Medical Device Labeling Requirements Canada

Guidance on the content of quality management system audit reports.

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

Canada s consumer packaging and labelling regulations define a label as. Medical devices offered or imported for sale or use in canada must meet the labelling requirements listed in sections 21 23 of the regulations. Labeling regulations pertaining to medical devices are found in the following parts of title 21 of the code of federal regulations cfr. This guidance is to be used in the preparation of labelling material for ivdds.

This guidance is to be used in the preparation of labelling material for non in vitrodiagnostic 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. Iso 13485 audit guidelines. The general labeling requirements for medical devices are contained in 21 cfr part 801.

These regulations specify the minimum requirements for all devices. All labels for products sold in canada must be clearly printed in english and french. 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. General device labeling 21 cfr part 801 use of symbols. The labelling requirements for consumer packaging food textiles precious metals and pharmaceutical drugs. Keyword index to assist manufacturers in verifying the class of medical devices.

1 3 scope and application. Any label mark sign device imprint stamp brand ticket or tag.