The article provides a brief overview of the approach to be applied when using standards for demonstrating compliance with the relevant regulatory requirements.
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Health Canada, a country’s regulating authority in the sphere of medical devices, has published a draft guidance document dedicated to using standards to support compliance with the Medical Devices Regulations. Once finalised, the document will provide an overview of the applicable regulatory requirements, as well as additional clarifications and recommendations to be taken into consideration by medical device manufacturers and other parties involved in order to ensure compliance.
At the same time, provisions on the guidance are non-binding in their legal nature, nor are they intended to introduce new rules or impose new obligations. Moreover, the authority reserves the right to make changes to the guidance and recommendations provided therein, should such changes be reasonably necessary to reflect corresponding amendments to the underlying legislation.
Introduction
The present draft guidance provides a framework for manufacturers on how to utilize recognized standards to demonstrate compliance with the Medical Devices Regulations. The guidance specifically addresses the requirements for safety, effectiveness, and labeling of medical devices, as mandated by the regulations.
This document is designed to assist manufacturers in ensuring that their medical devices meet the necessary regulatory requirements, particularly when applying for new or amended licenses, authorizations, and other specific types of device authorizations.
Scope and Application
In particular, the draft guidance emphasizes that recognized standards can be used to demonstrate compliance for all classes of medical devices. However, the primary focus of the guidance is on the use of standards in the context of applying for new or amended medical device licenses or authorizations.
This includes applications for investigational testing, special access, and custom-made device authorizations. The guidance is intended to provide manufacturers with a clear understanding of how standards can support their compliance efforts, ensuring that their devices meet the necessary safety and effectiveness criteria.
Background
According to the guidance, the Medical Devices Regulations outline specific requirements for the safety, effectiveness, and labeling of medical devices, as detailed in sections 10 to 23 of the regulations. However, these requirements are generally stated in broad terms, which can make it challenging for manufacturers to determine whether their devices fully comply.
Recognized national or international standards play a crucial role in providing well-defined criteria that help ensure devices are safe and effective. These standards can offer assurance to both manufacturers and regulators that the aspects of the medical devices they address meet the necessary requirements.
However, it is important to note that not all medical devices or all aspects of safety and effectiveness are covered by recognized standards. As further explained by the authority, this is particularly relevant for new types of devices and emerging technologies, where recognized standards may not yet exist.
In such cases, alternative approaches may be necessary to demonstrate compliance.
Consistency in Regulatory Interpretation
Health Canada additionally emphasizes that one of the key benefits of using recognized standards is that they promote consistency in the interpretation of regulatory requirements. When a manufacturer declares conformity to a recognized standard in the Declaration of Conformity Form, it often eliminates the need for Health Canada to review the test data for those aspects of the device covered by the standard.
This streamlines the application process and reduces the burden on both manufacturers and regulators. However, the guidance also acknowledges that conformance with recognized standards may not always be sufficient on its own to meet regulatory requirements.
In some cases, additional evidence or considerations may be needed to ensure a device is safe and effective.
International Collaboration
Health Canada has a long-standing commitment to collaborating with international partners to align its regulatory practices and standards with global norms. This collaboration helps to reduce regulatory barriers, enabling safe, effective, and high-quality medical devices to enter multiple markets more quickly.
By aligning with international standards, Health Canada ensures that Canadian regulatory practices are consistent with those in other jurisdictions, facilitating the global distribution of medical devices and supporting innovation in the medical device industry.
Regulatory Context
Health Canada issues medical device licenses or authorizations for Class II, III, and IV devices when there is acceptable evidence demonstrating that the device meets the regulatory requirements. Manufacturers are required to provide supporting evidence, which may include clinical data, to substantiate the safety and effectiveness of their devices.
The guidance also refers manufacturers to the List of Recognized Standards for Medical Devices, which is intended to help them comply with the Medical Devices Regulations. However, it is important for manufacturers to be aware that they may also need to adhere to other standards to comply with additional federal, provincial, territorial, or municipal regulations, acts, and certifications.
For example, devices may need to comply with the Radiation Emitting Devices Act, provincial and territorial electrical regulations, and certifications or registrations from Innovation, Science, and Economic Development Canada. These additional regulations are separate from the Medical Devices Regulations and are not addressed by the licensing or authorization process required by Health Canada.
Conclusion
In summary, the present draft guidance issued by Health Canada serves as a valuable resource for manufacturers seeking to demonstrate compliance with the Medical Devices Regulations through the use of recognized standards. The guidance emphasizes the importance of consistency in regulatory interpretation and highlights the benefits of international collaboration in aligning regulatory practices with global standards. Manufacturers are encouraged to utilize the List of Recognized Standards for Medical Devices, while also ensuring compliance with other relevant regulations and certifications that may apply to their devices under the existing legal framework.
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