be provided in downloadable format from the internet: Class IV medical devices and <\/span>in vitro <\/span><\/em>diagnostic devices (IVDDs) that do <\/span>not <\/span><\/strong>fall within the definition of near patient IVDD. The internet address must accompany these devices at the time of sale and\/or delivery, and be displayed in a manner that alerts the user to its purpose…<\/span><\/p>\n

Manufacturers should ensure that the labelling information provided in electronic format is identical in content to the paper format submitted with the device licence application…<\/span><\/p>\n

Upon request, a paper copy of the label information should be provided promptly to the user, without additional cost.<\/span><\/p>\n

Since this Notice is permissive in nature, it is effective immediately….”<\/span><\/p>\n

For full text of the notice click here<\/a> or go to the Health Canada webpage for this notice<\/a>.<\/span><\/p>\n","protected":false},"excerpt":{"rendered":"

On November 9, 2010 Health Canada’s Therapeutic Product Directorate (TPD) issued an interpretation of the Medical Devices Regulations (Regulations) with respect to electronic labeling (e-labeling) of certain medical devices sold or imported into Canada. \u00a0This interpretation only covers products for<\/p>\n","protected":false},"author":4,"featured_media":0,"comment_status":"closed","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_monsterinsights_skip_tracking":false,"_monsterinsights_sitenote_active":false,"_monsterinsights_sitenote_note":"","_monsterinsights_sitenote_category":0,"footnotes":""},"categories":[1],"tags":[99,274,275,276,277,100,278,149,279,280,281],"class_list":["post-1957","post","type-post","status-publish","format-standard","hentry","category-uncategorized","tag-canada","tag-canadian-medical-device-regulations","tag-cmdr","tag-e-label","tag-e-labeling","tag-health-canada","tag-medical-device-labeling","tag-medical-devices","tag-sor98-282","tag-therapeutic-product-directorate","tag-tpd"],"_links":{"self":[{"href":"https:\/\/eisnersafety.com\/eisnersafetycom\/wp-json\/wp\/v2\/posts\/1957","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/eisnersafety.com\/eisnersafetycom\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/eisnersafety.com\/eisnersafetycom\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/eisnersafety.com\/eisnersafetycom\/wp-json\/wp\/v2\/users\/4"}],"replies":[{"embeddable":true,"href":"https:\/\/eisnersafety.com\/eisnersafetycom\/wp-json\/wp\/v2\/comments?post=1957"}],"version-history":[{"count":0,"href":"https:\/\/eisnersafety.com\/eisnersafetycom\/wp-json\/wp\/v2\/posts\/1957\/revisions"}],"wp:attachment":[{"href":"https:\/\/eisnersafety.com\/eisnersafetycom\/wp-json\/wp\/v2\/media?parent=1957"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/eisnersafety.com\/eisnersafetycom\/wp-json\/wp\/v2\/categories?post=1957"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/eisnersafety.com\/eisnersafetycom\/wp-json\/wp\/v2\/tags?post=1957"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}