Medical Devices Establishment Licence Application Form

This Establishment Licence application form has been replaced. Please find the updated form-0292 here.

(December 23, 2005)

Contact Name: Establishment Licensing Unit
Tel: (613) 954-6790
Fax: (613) 957-4147
E-Mail: MDEL_questions_LEPIM@hc-sc.gc.ca

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

Please retain a copy of the completed application in your files.

Do you want to apply for a Licence

• Yes
• No

If no, please provide a written rationale for your decision not to apply, to the address above:

COMPANY INFORMATION

Establishment Licence Contact Name

Please make any corrections in this column

Telephone:

Extension:

Fax:

E-Mail:

Language:

ACTIVITIES: (Please indicate any changes)

DISTRIBUTOR: for the purposes of this 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.

IMPORTER: for the purposes of this 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 per the Regulations): 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.

• For those devices for which you are a distributor only, indicate this in the "Distributor" column
  
  
• For those devices for which you are an importer, indicate this in the "Importer" column
  
  
• For Class I devices for which you are the manufacturer, and you sell some/all directly to end-users in Canada (ie: the devices are not sold solely through licenced importers or distributors), indicate this in the "Manufacturer of Class I devices" column.

Class I

• Distributor
• Importer
• Manufacturer of Class I devices

Class II

• Distributor
• Importer
• Manufacturer of Class I devices

Class III

• Distributor
• Importer
• Manufacturer of Class I devices

Class IV

• Distributor
• Importer
• Manufacturer of Class I devices
  

ATTESTATIONS

Pursuant to Part I, Section 45, paragraph (g), (h) and (i) of the Medical Devices Regulations (MDR), a senior officer of establishment applying for an establishment licence shall submit an application to the Minister that contains attestations based on the activities conducted by this establishment.
Please check all relevant attestations listed below.

Section 45(g) Required of all establishments

The establishment has documented procedures in place in respect of

• distribution records
• complaint handling
• recalls

Section 45(h) Required if the establishment is an importer

• The establishment has documented procedures in place in respect of mandatory problem reporting.
• Not applicable. Not an importer.

Section 45(i) Required if the establishment is an importer or distributor of Class II, III or IV devices (where applicable)

The establishment has documented procedures in place for:

handling, storage and delivery
installation
corrective action
servicing
Not applicable. Not an importer or distributor of Class II, III or IV devices.

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 statements are true as they apply to this establishment.

• 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 MDR.
  
  
• 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 MDR.
  
  
• I acknowledge that, for Class II, III, IV devices, this establishment shall only sell licenced devices, as per section 26 of the (MDR), unless authorized elsewhere in the MDR.
  

Signature:

Date:

Name:

Title:

Please review the information provided below and make the appropriate correction(s) in the designated area(s).

Under the Address Information section, only an address change is permitted. If any lines of the address information are incorrect, please enter the correct address.

For Sites, only the status of the site can be changed. For address correction, use the Site Address Form.

For Manufacturers, only the status of the manufacturer, the risk class and the medical speciaties can be corrected. For any other corrections, please use the Manufacturer Information Form.

Address Information

Licence Address

Please make any corrections here

Street:

Suite:

Post Office Box:

City:

Province:

Country:

Postal Code:

Mailing Address

Please make any corrections here

Name:

Street:

Suite:

Post Office Box:

City:

Province:

Country:

Postal Code

Billing Address

Please make any corrections here

Name:

Street:

Suite:

Post Office Box:

City:

Province:

Country:

Postal Code

Site Address List

Company I.D.#:

Site Status: Active Inactive

Street:

Post Office Box:

City:

Province:

Postal Code:

Company I.D.#:

Site Status: Active Inactive

Street:

Post Office Box:

City:

Province:

Postal Code:

Manufacturers Address List

Company I.D.#:

Manufacturer Status: Active Inactive

Street:

Post Office Box:

City:

Province:

Postal Code:

Risk Class: (Please indicate any changes)

Class I:
Class II:
Class III:
Class IV:

Code

• Add new code numbers, here

English Description (please see Annex A to add more codes)

Annexe A - Medical Specialty

(73) Anaesthesiology
(74) Cardiovascular
(76) Dental
(77) Ear, Nose, & Throat
(78) Gastro-urology
(79) General & Plastic Surgery
(80) General Hospital
(84) Neurology
(85) Obstetrics/Gynaecology
(86) Ophthalmic
(87) Orthopaedic
(89) Physical Medicine
(90) Radiology

In Vitro Diagnostics

(75) Clinical Chemistry
(81) Haematology
(82) Immunology
(83) Microbiology
(88) Pathology
(91) Clinical Toxicology