Quality Smart Solutions on MDALL, MDL & MDEL Listing Classification Compliance for Medical Devices in Canada
Quality Smart Solutions is a global consulting regulatory compliance firm headquartered near Toronto; their regulatory experts can answer all your questions regarding Medical Device licensing with Health Canada.
Burlington, Canada, May 28, 2022 --(PR.com)-- Quality Smart Solutions Released MDALL, MDL & MDEL Listing Classification Compliance Information for Medical Devices in Canada.
It is very important to understand the Regulatory Classification basics of your medical devices as they vary by perceived risk and product type. Medical device manufacturers selling internationally need to familiarize themselves with the applicable regulations within the Canadian market.
Knowing how medical devices are classified is important so that we can determine what is required to be done before the medical device is sold in Canada.
Furthermore, the classification determines how the product is to be designed and what controls are required. Lastly, timelines around what it would take to bring your device to market and costs can be estimated once the device class is determined.
The medical device regulations in Canada are established by the Government of Canada and regulated by Health Canada. There is a risk-based classification system defined by Health Canada for non-in vitro diagnostic (non-IVDDs) medical devices:
1. Invasive Devices (Rules 1-3)
2. Non-Invasive Devices (Rules 4-7)
3. Active Devices (Rules 8-12)
4. Special Rules (Rules 13-16)
Manufacturers should follow the rules (which are different for each broad category) to determine the risk classification of their medical devices. To contact, us with your Regulatory & Compliance questions, email us at info@qualitysmartsolutions.com or call us at 1-866-396-5144.
Kalpna Mistry the Regulatory Project Specialist at Quality Smart Solutions said this regarding the importance and distinction of an MDL & MDEL: “A medical device license (MDL) is required for Class II, III, and IV medical devices in Canada. A medical device establishment license (MDEL) is issued to manufacturers of Class I devices and importers/distributors of all device classes (I-IV). The MDL demonstrates product approval whereas the MDEL demonstrates establishment approval.”
Andrew Parshad the President of Quality Smart Solutions said, "Medical devices have gained a lot of attention during the pandemic, particularly gloves, masks, and antigen tests. However, medical devices transcend these products and are a vital category in healthcare as well as software-related innovation. With an aging population and the crossover with technology we see an ever-growing need for devices and ensuring they comply with Health Canada and FDA regulations."
Quality Smart Solutions is a Health Canada and FDA compliance solutions provider, having served over 1,400 clients and completed over 100,000 services over the past 16 years. We offer regulatory advice and support related to securing your medical device license. We can help you by responding to potential information requests, keeping your license updated, and reviewing your device labels. If you are looking to get your MDL or MDEL or need help renewing your medical license we make your job effortless.
Quality Smart Solutions is headquartered near Toronto, Ontario. For more information, Visit https://qualitysmartsolutions.com.
Website: https://qualitysmartsolutions.com/
Email: info@qualitysmartsolutions.com
Phone Number: 1-866-396-5144
It is very important to understand the Regulatory Classification basics of your medical devices as they vary by perceived risk and product type. Medical device manufacturers selling internationally need to familiarize themselves with the applicable regulations within the Canadian market.
Knowing how medical devices are classified is important so that we can determine what is required to be done before the medical device is sold in Canada.
Furthermore, the classification determines how the product is to be designed and what controls are required. Lastly, timelines around what it would take to bring your device to market and costs can be estimated once the device class is determined.
The medical device regulations in Canada are established by the Government of Canada and regulated by Health Canada. There is a risk-based classification system defined by Health Canada for non-in vitro diagnostic (non-IVDDs) medical devices:
1. Invasive Devices (Rules 1-3)
2. Non-Invasive Devices (Rules 4-7)
3. Active Devices (Rules 8-12)
4. Special Rules (Rules 13-16)
Manufacturers should follow the rules (which are different for each broad category) to determine the risk classification of their medical devices. To contact, us with your Regulatory & Compliance questions, email us at info@qualitysmartsolutions.com or call us at 1-866-396-5144.
Kalpna Mistry the Regulatory Project Specialist at Quality Smart Solutions said this regarding the importance and distinction of an MDL & MDEL: “A medical device license (MDL) is required for Class II, III, and IV medical devices in Canada. A medical device establishment license (MDEL) is issued to manufacturers of Class I devices and importers/distributors of all device classes (I-IV). The MDL demonstrates product approval whereas the MDEL demonstrates establishment approval.”
Andrew Parshad the President of Quality Smart Solutions said, "Medical devices have gained a lot of attention during the pandemic, particularly gloves, masks, and antigen tests. However, medical devices transcend these products and are a vital category in healthcare as well as software-related innovation. With an aging population and the crossover with technology we see an ever-growing need for devices and ensuring they comply with Health Canada and FDA regulations."
Quality Smart Solutions is a Health Canada and FDA compliance solutions provider, having served over 1,400 clients and completed over 100,000 services over the past 16 years. We offer regulatory advice and support related to securing your medical device license. We can help you by responding to potential information requests, keeping your license updated, and reviewing your device labels. If you are looking to get your MDL or MDEL or need help renewing your medical license we make your job effortless.
Quality Smart Solutions is headquartered near Toronto, Ontario. For more information, Visit https://qualitysmartsolutions.com.
Website: https://qualitysmartsolutions.com/
Email: info@qualitysmartsolutions.com
Phone Number: 1-866-396-5144
Contact
Quality Smart Solutions
Andrew Parshad
800-396-5144
https://qualitysmartsolutions.com/
Andrew Parshad
800-396-5144
https://qualitysmartsolutions.com/
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