Health Canada requires medical device manufacturers to submit detailed technical documentation when applying for a Medical Device License (MDL) to ensure the quality, safety and efficacy of the medical device. The following are the main requirements and information that are usually required to be included in the MDL technical documentation:
Description of the medical device: Provide a detailed description of the medical device, including information such as name, model, specification, and use.
Technical specifications: including the design and manufacturing specifications of medical devices, such as size, materials, construction, working principle, etc.
Safety and efficacy data: Provides clinical trials, laboratory tests, and other relevant data on medical devices to demonstrate their safety and efficacy.
Quality management system: describes the manufacturing and quality control process of medical devices, including production equipment, material procurement, inspection and testing methods, quality control procedures, etc.
Medical device identification: including product labels, packaging and instructions for use.
Risk analysis: Explain the possible risks of medical devices and provide corresponding risk management measures.
Clinical data (if applicable): If clinical trials are required to support the safety and efficacy of the medical device, relevant clinical study data should be included.
Literature Review: Provides scientific literature and research findings related to medical devices to support claims of their safety and efficacy.
Manufacturer Information: Provide detailed information about the manufacturer, including documentation of the company's qualifications and quality management system.
Post-purchase monitoring program: Describes the monitoring and feedback mechanism of a medical device after it is sold on the market in order to identify and address potential safety issues in a timely manner.