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Guidance on Risk Classification of Medical Device Observations (GUI-0079)
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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: August 13, 2010
Date of implementation: October 1st, 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
- 1.0 Purpose
- 2.0 Scope
- 3.0 Guide
- Appendix 1. Risk Rating Classification
1.0 Purpose
To classify the observations noted during inspections at medical device establishments (establishments) under the Medical Devices Inspection Program (Inspection Program), according to their risk.
To ensure uniformity among the inspectors of the Health Products and Food Inspectorate (the Inspectorate) in the attribution of the overall establishment rating following establishment inspections.
To inform the industry of the situations that the Inspectorate considers unacceptable and that will generate a Non-Compliant (NC) rating following an inspection.
2.0 Scope
This Guidance Document explains the risk classification assigned to observations made during inspections of medical device manufacturers, importers and/or distributors. The risk classification of an observation is determined by the inspector through the use of this document and other relevant documents and information, and considers the compliance history of the establishment and the real and/or potential risk involved.
3.0 Guide
3.1 Background:
During an establishment inspection, deviations from the Food and Drugs Act (Act) and the Medical Devices Regulations (Regulations) are noted by the inspector and appear as observations in the Inspection Report. Based on these observations, the inspector makes an overall recommendation for the continuation of the establishment licence (rating of Compliant; C) or not (rating of Non-Compliant; NC).
3.2 Definitions
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)
- Regular: an inspection against the applicable sections of the Act and Regulations specified in this procedure.
- 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.
- 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 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.
3.3 Acronyms
C: Compliant
MDEL: Medical Device Establishment Licence
MDR: Medical Devices Regulation
NC: Non-Compliant
3.4 Risk Assignment
3.4.1 Assignment of the risk category to an observation
Appendix 1 provides examples of Risk 1, 2, and 3 observations. While it is impossible to encompass every situation, the category assigned to an observation will be in relation to the nature of the risk associated with the deviation, and this can vary depending on the context. To that end similar observations may be assigned a different risk category. Additionally, an observation that was noted during a previous inspection (and was not corrected) may be assigned a greater risk category.
3.4.2 Assignment of the overall inspection rating
The overall inspection rating is based on the categorized observations and will be assigned at the closing meeting. An NC rating may result when a Risk 1 observation is noted during an inspection, and such a situation shall immediately be brought to the attention of the establishment’s officials and the Inspectorate management. In addition, a situation in which the establishment is not in control of its operation (as indicated by numerous Risk 2 observations) may also result in an NC rating.
When an observation leading to an NC rating is made, the Inspection Report could be issued with a C rating if, during the inspection the establishment immediately implements all necessary actions to resolve the cause(s) of the observation(s) leading to the NC rating, and, sufficient assurance can be provided that a recurrence shall be prevented. In such instances, the risk assigned to the observation will remain the same. An NC rating may have serious consequences for an establishment, including the suspension of the Medical Device Establishment Licence (MDEL).
3.4.3 Additional information/guidance
Inspection Reports are periodically selected and reviewed for quality assurance purposes to ensure national consistency.
If the management of the establishment wishes to dispute the results of the inspection report or the overall inspection rating, the reconsideration process described in the Guidance on Medical Device Compliance and Enforcement, Guide-0073 and the Inspectorate Compliance and Enforcement Policy, POL-0001 should be followed.
Appendix 1.
2"↑": Observations found under certain regulatory requirements classified as a risk 2, may be upgraded to a higher risk classification when accompanied with the arrow "↑", depending on the quantity and/or nature of the deviation.
| Regulation | Rating | Rating Notes |
|---|---|---|
| Act s.19 No sale of hazardous devices | 1 | |
| Act s.20(1) Prohibition of misrepresentation | 2 ↑ | Deception that may pose a risk to health and safety 1 , otherwise 2 |
| Act s.20(2) Label violations contravene 20(1) | 2 ↑ | Deception that may pose a risk to health and safety 1 , otherwise 2 |
| Act s.21 Compliance with prescribed standards | 2 ↑ | If there is a significant risk to health, then a 1 |
| Act s.3(1) No Schedule A claims in ads | 2 | |
| Act s.3(2)(a) Schedule A label claims - no sale to public | 2 | |
| Act s.3(2)(b) No Schedule A label claim general public | 2 | |
| Act s.3(3) No contraceptive ads to general public | 2 | Please note that s.24 of the Regulations makes allowances for some contraceptive device advertisement |
| MDR s.21(1) Multiple label deficiencies | varies | Highest risk rating based on missing components will be applied, see ratings for 21(1) through 23(3) |
| MDR s.21(1) No label | 2 | |
| MDR s.21(1)(a) Name of device | 2 | |
| MDR s.21(1)(b) Manufacturer | 2 | |
| MDR s.21(1)(c) Device identifier | 2 | If an identifier issue, but device is licensed, is a 2 . If device is unlicensed, it is assess under s.26 |
| MDR s.21(1)(d) Control number | 2 | |
| MDR s.21(1)(e) Contents | 3 | |
| MDR s.21(1)(f) Sterile | 2 | |
| MDR s.21(1)(g) Expiry date | 2 | |
| MDR s.21(1)(h) Intended use | 2 ↑ | Could be a 1 if missing elements pose a health risk |
| MDR s.21(1)(i) Directions for use | 2 ↑ | Could be a 1 if missing elements pose a health risk |
| MDR s.21(1)(j) Storage | 2 | |
| MDR s.21(2) Legibility | 2 | If parts of the label are illegible, is a 2 . If not legible at all, is technically not a label and would be cited under s.21(1) No Label |
| MDR s.22(1)(a) Placement for general public | 3 | |
| MDR s.22(1)(b) Visibility for general public | 3 | |
| MDR s.22(2) Directions for use on small packages | 3 | |
| MDR s.23(1) Official languages | 2 | |
| MDR s.23(2) Directions for use - bilingual option | 2 | |
| MDR s.23(3) Sale to general public - Bilingual requirements | 3 | |
| MDR s.25(2)(a) Stop sale if safety & effectiveness not submitted | 2 ↑ | Manufacturer not cooperative, then 1 |
| MDR s.25(2)(b) Stop sale if safety & effectiveness not met | 2 ↑ | Company received official notice and is still selling, then a 1 |
| MDR s.26 No sale or import of unlicensed devices | 2 ↑ | If there is documented evidence that the unlicenced device(s) poses a risk to health or significant number of unlicenced devices are found, then a 1 |
| MDR s.27(a) No advertising of unlicensed devices | 2 | |
| MDR s.27(b) Catalogue advertising of devices | 3 | |
| MDR s.44(1) No sale or import without Establishment Licence | 2 | |
| MDR s.45(a) Name and address of establishment | 3 | |
| MDR s.45(b) Name, address, phone number of EL contact person | 3 | |
| MDR s.45(c) Activities | 2 | |
| MDR s.45(d) Names of manufacturers | 3 | |
| MDR s.45(e) Medical specialties of devices | 3 | |
| MDR s.45(f) Device classes | 2 | |
| MDR s.45(g) Distribution, complaints, recalls | 2 | If one or more procedure(s) are missing or ineffective. (These procedures will also be evaluated under sections 52 to 58, 64 and 65 of the Regulations) |
| 3 | If missing elements, but could still be functional | |
| MDR s.45(h) Mandatory problem reporting | 2 | If procedure is missing or ineffective. (This procedure will also be evaluated under Sections 59 to 61 of the Regulations) |
| 3 | If missing elements, but could still be functional | |
| MDR s.45(i) Handling, storage, delivery, etc. | 2 | If one or more procedure(s) are missing or ineffective |
| 3 | If missing elements, but could still be functional | |
| MDR s.45(j) Listed sites | 3 | |
| MDR s.48 Notification with respect to change to 45(a),(b) in 15 days | 3 | |
| MDR s.52(1) Distribution records per device | 1 | Completely missing records and/or procedures for all of their devices |
| 2 | If some are missing, then a 2 . The more that are missing, the higher the risk, then a 1 | |
| MDR s.53 Sufficient for product withdrawal | 1 | If all would be insufficient such as no effective recall can be conducted |
| 2 | If some would be insufficient, then a 2. The more that are insufficient, the higher the risk, then a 1 | |
| MDR s.54(1) Implant registration records | 1 | If all would be insufficient such as no effective recall can be conducted |
| 2 | If some are missing or if they would be ineffective, then a 2. The more that are missing or ineffective, the higher the risk, then a 1 | |
| MDR s.54(2) Update implant registration info | 2 | |
| MDR s.55 Retention time | 2 | |
| MDR s.56 Timely availability | 2 | |
| MDR s.57(1)(a) Records of problems, complaints | 2 | If completely missing |
| 3 | If missing elements, but could still be functional | |
| MDR s.57(1)(b) Records of actions taken | 2 | If completely missing |
| 3 | If missing elements, but could still be functional | |
| MDR s.58(a) Investigation procedure | 1 | If procedure is missing completely, and reported problems not being investigated, (no mechanism in place at all) |
| 2 | If it would be ineffective, or if it is missing completely but reported problems are being investigated | |
| 3 | If missing elements, but could still be functional | |
| MDR s.58(b) Recall procedure | 1 | If procedure is missing completely, and recalls not being conducted (no mechanism in place at all) |
| 2 | If it would be ineffective, or if it is missing completely but recalls are being conducted | |
| 3 | If missing elements, but could still be functional | |
| MDR s.59(1) Obligation to report | 2 ↑ | If procedure is missing completely, and problems are not being reported, (no mechanism in place at all), then rate a 1 |
| MDR s.59(2) Mandatory problems outside Canada | 3 | |
| MDR s.60(1)(a)(i) Preliminary report - 10 days | 2 | If reporting outside of 10 day timeline |
| MDR s.60(1)(a)(ii) Preliminary report - 30 days | 2 | If reporting outside of 30 day timeline |
| MDR s.60(1)(b) Time limits - outside Canada | 3 | |
| MDR s.60(2)(a)-(i) Contents of preliminary report | 3 | |
| MDR s.61(1) Submit final report with respect to 60(2)(h) | 3 | |
| MDR s.61(2)(a) Contents - incident description | 3 | |
| MDR s.61(2)(b) Contents - cause/correction | 3 | |
| MDR s.61(2)(c)(i),(ii) Contents - other actions | 3 | |
| MDR s.61.1(2) Inform with respect to reporting permission | 3 | |
| MDR s.64 Submit initial recall report | 2 ↑ | Did not report recall and did not conduct it, then rate a 1 |
| MDR s.64(a)-(k) Contents of initial recall report | 3 | |
| MDR s.65 Submit final recall report | 3 | |
| MDR s.65(a),(b) Contents of final recall report | 3 | |
| MDR s.65.1(2) Inform with respect to reporting permission | 3 | |
| MDR s.66(1)(a)-(d) Info provided to patient | 2 | |
| MDR s.66(2)(a)-(e) Patient info to record | 2 | |
| MDR s.66(3) Bilingual format | 2 | |
| MDR s.67(1) Role of health care facility | 3 | |
| MDR s.67(2) Protection of patient identity | 3 | |
| MDR s.67(3) Nondisclosure of patient identity | 3 | |
| MDR s.68(3) Approved alternate method | 2 | |
| MDR s.70 No sale/import without authorization | 2 ↑ | If consistently importing or selling without authorization, is a 1 for any class of device |
| MDR s.75(a)-(c) Specific labelling | 2 | |
| MDR s.76 Distribution records per device | 1 | Completely missing records and/or procedures for all of their device section |
| 2 | If some are missing, then a 2. The more that are missing, the higher the risk, then 1 | |
| MDR s.77 Mandatory reports | 2 | |
| MDR s.78 Implant registration | N.A. | Evaluated under s.66-68 |
| MDR s.80(1) Sale/import restrictions | N.A. | Evaluated under s.80(2) or 80(3) |
| MDR s.80(2) Authorization and records | 2 ↑ | If consistently selling without authorization and not possessing records, is a 1 |
| MDR s.80(3) Class I device - records | 3 | |
| MDR s.81(a) Records - manufacturer or importer | 3 | |
| MDR s.81(b) Records - device identification | 3 | |
| MDR s.81(c) Records - device description/materials | 3 | |
| MDR s.81(d) Records - device features/purposes | 3 | |
| MDR s.81(e) Records - device market history | 3 | |
| MDR s.81(f)(i)-(iii) Records - risk management | 3 | |
| MDR s.81(g) Records - qualified investigators | 3 | |
| MDR s.81(h) Records - institutions/approvals | 3 | |
| MDR s.81(i) Records - protocol/patient consent form | 2 | If records are missing |
| 3 | If records are incomplete | |
| MDR s.81(j) Records - device label | 3 | |
| MDR s.81(k)(i) Investigational consent - follow protocol | 2 | |
| MDR s.81(k)(ii) Investigational consent - patient consent | 2 | |
| MDR s.81(k)(iii) Investigational consent - limited purpose | 2 | |
| MDR s.81(k)(iv) Investigational consent - controlled use | 2 | |
| MDR s.81(k)(v) Investigational consent - mandatory reports | 2 | |
| MDR s.86(a) Label - manufacturer name | 2 | |
| MDR s.86(b) Label - device name | 2 | |
| MDR s.86(c) Label - "Investigational Device", bilingual | 3 | |
| MDR s.86(d) Label - user restriction, bilingual | 2 | |
| MDR s.86(e) Label - status of specs, bilingual | 2 | |
| MDR s.87(a) No ads without investigational test authorization | 2 | |
| MDR s.87(b) Ads attest to investigational test and purpose | 3 | |
| MDR s.89(1) Schedule 3 form for Act s.37 | 3 | |
| MDR s.89(2)(a),(b) Required signatures | 3 | |
| MDR s.90 Misleading contents | 3 | |
| MDR s.91 Availability of records | 3 | |
| MDR s.92 Records retention - 5 years | 3 |
