Medical Device Establishment License
If you have a device that improves the lives of the patients and you would like to market and sell it in Canada. Get complete end-to-end licensing solution by Pharma 4u Inc – our solution is a complete compliance package. We’ll ensure every part of your operations is compliant with Health Canada requirements:
- Medical device licensing
- Drafting of standard operating procedures
- Product Testing
- Develop reporting structure
Enjoy the peace of mind that comes from knowing your business is protected. We identify your toughest compliance challenges and address them with custom solutions. We’ll provide you with compliance security that grows and adapts with your business or needs, so you’ll have the best possible quality system for years to come.
What is a Medical Device?
A medical device is any instrument, apparatus, machine, software, implant, or other similar article that is intended for use in the:
- Diagnosis of disorder.
- Treatment of an illness.
- Prevention of disease or other medical conditions.
Medical devices are used in healthcare to improve patient outcomes, to monitor health conditions, and to provide therapeutic treatments.
Medical devices can be:
- MRI scanners.
- Surgical instruments such as scalpels or forceps.
- Implantable devices.
- Diagnostic tests.
- Software that supports the use of medical devices.
Medical devices are regulated by Health Canada and other governmental regulatory agencies to ensure that they are safe, effective, and meet certain quality standards. The specific requirements for regulatory approval may vary depending on the country, the type of device, and its intended use.
The classification of a medical device is the responsibility of the device manufacturer, importer, or distributor, based on the device's intended use, mechanism of action, and potential risks to patients. Health Canada provides guidance on the classification of medical devices, but the ultimate responsibility for classification lies with the industry.
Who needs Medical Device Establishment License (MDEL)?
Medical Device Establishment License is required by Health Canada for companies that:
- Manufacturers of medical devices.
- Importers of medical devices.
- Distributors of medical devices.
- Wholesalers of medical devices.
- Retailers of medical devices.
- Health facilities that use medical devices.
- Testing laboratories that test medical devices.
What Activities do not require Drug Establishment License (DEL)?
- Wholesale of drug products
- Distribution or wholesale of active pharmaceutical ingredients (API).
- Storage of medical products.
- Transportation of drug products.
- Importation or compounding by pharmacist or physicians of medical products that are not commercially available for sale in Canada.
Classes and types of Medical Devices
Before medical device can be sold in Canada, manufacturers of Class II, III and IV devices must obtain a medical device license. Although Class I devices do not require a licence, they are monitored through the establishment licensing process.
Class I medical devices are considered to be the lowest risk category of medical devices in Canada, as they are intended to be used for relatively simple medical procedures. These devices have a low potential for harm if they malfunction or are used improperly.
Examples of Class I medical devices include:
- Wound care equipment
- Non-surgically invasive devices, such as bandages, crutches, and stethoscopes
- Surgical masks
The regulatory requirements for Class I medical devices in Canada are generally less stringent than for higher-risk devices, such as Class II, III, and IV devices. However, Class I medical devices are still subject to certain regulatory requirements such as:
- Reporting of adverse events
Manufacturers of Class I medical devices are required to demonstrate that their products are:
- Effective for their intended use
- Provide evidence to support any claims they make about the device
- Subject to periodic inspections by Health Canada to ensure compliance with regulatory requirements.
Overall, the regulatory requirements for Class I medical devices are designed to ensure that these devices are safe, effective, and of reasonable quality, and to minimize the risk of harm to patients. However, the regulatory burden for Class I devices is generally lower than for higher-risk devices, in recognition of the lower potential risks associated with these products.
Class II medical devices are considered to be medium-risk devices in Canada. They are intended for use in more complex medical procedures than Class I devices, but still have a moderate potential for harm if they malfunction or are used improperly.
Examples of Class II medical devices include:
- x-ray machines
- insulin pumps
- diagnostic imaging equipment
Manufacturers of Class II medical devices are required to provide evidence to demonstrate that their products are safe and effective for their intended use.
Manufacturers of Class II medical devices are also subject to certain regulatory requirements, and need to comply with the Medical Devices Regulations, including:
- Reporting of adverse events
- Subject to periodic inspections by Health Canada
Class III medical devices are considered to be medium-to-high risk devices in Canada, as they are intended to be used for more complex medical procedures and have a higher potential for harm if they malfunction or are used improperly.
Examples of Class III medical devices include:
- Hip implants
- Glucose monitors
- Ultrasound diagnostic imaging equipment
- Surgically invasive devices that are intended to be absorbed into the body
- Devices that are intended to remain in the body for at least 30 consecutive days.
Health Canada requires that manufacturers of Class III medical devices provide more extensive evidence:
- Efficacy through clinical trials
- Demonstrate that the benefits of the device outweigh the potential risks
- Ensure compliance with ISO 13485 for Quality Management System (QMS)
- Rigorous reporting requirement for adverse events and recalls
Class IV medical devices are considered to be the highest risk category of medical devices in Canada, as they are intended to be used for the most complex medical procedures and have the highest potential for harm if they malfunction or are used improperly. Examples of Class IV medical devices:
- surgically invasive devices that diagnose, control, or correct a defect in the central cardiovascular system
In addition to the regulatory requirements for Class III devices, manufacturers of Class IV medical devices are subject to even more rigorous quality management and reporting requirements. They are also required to comply with international standards for risk management, such as ISO 14971.
1. Submit License application and associated fees to Health Canada.
2. Health Canada will process and review the application. Health Canada will examine information about the company. This may include details about the company's:
- manufacturing processes
- quality control procedures
- testing methods
- material handling
3. Health Canada will schedule GMP (Good Manufacturing Practices) inspection of the facility.
4. If the application is approved, the company will be issued a Drug Establishment Licence that is valid for a specified period of time (usually two years). The licence will specify the activities that the company is authorized and may include conditions that the company must comply with to maintain the license.
5. Companies that hold a Drug Establishment License are subject to ongoing monitoring and inspections by Health Canada, to ensure that they continue to comply with the regulatory requirements.
6. Companies are also required to report any adverse reactions or other safety issues associated with their products to Health Canada, and to maintain appropriate records of their activities related to drugs.
Health Canada Fees for Medical Drug Establishment License Application
Applications for Class I licence
Applications for Class II licence
Applications for Class III licence
Applications for Class IV licence
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