How do I file a complaint with Health Canada?
Report complaints involving medical devices to Health Canada by calling toll-free at 1-800-267-9675, or by reporting online. Stay connected with Health Canada and receive the latest advisories and product recalls.
Who regulates medical devices in Canada?
Who regulates medical devices in Canada? The Medical Devices Bureau of the Therapeutic Products Directorate (TPD) is the national authority that monitors and evaluates the safety, effectiveness and quality of diagnostic and therapeutic medical devices in Canada.
What is a medical device complaint?
“Complaint means any written, electronic, or oral communication that alleges deficiencies related to the identity, quality, durability, reliability, safety, effectiveness, or performance of a device after it is released for distribution.”
What is Canadian medical device Regulations?
In Canada, you are required to obtain a Medical Device Establishment License (MDEL) if you intend to market your Class I device, or a Medical Device License (MDL) for your Class II, III or IV device. If you intend to distribute licensed medical devices into Canada, you will require a MDEL.
How do I report unsafe working conditions in Ontario?
If you believe you or another worker are in immediate danger and something needs to be done right away, call our Health and Safety Contact Centre at 1-877-202-0008 ( TTY : 1-855-653-9260 ). The number operates 24 hours a day, seven days a week. Do not file your complaint online.
How do I report a restaurant in BC?
You can report concerns about restaurant food to your local public health department. If you suspect that your health has been compromised because of food, contact your doctor or local public health centre, who will follow up with the appropriate treatment.
Who enforces the medical device regulation?
In the UK the competent authority is the Medicines and Healthcare products Regulatory Agency (MHRA). The Medical Devices Directive (93/42/EEC) classifies products according to their level of risk.
Which legal act is directly responsible for medical device reprocessing?
Assessing MDR in Alberta CPSA is responsible for overseeing Medical Device Reprocessing (MDR) in Alberta medical clinics that perform procedures using reusable medical devices.
What information is needed to investigate a medical device complaint?
Records of investigation must include:
- The name of the medical device investigated.
- The date the complaint was received.
- Any UDI or UPC codes, or any other identifying or control number fixed to the device.
- The contact information of the complainant, including name, address and phone number.
Who is responsible for health and safety in Canadian workplaces?
What are the employer’s responsibilities? An employer must: Establish and maintain a health and safety committee, or cause workers to select at least one health and safety representative. Take every reasonable precaution to ensure the workplace is safe.
How do I file a complaint about a medical device?
For Medical Devices If you are a consumer looking to report a problem with a medical device, access this online form. If you are an industry representative, looking to file a complaint about a competitor’s medical device or report a problem not covered by mandatory reporting requirements, access this online form.
How do I submit a health product complaint?
There are 2 different forms for submitting a complaint depending on the type of health product involved: For Medical Devices If you are a consumer looking to report a problem with a medical device, access this online form.
How does Health Canada handle medical device recalls?
Our procedures have set timelines to ensure that recalls are initiated in a timely fashion, according to the level of risk. Our procedures require importers and manufacturers of the medical device to provide Health Canada with an initial recall report.
When was the guidance for medical device complaints handling and recalls?
Supersedes: Guidance for Medical Device Complaint Handling and Recalls Date issued: March 25, 2011 Date of implementation: March 25, 2011