Letter - Annual Review of Medical Device Establishment Licences (MDELs) for 2012

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Contact Information

Health Products and Food Branch Inspectorate
Graham Spry Building, 2^nd Floor
250 Lanark Avenue
Address Locator #2002A
OTTAWA, Ontario
K1A 0K9

July 29, 2011

To: Establishment Licence Holders

Re: Annual Review of Medical Device Establishment Licences (MDEL) for 2012

This notice is to initiate the 2012 Annual Review process for Medical Device Establishment Licences.

What has changed?

Establishment Licences will no longer expire on December 31^st of each year.

Pursuant to amendments to the Medical Device Regulations (MDR), Medical Device Establishment Licences issued by Health Canada will no longer expire on December 31^st of each calendar year. A licence issued pursuant to section 46 of the MDR, will remain valid, as long as an application for annual review is submitted before April 1^st of each year. However, if there is information available to Health Canada, for instance issues identified through inspection, it may result in suspension of an existing licence. Establishments operating without a valid licence and performing any regulated activity would be in contravention of the requirements of the Medical Devices Regulations, and may be subject to compliance and enforcement action.

As of April 1^st, 2011 the Health Canada sticker on an Establishment Licence will no longer indicate a date.

Applicable Fees must accompany applications

In addition to the above changes, amendments to the  User Fees Act, require that as of April 1^st, 2011, payment must accompany the following application types: new, amendments if applicable, as well as applications for annual reviews. Applicants submitting applications without applicable payment will be invoiced for the amount owing and will have 30 days to pay before interest is accrued.

The 2011-2012 Annual review Process

Licences issued with a December 31^st 2011, will continue to be valid until April 1^st, 2012.

For this year, in order to re-issue licences with new stickers with no expiry date, before April 1^st, 2012, completed application packages along with payment must be received by Health Canada before August 22, 2011. Annual review applications must be supported by the required renewal documentation, including fee deferral or fee remission requests. These documents should be submitted to the Establishment Licensing Unit at the address listed below. Failure to return the completed application by this date may either result in the delay of the issuance or no renewal of your Establishment Licence.

Note:

If you are no longer conducting licensable activities as per the Medical Devices Regulations, please reply in writing indicating that your company wishes to withdraw its medical device establishment licence and when licensable activities ceased. For return address information, please refer to the Submissions information below.

Please refer to the attached checklist and relevant documentation for completing your application. Application Completion Checklist once completed along with an endorsement that payment has been included, should be appended to the completed application package.

Relevant Documentation

The following information is available on the Health Canada website and can be accessed on the Establishment Licences website:

• Medical Device Establishment Licence Application: Form and Instructions (including the fee form)
• Medical Device Establishment Licence Calculation Chart
• Guidance on Medical Device Establishment Licensing and Medical Device Establishment Licence Fees

Fee Deferral and Fee Remission:

A request for fee remission or fee deferral that is not submitted at the time of the application and submitted after issuance of a licence will not be considered and full fees will be applicable.

If an applicant has completed one calendar year of conducting activities under an establishment licence and wishes to be considered for a fee remission, they must submit at the time of application along with their completed application forms, a Certified Statement of Revenue, payment, a completed Fee Form and a completed Calculation Chart.

If an applicant has not completed its first full calendar year of conducting activities under any MDEL, the payment of the applicable DEL fee is deferred until the end of that first full calendar year. "Calendar year" means a period of twelve consecutive months commencing on January 1^st. In this case, applicant will need to complete the Fee Form to be considered for a payment deferral.

Please note that fee remission or fee deferral requests, where applicable, must accompany applications or else they will not be considered.

Should you require further assistance please contact us by email or phone:

Establishment Licensing Unit:

Tel: 613-954-6790
Email: SIPDMail@hc-sc.gc.ca

Billing and Invoicing Section:

Tel: 613-946-5141
Email: ELIU_UFLE@hc-sc.gc.ca.

Please note that we will endeavour to respond to all inquiries within 15 days of receipt.

Submission Information

Mail: Establishment Licensing Unit
2^nd Floor, Graham Spry Building
Address Locator 2002D
250 Lanark Avenue
Ottawa, Ontario
K1A 0K9
Fax: 613-957-6711 or 613-957-4147

Original signed by

Diana Dowthwaite
Director General
Health Products and Food Branch Inspectorate