Medical Device Consulting: MDL & MDEL applications for Canada

MEDICAL DEVICE CONSULTING SERVICES for Canada

per Health Canada’s Medical Device Regulations (MDR)

What is a Medical Device?

Our Medical Device Licence (MDL) Application Services

Our Medical Device Establishment Licence (MDEL) Application Services

 medical device licence (MDL) application consultant

What is a Medical Device?

These devices can be invasive to the body (syringes, dental fillings or other orthodontic appliances, medical implants such as a heart valve, arthroscope, or contraceptive devices such as a diaphragm), or they can be non-invasive (stethoscope, intravenous pump, X-ray machine, MRI, or contact lens cleaners).

Our medical device consulting services is broken into the following categories:

  • Applications for a Medical Device Licence (MDL) registration;
  • Applications for a Medical Device Establishment Licence (MDEL) registration
  • Assistance with the Quality Management System (QMS) registration

Our Medical Device Licence (MDL) Application Services

We can gather up and fill out the lengthy the application forms to ensure that the correct activities and device classifications are selected.

We can also provide you with calculations of the initial and annual Licence fees, including requests for fee reductions or adjustments.

Medical Device Establishment Licence (MDEL) Application Services

We can provide assistance with:

  • completing the application forms to ensure that the correct device classifications are selected; and
  • calculations of the initial and annual fees, including requests for fee reductions or adjustments.
  1.    Determine if ISO 13485 or 13488 are required, or if your company can be exempted.
  2.    Depending on the Class of the device (I – IV), determine if Health Canada’s Quality Management System (QMS) can be implemented instead.
  3.    Assist with the training, implementation & auditing of your Quality Assurance programme.
  4.    Obtain and help complete all Establishment Licence applications.
  5.    Identify and obtain price quotes from accredited ISO 13485 / 13488 registration auditors.
  6.    Be the technical liaison between the registration auditor and the company, during the official audit.
  7.    Perform annual internal audits thereafter, on behalf of the company.

QMS Consulting Servicesmedical device establishment licence (MDEL) application consultant

Please check out our pages related to:

Other Establishment Application Services

We can:

  1.     Determine Health Canada’s timeline goals for screening and reviewing the application.
  2.    Determine the fees charged by Health Canada to screen and review the application.
  3.    Determine if your company is eligible for applying for a fee reduction. If so, obtain and forward the fee reduction request to you.
  4.    Identify the amount of time Health Canada expects responses to any requests for clarification.

Why use a consultant?

Weighing the numerous pros & cons of bringing in a consultant vs. tackling it all in-house?  Please see our web pageWhy Use a Consultantas part of that critical thinking process. Based in British Columbia, but covering all of Western Canada.


1 Comment

John Haldane

October 29, 2018at 8:39 pm

Looking for help to keep up to date with our medical device licence & also potentially drug / NPN products

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