How Health Canada inspects medical device establishments: Overview
Replaces: GUI-0064v5, How Health Canada inspects medical devices establishments, November 17, 2016
Disclaimer: This document does not constitute legislation. In the event of any inconsistency or conflict between the legislation and this document, the legislation takes precedence. This document is an administrative document that is intended to facilitate compliance by the regulated party with the legislation and the applicable administrative policies.
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These guidelines describe how Health Canada inspects licensed medical device establishments (companies). They describe the inspection process and explain how inspectors assess compliance with the Food and Drugs Act (the Act) and Medical Devices Regulations (the Regulations).
These guidelines will help anyone with a medical device establishment licence (MDEL) understand and prepare for an inspection. They also ensure that inspections are carried out in a consistent manner no matter where or when they take place.
These guidelines apply to you if you have an MDEL and you are a:
- manufacturer (Class I medical devices)
- importer (Classes I to IV medical devices)
- distributor (Classes I to IV medical devices)
Note: You are a distributor or an importer if you:
- rent or loan medical devices
- distribute devices for use as samples, sell devices (regardless of number or amount) to health care facilities or providers who then sell the device to a patient (ultimate consumer or end-user)
- supply devices to a chain of retail outlets that are individually owned and operated (either independently or under a franchise agreement)
A distributor or importer is not the same as a retailer, who sells medical devices (or services using a device) only to the end-user. As a distributor or an importer, you must have an MDEL to carry out your activities legally. (Retailers do not need an MDEL.)
You may also be inspected if you do not have an MDEL, but you are subject to the Act and Regulations. This includes a:
- manufacturer of Class I devices who imports or distributes their medical device solely through someone who has an MDEL
- company or person subject to 1 of the following sections in the Regulations:
- Part 2, “Custom-made devices and medical devices to be imported or sold for special access”
- Part 3, “Medical devices for investigational testing involving human subjects”
- manufacturer of Class II, III or IV devices (including private-label manufacturer) who has a medical device licence
Note: If you do not have an MDEL or need help to complete the application, consult the following guidance document:
These definitions explain how terms are used in this document. If there is a conflict with a definition in the Act or the Regulations, the definition in the Act or Regulations prevails.
- Any regulated party subject to the Food and Drugs Act and Medical Devices Regulations, including manufacturers, importers, distributors, persons, partnerships and associations.
- Corrective action:
- Steps taken to eliminate the root cause of a deficiency and to prevent recurrence. (For example, a contravention to the Food and Drugs Act and/or Medical Devices Regulations cited in an inspection observation.) Note 1: There can be more than one cause for a deficiency. Note 2: Corrective action is taken to prevent recurrence, whereas preventive action is taken to prevent occurrence.
- Action taken to eliminate a deficiency. (For example, a contravention to the Food and Drugs Act and/or Medical Devices Regulations cited in an inspection observation.)
- Corrective action plan:
- A statement of the steps and actions that will be taken to eliminate the deficiencies identified during an inspection.
- Custom-made device:
- A medical device, other than a mass-produced medical device that:
- is manufactured in accordance with a health care professional’s written direction giving its design characteristics
- differs from medical devices generally available for sale or from a dispenser and
- for the sole use of a particular patient of that professional, or
- for use by that professional to meet special needs arising in the course of their practice (Medical Devices Regulations)
- A person who is a member of a professional governing body and who is entitled, by virtue of their membership in that body, to manufacture or adapt a medical device in accordance with a health care professional’s written directions in order to meet the specific requirements of a patient. (Medical Devices Regulations)
- A person other than a manufacturer, importer or retailer who sells a medical device in Canada for the purpose of resale or use, other than for personal use. A person outside of Canada selling medical devices into Canada is also considered to be a distributor.
- Export certificate:
- A certificate signed by the fabricator (the person who made the product) and a Commissioner for Taking Oaths, which declares that:
- the device listed in the certificate is not manufactured or sold for use in Canada
- the package and contents of the device do not violate any known requirements of the importing country
- Health care facility:
- A facility that provides diagnostic or therapeutic services to patients. It includes a group of such facilities that report to one common management that has responsibility for the activities carried out in those facilities. (Medical Devices Regulations)
- A person in Canada, other than the manufacturer of a device, who is responsible for the medical device coming into Canada for sale.
- Investigational testing:
- Also known as a clinical trial or study, investigational testing is a research study of 1 or more human subjects to assess the safety or performance of a medical device.
- A person who:
- sells a medical device under their own name or under a trademark, design, trade name or other name or mark owned or controlled by the person and
- is responsible for designing, manufacturing, assembling, processing, labelling, packaging, refurbishing or modifying the device, or for assigning to it a purpose, whether those tasks are performed by that person or on their behalf (Medical Devices Regulations)
- Medical device:
- A device within the meaning of the Act, but does not include any device that is intended for use in relation to animals. (Medical Devices Regulations)
- Preventive action:
- Steps taken to eliminate the cause of a potential deficiency. (For example, a potential contravention to the Food and Drugs Act and/or Medical Devices Regulations.) Note 1: There can be more than one cause for a potential contravention. Note 2: Preventive action is taken to prevent occurrence whereas corrective action is taken to prevent recurrence.
- A logically distinct set of activities designed to accomplish a specific task(s). It is concerned with how to achieve the task rather than what is to be achieved. It defines the work that should be done and explains how it should be done, who should do it and under what circumstances. The procedure defines what authority and what responsibility has been allocated, which supplies and materials should be used, and which documents and records must be used to carry out the work.
- A set of interrelated resources and activities that transform inputs into outputs. Resources may include management, services, personnel, finance, facilities, equipment, techniques and methods.
- A document that states the results achieved or provides evidence of activities performed. (ISO 9001:2008)
- A person who sells a device, or a service using a device, solely to the ultimate consumer. Many retailers may not be aware whether devices are being purchased by the ultimate consumer for their own use. Where a sale occurs to those who are identifiable as not being the ultimate consumer, the seller is considered to be a distributor, and not a retailer.
- Any additional building that is used by the MDEL holder (establishment) for keeping the procedures attested to in paragraphs 45(g) to (i) of the Medical Devices Regulations. A P.O. box is not considered an acceptable site address. A site must be in the same country as the establishment.
- Special Access Program:
- Under the Act and Regulations, physicians and dentists can access medical devices for human use that do not have market authorization (permission to market the device for sale) in Canada. Health Canada decides whether to allow access to these devices based on the details of each case. If warranted, Health Canada will provide a letter of authorization to the health care provider. A copy of this letter must be sent with the shipment to allow timely entry of the drug or medical device into Canada.
- Ultimate consumer:
- The individual (also “end-user”) who:
- buys or receives a medical device for their own personal use (including within their household) or
- receives treatment or is diagnosed with a device from a third party such as a health care facility or provider
Businesses that buy devices (for example, first aid kits, disposable gloves) solely for use by their employees during work hours are also ultimate consumers, so long as their business does not offer health services to employees or other individuals.
Licence and other applications
- Guidance on medical device establishment licensing and medical device establishment licence fees (GUI-0016)
- Guidance on how to complete the application for a new medical device licence
- Guidance document: How to complete the application for a new medical device licence/medical device licence amendment for a private label medical device
- Preparation of an application for investigational testing – In vitro diagnostics devices
- Guidance document applications for medical device investigational testing authorization
- Guidance document – Labelling of in vitro diagnostic devices
- Guidance for the risk-based classification system of in vitro diagnostic devices
- Incident reporting for medical devices: Guidance document
- Foreign risk notification for medical devices guidance document
- Guidance on summary reports and issue-related analyses for medical devices
- Guidance for the labelling of medical devices, not including in vitro diagnostic devices, appendices for labelling of soft contact lenses, decorative contact lenses and menstrual tampons
- Guidance document: Recognition and use of standards under the Medical Devices Regulations
- Guidance document: Schedule A and Section 3 to the Food and Drugs Act
- Guidance for industry – Device licence applications for ultrasound diagnostic systems and transducers
- Guidance for industry: Keyword index to assist manufacturers in verifying the class of medical devices
- Guidance for the interpretation of sections 28 to 31: Licence application type
- Guidance for the interpretation of significant change of a medical device
- Guidance on investigation of reported medical device problems (GUI-0065)
- Guidance on medical device compliance and enforcement (GUI-0073)
- Guidance on the risk-based classification system for non-in vitro diagnostic devices (non-IVDDs)
- Guide to recall of medical devices (GUI-0054)
- Risk classification guide for medical device establishment inspections (GUI-0079)
- Compliance and enforcement policy for health products (POL-0001)
- Policy on accessing the premises of a regulated party remotely to verify compliance (POL-0138)
- List of registrars recognized by Health Canada under section 32.1 of the Medical Devices Regulations
- Medical device inspections
- Medical devices special access program
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