MMD-126 Understanding of Medical Devices Regulations (SOR/98-282)
Understanding of Medical Devices Regulations (SOR/98-282) involves familiarity with the Canadian regulatory framework that governs the safety, effectiveness, and quality of medical devices sold in Canada. These regulations, established under the Food and Drugs Act, outline the requirements for manufacturers, importers, and distributors to ensure that medical devices meet predefined standards before and after they enter the market.
The regulations classify medical devices into four risk-based classes (Class I to IV), with increasing levels of regulatory control depending on the potential risk to patients and users. Higher-risk devices (Class III and IV) are subject to more stringent requirements, including licensing, detailed technical documentation, and evidence of safety and performance through clinical data or equivalent validation.
In addition, SOR/98-282 emphasizes post-market responsibilities such as complaint handling, incident reporting, recalls, and quality management system implementation. Organizations must maintain proper documentation and demonstrate ongoing compliance to ensure continuous monitoring of device performance and prompt action in the event of safety concerns.
The regulations classify medical devices into four risk-based classes (Class I to IV), with increasing levels of regulatory control depending on the potential risk to patients and users. Higher-risk devices (Class III and IV) are subject to more stringent requirements, including licensing, detailed technical documentation, and evidence of safety and performance through clinical data or equivalent validation.
In addition, SOR/98-282 emphasizes post-market responsibilities such as complaint handling, incident reporting, recalls, and quality management system implementation. Organizations must maintain proper documentation and demonstrate ongoing compliance to ensure continuous monitoring of device performance and prompt action in the event of safety concerns.
The training provides:
- Understand the fundamentals of SOR/98-282 and its regulatory scope
- Gain awareness of Health Canada CMDR updates (2021)
- Develop practical knowledge in applying regulatory requirements
- Identify key compliance obligations for medical device stakeholders
- Utilize available regulatory resources and references effectively
- Module 1: Overview of Canadian Medical Devices Regulations (SOR/98-282)
- Module 2: Health Canada CMDR Updates 2021
- Module 3: Working Knowledge in Application of Requirements
- Module 4: Resources and References
This course is designed for anyone who may involve in the implementation and execution of this Quality System Regulation.
This is a 1-day programme.
This course runs from 9:00am – 5:00pm with an hour for lunch and periodic short breaks.
This is an intensive session designed to include as much discussion as possible. Lunch and breaks provide an opportunity for further questioning and discussion with the instructors.
This course runs from 9:00am – 5:00pm with an hour for lunch and periodic short breaks.
This is an intensive session designed to include as much discussion as possible. Lunch and breaks provide an opportunity for further questioning and discussion with the instructors.
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