Medical Device Labeling Requirements Canada

Labeling regulations pertaining to medical devices are found in the following parts of title 21 of the code of federal regulations cfr.

Medical device labeling requirements canada.

Iso 13485 audit guidelines. General device labeling 21 cfr part 801 use of symbols. General device labeling 21 cfr part 801 use of symbols. Guidance for labeling medical devices.

What information is required on canadian product labels. Keyword index to assist manufacturers in verifying the class of medical devices. 1 3 scope and application. Medical devices offered or imported for sale or use in canada must meet the labelling requirements listed in sections 21 23 of the regulations.

The general labeling requirements for medical devices are contained in 21 cfr part 801. Medical devices offered or imported for sale or use in canada must meet the labelling requirements listed in sections 21 23 of the regulations. Later sections in this chapter discuss. These regulations specify the minimum requirements for all devices.

This guidance is to be used in the preparation of labelling material for non in vitro diagnostic devices. Labeling regulations pertaining to medical devices are found in the following parts of title 21 of the code of federal regulations cfr. 1 3 scope and application. 1 3 scope and application.

This guidance is to be used in the preparation of labelling material for ivdds. Any label mark sign device imprint stamp brand ticket or tag. Guidance on the content of quality management system audit reports. Canada s consumer packaging and labelling regulations define a label as.

Application for a medical device licence amendment for a private label medical device 2005 06 01 guidance document on the regulation of medical devices manufactured from or incorporating viable or non viable animal tissue or their derivative s 2004 07 12 pre market guidance on bare cardiovascular stents 2004 04 28. Medical devices offered or imported for sale or use in canada must meet the labelling requirements listed in sections 21 23 of the regulations.