Medical Devices: Reviewing the Medical Devices Inspection Cycle - Consultation Workbook Introduction

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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: August 11, 2011

Date of implementation: August 11, 2011

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.

Consultation Workbook Introduction

Welcome

Health Canada is in the process of creating a Medical Devices Inspection Cycle. Our goal is to make this inspection cycle risk-based. This document provides potential options in inspecting scheduling and cycles.

We are exploring changes and we would appreciate your input on key concepts that we are considering. Specially, we welcome input on (i) how we assess the risk of an establishment; (ii) appropriate inspection cycles for different levels of risk.

The following suggestions may help you prepare your comments:

• Please explain your views as clearly and concisely as possible.
• Be sure to distinguish between what you support and what you object to in this document.
• Provide rationale for your views, particularly your concerns, with facts, data or specific examples.
• Describe any assumptions that you made.

Please submit your comments by November 16, 2011.

In order to provide your comments you must submit them by sending the Word or PDF format and email them to the mdcu-ucim@hc-sc.gc.ca.

Please note that any information collected will only be used for input to this consultation. The information collected will be used to create a summary report and will guide recommendations made as part of this review. The summary report will be made available to stakeholders once consultations are complete.

Background

The Inspectorate is committed to taking an integrated approach to managing the health related risks and benefits of health products by minimizing health risk factors to Canadians while maximizing the safety provided by the regulatory system for health products; and promoting conditions that enable Canadians to make healthy choices and providing information so that they can make informed decisions about their health.

The Inspectorate meets these commitments, in part, through a program of inspection of companies holding Medical Devices Establishment License (MDEL) such as any company that engaged in manufacturing class I medical devices, importation and distribution.

The medical devices inspection program facilitates both promotion and enforcement of these regulatory obligations, thereby helping to minimize health risks associated with regulated activities.

As part of its quality system, the Inspectorate is committed to continuous improvement in the delivery of its programs and services. To facilitate the continuous improvement, the Inspectorate is conducting a review of activities specifically to the creating of a medical devices inspection cycle. The review is being conducted with the intent of increasing efficiency, effectiveness and optimum for the scheduling of inspections of both domestic and international inspections to effectively mitigate the risks to consumer.

The goal of this review is to determine the most effective and efficient risk-based use of resources in carrying out the inspection mandate of the Inspectorate. The delivery of the new inspection model will be achieved through research, education, communication, consultation, analysis, recommendation, approval, implementation and reassessment.

Medical Device Review

In October 2010, The Inspectorate implemented a risk-based measure in conducting inspections which was the classification of observations noted during an inspection and the assignment of an overall compliance rating to the inspection. For more information and background on medical devices risk rating please refer to "GUI-0079 Guidance on Risk Classification of Medical Device Observations"

Establishments that fail to meet regulatory requirements must take corrective measures in a manner that is appropriate and proportionate to the risk associated with the inspection finding.

Health Canada requires an inspection model that will allow it to equate oversight with the level of risk, is sustainable and allows for consistency and transparency.

Assessing the Risk

An Overview

Establishments that hold MDEL are subject to inspections. Any other party subject to the Food and Drug Act and the Medical Devices Regulations (Regulations), such as class I manufacturers exempt from MDEL requirements and private label manufacturers, may also be subject to inspections.

Under the current framework risk plays a limited role in determining who gets inspected. In basing the regular inspection cycle only on the number of MDEL holders (class I manufacturer, importer and distributors) and their activities, the Inspectorate may not taking into consideration all risk associated with specific products and processes.

The Inspectorate wants to shift away from this approach to a model where risk determines the cycle. Under such a model, two establishments that perform similar activities may have different inspection cycles depending on an evaluation of the risk. In addition, the inspection cycle for one establishment may change from one inspection to the next, if circumstances support such a change.

In adopting this new model, the Inspectorate had to identify the factors that should be used in assessing the risk of an establishment. The factors that are ultimately chosen need to be applicable and appropriate in almost all inspection situations, need to be reasonable in the Canadian context, and be dependent on information that is accessible and that inspectors are able to validate within a reasonable timeframe.

Inspection Cycle

An Overview

The Inspectorate would like to move to a model where the inspection cycle is decided depending on the risk. Therefore, in addition to identifying the criteria that can be used to assess each establishment, the Inspectorate will also need to decide on inspection cycles that are appropriate for various levels of risk.

Option 1: A series of risk factors classifies each MDEL holder via a quantitative risk- based approach.

With this option a series of risk factors will take into account many facets of the establishments, such as compliance history of inspections, mandatory problem reports, recalls, as well as the state of the industry. For example each risk factor will be scored from 1 to 5. A score of 1 means minimal risk, while the score of 5 would mean substantial risk. These scores are added to determine the overall risk of the MDEL holder. All overall risks will be assigned a specific inspection cycle.

Inspection Cycle Chart

Score	Inspection Cycle (years)
8-12	5
13-20	3-4
21-30	2-3
31-40	1-2

Note: Inspection would be based on risk, however, some factors are only discovered during inspections (i.e.: additional, unreported activities being performed, unreported recalls, other changes, etc). Also a low risk value for a company with respect to recalls or mandatory problem reports, could mean that they are not reporting.

Below is a list of possible risk factors the Inspectorate could use in assessing the risk of an establishment. In order to evaluate some factors, companies may be asked to submit annual compliance reports. Please indicate if you support each for the new model and explain why or why not.

Questions

New licence holder

Support: Yes or No

Explanation:

Importing vs Distributing vs Class I Manufacturing

Support: Yes or No

Explanation:

Medical Devices Compliance History

Support: Yes or No

Explanation:

Changes at company (i.e.: new management, processes, products, etc.)

Support: Yes or No

Explanation:

Concerns raised by public/other regulatory authorities

Support: Yes or No

Explanation:

Previous enforcement measures taken and/or lack of establishment cooperation

Support: Yes or No

Explanation:

From previous inspections, significant failures to complete actions to close previous deficiencies

Support: Yes or No

Explanation:

Number of recalls since last inspections

Support: Yes or No

Explanation:

Mandatory Problem Report filled efficiently and/or timely

Support: Yes or No

Explanation:

Are there any factors missing from the list above? If so, please list an explanation.

Which of the factors that you believe to be appropriate, are most important and indicative of risk? Please explain.

Option 2: Activities conducted and previous inspection results

This option is to base the inspection frequency on two factors which approximate the overall risk profile of the establishment, namely (1) the activities being conducted (manufacturing vs importing vs distribution) and (2) the results of the previous inspection. This approach would function as follows:

All uninspected establishments must receive an initial risk-rated inspection as soon as possible. The goal would be that all new establishments be inspected within the first year of their operation. Establishments that have had unrated inspections under the old system will be treated as if the highest risk-rated observation was rated risk 2.

Inspection Frequency Table. Highest Risk-Rated Observation from Prior Inspection

Establishment Type	Risk 1	Risk 2	Risk 3
Manufacturer	1 year	3 years	5 years
Importer	1 year	4 years	5 years
Distributor	1 year	5 years	5 years

Note: Establishments risk is estimated based on the activities performed and the risk posed by the establishment as measured by the previous inspection. This option provides an incentive to the establishment to have a high degree of compliance since they will have a lower inspection frequency.

Option 3: Activity and risk class based

This option would utilize a simple matrix cross examining the type of facility and device class being used. The type of facility, i.e.: manufacturer, importer, and distributor, and device class hold different risk levels and should be inspected with different frequencies. See below for an example of this matrix. The numbers represent a cycle time frame in years.

Inspection Frequency Table. Highest Risk-Rated Observation from Prior Inspection

	Device Class 1	Device Class 2	Device Class 3	Device Class 4
Manufacturer	1
Importer	5	3	3	2
Distributor	5	5	5	4

Option 4: Intrinsic and compliance risk

This option combines elements used in options 1, 2, and 3 and uses three steps to determine risk. The first step is based on determining the risk intrinsic to the activities and risk classes of devices similar to option 3 (see table below).

Inspection Frequency Table. Highest Risk-Rated Observation from Prior Inspection

	Device Class 1	Device Class 2	Device Class 3	Device Class 4
Table 1 footnotes Table 1 footnote 1 Note: manufacturers of class I devices have been assigned a high intrinsic risk because their devices are not subject to any scrutiny through pre-market review and the inspection program is the only means of oversight. Return to table 1 footnote referrer
Manufacturer	highTable 1 footnote
Importer	medium	medium	high	high
Distributor	low	low	medium	medium

The second step is based on determining the compliance risk based on previous inspection results (see table below). As in option 2, all uninspected establishments must receive an initial risk-rated inspection as soon as possible. The goal would be that all new establishments be inspected within the first year of their operation. Establishments that have had unrated inspections under the old system will be treated as if the highest risk-rated observation was rated risk 2.

Inspection Frequency Table. Highest Risk-Rated Observation from Prior Inspection

Compliance Risk	Number and type of observations
Low	0-5 Risk 2 observations
Medium	6-9 Risk 2 observations
High	≥ 10 Risk 2 observations or any Risk 1

The third step is to adjust the intrinsic and compliance risk based on an assessment of other risk factors as discussed in option 1. After reviewing the risk factors, the intrinsic risk and/or compliance risk can be increased one level based on additional risks identified e.g.:. uncompleted recalls, inadequate problem report investigations.

After the intrinsic risk and compliance risk ratings are finalized the frequency is determined using the table below.

Medical Device Program Information Sessions

Intrinsic Risk	Compliance Risk
	Low	Medium	High
Low	5 years	4 years	3 years
Medium	4 years	3 years	2 years
High	3 years	2 years	1 years

Questions

What are your comments on each of the options presented and what would your preferred option?

Inspection Frequency Table. Highest Risk-Rated Observation from Prior Inspection

	Option 1	Option 2	Option 3	Option 4
Comments
Preferred option (Yes/No)?

1. What do you think is an appropriate inspection cycle for Manufacturers of Class I medical devices? Please explain
2. What do you think is an appropriate inspection cycle for Importers medical devices? Please explain
3. What do you think is an appropriate inspection cycle for Distributors medical devices? Please explain
4. What do you think is an appropriate period of time for a complete inspection cycle? Please explain
5. What do you think about inspecting companies before issuing their MDEL? Please explain
6. Do you have an alternative or proposal for a risk-based cycle? Please explain
7. From an inspection perspective what are your expectations in relation to service standards, which is define as the level of service clients can expect to receive under normal circumstances; for example, time to issue the final inspection report.

About you

1. Do your comments represent an:
   • Association
   • Establishment
   • User/User group