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Quality Management Systems that build productivity, win customers and attract investment.

Medical Devices Regulatory Compliance

"Mind the Gap" - the sense and nonsense of gap analysis

If you manufacture risk class II, III or IV medical devices for sale in Canada, your Quality System must be registered to ISO 13485 in order to obtain or renew the device licences required under the Medical Devices Regulations and Canadian Medical Devices Conformity Assessment System (CMDCAS).

Since January 1, 2003, most manufacturers of Medical Devices selling in Canada have been required to have their quality system registered by a Health Canada Recognized Registrar in order to obtain or renew their licences.

After November 1, 2003, the Therapeutic Products Directorate (TPD) delisted several medical device manufacturers who could not supply the necessary proof of registration with their licence renewal applications, costing them significant Canadian sales opportunities and potentially placing several in an illegal position if they continue to advertise or offer their products for sale contrary to the regulations.

The latest edition of the standard, ISO 13485:2003, is aligned with the year 2000 version of ISO 9001 but there are significant differences between these standards; Health Canada does not accept ISO 9001 for regulatory purposes.

The previous version of ISO 13485 (and the companion standard ISO 13488) is no longer accepted by Health Canada. As of March 15, 2006, all licence applications and renewals must be supported by evidence of registration to ISO 13485:2003.  

Note that the onus is on the manufacturer, not the buyer, to have the device licence. The manufacturer is the person or organization under whose name or mark the device is sold - regardless of whether they design and manufacture their own products or have these functions performed by others.

Importers of products under their own brand are therefore "manufacturers" under the regulations. However, on June 1, 2005, TPD issued guidance for Private Label Device Manufacturers permitting an exception to the quality system registration requirements under certain circumstances.

As you plan for ISO 13485 registration and medical device licensing, you should consider the implications for your Canadian business strategy, particularly sales and marketing plans. Your advertising and product introduction campaigns may be compromised if you do not obtain your registration in time: "No person shall advertise a Class II, III or IV medical device for the purpose of sale unless (a) the manufacturer of the device holds a licence in respect of that device ... or (b) the advertisement is placed only in a catalogue that includes a clear and visible warning that the devices advertised in the catalogue may not have been licensed in accordance with Canadian law. " (excerpt from Medical Devices Regulations)

Collier Management Consulting can help you make the right choices and guide you quickly and efficiently through the registration process, sharing the latest insights from our participation in the Canadian Advisory Committee for ISO 13485. As a Certified Management Consultant and Professional Engineer, Collier emphasizes Productivity through Quality, not mere compliance.

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The "gap" (not the chic clothing brand) is a visual metaphor for the amount of work required to change from the way we are now to the way we wish to be. It has become common to use a free or under-priced "gap analysis" as a selling aid to persuade a client to embark on a project. Many consultants have conscientiously completed reports titled "Gap Analysis for xxx Incorporated" that have been well received by the client and used as the justification for subsequent work. But experience proves the old saying, "You get what you pay for" and we have learned that, in fact, these "loss leaders" contribute little to the ensuing project. Here's why:

To define a "gap" one needs to know both the status quo and the desired result; not just "today we are not registered" and "tomorrow we wish to be registered" but meaningful descriptions of the organization as it is and as management desires it to be. The first is not merely the subject of a free afternoon of casual interviews and observations; and the second is seldom clearly defined and usually changes during the course of the project. Hence, a meaningful gap analysis arises out of a dialogue with the company in which management, as much as the consultant, explores the organization and develops an understanding of its structure and dynamics that enables the definition of objectives and the development of a project to attain them.

At Collier Management Consulting we prefer to not to perform a "gap analysis" but to commence each project with a "project definition" phase. This is not a throw-away sales perk but the initial activity in the project that defines the objectives and responsibilities of both consultant and client. And it works!

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Examples of projects ...

Large Engineering Projects
Health Care
Medical Devices
Custom Manufacturing
Construction and Contracting
Quality systems
Quality management and engineering
ISO 9001/QS 9000 registration
Improvement programs

Professional background ...

Of interest ...

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