Medical Device Labeling Requirements Health Canada

32 application for a medical device licence.

Medical device labeling requirements health canada.

21 labelling requirements. Labeling regulations pertaining to medical devices are found in the following parts of title 21 of the code of federal regulations cfr. Guidance for labeling medical devices. The device licence is issued for a the device name on the label which may describe one device b an administrative grouping of devices sold for convenience under a single name or c a grouping of devices that carry.

Keyword index to assist manufacturers in verifying the class of medical devices. Health canada guidance for the labelling of medical devices guidance document date adopted. 10 safety and effectiveness requirements. Iso 13485 audit guidelines.

Canadian medical device market regulator health canada now requires all class ii medical device license mdl applicants to include labeling information in their submissions. Applicants are responsible for ensuring that the label complies with the labelling and packaging requirements set out in part 5 of the natural health products regulations nhpr specifically sections 93 94 95 and 97 if applicable. 28 medical devices deemed licensed. General device labeling 21 cfr part 801 use of symbols.

They also serve to. 26 class ii iii and iv medical devices. Medical devices guidance documents. Guidance on the content of quality management system audit reports.

24 contraceptive devices advertising. 32 1 quality management system certificate. Medical device licence. As it pertains to the electronic labelling e labelling of certain medical devices not sold to the general public health canada considers e labelling to refer to the information required by section 21 1 of the regulations that would ordinarily be found in the directions for use.

As per section 86 1 no person shall sell a natural health product unless it is packaged and labelled in accordance with these regulations. Health canada has provided an updated application form for class ii mdls as well as for class ii mdl amendments for which device labeling is also now required. 25 class i medical devices. 2015 07 16 i foreword guidance documents are meant to provide assistance to industry and health care professionals on how to comply with the policies and governing statutes and regulations.