The Guidance on Clinical Evidence Requirements for Medical Devices has been finalized by Health Canada. The general guidelines and standards for clinical evidence are outlined in this guidance, along with other requirements throughout the life cycle of a medical device that may be necessary for Class III and IV license applications or sought for specific Class II license applications.
The guidance also discusses whether clinical data or proof is necessary, common techniques for gathering clinical data, and suitable comparisons of devices. The advice also includes a companion paper that gives particular examples of clinical evidence requirements to assist manufacturers in deciding if clinical evidence will be sought or required.
Details of the advice on the clinical evidence requirement
A number of particular points about the requirements for clinical evidence are outlined in the guidance booklet.
The guidance outlines:
When a pre-market license application may call for clinical data or evidence.
Forms and standards of clinical evidence that may be needed to substantiate a medical device's efficacy and safety.
The utilization of clinical data from comparable devices for pre-market applications.
The numerous methods via which clinical data might be produced.
How sex, gender, color, and ethnicity may all be blended differently.
Sometimes a post-market duty may call for clinical evidence.
A medical device license application's needed evidence is inversely correlated with the device's hazards. Devices classified as Class I pose the lowest possible risk (such as a tongue depressor), and Class IV pose the highest possible risk (for example, a pacemaker).
The document's clinical evidence should be included in one of the following submissions for review:
The information required for medical device license applications mentioned in subsections 32(3) and (4) of the Regulations or
Request for post-market data in accordance with section 39.
Devices used for in vitro diagnostics (IVD) are not covered by this advice.
Contact us at info@arqon.com for more information.
Source: Health Canada