Medical Device Labeling Requirements Canada

What information is required on canadian product labels. Any label mark sign device imprint stamp brand ticket or tag. This guidance is to be used in the preparation of labelling material for non in vitro diagnostic devices.

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1 3 scope and application.

Medical device labeling requirements canada.

1 3 scope and application. Labeling regulations pertaining to medical devices are found in the following parts of title 21 of the code of federal regulations cfr. Canada s consumer packaging and labelling regulations define a label as. Labeling regulations pertaining to medical devices are found in the following parts of title 21 of the code of federal regulations cfr.

The general labeling requirements for medical devices are contained in 21 cfr part 801. Guidance for labeling medical devices. 1 3 scope and application. All labels for products sold in canada must be clearly printed in english and french.

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. These regulations specify the minimum requirements for all devices. Later sections in this chapter discuss. General device labeling 21 cfr part 801 use of symbols.

Iso 13485 audit guidelines. 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 labelling requirements for consumer packaging food textiles precious metals and pharmaceutical drugs. General device labeling 21 cfr part 801 use of symbols.

This guidance is to be used in the preparation of labelling material for non in vitrodiagnostic devices. Keyword index to assist manufacturers in verifying the class of medical devices. Medical devices offered or imported for sale or use in canada must meet the labelling requirements listed in sections 21 23 of the regulations. 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. Guidance on the content of quality management system audit reports.

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