Classification I
Devices are classified according to their:
potential risk
number of rules of Non-IVDD classification
16
Who has the authority to enforce the Canadian Food and Drugs Act?
Health Canada
Quality System for Medical Devices
ISO 13485
HC Medical device database is called
Medical Device Active License listing
Differences between US, EU and Canada medical device classification
Canada | USA | Europe |
Class I | Class I | Class I |
Class II | Class IIa | |
Class III | Class II | Class IIb |
Class IV | Class III | Class III |
disinfecting or sterilizing a medical device is classified as
ClassII (Rule 13)
what is Mandatory Reporting
Manufacturers and importers have the obligations to report to the Minister of any incidents occurring inside or outside of Canada that have come to their attention involving medical devices sold in Canada. Specifically, these incidents involve failures, deterioration, inadequacy of labeling/directions for use which led to death or serious deteriorations of the state of health to anyone
Technical reports, Technical specifications, Technical Guidances are....
ISO publication
Regulations Governing Medical Devices-FDA
Pre-market Notification (510k) unless exempt or Pre-market Application (PMA); Establishment Registration
Medical Device Listing, Quality System Regulation
Labeling Requirements, Medical Device Reporting
Breast Implants classification
Class IV (Rule 16- exceptions)
IVDDs have 9 rules grouped into 3 categories
Special rules 6-9, transmissible agents and others.
Advertising
No person shall advertise an investigational medical device unless the person holds the relevant investigational testing authorization
CDMAS
Canadian Medical Device Conformity Assessment System
parameters determining the potential risk of a medical device
-How the device will be used
-Invasiveness i.e. local vs. systemic
- Duration of contact
- The potential harm that could be inflicted on a patient if the device fails
- Complexity of design
Non IVDD rules 1-3 apply to
Invasive medical devices
Closed loop glucose controller classification
Class IV (Rule 11 subrule 3.)
Clinical trials are needed if a medical device falls into this class
Class III and IV
Benefits of Having a Quality Management System
Simplify, Clarify and Control your company’s processes
Is this correct?
Devices used for medical purposes are all medical devices regardless if the patient are human or not.
No- vetenary use devices are NOT called medca devices
Definition of an active medical device
A medical device that depends, for its’ operation, on a source of energy other than energy generated by the human body or gravity. A medical device that transmits or withdraws energy (or a substance) to or from a patient without substantially altering the energy or the substance is not an active device.
IVDD intended to be used to monitor levels of drugs, substances or biological components, if there is a risk that an erroneous result will lead to a patient management decision resulting in an imminent life-threatening situation is classified as ...
classified as Class III: (Rule 4)
What is the difference between MDEL and MDL
MDEL- Medical device establishment license- for the company
MDL- each medical device has to have its own license to be sold in Canada
§Quality policy and Quality Objectives
Management Responsibilities-commitment to QMS
Laws of the European Union
A Directive is a legislative act of the European Union which requires member states to achieve a particular result without dictating the means of achieving that result (i.e. member states can have their own requirements)
Three European Directives regulate (and define requirements) the sales and marketing of medical devices in the EU