Medical Device Labeling Requirements Canada

The labelling requirements for consumer packaging food textiles precious metals and pharmaceutical drugs.

Medical device labeling requirements canada.

The general labeling requirements for medical devices are contained in 21 cfr part 801. Guidance on the content of quality management system audit reports. 1 3 scope and application. This guidance is to be used in the preparation of labelling material for non in vitro diagnostic devices.

Iso 13485 audit guidelines. Labeling regulations pertaining to medical devices are found in the following parts of title 21 of the code of federal regulations cfr. Any label mark sign device imprint stamp brand ticket or tag. 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. What information is required on canadian product labels. This guidance is to be used in the preparation of labelling material for non in vitrodiagnostic devices. General device labeling 21 cfr part 801 use of symbols.

All labels for products sold in canada must be clearly printed in english and french. Guidance for labeling medical devices. 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. 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. This guidance is to be used in the preparation of labelling material for ivdds. General device labeling 21 cfr part 801 use of symbols. 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. Canada s consumer packaging and labelling regulations define a label as.