Consultation: Guidance on clinical evidence requirement for medical devices

From Health Canada

The purpose of the consultation was to engage with medical device stakeholders on the draft guidance on clinical evidence requirements for medical devices and its companion piece, which gives manufacturers a list of examples to consider. This guidance document is the result of a commitment under the Medical Devices Action Plan to improve the safety and effectiveness of medical devices and how they get to the Canadian market.

This consultation contained 2 documents:

1. Guidance on clinical evidence requirements for medical devices
2. Companion document: Examples of clinical evidence requirements for medical devices

Who was the focus of this consultation

We engaged with medical device stakeholders, mainly:

• manufacturers of class II to IV medical devices
• regulatory representatives

Key questions for discussion

We were seeking feedback on the overall clarity and content of the draft guidance document, as well as on the examples provided in the companion piece.

In particular, we were seeking comments from medical device stakeholders on the following items:

• when clinical data and evidence may be required as part of a pre-market licence application
• the types and quality of clinical evidence that may be required to support the safety and effectiveness of a medical device
• the use of clinical evidence from comparator devices for the purpose of a pre-market application
• the various ways that clinical data may be generated
• the various ways sex, gender and other factors may be integrated
• when clinical data and evidence may be required as part of a post-market obligation

What was heard

Health Canada is grateful for all of the feedback provided on the draft guidance on clinical evidence requirements for medical devices and the companion document.

Stakeholders were mostly seeking clarification on the following items throughout different sections of the guidance and companion document:

• certain definitions and terminology, including those related to sex and gender-based analysis plus (SGBA Plus)
• for Class II medical devices, when clinical evidence may be required and situations when Health Canada may request clinical evidence
• whether the SGBA Plus considerations are guidelines or requirements
  • some stakeholders noted that it can be sometimes difficult to address SGBA Plus considerations in certain clinical trials

Health Canada has considered all comments received as a part of this consultation. Your feedback has helped inform the final guidance document and companion document.

We have included additional clarity and information, where necessary, to ensure the guidance document is applied consistently and accurately.

Related information

• Food and Drugs Act
• Medical Device Regulations
• Guidance on supporting evidence to be provided for new and amended licence applications for Class III and Class IV medical devices, not including in vitro diagnostic devices (IVDDs)
• Draft Health Canada IMDRF table of contents for medical device applications

Contact us

Medical Devices Directorate
Health Products and Food Branch
Health Canada
11 Holland Ave, Tower A
Address Locator: 3002A
Ottawa ON K1A 0K9
Email: hc.meddevices-instrumentsmed.sc@hc-sc.gc.ca