British Columbia - Apply for Medical Device Establishment Licence

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Procedure

Preliminary processes
Before applying for the license, the applicant will have to accomplish some of the pre-processes:

1. Firstly, the applicant will have learn and review the Medical Device Establishment License with the help of the following document Guidance
2. Then, the applicant should determine if the product or device listed in their application is classified as medical device.
3. After that, the applicant should determine whether the activities which they are going involve in, requires a Medical Device Establishment License (MDEL).
4. Once determined that the activities needs an MDEL, the applicant should proceed to register their business as a small business.
   

For more information on preliminary processes, please refer Step 1,2,3 and 4 in the following link Application instructions

Apply through email

1. To apply for Medical Device Establishment Licence through email, the application has to forward an application to the MDEL application email account.
2. The email address is as follows: [email protected]
3. Firstly, the applicant has to download the Medical Device Establishment Licence application form from the following link Application form
4. Make sure that the documents in the “Required Documents” section of this page are available.
5. The applicant has to complete the application with required details in respective fields under each section.
6. After that, the applicant should make scanned copies of the application form and the required documents. The scanned copies of application and required documents should be then sent to the email address mentioned above.
7. On receiving the application, the Department will screen it for checking its completeness. If it is found complete, other verification and assessment processes will begin.
8. Once Health Canada screens the application and determines that the application is accepted for further review, it will notify the applicant, via email, and include an invoice for the applicable fees.
9. During the application processing, the Department may contact the applicant through email for additional information, if required.
10. Within 120 calendar days, upon completion of the assessment and verification, the applicant will be intimated through email regarding the approval of the licence.

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Required Documents

• Completed Application form
• Cover Letter
• Any supporting document (as instructed)

Office Locations & Contacts

Health Canada office,
Federal Building Sinclair Centre,
218-757, Hastings St W,
Vancouver,
BC V6C 1A1
Telephone: 1-866-225-0709
Facsimile: 604-666-6024
Teletypewriter: 1-800-465-7735 (Service Canada)
Email: [email protected]
Website link
Contact link

Eligibility

• Any Class 1 manufacturer, importer or distributor of medical devices (irrespective of class), can apply.

Reference: Eligibility

Fees

• Once Health Canada screens the application and determines that the application is accepted for further review, it will notify the applicant, via email, and include an invoice for the applicable fees.

Refer “Step 6” in the following link for more details: Fees details

Validity

• The Medical Device Establishment Licence is valid for a period of one year.

Documents to Use

• Medical Device Establishment Licence Application form

Sample Documents

Please attach sample completed documents that would help other people.

Processing Time

• The performance standard to issue a decision is 120 calendar days from the day a complete application is received.

Reference Processing time

Related Videos

Videos explaining the procedure or to fill the applications.
Attach videos using the following tag <&video type='website'>video ID|width|height<&/video&>
from external websites.
Please remove the '&' inside the tags during implementation.
Website = allocine, blip, dailymotion, facebook, gametrailers, googlevideo, html5, metacafe, myspace, revver,
sevenload, viddler, vimeo, youku, youtube
width = 560, height = 340, Video ID = Can be obtained from the URL of webpage where the video is displayed.
e.gIn the following url 'http://www.youtube.com/watch?v=Y0US7oR_t3M' Video ID is 'Y0US7oR_t3M'.

Instructions

• Any fees that the applicants pay for the review of this application will not be refunded if they list products that are not medical devices or choose the wrong class.
• A deficiency is when an application cannot be processed by Health Canada because it does not meet regulatory requirements or the intent/scope of the application is unclear.
• The applicant is provided an opportunity to submit the missing or incomplete information in order to avoid receiving a negative decision within 30 business days.
• During a regulatory inspection, inspectors will request a copy of the MDEL application submitted to Health Canada for review and copies of documented procedures attested to in the application. Establishments must have this information available.

Refer for more Instructions

Required Information

• Current Medical Device Establishment License (MDEL) number
• Current or previous company ID
• Any previous MDEL number
• Name of the Establishment
• Operating, trade, or partnership name
• Building name or number
• Street, suite and City
• Province/state, Postal code and country
• Business number
• Contact person details
• Mailing address
• Billing address
• Activities and Site information
• Manufacturer or Supplier information

Need for the Document

• Medical Device Establishment Licence (MDEL) is an authorization issued to Class I manufacturers as well as importers or distributors of all device classes to permit them to import or distribute a medical device in Canada.

Information which might help

• Medical devices are categorized into four classes (I, II, III or IV) based on the level of potential risk related to their use. Class I medical devices present the lowest potential risk (for example, wheelchairs), while Class IV medical devices present the highest potential risk (for example, pacemakers).
• If the applicant company is not registered as a small business when they file the MDEL application, they will be charged the full fee and will not be considered for the small business fee mitigation.
• Contact person for the establishment licence is the person Health Canada will contact concerning the MDEL application. For example, Health Canada will send the annual licence review package to the contact person for the establishment licence.

Other uses of the Document/Certificate

Please explain what are other uses of obtaining this document/certificate.
e.g. Birth Certificate can be used as proof of identity.

External Links

Guidance on Medical Device Establishment Licensing

Others

More information which might help people.