Medical Devices in Canada and the United States must follow specific label requirements before they can be sold.
United States
In the United States, labeling requirements for medical devices are outlined within the FDA’s Title 21 of the Code of Federal Regulations (CFR)
- General device labeling – 21 CFR Part 801
- In-Vitro Diagnostic Medical Devices – 21 CFR Part 809
- Investigational Device Exemptions (IDE) for Clinical Studies – 21 CFR Part 812
- Good Manufacturing Practices – 21 CFR 820
- Unique Device Identification – 21 CFR 830
Canada
In addition to the consumer packaging and labelling requirements in Canada, medical devices are also subject to additional labelling requirements as outlined by the Canadian Medical Device Regulations Statutory Order and Regulations (SOR/98-282) in sections 21, 22, and 23:
- Section 21: Outlines general requirements for packaging and labelling of most medical devices
- Section 22: For medical device packaging that is too small to display all pertinent information, an insert can be included
- Section 23: For medical devices sold to the public, the labelling must be provided in both English and French. For medical devices for professional use, the labelling must be provided in English or French.
dicentra’s Medical Device Label Compliance Services include:
- Substantiate therapeutic and health claims
- Evaluate devices for safety and efficacy
- Develop product monographs for consumer and medical professionals
- Complete all required scientific and medical writing
- Develop compliant labels and provide translation services
- Review labels for compliance
- Create graphic labels ready-for-print, including necessary fact panels.
Contact our medical device specialists using the form below for support with medical device labels