Medical Device Labeling Requirements Canada

General device labeling 21 cfr part 801 use of symbols.

Medical device labeling requirements canada.

Canada s consumer packaging and labelling regulations define a label as. This guidance is to be used in the preparation of labelling material for non in vitrodiagnostic devices. 1 3 scope and application. All labels for products sold in canada must be clearly printed in english and french.

Any label mark sign device imprint stamp brand ticket or tag. Guidance on the content of quality management system audit reports. Labeling regulations pertaining to medical devices are found in the following parts of title 21 of the code of federal regulations cfr. 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. 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. What information is required on canadian product labels.

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. Labeling regulations pertaining to medical devices are found in the following parts of title 21 of the code of federal regulations cfr. Iso 13485 audit guidelines.

Later sections in this chapter discuss. These regulations specify the minimum requirements for all devices. Guidance for labeling medical devices. 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 ivdds.