This guidance document is intended to explain sections 44 to 51 of the Medical Devices Regulations (Regulations) dealing with medical device establishment licensing. It also details the regulatory responsibilities of persons who import or sell medical devices in Canada and the responsibilities of the Health Products and Food Branch Inspectorate of Health Canada (Inspectorate). It describes what a medical device establishment licence (MDEL) is, when it is required, who is required to hold a licence, and the activities it covers. The application process is also described, including how to obtain a new licence, how and when to amend an existing licence and the annual application process.

1.2 Background

The intent of the medical device establishment licensing requirements in the Regulations is:

To ensure that the Inspectorate is made aware of:
1. who is importing and/or selling medical devices in Canada,
2. the identity of the manufacturers of the devices sold by the holder of the MDEL (licence holder), as well as the classification of those devices,
3. the identity of manufacturers of Class I devices.
To require licence holders to provide some assurance to the Inspectorate that they have met the regulatory requirements and have documented procedures in place, where applicable, related to distribution records, complaint handling, recalls, mandatory problem reporting and for handling, storage, delivery, installation, and servicing, with respect to the medical devices they sell.

1.3 Scope

This document provides guidance on all aspects of medical device establishment licensing mandated by Part 1 of the Regulations.

This document also provides reference to guidance on preparing for a regulatory inspection conducted by the Inspectorate.

1.4 Definitions

Definitions that do not indicate they are set out in the Regulations or the Food and Drugs Act (Act) are intended as guidance in this document and are interpretive or claritive in nature.

APPLICANT: for the purposes of this guidance document, an applicant is the person applying for a MDEL.

CUSTOM-MADE DEVICE (as set out in the Regulations): means a medical device, other than a mass-produced medical device, that

is manufactured in accordance with a health care professional's written direction giving its design characteristics;
differs from medical devices generally available for sale or from a dispenser; and
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.

DISTRIBUTOR: for the purposes of this guidance document, a distributor 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.

DISPENSER (as set out in the Regulations): 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 manufacture 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.

DEVICE (as set out in the Act): means any article, instrument, apparatus or contrivance, including any component, part or accessory thereof, manufactured, sold or represented for use in

the diagnosis, treatment, mitigation or prevention of a disease, disorder or abnormal physical state, or its symptoms, in human beings or animals,
restoring, correcting or modifying a body function or the body structure of human beings or animals,
the diagnosis of pregnancy in human beings or animals, or
the care of human beings or animals during pregnancy and at and after birth of the offspring, including care of the offspring,

and includes a contraceptive device but does not include a drug;

HEALTH CARE FACILITY (as set out in the Regulations): means 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.

HEALTH CARE PROVIDER: for the purposes of this guidance document, a health care provider is any person who provides diagnostic or therapeutic services to individuals including the provision of emergency first aid services by fire and ambulance departments.

IMPORTER: for the purposes of this guidance document, an importer is a person, other than the manufacturer of a device, who causes the medical device to be brought into Canada for sale.

MANUFACTURER (as set out in the Regulations): 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 (as set out in the Regulations): means a device within the meaning of the Act, but does not include any device that is intended for use in relation to animals.

PERSON (as set out in the Regulations): includes a partnership and an association.

RETAILER: for the purposes of this guidance document, retailers are persons who sell a device, or a service utilizing a device, solely to the ultimate consumer.

NOTE: 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 medical device to the consumer or sells services involving the use of the medical device. Therefore, persons selling medical devices to healthcare facilities or providers are not retailers. They are distributors and are subject to the MDEL requirements. A central purchasing and distribution facility that supplies medical devices to a chain of retail outlets which are individually owned and operated (either independently or under a franchise agreement) is not a retailer, but a distributor and requires a MDEL.

SELL (as set out in the Act): includes offer for sale, expose for sale, have in possession for sale and distribute, whether or not the distribution is made for consideration.

SITE: for the purposes of this guidance document, a site is a place, other than the primary business address, where the same activities listed on the MDEL application are conducted.

ULTIMATE CONSUMER: for the purposes of this guidance document, 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.

2. Legislated Requirements

Any person who imports into Canada, or sells in Canada, a medical device for human use requires an establishment licence with the exception of

a retailer
a healthcare facility,
a manufacturer of Class II, III or IV medical devices that only sells
- medical devices for which they hold a valid licence, or
- medical devices subject to Parts 2 and 3 of the Regulations,
a manufacturer of a Class 1 medical device who sells solely through a licenced establishment,
a person solely selling medical devices subject to Parts 2 and 3 of the Regulations
a dispenser.

Explanatory Notes

For manufacturers who are also involved in sales of other medical devices (for which they are not the manufacturer), the MDEL requirements are as follows:
1. If they are solely selling these medical devices to the ultimate consumer, they are a retailer of these other medical devices and are exempt from the MDEL requirements.
2. If they are involved in any distribution activities, such as sales to healthcare facilities, they are acting as a distributor for these other medical devices and require a MDEL for these activities.
Manufacturers of Class I medical devices who sell their devices solely to the ultimate consumer require a MDEL. By virtue of paragraph 44(2)(d) of the Regulations, only those manufacturers of Class I medical devices who import or distribute those devices solely through a person who holds a MDEL are exempt from the requirements to be a licence holder themselves.
For persons who provide medical devices to the ultimate consumer but are paid by a third party, such as a health insurer, the following applies:
1. If the ultimate consumer becomes the owner of the medical device, the person is considered a retailer for this activity and does not require a MDEL.
2. If the ultimate consumer does not become the owner of the medical device, because the third party retains ownership of the device (i.e. the third party retains the right to recover the device from a user and provide it to other users), the person providing the medical device to the third party is acting as a distributor and requires a MDEL.

A complete summary of exemptions to the MDEL requirements may be found in Appendix 1.

3. The Application Process

The information required to obtain a MDEL is listed in section 45 of the Regulations, and includes the name and address of the applicant, other sites if applicable, identification of a regulatory affairs contact person for the applicant, the activities of the applicant, the manufacturers whose medical devices are to be sold by the applicant, and the risk classes of those devices, and the medical specialties of devices for each manufacturer listed. There is also a requirement for signed attestations to be made by a senior official of the applicant, that documented procedures are in place in respect of distribution records, complaint handling, recalls, mandatory problem reporting and other areas where applicable.

Note: if some of the medical devices that are imported or distributed are obtained from another MDEL holder, and not from the manufacturer, the manufacturer's information should still be submitted with the application.)

Application forms for a MDEL, in a format prescribed by the Minister, are available in hard copy or as electronic files on the Compliance and Enforcement section of Health Canada's website at:

http://www.hc-sc.gc.ca/dhp-mps/compli-conform/licences/index-eng.php

To minimize delay in the processing of the application, the form must be completed in full and in the designated format.

An application will be screened against the following criteria:

Is the information submitted complete and appropriate, relative to the licence application type, i.e. new, amendment, or annual application?
Are the names and addresses of the applicant, other sites covered by the MDEL, and manufacturers whose devices are sold provided in full and in the prescribed format?
Are all relevant fields, including attestations and signatures, completed as per the required format?

Where an application fails to meet any one of these criteria it will be returned to applicant and the reason for rejection will be explained. Consequently, to avoid delays in the processing of your licence application, it is important to complete all applicable fields in the form.

All completed applications should be sent to the following address:

Establishment Licensing Unit
Health Products and Food Branch Inspectorate
250 Lanark Avenue
Graham Spry Building - Second Floor
Address Locator 2002C
Ottawa, ON K1A 0K9
Fax: (613) 957-4147
(613) 957-6711

MDEL_questions_LEPIM@hc-sc.gc.ca (this is for MDEL application-related information only.)

Under section 46(1) of the Regulations, if an application meets the requirements of section 45, an MDEL will be issued to the applicant. If issuance of a licence is refused due to the conditions listed in section 47 of the Regulations, the applicant will be notified and given an opportunity to be heard. A valid MDEL is one that has been signed, dated and issued by the Director General, Health Products and Food Branch Inspectorate, for the Minister of Health.

One MDEL can apply to one or many sites provided the activities conducted at these sites are operated by the same legal entity. Only list those sites where a person, responsible for the procedures noted in the attestation, is located. A listing of all sales offices is not required. A sales agent, taking orders on behalf of a manufacturer where the device is sent directly to the purchaser from the manufacturer and the manufacturer is responsible for all regulatory requirements, is not required to hold a MDEL.

A list of establishments with valid MDELs is posted on the Compliance and Enforcement section of Health Canada's website at:

http://www.hc-sc.gc.ca/dhp-mps/compli-conform/licences/index-eng.php

4. Attestations

The attestations page of the application contains three statements with respect to documented procedures that must be in place depending on the activities conducted by the applicant. The applicable procedures are to be identified by a check mark in the appropriate box. The CEO or other senior officer of the applicant must then sign the application in order to make the attestations and to acknowledge the following:

"I hereby attest, as a senior official of the establishment named in this application, that I have direct knowledge of the procedures in place as checked above and that these identified statements are true as they apply to this establishment and all listed sites."

"I acknowledge that it is a serious offence to knowingly make false attestations on this application."

"I acknowledge that knowingly making false attestations is grounds for refusal to issue an establishment licence, in accordance with subsection 47(1) of the Medical Devices Regulations."

"I acknowledge that the discovery, at some future time, that false attestations were knowingly made in this application is grounds for suspension of my establishment licence, in accordance with paragraph 49(1)(b) of the Medical Devices Regulations."

The attestation from a senior representative of an applicant that certain procedures required under the Regulations are in place assures us that establishments are aware of their responsibilities under the Regulations. It provides a level of assurance that medical devices sold or imported into Canada meet the safety and effectiveness requirements set out in the Regulations, and that procedures are in place to protect the public should a problem with a device be identified.

The documented procedures attested to include procedures with respect to distribution records, complaint handling and recalls, (required by paragraph 45(g) of the Regulations); mandatory problem reporting (paragraph 45(h) of the Regulations); and for handling, storage, delivery, installation, and servicing in respect of any Class II, III or IV devices, where applicable (paragraph 45(i) of the Regulations and Appendix 2 of this guidance document).

If the information submitted during the application process is false or incomplete, the Minister may refuse to issue a MDEL. Making a false attestation regarding required procedures or listing manufacturers who do not hold valid medical device licences are grounds for the refusal to issue a licence.

"Documented procedures" in these sections, means procedures that are implemented and that are adequate for the purposes for which they are implemented. Guidance is provided in the following documents:

Mandatory and Voluntary Problem Reporting for Medical Devices

Guidance for Medical Device Complaint Handling and Recalls

These documents are located on the Compliance and Enforcement section of Health Canada's website at:

http://www.hc-sc.gc.ca/dhp-mps/compli-conform/info-prod/md-im/index-eng.php

Note: although the attestation with respect to procedures for mandatory problem reporting only refers to importers of medical devices and does not include manufacturers, the requirement for mandatory problem - reporting that is set out in section 59 of the Regulations does not limit the requirement to persons that import medical devices into Canada, but includes medical device manufacturers.

5. Amendments and Annual Applications

Under section 48 of the Regulations, licence holders are required to notify the Minister within 15 days whenever there is a change to the name or address of the licence holder or a change to the name, title or telephone number of the contact person identified on the application. The information should be sent to the Establishment Licensing Unit of the Inspectorate at the address specified above. A new licence will be issued that reflects the amendments. Other licence information is to be updated at the annual application.

As indicated in subsection 46(2) of the Regulations, all MDELs expire on December 31 of each year. Forms for the annual application will be mailed out by the Establishment Licensing office prior to the expiry date. When returning your application, please ensure all relevant changes are appropriately referenced.

6. Licence Suspension

Under Section 49 of the Regulations, a MDEL may be suspended if there are reasonable grounds to believe that:

the licence holder has contravened the Regulations or any provision of the Act relating to medical devices;
the licence holder has made any false or misleading statements in their MDEL application; or
failure to suspend the establishment licence would constitute a risk to the health and safety of patients, users or other persons.

The compliance history of the licence holder and the risk to the health and safety of patients, users or other persons of allowing the licence to remain valid will also be considered. When a decision to suspend a licence has been taken, the licence holder is given written notice of the reason(s) and the appropriate corrective action(s) to be taken. The licence holder is also given an opportunity to be heard prior to the suspension, unless immediate suspension is required to prevent injury to the health or safety of patients, users or other persons (as described in section 50 of the Regulations). In accordance with section 44 of the Regulations, as soon as a MDEL is suspended, the licence holder is required to immediately suspend all activities related to importation or sale of medical devices until such time as the MDEL is reinstated. The licence must also be returned to the MDEL office pending reinstatement.

Section 51 of the Regulations provides for reinstatement of a licence if the situation that gave rise to the suspension is corrected or the reason for the suspension was unfounded.

The "Medical Device Compliance & Enforcement Directive" (Policy 45) contains additional information on enforcement activities related to MDELs. This document may be found on the Compliance and Enforcement section of Health Canada's website at:

http://www.hc-sc.gc.ca/dhp-mps/compli-conform/info-prod/md-im/pol_45_tc-tm-eng.php

7. Fees and Fee Reduction

Fees are charged for a MDEL to help recover the cost of administering the establishment licensing program and ensuring compliance with the applicable requirements. The fees include the costs of activities such as monitoring device recalls, importations, and inspections. The annual fee is $2,120, payable upon invoicing. Do not send payment prior to invoicing, since the invoice and licence are mailed together. If the annual fee is greater than 1% of an applicant's gross annual revenue from licensed sales of medical devices in Canada, a fee reduction may be applied that is equivalent to 1% of the applicant's gross annual revenue from licensed sales of medical devices in Canada. A fee reduction form must be submitted with each application whether or not a fee reduction is being requested.

If an applicant has not completed one fiscal year prior to submission of the MDEL application, the fee of $2,120 shall be paid upon receipt of the invoice. A post-invoice fee reduction request may be submitted upon completion of the first fiscal year. If a licence holder is applying for a post-invoice fee reduction, the fee reduction request, stating the establishment's gross annual revenue for licensed sales of medical devices in Canada, shall be submitted within 90 days of the end of the first fiscal year. If the data demonstrates that the fee charged is greater than 1% of the licence holder's gross annual revenue from licenced sales of medical devices in Canada for the first fiscal year, Health Canada will approve the fee reduction request and remit the difference between the fee charged and 1% of the licence holder's gross annual revenue from licenced sales of medical devices in Canada for their first fiscal year. Applicants must be prepared to present financial records to substantiate the sales revenue claimed, if requested by Health Canada.

The form for fee reduction is found on the Compliance and Enforcement section of Health Canada's website at:

http://www.hc-sc.gc.ca/dhp-mps/compli-conform/licences/index-eng.php

For further information regarding fees for MDELs, please telephone (613) 946-1149 or fax to (613) 957-6711. The following email address may be used to enquire about MDEL fee reductions, but this should be indicated in the subject line:

MDEL_questions_LEPIM@hc-sc.gc.ca

8. Other Regulatory Responsibilities of Licence Holders

Under the Regulations, a licence holder has other responsibilities. The sections of the guidance document that follow describe these further obligations. It is imperative that a licence holder have access to and be familiar with the current version of the Regulations in order to meet the regulatory requirements. The Regulations may be found at the following website:

http://laws.justice.gc.ca/en/F-27/SOR-98-282/index.html

8.1 Labelling - Section 21(1) of the Regulations states that no person shall import or sell a medical device unless the labelling of the device bears the information described in that section. In order to comply with the Regulations, it is sufficient that a licence holder has a procedure in place to ensure compliance with this labelling requirement for the medical devices they import or sell. Class I medical devices do not require licensing but must comply with the labelling requirements. A guidance document for the labelling of medical devices:

Guidance for the Labelling of Medical Devices under Section 21 to 23 of the Medical Devices Regulations, Appendices for Labelling: Soft Contact Lenses and Menstrual Tampons

may be found on the Medical Devices section of Health Canada's website at:

http://www.hc-sc.gc.ca/dhp-mps/md-im/applic-demande/guide-ld/index-eng.php

8.2 Class of Medical Devices Imported or Sold - The application for a MDEL must set out, for each manufacturer, the classes of the medical devices from that manufacturer that are being imported or sold. This requires the applicant to determine the class of the medical devices that are being imported or sold by them. The class of a particular medical device may be determined by applying the classification rules listed in Schedule I of the Regulations. Examples of medical device classifications are also provided on the Medical Devices section of Health Canada's website at:

http://www.hc-sc.gc.ca/dhp-mps/md-im/applic-demande/guide-ld/keyword_motscles-eng.php

Note: This keyword index may contain some incorrect classification information for a few medical devices, owing to medical device classification rulings made since its publication date. If an applicant is unsure of the class of a medical device, they should request a classification ruling from TPD's Medical Devices Bureau using the following email address:

device_licensing@hc-sc.gc.ca

8.3 Device Licensing - Section 26 of the Regulations states that no person shall import or sell a Class II, III or IV medical device unless the manufacturer of the device holds a licence, or an amended licence if appropriate, in respect of that device. Every licence holder must put in place a mechanism to ensure that only appropriately licensed devices are imported or sold by the licence holder. All current medical device licences are listed on the Medical Devices section of Health Canada's website at:

http://www.mdall.ca

This information is also available from each manufacturer that an applicant lists in their MDEL application. The mechanism(s) utilized by the applicant to ensure that all medical devices that they import or sell are licensed, if required by the Regulations, should be appropriately referenced in a procedure as a way to verify the applicant's ability to consistently meet this requirement.

8.4 Device Advertising - The attendant requirements of section 27 of the Regulations and section 3 of the Act, regarding the advertising of devices, should also be referenced in a procedure.

8.5 Maintenance of Records

8.5.1 Distribution Records - Section 52(1) of the Regulations requires that manufacturers, importers and distributors each maintain records of distribution for each device sold. The application for a MDEL contains an attestation, required by paragraph 45(g), that the applicant has a documented procedure in place in respect of distribution records. Section 53 requires that the distribution records contain sufficient information to permit a complete and rapid withdrawal of the device from the market. The Regulations also specify minimum retention periods for distribution records (section 55) and a manner of maintaining distribution records that will allow for their timely retrieval (section 56). The time of retention for distribution records and the manner of maintenance should also be referenced in the procedure.

8.5.2 Complaint Handling - Section 57(1) of the Regulations requires manufacturers, importers and distributors to maintain records of reported problems regarding medical devices they have sold. These records must include all actions taken in response to these problems. Section 58 prescribes the requirements, to which reference is made in paragraph 45(g), for documented procedures for complaint handling and recalls.

8.6 Mandatory Problem Reporting - Section 59 of the Regulations requires importers and manufacturers of medical devices to report incidents involving devices. Sections 60 and 61 specify the information that must be submitted to Health Canada in a mandatory problem report. The manufacturer of the device may permit the importer to prepare and submit the report on the manufacturer's behalf if the information to be submitted is identical (subsection 61.1(1)). This would reduce duplicate reporting. The manufacturer must inform Health Canada in writing if this is the situation (subsection 61.1(2)). A manufacturer may not prepare and submit a report on behalf of an importer.

8.7 Recalls - Section 64 of the Regulations require the manufacturer and importer of a device that is the subject of recall to submit to Health Canada the information specified in these sections on or before undertaking a recall. As soon as possible after completion of a recall, section 65 requires the manufacturer and importer to report to Health Canada the results of the recall and the action taken to prevent a recurrence of the problem. As referenced in subsections 65.1(1) and 65.1(2), a manufacturer may designate the importer to submit the recall information, if identical, on their behalf by notifying Health Canada in writing.

9. Inspections

The Inspectorate is currently conducting inspections of licence holders to determine their compliance with the Regulations. The Inspection Programme applies mainly to medical device importers, distributors and to manufacturers of Class I devices. Guidance is provided in the following documents:

Inspection Strategy for Medical Device Companies

Guidance on the Medical Device Inspection Programme

These documents can be found on the Compliance and Enforcement section of Health Canada's website at:

http://www.hc-sc.gc.ca/dhp-mps/compli-conform/info-prod/md-im/index-eng.php

If you have specific questions or require assistance with respect to medical device inspections, please contact the Inspectorate's Medical Device Inspection Programme coordinator at:

mdip@hc-sc.gc.ca

Please include your company name, the name of the contact person and full mailing address, telephone and fax numbers, along with your request, in the email.

Appendix 1: Summary of Medical Device Establishment Licence (MDEL) Exemptions

The regulatory basis for MDEL exemptions is as follows:

1. Veterinary Devices

Section 1 of the Regulations defines "medical device" and in doing so exempts devices intended for use in relation to animals. Therefore, establishments importing or selling only veterinary devices are exempt from medical device establishment licensing under the Regulations.

2. Personal Use

Section 2(b) of the Regulations exempts from the application of the Regulations persons who import a medical device for their own personal use.

3. Dispensers

Section 4 of the Regulations exempts "dispensers", as defined in Section 1 from the application of many of the provisions of the Regulations, including the MDEL requirements. The dispenser exemption only applies to the individual dispenser. The exemption also applies to persons who perform the fitting, adaptation, or adjusting of devices as a contract service to a dispenser, e.g. an optical lab. However, persons selling the following medical devices to dispensers are subject to MDEL requirements:

mass produced devices which are adapted, fitted or adjusted by the dispenser for a specific patient (e.g. hearing aids, eye glasses, orthotic and prosthetic devices, contact lenses), or
materials which are designed for the specific purpose of being configured or arranged into a mould or shape by the dispenser or a health care professional to meet the needs of an individual (denture materials, dental alloys, orthodontic wires)

Persons who supply dispensers with materials that the dispenser uses to fabricate into a medical device, are not subject to MDEL requirements if the materials are not considered to be capable of functioning as a device without further processing or assembly, other than the molding or shaping described in exemption 3b, above (e.g. contact lens buttons or blank, hearing aid circuits).

4. Part 2 and Part 3 Medical Devices

Section 8 of the Regulations indicates that Part 1 of the Regulations applies only to medical devices that are not subject to Parts 2 or 3. Since Parts 2 and 3 deal with the importation or sale of custom-made medical devices, medical devices for special access and medical devices for investigational testing involving human subjects, the importation or sale of such devices are exempt from MDEL requirements. However, authorizations are required under Part 2 for importation or sale of all special access devices and for Class III and IV custom-made devices. Authorizations are also required under Part 3 for the importation or sale of Class II, III, and IV devices for investigational testing involving human subjects.

5. Regulatory Exemptions

Section 44(2) exempts the following persons from the requirement to hold an MDEL:

retailers;
health care facilities (as defined in section 1 of the Regulations.)
in the case of Class II, III or IV medical devices, the manufacturer of the medical device (for which the manufacturer holds the Medical Device Licence). However, if this manufacturer also imports or sells other medical devices (that are licensed by another manufacturer), then they must obtain a MDEL with respect to the importation or sale of those medical devices.
in the case of a Class I device, the manufacturer of the medical device, if the manufacturer imports or distributes solely through a person who holds a MDEL. However, if this manufacturer also imports or sells other medical devices, then they must obtain a MDEL with respect to the importation or sale of those medical devices.

Note: The definition of manufacturer, as set out in the Regulations, appears on page 4 of this document. Essentially, the manufacturer is the person named on the label of the device. It is important to note that contractors who perform a function or service on a product on behalf of another person who is assuming legal responsibility for the product do not meet the definition of manufacturer for the product. For example, anyone who designs, manufactures, fabricates, assembles, processes, labels, packages, refurbishes, or modifies a device on behalf of another person who sells the product under their own name and has licensed the device is not required to have a MDEL. Contract sterilizers, contract designers and contract software developers, re-packagers or re-labelers would not be required to licence their establishments.

6. Helpful hints

An applicant can register many sites on a single MDEL. Only list those sites where a person, responsible for the procedures noted in the attestation, is located. Any site which sells devices on consignment or by contract should be listed on an MDEL. A sales office that takes orders which are then sent to a parent company or manufacturer for processing would not be listed as a site.

A commercial warehouse would not require an establishment licence if they are only providing storage service and do not purchase, accept products on consignment, or enter into contracts for the sale of consumer goods. However, if they are also acting as a distributor of the product, a MDEL will be required.

The manufacturer of every Class I device sold in Canada must be identified on an MDEL. Where the manufacturer is not distributing through a licence holder, the manufacturer is required to have a MDEL to distribute their own Class I devices. Where the manufacturer sells solely through a licensed establishment, the manufacturer is not required to have a MDEL but they will appear as a manufacturer of Class I devices on the importer's or distributor's MDEL.

Appendix 2: 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:

protection from environmental conditions that may affect medical device safety or effectiveness,
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,
stock rotation (first in - first out) for any medical devices that have a limited shelf-life or expiry date,
handling of product to prevent damage, deterioration or contamination,
segregation of returned or recalled medical devices to prevent them from being inadvertently shipped out, and
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:

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
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:

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),
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,
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,
servicing equipment should be adequate for the task being performed and should be subject to testing, calibration and servicing as required,
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,
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,
repairs should not modify the function, design, or performance specifications of the medical device unless specifically authorized by the manufacturer, and
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.