Medical Device Labeling Requirements Canada

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 device labeling requirements canada.

1 3 scope and application. These regulations specify the minimum requirements for all devices. 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 vitro diagnostic 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. General device labeling 21 cfr part 801 use of symbols. Guidance for labeling 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. Any label mark sign device imprint stamp brand ticket or tag. 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. Iso 13485 audit guidelines.

All labels for products sold in canada must be clearly printed in english and french. This guidance is to be used in the preparation of labelling material for non in vitrodiagnostic devices. Later sections in this chapter discuss. This guidance is to be used in the preparation of labelling material for ivdds.

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 on the content of quality management system audit reports. Canada s consumer packaging and labelling regulations define a label as.

What information is required on canadian product labels. Keyword index to assist manufacturers in verifying the class of medical devices.