Notice - Publication of the Regulations Amending the Medical Devices Regulations - Non-Corrective Contact Lenses and Labelling of Class II Medical Devices and related documents

July 29, 2015
Our file number: 15-104648-736

Health Canada is pleased to announce the publication of the Regulations Amending the Medical Devices Regulations - Non-Corrective Contact Lenses and Labelling of Class II Medical Devices, in Canada Gazette, Part II and the release of the following final guidance documents and application forms:

1. Guidance for Industry - Guidance for the Labelling of Medical Devices, Not Including In Vitro Diagnostic Devices - Appendices for the Labelling of Soft Contact Lenses, Decorative Contact Lenses, and Menstrual Tampons;
2. Guidance Document - How to Complete the Application Form for a New Medical Device Licence;
3. New Class II Medical Device Licence Application Form;
4. Class II Medical Device Licence Amendment Application Form.

The draft versions of these documents were amended to reflect the proposed regulatory amendments contained in the Regulations Amending the Medical Devices Regulations and were posted to the Health Canada website from October 20, 2014 for a 75-day consultation. Stakeholder comments received on the draft version of these documents were considered in the finalization of these guidance documents and application forms. A summary of comments received is available upon request to the address below.

Please note that the amendment to the Food and Drugs Act and the regulatory amendments to the Medical Devices Regulations regarding non-corrective (decorative) contact lenses will come into force on July 16, 2016.  Therefore, all revisions to the aforementioned guidance documents and application forms related to decorative contact lenses will come into effect on July 16, 2016.

All other revisions to the guidance documents and application forms are effective immediately.

Questions or concerns regarding this guidance document should be directed to:

Device Licensing Division
Medical Devices Bureau
Therapeutic Products Directorate
Health Products and Foods Branch
Health Canada
2934 Baseline Road, Tower B
Address Locator:  3403A
Ottawa, Ontario K1A 0K9

Email: devicelicensing-homologationinstruments@hc-sc.gc.ca
Telephone: 613-957-7285