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ARCHIVED - Summary of the Results of the Medical Devices Inspection Program From 2004-2009
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(ARCHIVED - PDF Version - 214 K) Contact Information for Medical Devices Compliance Unit
Cover Letter
Our Mandate:
To promote good nutrition and informed use of drugs, food, medical devices and natural health products, and to maximize the safety and efficacy of drugs, food, natural health products, medical devices, biologics and related biotechnology products in the Canadian marketplace and health system.
Supersedes: New document
Date issued: June 11, 2010
Date of implementation: June 11, 2010
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. This document is not intended to provide legal advice regarding the interpretation of the Act or Regulations. If a regulated party has questions about their legal obligations or responsibilities under the Act or Regulations, they should seek the advice of legal counsel.
Table of contents
- Executive Summary
- 1.0 Introduction
- 2.0 Analysis of Noncompliances:
- 2.2 Noncompliance by Regulation
- 3.0 Concluding Remarks
- 4.0 References
- Appendix 1
Executive Summary
The mandate of the Health Products and Food Branch (HPFB) of Health Canada is to take an integrated approach to managing the health-related risks and benefits of health products and food, including medical devices used by Canadians. This report describes the results of inspections of medical devices companies conducted by the Health Products and Food Branch Inspectorate (Inspectorate) between 2004 and 2009, and gives an analysis of the findings.
The Medical Devices Inspection Program, adopted in March 2004, was directed towards medical devices manufacturers, importers and distributors. For most of the companies/establishments that were inspected at least some issues of noncompliance were cited. However, the majority of the compliance issues were related to the documentation of risk-management procedures. Where noncompliances associated with a potential direct risk to health and safety were observed, Health Canada worked with companies involved to immediately resolve the issue.
Aside from identifying and addressing risks to health and safety, the inspections achieved further benefits. Through this process, the companies gained a better understanding of the Regulations and inspection procedures. As well, the Inspectorate was able to determine the regulatory areas that need greater clarification. To address this, the Inspectorate will continue to develop compliance promotion activities aimed at achieving greater regulatory compliance. These efforts include a pre-inspection package to help establishments prepare for the inspection process.
1.0 Introduction
The Health Products and Food Branch Inspectorate (Inspectorate) has the role of delivering a national compliance and enforcement program for products regulated under the mandate of the Health Products and Food Branch. The authority to deliver this compliance and enforcement program with respect to the sale and importation of medical devices is derived from the Food and Drugs Act (Act) and the Medical Devices Regulations (Regulations). It is within this context that manufacturers, importers and distributors of medical devices are inspected. This document presents the first summary of the results of the Inspectorate's Medical Devices Inspection Program. While the Medical Devices Regulations also stipulate standards for the design and manufacture of devices, conformity with these standards is assessed by third-party Quality Management System auditors authorized under Health Canada's Canadian Medical Devices Conformity Assessment System (CMDCAS). Results of these audits are not included in this summary.
The Medical Device Inspection Program was initiated in March, 2004, and over 700 inspections were performed up to and including March 31, 2009. The geographic distribution of inspected sites was an accurate representation of the distribution of licensed companies/establishments in Canada (see Appendix 1 for details). Sites to be inspected were selected based on risk and in light of this, both the medical device being sold and the activities conducted by the establishment (i.e. manufacturing, importing and/or distributing) were considered. With respect to risk, medical devices are placed into one of four classes (I-IV). Class I devices (such as eyeglasses) are considered to be associated with the lowest risk and are subject to fewer regulatory requirements, particularly with respect to their licensing. Conversely, Class IV devices (such as pacemakers) are associated with the highest risk. With respect to activities conducted by an establishment, distributing and importing are considered to be associated with a lower risk than manufacturing.
Inspections consist of a pre-inspection review of relevant company information, the actual on-site inspection, and a post-inspection follow-up where a report listing the observed noncompliances is presented to company representatives. At this time, corrective actions are discussed; inspections are not closed until adequate corrective actions had been established. If during the inspection, an inspector feels that a noncompliance represents an unacceptable level of risk, the issue is brought to the attention of the company and corrected immediately.
Inspections assess an establishment's conformity with sections of the Act and Regulations that mostly deal with either the safety/efficacy of medical devices or the administration of procedures designed to detect potential risks and respond when risks are identified. Thus, while all sections of the Act and Regulations are important for ensuring the health and safety of Canadians, some instances of noncompliance are deemed as representing a more immediate threat than others. Accordingly, the expectations on the part of the company for corrective action can vary in their stringency.
The number of inspections conducted per fiscal year has been increasing. This reflects the continued development of inspection procedures, the training of inspectors, and the provision of additional resources. Despite this, a target inspection frequency has not been established at this time.
2.0 Analysis of Noncompliances:
The document, Guidance on the Medical Devices Inspection Program (GUI-0064) provides guidance on the interpretation of Regulations as they pertain to inspections of medical device companies. Figure 1 shows the distribution of noncompliances as they were assigned to sections within the Food and Drugs Act and Medical Devices Regulations (as a percent of total noncompliances; refer to Appendix 1 for details). The distribution of observed noncompliances was not uniform across sections of the Act and Regulations. The majority of noncompliances appear to be commonly associated with a limited number of sections. It is important to note that most of the noncompliance citations did not involve a direct health risk, but rather they represented deficiencies in the documentation of risk management procedures. For example, almost one-third of the compliance issues involved incomplete or erroneous attestations made on establishment licence renewal submissions. As indicated earlier, these noncompliances are not associated with a direct risk to health, however, the proper documentation of risk management procedures is vital in order for Health Canada to ensure that medical device companies can investigate potential risks and respond appropriately when risks are identified.
Figure 1. Noncompliances observed during inspections of Canadian Medical Device Establishment Licence holders. A complete set of the 
Food and Drugs Act and Medical Devices Regulations can be found.
2.1 Noncompliance by Regulatory Area
Most noncompliances were associated with only four regulatory areas of the Regulations; Establishment Licensing, Complaint Handling, Devices/Device Licensing and Labelling (see Figure 2). Collectively, noncompliances with these sections account for over 90% of total noncompliances that were observed during inspections. These sections are discussed below.
Figure 2. Regulatory areas of the Medical Devices Regulations showing the four that were associated with the greatest number of observed noncompliances (shown as a percentage of the total noncompliances observed).
2.1.1 Establishment Licensing - s.45-48
The most frequently observed compliance issues involved incomplete or erroneous establishment licence renewal submissions (Fig. 2). Noncompliances with these sections accounted for almost half of the total observed. Under the Regulations, no person shall import or sell a medical device unless the person holds and establishment licence. The Regulations also provide that an establishment licence expires at the end of each calendar year. As part of the licence application process, some of the information required to be provided by the applicant includes the activities conducted by the establishment, the names and addresses of manufacturers of the devices being imported or distributed, classes of devices being imported or distributed, etc. In addition, applicants are required to attest that they have documented procedures in place (depending on their activities) for example, in the event of a recall.
2.1.2 Complaint Handling - s.57-58
The second highest number of noncompliances related to the regulatory area of complaint handling (Fig. 2). This includes the maintenance of records of reported problems and complaints, their follow-up, and the establishment and implementation of procedures which allow the company to carry out timely and effective problem investigations.
2.1.3 Devices/Device Licensing - s.26-34
This regulatory area outlines the licensing requirements for the sale and importation of Class II-IV medical devices. This area also includes requirements for the sale and importation of Class I medical devices, which are not licensed. Approximately two-thirds of these particular noncompliances were related to the sale or importation of unlicensed devices. Unlicensed devices have not been authorized for sale in Canada, nor has the evidence for their safety and efficacy been reviewed by Health Canada prior to their sale or import, when required by the Regulations.
2.1.4 Labelling - s.21-23
This regulatory area outlines the requirements for labelling of medical devices for importation into or sale in Canada. Most labelling noncompliances involved issues related to an incorrect name of the manufacturer on the device, as well as to issues of incorrect identifiers on the devices.
The fact that the majority of noncompliances were common to certain sections of the Regulations suggests Health Canada needs to provide greater clarification to the medical devices industry in these particular areas. For this reason, the Inspectorate places a strong emphasis on compliance promotion and education activities. The inspection process itself is facilities more effective compliance promotion efforts. By reviewing inspections, the Inspectorate is able to pinpoint areas of concern, and tailor its compliance promotions activities accordingly.
2.2 Noncompliance by Regulation
The overall level of compliance was encouraging given that this was the first time companies had been inspected for conformity with the entire set of Regulations. Most of the inspected establishments had six or fewer noncompliance citations. Moreover, more than 20 of these establishments received no citations at all. Reflective of the fact that observed noncompliances tended to be associated mostly with four main areas of the Regulations (see above), companies/establishments tended to receive citations for noncompliance with certain regulations. Figure 3 shows the four regulations that were most-commonly cited (s.45(g), s.45(h), s.58(a), and s. 58(b)). For each of these regulations, approximately half of inspected establishments were cited at least once for noncompliance (Fig. 3). It is interesting to note that two of these regulations (s.45(g, h)) involved attestation requirements for an establishment licence application. Noncompliances with regulations related to these attestations (s.45(g-i)) accounted for almost one-third of all noncompliances. As a result, the Inspectorate intends to review the published instructions accompanying the Medical Device Establishment Licence application that deal with these provisions.
Figure 3. The four sections within the Regulations most commonly cited for noncompliance indicating the percentage of inspected establishments that were cited.
3.0 Concluding Remarks
Health Canada remains committed to the health and safety of Canadians who use medical devices. The Inspection Program has resulted in the inspections of approximately one-third of licensed establishments between 2004 and 2009. It is anticipated that similar types of non-compliance issues identified in this summary exist in those that remain. While previous Inspectorate activities have been effective at reducing the noncompliances that could potentially lead to serious health risks for Canadians, noncompliances of this nature were still observed. In addition, the more frequently observed, lower-risk deficiencies are not trivial in that document management practices are vital to Health Canada for the effective identification of risks and the management of corrective actions. The Inspectorate will continue to encourage awareness of the Inspection program within the industry. To facilitate the pre-emptive identification and correction of noncompliances, the Inspectorate is developing a pre-inspection package with information to help industry prepare for an upcoming inspection. The package is expected to be ready by the fall of 2009.
Over the next two years, the Inspectorate plans to implement a risk-rating scheme for these inspections. Once instituted, each noncompliance citation will be associated with a risk level. An establishment will be assigned an overall rating of ‘compliant' or ‘noncompliant' based on its cumulative rating of risk.
The results of the Inspectorate's Medical Device Inspection Program have clearly demonstrated the need for on-site, post-market compliance monitoring through inspections. Additionally, these inspections provide information that facilitates the development of effective compliance promotion activities.
4.0 References
1. Inspection Strategy for Medical Device Companies (POL-0035) [2011-08-12]:
2. Guidance on the Medical Device Inspection Program (GUI-0064):
4. Medical Devices Regulations:
Appendix 1
The number of noted noncompliances classified by the specific sections of the Act and Regulations. Only regulatory areas and sections linked to noncompliances made during the inspections are listed. During the period covered by this report, 40 inspections were conducted in the Atlantic Operational Centre (OC), 112 in the Quebec OC, 363 in the Ontario OC, 45 in the Manitoba/Saskatchewan OC, and 155 in the Western OC.
| Regulatory Area | Section of the Act or the Regulations | Number of Noncompliances (%) | |
|---|---|---|---|
| Total for Regulatory Area | Total for Act or Regulatory Requirement | ||
| Food & Drugs Act - Devices | 25 (0.62%) | ||
| Act s.19 - No sale of hazardous devices | 2 (0.05%) | ||
| Act s.20(1) - Prohibition of misrepresentation | 22 (0.55%) | ||
| Act s.20(2) Label violations contravene 20(1) | 1 (0.02%) | ||
| Food & Drugs Act - General | 12 (0.30%) | ||
| Act s.3(1) - No Schedule A claims in ads | 6 (0.15%) | ||
| Act s.3(2)(b) - No Schedule A ads to general public | 3 (0.07%) | ||
| Act s.3(3) - No contraceptive ads to general public | 1 (0.02%) | ||
| Act s.37(1) - Export exemption - Conditions | 2 (0.05%) | ||
| Regulations - Safety & Effectiveness | 16 (0.39%) | ||
| MDR s.9(1) Safety and effectiveness - obligation | 3 (0.07%) | ||
| MDR s.9(2) - Safety and effectiveness - evidence | 8 (0.20%) | ||
| MDR s.10 - Risk management | 2 (0.05%) | ||
| MDR s.14 - Transport and storage | 3 (0.07%) | ||
| Regulations - Labelling | 399 (9.91%) | ||
| MDR s.21(1) - Multiple label deficiencies | 8 (0.20%) | ||
| MDR s.21(1) - No label | 3 (0.07%) | ||
| MDR s.21(1)(a) - Name of device | 54 (1.34%) | ||
| MDR s.21(1)(b) - Manufacturer | 188 (4.67%) | ||
| MDR s.21(1)(c) - Device identifier | 71 (1.76%) | ||
| MDR s.21(1)(d) - Control number | 1 (0.02%) | ||
| MDR s.21(1)(e) - Contents | 5 (0.12%) | ||
| MDR s.21(1)(f) - Sterility requirements | 3 (0.07%) | ||
| MDR s.21(1)(g) - Expiry date | 4 (0.10%) | ||
| MDR s.21(1)(i) - Directions for use | 6 (0.15%) | ||
| MDR s.21(1)(j) - Storage requirements | 2 (0.05%) | ||
| MDR s.21(2) - Legibility | 5 (0.12%) | ||
| MDR s.22(1)(a) - Placement for general public | 3 (0.07%) | ||
| MDR s.22(2) - Directions for use on small packages | 1 (0.02%) | ||
| MDR s.23(1) - Official language requirements | 7 (0.17%) | ||
| MDR s.23(2) - Directions for use - bilingual option | 13 (0.32%) | ||
| MDR s.23(3) - Self-service display - bilingual directions | 25 (0.62%) | ||
| Regulations - Class I Devices and Class II-IV Device Licensing | 421 (10.46%) | ||
| MDR s.25(2)(b) Stop sale if safety/effectiveness not met | 1 (0.02%) | ||
| MDR s.26 - No sale or import of unlicensed devices | 281 (6.98%) | ||
| MDR s.27(a) - No advertising of unlicensed devices | 98 (2.44%) | ||
| MDR s.27(b) - Catalogue advertising of devices | 37 (0.92%) | ||
| MDR s.34(d) Name of device | 1 (0.02%) | ||
| MDR s.34(e) - Licence Amendments - Device identifier | 2 (0.05%) | ||
| MDR s.36(2)(b) Submission of safety/effectiveness test results | 1 (0.02%) | ||
| Regulations - Establishment Licensing | 1959 (48.68%) | ||
| MDR s.44(1) - No sale or import without Establishment Licence | 10 (0.25%) | ||
| MDR s.45(a) - Name and address of establishment | 9 (0.22%) | ||
| MDR s.45(b) - Name, address, phone number of EL contact person | 7 (0.17%) | ||
| MDR s.45(c) - Activities | 132 (3.28%) | ||
| MDR s.45(d) - Names of manufacturers/suppliers | 330 (8.20%) | ||
| MDR s.45(e) - Medical specialties of devices | 19 (0.47%) | ||
| MDR s.45(f) - Device classes | 102 (2.53%) | ||
| MDR s.45(g) - Distribution, complaints, recalls | 515 (12.80%) | ||
| MDR s.45(h) - Mandatory problem reporting | 404 (10.04%) | ||
| MDR s.45(i) - Handling, storage, delivery, installation, corrective action and servicing | 336 (8.35%) | ||
| MDR s.45(j) - Listed sites | 52 (1.29%) | ||
| MDR s.48 - Notification with respect to change to 45(a),(b) in 15 days | 43 (1.07%) | ||
| Regulations - Distribution Records | 78 (1.94%) | ||
| MDR s.52(1) - Distribution records per device | 16 (0.40%) | ||
| MDR s.53 - Sufficient for product withdrawal | 22 (0.55%) | ||
| MDR s.55 - Retention time | 33 (0.82%) | ||
| MDR s.56 - Timely availability | 7 (0.17%) | ||
| Regulations - Complaint Handling | 970 (24.11%) | ||
| MDR s.57(1)(a) - Records of problems, complaints | 66 (1.64%) | ||
| MDR s.57(1)(b) - Records of actions taken | 57 (1.42%) | ||
| MDR s.58(a) - Investigation procedure | 378 (9.39%) | ||
| MDR s.58(b) - Recall procedure | 469 (11.66%) | ||
| Regulations - Mandatory Problem Reporting | 24 (0.60%) | ||
| MDR s.59(1) - Obligation to report | 15 (0.37%) | ||
| MDR s.59(2) Mandatory problems outside Canada | 2 (0.05%) | ||
| MDR s.60(1)(a)(i) - Preliminary report - 10 days | 1 (0.02%) | ||
| MDR s.60(1)(a)(ii) - Preliminary report - 30 days | 2 (0.05%) | ||
| MDR s.60(1)(b) - Time limits - outside Canada | 1 (0.02%) | ||
| MDR s.60(2)(a)-(i) - Contents of preliminary report | 2 (0.05%) | ||
| MDR s.61.1(2) - Inform with respect to reporting permission | 1 (0.02%) | ||
| Regulations - Recall | 80 (1.99%) | ||
| MDR s.64 - Submit initial recall report | 53 (1.32%) | ||
| MDR s.64(a)-(k) - Contents of initial recall report | 12 (0.30%) | ||
| MDR s.65 - Submit final recall report | 11 (0.27%) | ||
| MDR s.65(a),(b) - Contents of final recall report | 4 (0.10%) | ||
| Regulations - Custom/Special Access Devices | 20 (0.50%) | ||
| MDR s.70 - No sale/import without authorization | 4 (0.10%) | ||
| MDR s.71(1) - Application for authorization | 2 (0.05%) | ||
| MDR s.72(2)(a) Quantity authorized - import | 1 (0.02%) | ||
| MDR s.75(a)-(c) - Specific labelling | 11 (0.27%) | ||
| MDR s.76 - Distribution records per device | 2 (0.05%) | ||
| Regulations - Investigational Testing | 16 (0.39%) | ||
| MDR s.80(1) Sale/import restrictions | 2 (0.05%) | ||
| MDR s.80(2) - Authorization and records | 4 (0.10%) | ||
| MDR s.81(e) - Records - device market history | 1 (0.02%) | ||
| MDR s.81(f)(i)-(iii) - Records - risk management | 1 (0.02%) | ||
| MDR s.81(k)(i) - Investigational consent - follow protocol | 1 (0.02%) | ||
| MDR s.86(c) - Label - "Investigational Device", bilingual | 4 (0.10%) | ||
| MDR s.86(d) - Label - user restriction, bilingual | 3 (0.07%) | ||
| Regulations - Export Certificates | 4 (0.10%) | ||
| MDR s.89(1) - Schedule 3 form for Act s.37 | 4 (0.10%) | ||
| TOTAL | 4024 | ||
