Class II - IV Medical Device Investigational Testing in Canada - Vantage BioTrials

 

health canada class iii medical device license application

Jul 14,  · For a Class III medical device intended to be used with another Class II, III, or IV device, provide a list of all medical devices that this device is intended to be used or function with, including their medical device licence number. Feb 09,  · The target processing time for a Health Canada Class III medical device licence application is 75 days (15 screen days plus 60 review days) according to their guidance. Does anyone have practical experience about how long it will take to issue licence to you? Thanks. Jun 29,  · Roughly speaking, Class I devices constitute approximately 40% of devices on the Canadian market, 40% Class II, 15% Class III, and 5% Class IV. As the device class increases, so does the level of premarket regulatory scrutiny. Market authorization granted by Health Canada takes the form of a medical device “license.”.


New Class III Medical Device Licence Application Form - taoplinkss.ga


Clinical trials for medical devices are not classified by phased development as with drugs i. In addition, based on the Special Access Program, a medical device that is not yet tested or licensed in Canada can be used in emergency cases where conventional or available treatments have failed.

In such a case, health care professionals can apply for authorization to use medical devices through the Therapeutic Products Directorate to assess whether potential risks of using the device outweigh potential benefits. When applying for an authorization to perform a clinical study to assess the safety and performance of a new medical device to Health Canada, you need to submit an ITA according to the Canadian health program governing the use of Class II, III, and IV medical devices.

The requirements for this application are summarized in the table below:. First, health canada class iii medical device license application, the application will go through a screening process, and if it is accepted for review, a screening acceptance letter will be issued.

However, Health Canada requires notification of ethics clearance for the study through a Research Ethics Board prior to issuing a No Objection letter. The clinical development of a new medical device involves exploratory pilot and pivotal clinical studies as well as in vitro and in vivo pre-clinical investigations, if possible. Pilot studies are performed in the early phase of medical device development to capture preliminary safety and effectiveness information on the device before the pivotal study design, and are typically performed at one or two sites with less than patients.

Based on pilot study work, Pivotal studies are conducted to determine the safety and effectiveness of a device in a statistically justified number of subjects. In Canada, there is no equivalent to the FDA k clearance that allows a medical device company to bypass the expensive and time consuming randomized clinical trial process. In addition, over the last five years, the Canadian regulation requirements have become more stringent, which has resulted in significant delays for starting up Clinical studies for a medical device.

This, along with the continued increase of clinical research costs, has forced Sponsors or Manufacturers to re-evaluate clinical development approaches for medical devices. Additionally, this version also health canada class iii medical device license application the electronic data capture systems used in medical device studies that are a critical step in central monitoring activities and part of the new FDA guidelines regarding the Risk-based monitoring approach.

This methodology uses adaptive monitoring based on risk assessments that increase Clinical Research Associate CRA efficiency and productivity combined to data quality and subject safety. In conclusion, Vantage BioTrials has a deep understanding of the challenges faced in clinical health canada class iii medical device license application for medical devices in Canada.

Our team can provide experienced professionals to meet your clinical development needs for both pilot and pivotal studies using efficient study management strategies that can reduce costs and shorten time lines by: Developing a well-designed protocol and case report forms CRFs to ensure high quality data and efficient monitoring. She has a strong understanding and experience with the conduct and implementation of clinical research and medical device studies and in accordance to regulatory and agency requirements.

Fri 24 Oct. It includes a vast range of equipment, from a simple tongue depressor to robotically assisted surgical machines. Challenges in Medical Device Clinical Development in Canada The clinical development of a new medical device involves exploratory pilot and pivotal clinical studies as well as in vitro and in vivo pre-clinical investigations, if possible.

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Health Canada Regulatory Approval Process for Medical Devices

 

health canada class iii medical device license application

 

Jun 29,  · Roughly speaking, Class I devices constitute approximately 40% of devices on the Canadian market, 40% Class II, 15% Class III, and 5% Class IV. As the device class increases, so does the level of premarket regulatory scrutiny. Market authorization granted by Health Canada takes the form of a medical device “license.”. Feb 09,  · The target processing time for a Health Canada Class III medical device licence application is 75 days (15 screen days plus 60 review days) according to their guidance. Does anyone have practical experience about how long it will take to issue licence to you? Thanks. Apr 03,  · Application for a Medical Device Licence Amendment for a Private Label Medical Device [] Application for a New Medical Device Licence for a Private Label Medical Device [] Bed-related Entrapment and Fall Report Form [] Class II Medical Device Licence Amendment Application Form (PDF fillable/saveable (1, K.