Policy for the Inspection of Medical Device Companies (POL-0035)

Introduction

This document outlines the strategy for the effective and uniform delivery of a national inspection program for the medical device industry, which now includes an inspection cycle for domestic Medical Device Establishment Licence holders.

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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: August 12, 2011
• 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

• 1.0 Purpose
• 2.0 Background
• 3.0 Scope
• 4.0 Definitions
• 5.0 Responsibility and Authority
• 6.0 Inspection Program
  • 6.1 Approach
  • 6.2 Inspection Types & Inspection Ratings
  • 6.3 Inspection Time
  • 6.4 Inspection Reporting
• 7.0 Enforcement Response to Noncompliance
• 8.0 Policy/Guidance Documents
  • 8.1 Policy
  • 8.2 Regulatory Guidance
• 9.0 Effective Date
• 10.0 References

1.0 Purpose

The purpose of this document is to detail the strategy for the effective and uniform implementation of a national inspection program for the medical device industry in order to assess compliance against applicable requirements of the Food and Drugs Act (Act) and the Medical Devices Regulations (Regulations).

2.0 Background

Historically, the medical device regulatory compliance program has primarily utilized a responsive approach, resolving issues of noncompliance on a case by case basis. A more systematic approach in the form of a proactive medical device inspection program is needed to improve and maintain compliance across the industry. For manufacturers holding device licences, regulatory compliance is assessed through CAN-ISO 13485:03 quality system audits under the Canadian Medical Devices Conformity Assessment System (CMDCAS), conducted by accredited registrars. This inspection program is designed to address regulatory compliance of companies subject to establishment licensing and the manufacturers of class I devices.

The synergy resulting from the continued responsive approach, together with the proactive Inspection Strategy described in this document, is expected to significantly enhance regulatory compliance and, thereby, the safety and effectiveness of medical devices on the Canadian market.

3.0 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 Regulations

Any other party subject to the Food and Drugs Act and the 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.

4.0 Definitions

Compliance:

means the state of conformity of a regulated person (including a corporation, individual or other legal entity) or product with a legislative requirement or a recognized standard.

Consumer:

means the "ultimate consumer" who is the individual who purchases or receives a medical device for their own personal use (including use within their household) or receives treatment or diagnosis with a medical device from a health care facility or provider. Businesses which purchase medical devices solely for use by their employees during work activities (e.g. first aid kits, disposable gloves) or for incidental emergency use are also considered ultimate consumers as long as they are not in the business of offering healthcare services to employees or other individuals.

Dispenser:

means 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 (medical devices):

means a person who sells a medical device to anyone other than the ultimate consumer. The establishment licencing requirements apply to any distributors of devices for human use except for:

• a health care facility,
• a manufacturer of a Class II, III or IV device that sells only devices for which they hold a licence or devices subject to Part 2 and 3 of the Regulations,
• a manufacturer of a Class I device who sells solely through a licensed establishment,
• a person selling solely devices subject to Part 2 and 3 of the Regulations
• a dispenser.

Enforcement:

means actions that may be taken to induce, encourage or compel compliance with the FDA and its associated Regulations.

Importer (medical devices):

a person, other than the manufacturer of a device, who causes the medical device to be brought into Canada for sale.

Inspection:

means an on-site monitoring and assessment against the applicable requirements of the FDA and its associated Regulations. Inspections are routinely conducted on a predetermined cycle or as required to assess compliance.

Manufacturer (medical devices):

means 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 device:

means a device within the meaning of the Act but does not include any device that is intended for use in relation to animals.

Retailer:

any company who sells a device solely to the ultimate consumer. 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.

For additional definitions, please consult the Act, the Regulations and appropriate guidance documents.

5.0 Responsibility and Authority

Compliance will be assessed through inspections conducted by inspectors of the Inspectorate (Inspectorate) of Health Canada, designated under Section 22(1) of the Act. Inspections for compliance with the Act and the Regulations are conducted under the authority of Section 23 of the Act, using relevant policies and guidance documents.

6.0 Inspection Program

The Medical Device Program, adopted in March 2004, was directed towards medical devices manufacturers, importers and distributors. Over 1,000 inspections were performed within the first six years of the Program. A report describing results of inspections of medical devices companies conducted by the Health Products and Food Branch Inspectorate (Inspectorate) between 2004 and 2009 can be found on our website.

The Medical Device Program has been updated October 1st, 2010, where medical device establishments (establishments) are being rated either compliant (C) or non-compliant (NC) according to the risk given to observations noted during inspections. An accompanying guidance document was also developed to provide criteria for assigning risk ratings to observations (see Guidance on Risk Classification of Medical Devices Observations (GUI-0079)).

6.1 Approach

Inspections of companies located in Canada are conducted on site. Domestic MDEL holders are inspected according to the following inspection program cycle:

• Manufacturers: 3 years
• Importers: 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 NC rating (see 6.2 below). A targeted inspection (see 6.2) 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.

6.2 Inspection Types & Inspection Ratings

Inspection Types

1. Regular: an inspection against the applicable sections of the Act and Regulations specified in this procedure.
2. Re-inspection: a follow-up inspection carried out in response to the assignment of an NC rating. The inspection is focused on, but not restricted to those regulatory requirements where observations were made.
3. Targeted Inspection : An inspection that is focused to meet previously identified criteria other than those specified for a regular inspection

Inspection Ratings:

There are two possible inspection ratings:

• C (Compliant): At the time of the inspection, the regulated party has demonstrated that the activities it conducts are in compliance with the Food and Drugs Act and its associated Regulations. Disclaimer - A C rating does not mean that there are no observations or corrective actions required.
• NC (Non-compliant): At the time of the inspection, the regulated party has not demonstrated that the activities it conducts are in compliance with the Food and Drugs Act and its associated Regulations.

Observation (Medical Devices):

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.

6.3 Inspection Time

The average time for the on-site portion of a regular inspection will vary depending on the type of activities and the size of the company, but is estimated to be approximately 1-3 days.

6.4 Inspection Reporting

Reports outlining observations are generated and issued to companies. Responses from the inspected company outlining corrective actions to the observations identified in the inspection report are required within a specified time frame.

7.0 Enforcement Response to Noncompliance

Voluntary compliance is the preferred option for companies that require corrective actions. The Inspectorate will, however, take appropriate enforcement actions, based on the nature of the observations, the level of risk, the company's response and compliance history. Actions may include, but are not limited to: stop sale, recall, import detention, seizure, licence suspension and prosecution. Enforcement actions to be initiated against foreign companies may include licence suspension, and import refusal.

8.0 Policy/Guidance Documents

The following documents support the Inspection Program:

8.1 Policy

• Inspectorate Compliance and Enforcement Policy, POL-0001

8.2 Regulatory Guidance

Guidance documents to the Regulations including:

• Guidance on Risk Classification of Medial Device Observations (GUI-0079)
• Guidance on Medical Device Compliance and Enforcement (GUI-0073)
• Guidance Document for Mandatory Problem Reporting for Medical Devices
• Guide to Recall of Medical Devices (GUI-0054)
• Guidance on Investigation of Reported Medical Device Problems (GUI-0065)
• Guidance on Medical Device Establishment Licensing and Medical Device Establishment Licence Fees (GUI-0016)
• GDS210: ISO 13485:2003 Quality Management System Audits Performed by Health Canada Recognized Registrars
• How to Complete the Application for a New Medical Device Licence/Medical Device Licence Amendment for a Private Label Medical Device
• Guidance for the Labelling of Medical Devices under Sections 21 to 23 of the Medical Devices Regulations, Appendices for Labelling: Soft Contact Lenses and Menstrual Tampons
• Draft Guidance for the risk based classification system of in vitro diagnostic devices
• Guidance for the Interpretation of Significant Change of a Medical Device
• Guidance for the Interpretation of Sections 28 to 31: Licence Application Type
• How to Apply for Authorization to Obtain Custom-made or Special Access Devices
• Preparation of an Application for Investigational Testings - In Vitro Diagnostic Devices
• Draft Guidance for the risk based classification system
• Draft - Guidance for the Labelling of In Vitro Diagnostic Devices

9.0 Effective Date

The updated strategy was implemented April 1, 2012.

10.0 References

1.  Food and Drugs Act
2.  Medical Devices Regulations.