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Important Update: CDSCO Requires Mandatory Registration for Class C and D Medical Devices with Transition to Licensing | Operon Strategist

The Central Drugs Standard Control Organization (CDSCO) in India has recently announced a significant update regarding the registration and licensing...

Uzbekistan is a country with a growing healthcare sector and an increasing demand for medical devices. However, navigating the regulatory...

Performance evaluation is a crucial step in the development and validation of in vitro diagnostic (IVD) devices. It ensures that...

BD, a global medical technology company, has recently announced its expansion of access to advanced image-enabled, spectral cell sorters. This...

Greenlight Guru Clinical is a leading provider of quality management software for the medical technology industry. Their platform offers a...

Greenlight Guru, a leading provider of quality management software specifically designed for the medical device industry, has once again proven...

Managing budgets and meeting milestones are crucial aspects of conducting successful clinical investigations in the field of medical technology (MedTech)....

The National Medical Products Administration (NMPA) in China has been busy in April 2024, with several important updates and developments...

The Food and Drug Administration (FDA) has recently announced that it will be clearing Bluetooth medical devices for use in...

The Food and Drug Administration (FDA) has recently announced that it will be clearing the use of Bluetooth technology in...

The National Medical Products Administration (NMPA) recently issued a new guideline aimed at improving usability engineering in medical devices. This...

The National Medical Products Administration (NMPA) in China recently issued a new guideline for usability engineering in medical devices. This...

As the global healthcare industry continues to expand, medical device manufacturers are increasingly looking to explore international markets to tap...

As the global healthcare industry continues to expand, medical device manufacturers are increasingly looking to explore international markets for growth...

Sequana Medical, a leading medical device company focused on the development of innovative solutions for the management of fluid overload...

Introduction ISO 13485:2016 and Part 820.25 are two important standards that govern the quality management systems of medical device manufacturers....

Healthcare cloud computing has revolutionized the way medical devices are managed and operated in the healthcare industry. By utilizing cloud-based...

BioCardia, a leading biotechnology company focused on the development of innovative regenerative therapies for cardiovascular diseases, has recently received a...

ElectroCore, a leading bioelectronic medicine company, has recently been awarded a grant to further develop a groundbreaking treatment for post-traumatic...

The Food and Drug Administration (FDA) plays a crucial role in ensuring the safety and efficacy of medical products in...

Drug-device combination products are becoming increasingly popular in the healthcare industry, offering a unique approach to treating various medical conditions....

Haryana, one of India’s leading states in terms of industrial development, has recently announced its ambitious Medical Device Manufacturing Policy...

Colorectal cancer is a type of cancer that starts in the colon or rectum, and it is the third most...

Drug-device combination products have become increasingly popular in the healthcare industry, offering a unique approach to treating various medical conditions....

Vapotherm, a leading global medical technology company, is set to introduce its latest innovation, the Access365 Home Ventilation Solution, at...

Medtronic, a global leader in medical technology, recently announced a strategic shift in its approach to ventilators in response to...

Health Canada plays a crucial role in ensuring the safety and effectiveness of medical devices in Canada. One important aspect...

Sysmex Corporation, a leading global healthcare company, has been making waves in the field of robotics with its innovative approach...

The INHALE-3 study, a groundbreaking clinical trial comparing the efficacy of Afrezza® with traditional insulin delivery methods, has recently released...

Starting April 1, RF Aesthetic Equipment will need a Device Certificate As of April 1, 2022, all Radio Frequency (RF)...

Roles and Responsibilities outlined in Health Canada’s Guidance on Medical Device Recalls

Health Canada plays a crucial role in ensuring the safety and effectiveness of medical devices in Canada. One important aspect of this responsibility is overseeing the recall of medical devices that pose a risk to the health and safety of Canadians. In order to facilitate this process, Health Canada has outlined specific roles and responsibilities for all parties involved in a medical device recall.

The guidance provided by Health Canada on medical device recalls outlines the roles and responsibilities of manufacturers, importers, distributors, healthcare facilities, and Health Canada itself. Each party has a distinct role to play in ensuring that the recall is carried out effectively and efficiently.

Manufacturers are responsible for initiating a recall when they become aware of a potential issue with their medical device. They must notify Health Canada of the recall and provide detailed information about the nature of the issue, the affected devices, and the proposed corrective actions. Manufacturers are also responsible for communicating with their customers and ensuring that affected devices are removed from circulation.

Importers and distributors are responsible for assisting manufacturers in carrying out the recall, including notifying their customers and facilitating the return or replacement of affected devices. They must also keep records of all communications related to the recall and provide this information to Health Canada upon request.

Healthcare facilities play a crucial role in the recall process by identifying and quarantining affected devices, notifying patients who may have received them, and returning or replacing the devices as necessary. Healthcare facilities must also report any adverse events related to the recalled devices to Health Canada.

Health Canada’s role in a medical device recall is to oversee and monitor the process to ensure that it is carried out in a timely and effective manner. Health Canada may request additional information from the manufacturer or other parties involved in the recall, conduct inspections of facilities, and take enforcement action if necessary.

Overall, the guidance provided by Health Canada on medical device recalls is designed to ensure that all parties involved in the process understand their roles and responsibilities and work together to protect the health and safety of Canadians. By following these guidelines, manufacturers, importers, distributors, healthcare facilities, and Health Canada can effectively manage recalls and prevent harm to patients.