Notice - Draft Revisions: (1) Documents Amended as per the proposed Regulations Amending the Medical Devices Regulations - Decorative Contact Lenses and Mandatory Class II Medical Device Label Submission

October 20, 2014
Our file number: 14-105914-107

Health Canada is pleased to announce the release of the following two draft guidance documents and two draft application forms, for a 75-day comment period:

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 Draft Guidance Document - Guidance for the Labelling of Medical Devices, Not Including In Vitro Diagnostic Devices - Appendices for the Labelling of Soft Contact Lenses,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 Draft Guidance Document - How to Complete the Application Form for a New Medical Device Licence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

These draft guidance documents are intended to: (1) assist manufacturers in complying with the labelling requirements under section 21-23 of the Medical Devices Regulations and (2) provide manufacturers with assistance on how to complete an application form for a new medical device licence.

(1) Documents amended as per the proposed Regulations Amending the Medical Devices Regulations - Decorative Contact Lenses and Mandatory Class II Medical Device Label Submission

These draft documents (including the Class II medical device application forms listed above) have been amended to reflect the proposed regulatory amendments contained in the Regulations Amending the Medical Devices Regulations.  The proposed revisions include: updated format and language for greater clarity; inclusion of labeling requirements for decorative contact lenses, and a requirement to submit a copy of the device label with all Class II device licence application forms.

(2) Additional Draft Revisions

Health Canada is proposing additional changes to the above mentioned guidance documents and application forms to include information on: nanotechnology, radiation emitting medical devices and the proposed expansion of e-labelling to all classes of medical devices not sold to the general public.

The following changes have been made to the guidance document, Draft Guidance Document - Guidance for the Labelling of Medical Devices, Not Including In Vitro Diagnostic Devices - Appendices for the Labelling of Soft Contact Lenses,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:

Full Document: Rewritten to add clarity, conform to Good Guidance Practices and proposed regulatory amendments as per the Regulations Amending the Medical Devices Regulations - Decorative Contact Lenses and Mandatory Class II Medical Device Label Submission.

Section 21(2): Included new information on e-labelling of certain medical devices not sold to the general public.

Appendix 1: Included new information on decorative contact lenses.

The following changes have been made to the guidance document, Draft Guidance Document - How to Complete the Application Form for a New Medical Device Licence

Full Document: Rewritten to add clarity and conform to Good Guidance Practices.

Item 6: Removed reference to attestation of labelling requirements.

Item 7: This section has been updated to indicate that the intended use statement on the application must be verbatim as it appears on the device labeling. It also requests a red lined and a clean electronic copy of the latest version of the Information for Use/Package Insert (IFU/PI) be submitted with the application if there are any changes.

Item 11: The Radiation Emitting Medical Devices section has been added to provide manufacturers with more information about declaring a device that emits radiation.

Item 13: This section has been revised to provide Information on how to declare if your device contains nano-scale material.

Item 15: This section has been revised to include the requirement for a Declaration of Conformity form to accompany Class III and IV applications.

Item 16: Added reference to applicable guidance documents on labelling.

The following changes have been made to the Draft New Class II Medical Device Licence Application Form:

Section 6: The attestation section has been amended to remove reference to the labelling requirements (see new section 16) and to add a section specific to decorative contact lenses.

Section 7: The Purpose/Intended Use of Device section has been updated to request that the document, document version number and date where the formal intended use appears be indicated if applicable.

Section 10.1: The Non-In Vitro Diagnostic (IVD) Devices Containing Drugs section has been updated to include drug substances.

Section 11: A section for declaring Radiation Emitting Medical Devices has been added.

Section 13: Columns have been added to the device detail section of the application form to collect information on nano-scale materials that may be present in medical devices.

Section 16: A section for attaching a copy of the Class II medical device label has been added.

Section 24: Information on how to pay fees electronically has been provided in the fee section of all applications with associated fees.

The following changes have been made to the Draft Class II Medical Device Licence Amendment Application Form:

Section 7: The attestation section has been amended to remove reference to the labelling requirements (see new section 16) and to add a section specific to decorative contact lenses.

Section 9.1: The Non-IVD Devices Containing Drugs section has been updated to include drug substances.

Section 10: A section for declaring Radiation Emitting Medical Devices has been added.

Section 11: The Device History is now required to be indicated on amendment applications.

Section 12.2: This section has been added for the manufacturer to indicate the nature of the proposed change and any Health Canada assigned device identification numbers it might affect. This is also the section in which the document, document version number and the date where the formal intended use appears should be referenced if there is a change in the device labeling.

Section 13: Columns have been added to the device detail section of the application form to collect information on nano-scale materials that may be present in medical devices.

Section 16: A section for attaching a copy of the Class II medical device label has been added.

Comments on these draft documents should be submitted within 75 calendar days to the contact below:

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

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