Search
Close this search box.

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 for growth...

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

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)...

Overview of 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 providing guidance on medical device recalls. A recall is initiated when a medical device is found to pose a risk to the health and safety of patients or users. Health Canada’s guidance on medical device recalls outlines the steps that manufacturers, importers, and distributors must take to address safety concerns and protect the public.

Health Canada’s guidance on medical device recalls is based on the principles of transparency, accountability, and communication. The guidance outlines the responsibilities of all parties involved in the recall process, including the manufacturer, importer, distributor, and Health Canada itself. It also provides detailed instructions on how to conduct a recall effectively and efficiently.

One key aspect of Health Canada’s guidance on medical device recalls is the classification of recalls. Recalls are classified into three categories based on the level of risk posed by the device: Class I recalls are the most serious, involving devices that could cause serious injury or death; Class II recalls involve devices that could cause temporary or reversible health problems; and Class III recalls involve devices that are unlikely to cause any health problems.

Health Canada’s guidance also emphasizes the importance of communication during the recall process. Manufacturers, importers, and distributors are required to notify Health Canada of any potential safety issues with their devices and provide regular updates on the progress of the recall. They are also required to inform healthcare professionals, patients, and other relevant stakeholders about the recall and provide guidance on what actions they should take.

In addition to providing guidance on the recall process itself, Health Canada also offers resources and support to help manufacturers, importers, and distributors comply with their obligations. This includes training sessions, webinars, and other educational materials to help stakeholders understand their responsibilities and navigate the recall process effectively.

Overall, Health Canada’s guidance on medical device recalls is an essential tool for ensuring the safety and effectiveness of medical devices in Canada. By following this guidance, manufacturers, importers, and distributors can protect the public from potential harm and maintain the trust of healthcare professionals and patients.