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Guidance on the Medical Device Inspection Program (GUI-0064)

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Introduction

The present version of this Guidance Document details changes to the medical device inspection program. As of April 1st 2012, the inspection program includes an inspection cycle for domestic Medical Device Establishment Licence holders.

Our Mandate

To manage and deliver a national compliance and enforcement program for blood and donor semen; cells, tissues and organs; drugs (human and veterinary); medical devices and natural health products, collaborating with and across, all regions.

  • Supersedes: October 1, 2010
  • Date issued: April 1, 2012
  • Date of implementation: April 1, 2012

Disclaimer

This document does not constitute part of the Food and Drugs Act (Act) or its associated Regulations and in the event of any inconsistency or conflict between that 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.

Table of Contents

A. Purpose

This document is intended to provide an overview of the Health Products and Food Branch Inspectorate (Inspectorate) inspection process, how compliance is assessed during an inspection and, where necessary, an interpretation of the regulatory requirements.

B. Scope

The Inspection Program applies to:

  • medical device manufacturers, importers and distributors subject to establishment licensing
  • manufacturers of class I devices who are not subject to establishment licensing
  • companies subject to the requirements of Part 2 (Custom-made and Special Access) or Part 3 (Investigational Testing) of the Medical Devices Regulations

Any other party subject to the Food and Drugs Act and the Medical Devices Regulations, or a company holding a CAN/CSA-ISO 13485:03, Medical devices, Quality management systems certificate under CMDCAS, may also be inspected if there is an indication of noncompliance or suspected noncompliance.

In general, the primary focus of inspections is to assess compliance with sections of the Medical Devices Regulations (Regulations), such as complaint handling, recalls, mandatory problem reporting as they are not assessed through other mechanisms. Companies may also be assessed for compliance with the sections of the Food and Drugs Act (Act) which apply to medical devices, particularly sections 3, 19, 20 and 21.

C. Definitions

Company:
any regulated party subject to the Food and Drugs Act and the Medical Devices Regulations, including manufacturers, importers, distributors, persons, partnerships and associations.
Compliance:
the state of conformity of a regulated party (including a corporation, institution, individual or other legal entity) or a product with a legislative or regulatory requirement or a recognized standard.
Custom-made-device (as per the Regulations):
a medical device, other than a mass-produced medical device that
 
  1. is manufactured in accordance with a health care professional's written direction giving its design characteristics;
  2. differs from medical devices generally available for sale or from a dispenser; and
  3. is :
    1. for the sole use of a particular patient of that professional, or
    2. for use by that professional to meet special needs arising in the course of his or her practice.
Dispenser (as per the 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 manufacturer 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.
Distributor:
a distributor of a medical device is a person other than a manufacturer, an importer or a 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.
Health Care Facility (as per the Regulations):
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.
Importer:
an importer is a person, other than the manufacturer of a device, who causes the medical device to be brought into Canada for sale.
Medical Device Inspection:
A systematic and independent examination of objective evidence to determine compliance with the Act and Regulations, with the exception of the requirements of the applicable quality system standard under these Regulations.
Inspection Types (Medical Device)
  1. Regular: an inspection against the applicable sections of the Act and Regulations specified in this guidance document.
  2. Re-inspection: a follow-up inspection when a company has not provided adequate evidence that they have corrected any serious observation(s) identified in a regular inspection. The inspection is focused on, but not restricted to, the regulatory requirements against which the observation(s) were cited.
  3. Targeted Inspection: an inspection that is focused to meet previously identified criteria other than those specified for a regular inspection.
Inspection Plan:
a detailed agenda for an inspection.
Label:
Includes any legend, word, or mark attached to, included in, belonging to, or accompanying, any food, drug, cosmetic, device, or package.
Note: This includes not only information that is affixed to a device or the packaging but also information such as manuals, package inserts, brochures and leaflets.
Manufacturer (as per the Regulations):
a person who sells the medical device under their own name, or under a trademark, design, trade 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 behalf.
Medical Device (as per the Regulations):
a device within the meaning of the Act except any device that is intended for use in relation to animals. The definition in the Act includes used devices, parts and accessories.
Objective Evidence:
information that can be proved true, based on facts obtained through observation, measurement, testing or other means, (Reference: section 2.19 of ISO 8402:1994).
Observation (Medical Device):
A state of deviation or deficiency with a specific requirement of the Food & Drugs Act or the Medical Device Regulations noted by an inspector during an inspection of a medical device establishment, that is confirmed in writing to the establishment in the Inspection Report. Observations are classified as Risk 1, 2 or 3, where Risk 1 represents the greatest risk.
Risk 1:
An observation describing a situation that has resulted, or has the potential to result in an immediate or latent health risk, and may include any observation that involves fraud, misrepresentation or falsification of medical devices or records.
Risk 2:
An observation related to the failure of an establishment to meet the requirements of the Act and the Regulations related to the processing, importation, and/or distribution of medical devices, or a situation in which the probability of an immediate health risk is remote because procedures are in place to mitigate the risk.
Risk 3:
An observation that is neither Risk 1 nor Risk 2, but is related to a deviation from the Act or the Regulations.
Retailer:
any company (as defined above) who sells a device solely to the ultimate consumer (as defined, below).
With respect to sale to a healthcare facility or a healthcare provider, the patient is considered to be the ultimate consumer whether or not the facility or provider sells the device to the consumer or sells services involving the use of the device. Therefore, persons selling any devices (regardless of the amount) to healthcare facilities or providers are not retailers, but are distributors (as defined above). A central purchasing and distribution facility that supplies devices to a chain of retail outlets which are individually owned and operated (either independently or under a franchise agreement) is also not considered to be a retailer, but is a distributor.
Special Access Program:
The Special Access Programme (SAP), via exemptions set out in C.08.010 and C.08.011 of the Food and Drugs Act and Part 2 Section 69-78 of the Medical Devices Regulations, allows physicians and dentists to gain access to health products for human use that have not been granted market authorization in Canada. Decisions to authorize these exemptions are based on the circumstances and details of each situation. If authorization is granted, Health Canada provides a Letter of Authorization (LOA) to the practitioner. A copy of this letter must be sent with the shipment to allow timely entry of the drug/medical device into Canada.
Ultimate Consumer:
the individual who purchases or receives a device for their own personal use (including use within their household) or receives treatment or diagnosis with a device from a third party such as a healthcare facility or health care provider. Businesses which purchase devices solely for the use by their employees during work activities (e.g. first aid kits, disposable gloves) are also considered ultimate consumers as long as they are not in the business of offering health services to employees or other individuals.

D. Overview of the Inspection Process

Inspections of companies located in Canada are conducted on site.

Domestic Medical Device Establishment Licence (MDEL) holders are inspected according to the following inspection program cycle.

  • Manufacturers: 3 Years
  • Importer: 4 years
  • Distributors: 5 years

Establishments may be selected for inspection outside of the inspection program cycle using criteria that are risk-based. These include newly licensed establishments and the re-inspection of establishments that received an Non Compliant (NC) rating. A targeted inspection may also be conducted if there are concerns with an establishment's compliance with specific sections of the Act or Regulations.

In most cases, the company is given prior notice of the inspection. Notice is initially given by telephone contact followed by written confirmation. During this initial contact, certain basic administrative information including the types of medical device related activities of the company is requested or confirmed. Specific written procedures and list of manufacturers are usually requested prior to the inspection. Unannounced inspections may be conducted in situations where it is anticipated that this approach will provide a more accurate compliance assessment.

An inspection is typically conducted by one inspector from the Inspectorate. Additional inspectors may participate for training purposes or due to the complexity and size of the company inspected.

The inspection begins with an opening meeting. An inspection plan is presented and basic information on the company is reviewed. A tour of the facility may be conducted as appropriate. During the inspection, the inspector systematically gathers objective evidence of compliance with applicable regulatory requirements through interviewing staff, reviewing procedures and examining records.

When observations are identified, the risk associated are classified as risk 1, 2 or 3 as per GUI-0079 (Guidance on Risk Classification of Medical Device Observations) and appropriate corrective and preventative action is requested in order to mitigate the risk and achieve regulatory compliance, in accordance with the Medical Device Compliance and Enforcement Directive, GUI-0073. For example, noncompliant products may be subject to stop sale and recall. Depending on the nature of the observations and the company's response, enforcement action may be initiated at any point during the inspection.

Once the inspection has been completed, the inspector prepares a draft inspection report identifying the observations and comments. This report is discussed with the company at a closing meeting. Within 10 business days of issuing the final report, the establishment must provide a written response with a corrective action plan. However, if there is confirmation during the inspection that false attestations were made by the establishment regarding one or more required procedures, the establishment must provide copies of these procedures within 20 business days from the date of the closing meeting. If the required procedures are not submitted within 20 business days, proceedings may be initiated to suspends their MDEL (as per section 49 (1) (b)).

If one or more observations are classified as Risk 1, then the overall inspection rating may be NC (Non-Compliant). Should this be the case, the establishment will be given a reasonable time frame to address the observations which lead to the NC rating. Failure to adequately address the NC rating may lead to suspension of the company's MDEL. More information on risk classification of observations and overall ratings is available in GUI-0079 (Guidance on Risk Classification of Medical Device Observations).

E. Application of the Regulations to Medical Device Related Activities

Two tables found in Appendix 1 may be used by companies to determine which sections of the Regulations apply to them, based on their medical device related activities.

The first table contains the requirements from Part 1 of the Regulations. Part 1 applies to all devices except those regulated under Part 2 (custom-made devices and those devices under special access authorizations) and Part 3 (devices for investigational testing involving human subjects).

The second table contains the requirements for Parts 2, 3 and 4 of the Regulations. These requirements only apply to manufacturers, importers and distributors of devices described in those parts.

F. Assessing Compliance with Regulatory Requirements

F.1. Device classification (sections 6 and 7)

It is the responsibility of the manufacturer to establish the correct class of a device based on the rules found in Schedules 1 and 2 of the Regulations. Failure to classify devices correctly may result in noncompliance with the device licensing or other regulatory requirements.

Guidance is provided in the following documents located on the Therapeutic Products Directorate (TPD) web site:

Additional assistance is available by contacting the Licensing Services Division of the Medical Devices Bureau (MDB).

F.2. Part 1 - General (sections 8-68)

F.2.1. Safety and Effectiveness Requirements (sections 9-20)

Compliance with the safety and effectiveness requirements is not routinely assessed during an inspection. Such assessments may be initiated when significant health risks are identified during inspections or from another source or by the request of the MDB.

Guidance is provided in the following documents Recognition and Use of Standards under the Medical Device Regulations located on the TPD web site:

  • Draft Policy on Static Magnets Sold as Medical Devices

F.2.2. Labelling Requirements (sections 21-23)

Compliance assessment focuses primarily on labels for class I and II devices as these are not normally subject to Health Canada review by other means. Inquiries may be made to determine the nature of the controls established by the company to ensure ongoing compliance with labelling requirements. Labelling is then sampled and reviewed for regulatory compliance, taking into account the company's various product lines and device classes. The extent of sampling depends upon the adequacy of label controls observed and the compliance history with respect to labelling and other requirements.

Guidance is provided in the following documents located on the TPD web site:

F.2.3. Advertising of contraceptive devices (section 24)

Advertising material for contraceptive devices is reviewed for compliance.

F.2.4. Class I devices (section 25)

An assessment of distribution records is conducted where the company has been directed to stop sale of affected devices.

F.2.5. Importation, sale and advertising conditional on device licensing (sections 26-27)

Inquiries will be made to determine the nature of the controls established by the company to ensure that all class II, III or IV devices imported, advertised or sold are properly licensed with the exception of those devices subject to Part 2 (custom-made and special access) or Part 3 (investigational testing).

Compliance with the device licensing requirement is then assessed as follows:

The validity of device licences for products that are imported or sold (section 26) is verified by reviewing the company's evidence of current licences, taking account of the various product lines, device classes and kinds of licences (described in sections 28-31).

Medical device catalogues are reviewed for the presence of warning labels indicating that not all of the devices may be licensed, if such is determined to be the case (section 27).

Other advertising material is sampled from recent marketing promotions and licensing of the subject devices is verified by evidence provided by the company. The validity of claims made in the advertising material is verified by reviewing the claims upon which the licence was granted.

Where a licence has been suspended, cancelled, refused or amended, distribution and warehouse records are reviewed, on a sampling basis if necessary, for compliance with these regulatory restrictions.

The extent of sampling depends primarily on the adequacy of the company's licensing controls observed, as well as the complexity of the product lines, factors impacting on device licence amendments, such as, changing technology, the amount and complexity of advertising activities and the compliance history of the company.

F.2.6. Device licence application and issuance (sections 28-37)

Compliance with the requirements for a device licence application are assessed by the MDB and are therefore not normally included in an on site inspection.

Guidance is provided in the following documents located on the TPD web site:

F.2.7. Terms and conditions of device licences (sections 36-37)

Where a device licence has been issued with terms and conditions or amended terms and conditions, evidence of compliance with these special requirements (section 36) is reviewed.

In the case of an in vitro diagnostic device for which a licence has been issued with terms and conditions, evidence of submission of test results and protocol as well as sale in accordance with the Health Canada's permission is verified (section 37).

F.2.8. Establishment Licensing (sections 44-51)

Evidence of a valid MDEL is requested under section 44, where deemed to be applicable. Based on the presence of a valid MDEL, the following sections are subject to review to verify the accuracy of the information provided in the MDEL application:

  • 45(c) activities of the company,
  • 45(d) names and addresses of the manufacturers of the devices that are imported or distributed,
  • 45(g) documented procedure for distribution records,
  • 45(g) documented procedure for complaint handling,
  • 45(g) documented procedure for recalls,
  • 45(h) documented procedures for mandatory problem reporting, and
  • 45(i) documented procedures for handling, storage, delivery, installation, corrective action and servicing for any class II, III or IV devices where applicable

The documented procedures are reviewed to ensure that they have been implemented and are adequate. For sections 45(g) and 45(h), the procedures are assessed against the applicable requirements in the distribution records, complaint handling, recall and mandatory problem reporting sections of the Regulations. If the procedures are absent or are inadequate to meet the requirements for the applicable section, the company is considered to be in noncompliance. MDEL holders with missing or inadequate procedures are considered to have made a statement contrary to sections 45(g), 45(h) or 45(i).

For more guidance on assessing the adequacy of these procedures, please consult the sections on distribution records, complaint handling/recalls and mandatory problem reporting later in this document. Guidance on compliance with section 45(i) can be found Appendix II.

Guidance is provided in the following documents located on the Inspectorate web site

F.2.9. Distribution Record requirements (sections 52-55)

Evidence of the existence of distribution records and their adequacy to permit the retrieval of a list of all customers for a particular product is assessed.

F.2.10. Complaint handling requirements (sections 57 and 58a)

The documented procedure is reviewed to ensure that it has been implemented and meets the criteria outlined in the guidance document. Records of problem reports are also reviewed for compliance with the procedures and with the regulatory requirements and to determine if appropriate corrective and preventive actions have been taken.

Guidance is provided in the following documents located on the Inspectorate web site:

F.2.11. Recalls - procedure (section 58b) and notification (sections 63-65)

The documented procedure is reviewed to ensure that it has been implemented and meets the criteria outlined in the guidance document. Recall records are also reviewed for compliance with the procedures and with the regulatory requirements.

Guidance is provided in the following documents located on the Inspectorate web site

F.2.12. Mandatory Problem Reporting (sections 59-61)

Records of problem reports will be reviewed to determine the effectiveness of the established process for identification and reporting of problems meeting the mandatory reporting criteria.

Guidance is provided in the following documents located on the Health Canada web site:

F.2.13. Implant Registration (sections 66-68)

Where applicable, a manufacturer's implant registry is reviewed for compliance against sections 66 and 67. If the manufacturer has received authorization for an alternate method of implant registration, the records are reviewed against the authorized method.

F.3. Part 2 - Custom-made and Special Access Devices (sections 69-78)

Custom-made or special access devices are identified and reviewed for compliance with sections 69, 70 and 75-78.

Compliance with sections 71-74, involving the authorization of a request, is assessed by the MDB.

Guidance is provided in the following documents located on the TPD web site:

F.4. Part 3 - Devices for Investigational Testing Involving Human Subjects (sections 79-88)

Investigational testing devices are identified and reviewed for compliance with sections 79-81 and 86-88.

Compliance with sections 82-85, relating to the authorization of a request, is assessed by the MDB.

For interpretation of section 88 (other requirements) please see the respective interpretations in Part 1, above. Guidance on preparation of an application for authorization to obtain custom-made or special access devices is provided in the following documents located on the TPD web site:

F.5. Part 4 - Export Certificates (sections 89-92)

Where export activities are identified which are claimed to fall under the exemptions of section 37 of the Act, compliance with the following conditions is verified:

  • the device is not manufactured for use in Canada,
  • the device is not sold for use in Canada,
  • the label is marked in distinct overprinting with the words "Export" or "Exportation",
  • a certificate is on record for each shipment and the certificate meets the requirements of section 89(2), and
  • export certificates are retained for at least five years after the date of export as required by section 92.

G. Compliance and Enforcement

Compliance and enforcement activities related to inspections are conducted in accordance with the following document located on the Inspectorate web site:

Appendix I. Determining Regulatory Requirements that are Applicable, based on Medical Device Related Activities

When using the tables below, companies involved in more than one activity will need to consult all applicable columns to determine all of the Regulations that apply. For example, a company that is the manufacturer of devices but also distributes devices made by other manufacturers would need to look at the appropriate manufacturer column as well as the distributor column. The activities of importers and distributors only apply to companies that import or distribute devices for which they are not designated as the manufacturer. The presence of an "x" under an activity indicates that the activity may apply, but companies also need to review any exemptions to determine if they are applicable. For example, the table indicates that manufacturers of class I devices are subject to establishment licensing, but some may be exempt from this requirement because they distribute solely through a licensed distributor.

Part 1 General
Activity / Regulation Regulations sections Manufacturer of class I devices Manufacturer of class II, III or IV devices Importer Distributor
Safety and Effectiveness 9 to 20 checkmark checkmark    
Labelling 21-23 checkmark checkmark checkmark checkmark
Contraceptive advertising 24   checkmark checkmark checkmark
Class I devices 25 checkmark      
Device Licensing - Class II, III, IV devices
Sale 26   checkmark checkmark checkmark
Advertising 27   checkmark checkmark checkmark
Licensing 28-32   checkmark    
Foreign Manufacturers 33 Not in effect at this time
Licence Amendment 34   checkmark    
Additional Information and Samples 35   checkmark    
Issuance 36   checkmark    
Lot of in vitro Diagnostic Devices 37   checkmark    
Refusal to Issue 38   checkmark    
Additional Information 39   checkmark    
Suspension 40-42   checkmark    
Obligation to Inform 43   checkmark    
Establishment Licensing 44 checkmark   checkmark checkmark
Application 45 checkmark   checkmark checkmark
Issuance 46 checkmark   checkmark checkmark
Refusal 47 checkmark   checkmark checkmark
Notification 48 checkmark   checkmark checkmark
Suspension 49 checkmark   checkmark checkmark
Distribution Records 52-55 checkmark checkmark checkmark checkmark
Complaint handling 57-58 checkmark checkmark checkmark checkmark
Mandatory Problem Reporting 59-61 checkmark checkmark checkmark  
Recall 63-65 checkmark checkmark checkmark  
Implant Registration 66-68   checkmark    
 
Part 2, 3 and 4 Requirements
Activity / Regulation Regulations sections Manufacturer of class I devices Manufacturer of class II, III or IV devices Importer Distributor
Part 2 - Custom-made and Special Access Devices
General 70 checkmark checkmark checkmark checkmark
Authorization 71-72 checkmark checkmark checkmark  
Additional Information 73 checkmark checkmark checkmark  
Labelling 75 checkmark checkmark checkmark checkmark
Distribution Records 76 checkmark checkmark checkmark  
Reporting incident 77 reporting requirements apply to healthcare professional
Implant Registration 66-68   checkmark    
Part 3 - Medical Devices for Investigational Testing Involving Human Subjects
General 80 (1) - sale or importation 80(1) checkmark checkmark checkmark checkmark
General 80 (2) -class II, III and IV authorization 80(2) checkmark checkmark checkmark  
General 80 (3) - class I 80(3) checkmark   checkmark  
Records 81 checkmark checkmark checkmark checkmark
Authorization 82-83 checkmark   checkmark checkmark
Additional Information 84-85 checkmark checkmark checkmark  
Labelling 86 checkmark checkmark checkmark checkmark
Advertising 87 checkmark checkmark checkmark checkmark
Distribution record, complaint handling, mandatory problem reporting, recall and implant registration requirements 88 checkmark checkmark checkmark checkmark
Part 4 - Export Certificates
Export Certificates 89-92 checkmark checkmark checkmark checkmark

Appendix II: Interpretation of Procedures Required by Section 45(i)

1. Storage, Handling and Delivery Procedures

Taking into account the types of devices involved, procedures should address the following:

  1. protection from environmental conditions that may affect medical device safety or effectiveness,
  2. identification and appropriate storage, handling and delivery of medical devices that require special storage or transport conditions, such as test kits containing reagents that must not be frozen,
  3. stock rotation (first in - first out) for any medical devices that have a limited shelf-life or expiry date,
  4. handling of product to prevent damage, deterioration or contamination,
  5. segregation of returned or recalled medical devices to prevent them from being inadvertently shipped out, and
  6. delivery procedures, including a verification of orders prior to shipment to avoid incorrect product from being shipped.

2. Installation Procedures

For devices requiring installation, procedures should address the following, where applicable:

  1. installation, inspection and testing instructions established by the medical device manufacturer should be followed by properly trained and qualified personnel (including installation and performance qualification where required) - any deviations must be justified, and
  2. where testing is required, the testing equipment should be adequate for the measurements needed and the equipment should be calibrated on a regular basis.

3. Servicing Procedures

Preventative maintenance procedures and procedures for repairs should address the following, where applicable:

  1. service personnel should be properly trained and qualified for the types of medical devices being serviced (in some cases, service personnel may be required to be trained and authorized by the manufacturer),
  2. regular maintenance, such as cleaning, lubrication, adjustment, inspection, part replacement, calibration and testing, should be performed according to the manufacturer's instructions and should meet or exceed the frequency established by the manufacturer,
  3. servicing records should specify the name of the medical device, location, installation date, device identifier (model number), serial number or lot number as applicable, date of service, servicing personnel, service performed including identification of part replacement and any testing or inspection data,
  4. servicing equipment should be adequate for the task being performed and should be subject to testing, calibration and servicing as required,
  5. repairs should be monitored for trends indicating premature or unexpected medical device failure or malfunction especially in cases where the failure or malfunction may pose a risk to the health of the user or patient,
  6. reports of unexpected failure or deterioration in medical device performance should be investigated and reported to the manufacturer - investigations should include inspection of the specified device in other facilities to determine the extent of the problem,
  7. repairs should not modify the function, design, or performance specifications of the medical device unless specifically authorized by the manufacturer, and
  8. repairs should not involve the use of parts or components that have not been authorized by the manufacturer, especially if they do not meet the specification of the original manufacturer's parts.