Medical Device Labeling Requirements Health Canada

Guidance on the content of quality management system audit reports.

Medical device labeling requirements health canada.

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. Medical device licence. 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. Medical devices guidance documents. 10 safety and effectiveness requirements. 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.

Each device including a system medical device group medical device family or medical device group family must have a name. 25 class i medical devices. Canadian medical device market regulator health canada now requires all class ii medical device license mdl applicants to include labeling information in their submissions. Iso 13485 audit guidelines.

Labeling regulations pertaining to medical devices are found in the following parts of title 21 of the code of federal regulations cfr. 24 contraceptive devices advertising. Private label manufacturers must comply with the requirements of the medical devices regulations in order for private label manufacturers to fulfil their medical device application requirements health canada will accept a letter of authorization written by the original manufacturer to grant permission to health canada to cross reference the safety and effectiveness information and quality. Guidance for labeling medical devices.

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. 32 1 quality management system certificate. How to complete the application for a new medical device licence medical device licence amendment for a private label medical device 2020 04 01 applications for medical devices under the interim order for use in relation to covid 19 guidance document 2020 03 26. They also serve to.

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. General device labeling 21 cfr part 801 use of symbols. 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.