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Author: Health Canada
Date issued: November 17, 2016
Date implemented: November 17, 2016
Replaces: Guidance on the Medical Device Establishment Licence Inspection Program, April 1, 2012
This document does not constitute part of the Food and Drugs Act (the Act) or its regulations and in the event of any inconsistency or conflict between the Act or regulations and this document, the Act or the regulations take precedence. This document is an administrative document that is intended to facilitate compliance by the regulated party with the Act, the regulations 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 (Act) and Medical Devices Regulations (Regulations).
These guidelines will help anyone with a medical device establishment licence 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 a medical device establishment licence (MDEL) and you are a:
You are a distributor or an importer if you:
A distributor or importer is not the same as a retailer, who sells medical devices (or services using a device) only to the consumer. As a distributor or an importer, you must have an establishment licence to carry out your activities legally. (Retailers do not need a licence.)
You may also be inspected if you do not have an establishment licence but you are subject to the Act and Regulations. This includes:
If you do not have a medical device establishment licence or need help in completing the application, see Guidance on Medical Device Establishment Licensing and Medical Device Establishment Licence Fees (GUI-0016).
Health Canada may inspect anyone who has a medical device establishment licence to ensure they comply with the Food and Drugs Act (Act) and the Medical Devices Regulations (Regulations). Those inspections support Health Canada's national compliance and enforcement program.
During the inspection, inspectors assess whether your establishment (company) complies with the parts of the Act and the Regulations that apply to you. Companies are manufacturers, importers, distributors, persons, partnerships and associations.
Following the inspection, inspectors rate companies as compliant or non-compliant with the Act and Regulations. The inspector bases the rating on the risk associated with the inspection's findings.
You can find information about the risk ratings in Guidance on Risk Classification of Medical Device Observations (GUI-0079).
The activities you carry out under your medical device establishment licence (MDEL) are the focus of the inspection.
Health Canada inspectors will look at your procedures and processes to detect and respond to risks to safety and effectiveness. They will also look at the label and licence requirements that govern your actions to import, advertise and sell medical devices.
Separate inspections, called audits, assess your compliance with the quality management system standard (ISO 13485) needed to get a medical device licence. These audits are carried out by quality management system auditors working for registrars recognised by the Minister under the Canadian Medical Devices Conformity Assessment System (CMDCAS) or the Medical Device Single Audit Program (MDSAP). This type of inspection applies to you if you:
In spite of the audit of your quality management system, Health Canada inspectors may look to see that any Class II, III or IV device you import or sell:
Under section 22(1) of the Act, Health Canada appoints inspectors to enforce the Act and ensure compliance. Section 23 of the Act also outlines the powers given to inspectors so they can perform their role.
While inspectors focus on establishment licence activities, section 23 gives them the power to examine and take action against anything that is not compliant with the Act and Regulations. Inspectors decide on the course of action to take based on the risk the deviation, deficiency or failure poses to health and safety.
Health Canada inspects licensed companies located inside and outside of Canada.
Health Canada conducts inspections based on risk and works continuously to refine this approach to planning inspections. For the most part, inspections are currently carried out on a repeated basis as follows:
An inspection carried out within the inspection cycle is a "regular inspection." A regular inspection is the most common type of inspection Health Canada carries out. It assesses all the requirements of the Act and Regulations that apply to you. See Appendix B, Checklist of regulations that apply to you, for what you will be assessed against.
Health Canada also inspects companies outside of its inspection cycle. The decision to carry out a special-case inspection is based on risk factors such as:
There are five types of special-case inspections:
Inspections of companies in Canada are conducted on location. On-location inspections of small companies are generally completed in one day. Inspections of larger companies may take from two to five days.
Inspections will take a different form if you run a "virtual" or online company and do not rely on physical buildings to store your product.
If you operate at more than one location, the inspector may also inspect the other sites where you carry out activities listed on your establishment licence application and store your procedures. This will add more time to your inspection since inspections are typically carried out by a single inspector. If needed, the lead inspector may ask other inspectors to join the inspection.
Inspections of companies outside of Canada may be inspected on or off site.
Inspections comprise a series of steps that proceed in the same sequence with all inspectors. The following diagram provides a visual depiction of the process.
The inspector will contact you by telephone before the inspection to:
The inspector may choose to arrive without notice if it will result in a more accurate picture of your compliance. Likewise, the inspector may arrive unannounced if unable to reach you by phone.
The inspector may also ask you to provide:
Once the inspection date has been determined, the inspector will confirm the details in writing.
When reviewing your procedures, the inspector will look to see that they:
The inspector will meet with you to:
The inspector will ask for a tour of your site to get an overview of the activities and devices available for sale. During the tour, the inspector may want to look at the following areas:
The inspector may also interview staff in company areas.
The inspector will assess your compliance based on the interviews, tour and review of company procedures. The inspector will also collect and review samples of your company's records and medical devices. The review will take into account your company's product lines and the classification of your devices (i.e. Class I, II, III or IV). The number of samples looked at will depend on several factors:
Health Canada considers the data looked at (i.e. interviews, tour, samples) as "objective evidence" of your company's compliance at a specific moment in time. This is because the evidence is based on facts the inspector:
When looking at this evidence, the inspector will note a deviation, deficiency or failure to comply with the Regulations as an observation. Inspectors rate observations as:
For more information about the risk ratings, see Guidance on Risk Classification of Medical Device Observations (GUI-0079).
Throughout the inspection, the inspector will keep you informed of deviations, deficiencies, or failures. If a deviation, deficiency or failure poses a high risk, the inspector will bring it to your attention at once.
You are encouraged to take action to correct any deviations, deficiencies or failures the inspector points out to you. If corrected before the closing meeting, the inspector will show that the issue has been resolved in the final inspection report.
The inspector will take corrective action or ask you to act immediately to address a high-risk observation. The inspector will make sure that any such actions comply with the Guidance on Medical Device Compliance and Enforcement (GUI-0073).
The inspector will write the first draft of the inspection report based on the evidence of your company's compliance. The inspection report will include the risk ratings of any deviations, deficiencies or failures noted during the inspection. It will also include your company's rating if the inspector found you compliant with the Regulations. A non-compliant rating will not appear on the draft report.
Health Canada will make sure that anything seen as non-compliant is well defined, clear and supported by the Regulations. See Appendix B, Checklist of regulations that apply to you, for what you must comply with based on your activities (i.e. manufacturing, importing or distributing).
The inspector will hold a closing meeting with you on site or by telephone or videoconference. At the closing meeting, the inspector will:
Health Canada will post its initial findings on its website to honour its commitment to openness and transparency. You can see the results at Medical device inspections.
If a rating of non-compliant is recommended for your company, the inspector will give you a form letter with the draft inspection report. The letter serves to notify you that Health Canada will:
The letter will also ask you to start taking corrective actions immediately. You will be expected to explain the actions you will take to address observations rated as high risk (Risk 1). We encourage you to ask questions so that you fully understand the inspector's findings.
After the closing meeting, the inspector will complete the inspection report and send it to you with a cover letter. The cover letter will explain any next steps you are expected to take and provide deadlines. It will also tell you how to let Health Canada know if you disagree with anything in the inspection report.
When finalizing the report, the inspector will update the summary of the inspection and note any deviations, deficiencies or failures you acted to correct.
The final report will also confirm whether your company was found compliant with the Regulations.
Health Canada will post an inspection report card on its website as part of its commitment to openness and transparency. The report card summarizes the findings of the inspection. You can see the inspection findings at Medical device inspections.
You will be expected to respond to the final report within the following timeframe:
A condition of getting a medical device establishment licence is having written procedures in place for various activities. See Sections 44-51: Establishment licence in this guide for the licence requirements, including the mandatory procedures.
When you completed the application for the licence, you were asked to confirm that you had the required procedures in place. You must produce a missing procedure within 30 calendar days of the date on the final inspection report if:
The response you send Health Canada will vary depending on whether you receive a compliant or non-compliant rating.
If your company receives a compliant rating, you are expected to respond with a corrective action plan that:
If your company receives a non-compliant rating, you are expected to respond by:
If your company receives a non-compliant rating, the Establishment Licensing, Billing and Invoicing Unit within Health Canada will send you a "proposal to suspend" letter. You will be given a chance to respond to the proposal to suspend your licence.
The inspector will review your written response to the inspection report to ensure it is complete and the corrective and preventive actions effective.
If your response remains inadequate, the inspector may reassess your company. The reassessment is normally conducted within 12 months.
The inspector will notify the licensing unit whether your response is adequate or inadequate.
If you were asked to include documents that support your corrective action plan, the inspector will also review and assess those documents. If inadequate, you will be expected to resubmit new documents.
In keeping with the Compliance and Enforcement Policy (POL-0001), Health Canada prefers you to volunteer to come into compliance through corrective actions. But if you are unwilling or unable, Health Canada will enforce compliance.
In deciding on what action to enforce, we will consider the following factors:
If you are a domestic company, Health Canada can:
If you are a company outside of Canada, Health Canada can:
Any actions taken by inspectors will be consistent with Guidance on Medical Device Compliance and Enforcement (GUI-0073) and the Compliance and Enforcement Policy. Inspectors can take action at any time during the inspection.
If you manufacture, advertise or sell medical devices, certain sections of the Food and Drug Act apply to you. These sections are highlighted here to help you understand how inspectors assess your compliance with the Act. Inspectors look to see whether you are engaged in any activity the Act forbids. This is important since you are responsible for meeting the requirements of the Act.
Sections 3(1) and 3(2) forbid you from advertising and selling medical devices to the general public if the devices treat, prevent or cure the diseases, disorders, and abnormal physical states listed in Schedule A of the Act.
Section 19 forbids you from selling any device that may injure the health of the buyer or user when used as directed or under customary or usual conditions. No company shall sell a device that poses a health hazard.
Section 20(1) forbids you from labelling, packaging, treating, processing, advertising or selling a device in a manner that:
When Health Canada issues a medical device or a medical device establishment licence, it does not mean we approve of the device or the company, only that we authorize you to import or sell the device in Canada. So, advertising medical devices with claims that the device or company is "approved by Health Canada" or with displays of the Health Canada logo are not permitted. Under section 20(1), advertisements with these claims are considered misleading since they create an incorrect or mistaken impression about the device's merit or safety.
Section 20 (2) forbids you from labelling and packaging devices unless they meet the requirements of the Regulations.
Section 21 forbids you from labelling, packaging, selling or advertising any article in such a way that it could be mistaken for a device--unless the article meets the prescribed standard for that device.
This section explains what inspectors look for when they assess your compliance with the Medical Devices Regulations. It also directs you to more information that will help you understand and meet those requirements.
If you are a manufacturer, you are responsible for classifying a medical device based on the rules in Schedule 1 of the Regulations. Failure to classify a device correctly may mean that you do not comply with the device's licensing requirements.
For information on Health Canada's classification system, and help in classifying your device, see the following documents:
If you need more help to classify your device, contact the Licensing Services Division of the Medical Devices Bureau at:
If you are a manufacturer, you are responsible for showing and maintaining evidence that you meet the safety and effectiveness requirements in sections 9 to 20 of the Regulations.
As a result, the inspector may look to see that you have:
For help in using international standards to meet safety and effectiveness requirements, see Guidance Document: Recognition and Use of Standards under the Medical Devices Regulations.
If concerned before or during an inspection, the inspector may ask you to show that your devices are safe and effective and perform as the manufacturer intended. You will need to provide records to support this request. Manufacturers, importers and distributors may be cited under section 19 of the Food and Drugs Act if there is a violation.
Section 19 of the Food and Drugs Act (the Act) prohibits any person from selling "ůany device that, when used according to directionsů may cause injury to the health of the purchaser or user thereof."
If medical devices are not properly transported, stored or handled, their safety and effectiveness may be affected negatively. If you sell such medical devices, you may be in violation of the Act.
The inspector may issue observations to manufacturers under sections 10 to 20 of the Regulations. Two of the most common observations are as follows:
When assessing compliance with sections 21 to 23, inspectors tend to focus on labels for Class I and II devices. This is because the Medical Devices Bureau does not normally review labels when issuing the medical device licence for Class II devices. The Bureau also does not issue a licence for Class I devices. An inspector may ask questions to find out what type of controls you have in place to help you comply with labelling requirements.
A label can be a legend, word or mark that is affixed to a medical device or its packaging. It can also be information such as manuals, package inserts, brochures and leaflets. If the device is sold to the general public in Canada, most information on the label must be in English and French.
The inspector will also collect and review labels. The review will take into account your company's product lines and device classes (i.e. Class I, II, III or IV). The number of labels the inspector looks at will depend on:
You can find help for labelling your device in the following documents:
Inspectors will review advertisements of contraceptive devices for compliance. Under section 24(1), advertising for condoms sold to the general public can only claim to reduce the risk of transmitting sexually transmitted diseases. Condoms cannot claim to prevent the diseases.
If you manufacture Class I medical devices, you must comply with the safety and effectiveness requirements in sections 10 to 20 of the Regulations. (For more information, see Section 9-20: Manufacturer's obligations and Safety and effectiveness requirements in this document.)
Health Canada's Medical Devices Bureau is responsible for enforcing safety and effectiveness requirements. Following a complaint by a consumer (or a report from an inspector), the Medical Devices Bureau may send you a letter directing you to take certain actions so that you meet those requirements. An inspector may then assess the actions you take to ensure they are carried out properly.
If you import or sell a Class II, III or IV device, you must have a medical device licence. Inspectors may ask questions to find out what type of controls you have in place to ensure that all Class II, III or IV devices imported, advertised or sold are properly licensed. This does not apply to any devices subject to parts 2 (custom-made and special access) and 3 (investigational testing) of the Regulations.
Inspectors will assess your compliance with device licensing requirements in the following ways:
For the most part, the number of samples the inspector looks at will depend on the controls you have in place to ensure you classify devices correctly. Sampling will also take into account:
As well, the inspector will consider the factors that result in amendments to the device licence (e.g. a change in the device or manufacturer's name or to the device identifier).
The Medical Devices Bureau is responsible for assessing applications for a medical device licence. As a result, applications for the licence are not normally included in an inspection.
For help in completing the medical device application, see the following guidance documents:
If a medical device licence has been issued with terms and conditions, or the terms and conditions have been amended, the inspector will look for evidence that you complied with these special conditions (section 36).
If a licence for an in vitro diagnostic device has been issued with terms and conditions, the inspector will look for evidence that you sent the required test results and protocols to Health Canada. The inspector will also confirm that when you sold the device you did not do anything for which you were not given permission.
The inspector will ask you to provide the application form you completed to get your establishment licence. The inspector will then verify that the following information in your application form is accurate:
Find information on what to include in your procedures in Appendix D, Checklist for procedures (Class II, III or IV devices). This checklist can be helpful since the inspector may note deviations, deficiencies or failures related to your procedures (e.g. not following shipping procedures when packaging a temperature sensitive medical device).
The inspector will review your procedures to ensure you are using them and they are adequate. If you do not have procedures, or they are inadequate, your company will not be considered compliant with certain sections of the Regulations. For more information on how inspectors assess procedures, see the following sections in this document:
You can also find information on sections 44 to 51 of the Regulations in Guidance on Medical Device Establishment Licensing and Medical Device Establishment Licence Fees (GUI-0016).
Your distribution records should allow you to recall a medical device in an effective and timely way. The inspector will:
Find information on the requirements for your distribution records in Medical devices recall guide (GUI-0054).
The inspector will review your procedures to see that you are using them and that they meet the criteria in Handling complaints about medical devices (GUI-0065). The inspector will also review your records of reported problems to see whether:
You can find information on how to set up an effective system for investigating and resolving problems in Handling complaints about medical devices (GUI-0065).
The inspector will review your procedures to see that you are using them and that they meet the criteria in Medical devices recall guide (GUI-0054). The inspector will also review your recall records to see whether:
You can find information on how a device should be recalled in the Medical devices recall guide (GUI-0054).
If you are a manufacturer or importer, the inspector will review your problem reports to see whether:
Find information on what a problem report is, what incidents should be reported and what to include in the report in Guidance Document for Mandatory Problem Reporting for Medical Devices.
If you are a manufacturer, the inspector will review your implant registry to make sure it complies with sections 66 and 67. If you have been given permission to register implants with a different method, the inspector will review your records against the authorized method.
The inspector will identify and review custom-made or special access devices to make sure they comply with sections 69 and 70 and 75 to 78. The Medical Devices Bureau normally assesses compliance with sections 71 to 74.
If you are a health care professional and you want permission to sell or import a custom-made or special access device, see the Medical Devices Special Access Programme for how to go about it.
The inspector will identify and review devices used for investigational testing (clinical trials) to make sure they comply with sections 79 to 81 and 86 to 88.
The Medical Devices Bureau normally assesses compliance with sections 82 to 85. These sections involve asking Health Canada to permit the sale or import of a device for investigational testing.
For information on how section 88, "Other requirements," will be assessed, see the following sections in this document:
For help in putting together the information needed to get permission to sell in vitro and other medical devices for investigational testing, see the following documents:
If you are exporting a device that is exempt from the Regulations because it falls under section 37 of the Food and Drugs Act), the inspector will confirm the device meets the following conditions:
The inspector will also verify that you are keeping:
These definitions explain how terms are used in this document. If there is a conflict with a definition in the Food and Drugs Act or Medical Devices Regulations, the definition in the Act or Regulations prevails.
Company - Any regulated party subject to the Food and Drugs Act and the Medical Devices Regulations, including manufacturers, importers, distributors, persons, partnerships and associations.
Corrective action plan - A statement of the steps and actions that will be taken to eliminate the observations identified during an inspection.
Custom-made device - A medical device, other than a mass-produced medical device that
Dispenser - 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.
Distributor - 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:
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)
Importer - 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 one or more human subjects to assess the safety or performance of a medical device.
Manufacturer - A person who sells a medical device under their own name, or under a trade-mark, design, trade name or other name or mark owned or controlled by the person, and who 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)
Procedure - A logically distinct set of activities designed to accomplish a specific task. 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 it 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 to whom, which supplies and materials should be used and which documents and records must be used to carry out the work.
Process - A set of interrelated resources and activities that transform inputs into outputs. Resources may include management, services, personnel, finance, facilities, equipment, techniques and methods.
Record - A document that states the results achieved or provides evidence of activities performed. (ISO 9001:2008)
Retailer - Any company subject to the Food and Drugs Act and Medical Devices Regulations that sells a device, or services using the device, only to the ultimate consumer. (A company is a manufacturer, importer, distributor, person, partnership or association.)
Site - Any additional building within Canada that is used by a person or company with a medical device establishment licence (MDEL) for:
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 who receives treatment or is diagnosed with a device from a third party such as a health care facility or provider. Businesses that buy devices (e.g. 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.
Table 1 will help you find out which sections of the Medical Devices Regulations apply to you. The requirements will vary depending on whether you are:
A "yes" tells you the section of the Regulations you must comply with. Be sure to look at each activity you carry out to find out the requirements that apply to you.
If you manufacture Class I medical devices, check section 44(2)(d) of the Regulations to see if you need an establishment licence.
of Class I
of Class II, III or
|Part 1 - General|
|Safety and effectiveness||9-20||Yes||Yes||_||_|
|Class I devices||25||Yes||_||_||_|
|Class II, III and IV devices|
|Foreign manufacturers||33||Not in effect at this time.|
|Additional information and samples||35||_||Yes||_||_|
|Lot of in vitro diagnostic devices||37||_||Yes||_||_|
|Refusal to issue||38||_||Yes||_||_|
|Obligation to inform||43||_||Yes||_||_|
|Mandatory problem reporting||59-61||Yes||Yes||Yes||_|
|Part 2 - Custom-made devices and medical devices to be imported or sold for special access|
|Reporting incident||77||Reporting requirements apply to health care professionals.|
|Part 3 - Medical devices for investigational testing involving human subjects|
|General - sale or importation||80(1)||Yes||Yes||Yes||Yes|
|General - Class II, III and IV authorization||80(2)||Yes||Yes||Yes||_|
|General - Class I||80(3)||Yes||_||Yes||_|
|Distribution record, complaint handling, mandatory problem reporting, recall and implant registration requirements||88||Yes||Yes||Yes||Yes|
|Part 4 - Export certificates|
Use the following checklist to help you prepare before, during and after a medical device establishment licence (MDEL) inspection.
Have you gathered:
Have you checked and confirmed:
Are you prepared to give the inspector:
Have you sent the inspector the action plan:
Use this checklist for help with your procedures for Class II, III and IV devices. The checklist covers how to handle, store, deliver, install, correct and service the devices.
Keeping in mind the types of medical devices you deal with, do your procedures address:
If your device must be put together for use, do your procedures address:
Keeping in mind the types of devices you deal with, do your maintenance and repair procedures address: