A Medical Device Establishment Licence (MDEL) is a license issued to Class I medical device manufacturers, importers, or distributors of all device classes. In a recent guidance, Health Canada described how the Agency inspected the licensed medical device establishments, the inspection process and explained how inspectors should assess the compliance with the Food and Drugs Act and Medical Device Regulations.
One section of the guidance describes that the entities involved in manufacturing, promoting or marketing the medical devices should achieve and sustain compliance with the appropriate requirements set forth under the Food and Drugs Act. The other section describes the factors to be considered by inspectors when assessing the compliance of a medical device establishment with the Regulatory requirements set forth under the Medical Devices Regulations. Let us explore the key points covered.
Key Points Under the Food and Drug Act
- For medical devices intended to be used in the context of certain diseases and conditions listed in Schedule A of the Act, the entity should neither advertise nor offer to the public.
- The medical devices which expose patients to additional hazards when used for the intended purpose in a way described by the manufacturer should not be made available by any entity.
- Unless a medical device meets the applicable Regulatory requirements, it is prohibited to market any article as a medical device.
- The labeling and packaging information on the medical devices should not be incorrect or misleading and the device’s function and features or the safety-related issues should not be misrepresented.
- The Authority additionally emphasizes that granting a medical device or an MDEL should not be construed as an approval of any kind granted to the medical device or its manufacturer.
- It is also prohibited to include the logo of the regulating Authority on the label or on any other materials accompanying the device, as this would be treated as misleading.
Key Points Under the Medical Devices Regulations
- Determining the proper classification of a medical device in accordance with the applicable Canadian risk-based classification is the sole responsibility of a medical device manufacturer and the rules to be applied are prescribed in schedule 1 of the regulations. If a manufacturer fails to determine the class of a device that is subject to review correctly, it could potentially result in failure to comply with the applicable Regulatory requirements.
- Like the Food and Drugs Act, the Medical Device Regulations also prohibits the availability of devices that could cause harm to patients when being used for the intended purpose.
- In terms of safety and effectiveness, a medical device manufacturer is responsible for demonstrating compliance with the applicable requirements. This will include an inspection on the design and manufacturing of a medical device and proper identification of risks associated with the device and ensuring the device will not cause any harm to the patients, when used for the intended purpose. The clinical benefits of the device should outweigh the identified and associated potential risks and the device should not be harmed during transportation or storage. Additionally, the inspection will also cover the assessment of compliance with the labeling requirements, especially for Class I and II medical devices, as they are allowed to be placed on the market under a simplified procedure that does not require a mandatory review of labeling.
- The materials used to manufacture the device will be evaluated in terms of compatibility, and for sterile devices, special requirements will be applied, and the inspector will evaluate the effectiveness of the sterilization method and the controls used to ensure sterility. Additional validation will be performed to evaluate a device’s performance if it is software.
- The inspector is entitled to issue observations related to the effectiveness for the intended use, transport, and storage, upon completion of the evaluation.
In a nutshell, Health Canada’s guidelines will assist manufacturers with an MDEL to understand and prepare for an inspection and ensure that the inspections are carried out in a consistent manner, irrespective of where and when they take place. Get in touch with Freyr - a proven Regulatory expert to be a compliant license holder. Stay informed. Stay compliant.