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How to Identify New and Revised Canadian Medical Device Regulations

Canada How to Identify New and Revised Canadian Medical Device RegulationsThe author reviews four steps for identifying new and revised Canadian medical device regulations and guidance documents for management review meetings.

Several times throughout the year, clients ask me to help them prepare a slide for their Management Review that summarizes new and revised regulatory requirements. My recommendation is to conduct management reviews on a quarterly basis, and to perform a systematic review of new and revised medical device regulations just prior to each management review.

Each country has different websites for communicating medical device regulations. For Canada, the information you need can be located in two places. The first location is the Justice Canada website, where the most current version of the Canadian Medical Device Regulations (CMDR) can be downloaded. The second location is the Health Canada webpage that lists legislation and guidance documents.

Identifying New and Revised Canadian Medical Device Regulations-Step 1

You need to look up the most recent version of the CMDR (http://bit.ly/FindCMDR). This link tells you how to search for the Medical Device Regulations on the Justice Canada website (http://bit.ly/Justice-Canada). When you type in “Medical Device Regulations” in the proper search field, it will take you to a page with a link for Canadian Medical Device Regulations (i.e., CMDR or SOR/98-282; http://bit.ly/CanadianMDR). Then you can decide if you want to download the CMDR in HTML, XML or PDF format.

Why not click directly on the last link I provided?

Because the location on the Justice Canada website may change, and Health Canada does not control the Justice Canada website.

Step 2

Once you download the CMDR, you want to compare it for changes with the previous version you were using. In June, 2012, I wrote a blog that explains how to do this: http://bit.ly/CMDRChange. I’ll save you some time, however; the first page tells you what you need to know. The most current version of the CMDR is current to November 26, 2013 (it will change soon); but the last amendment was on December 16, 2011. Therefore, Health Canada has not made any changes to the wording of the CMDR in two years.

Step 3

Once you have reviewed the CMDR, you will want to search for new guidance documents. Health Canada provides a page summarizing the medical device guidance documents in chronological order, from most recent to oldest: http://bit.ly/CanadianGuidance. There have only been four new guidance documents in the past two years:

1. http://bit.ly/LicenseApplications – Final guidance document for Class III and IV medical device license applications was released on July 5, 2012.

2. http://bit.ly/UltrasoundLicenseApps – Updated guidance license applications for ultrasound systems and transducers was released on September 13, 2013.

3. http://bit.ly/CanadianRenewalandFees – Updated guidance on license renewal and fees for the right to sell medical devices was released on November 18, 2013.

4. http://bit.ly/CanadianFeesforReview – Updated guidance on review fees for medical device license applications was released on November 18, 2013.

Note: The most recent fees are now found on the following page http://bit.ly/Canadian-Fees.

Step 4

Review each guidance document and determine if the document impacts your organization’s quality system and procedures. This gap analysis should be performed by someone that is familiar with the specific process(es) addressed by the regulations. The most likely actions to be taken are:

  1. initiate specific changes to existing procedures,
  2. create new procedures, or
  3. initiate a quality plan for more substantial changes to your quality system.

If you need more help preparing for your management review, here’s a link to a free webinar I recorded: http://bit.ly/Clause5-6. You will also receive a management review powerpoint training slide deck.

Posted in: Health Canada

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Instructor Effectiveness and the Power of a SNICKERS

The author discusses his personal experience attending a training class, instructor effectiveness and reasons why he learned so much there.

I guess there are still some instructors out there that need to be reminded that we can all read the regulations on our own. We don’t need to pay $1,000+ per day in order to have someone read stuff for us. If that’s what you want, my 10-year old son is a fantastic reader. He’ll record anything you want, in any media format, for a much smaller dollar figure. If you want to learn something that is worth at least as much as your investment of time and money, then you need to find an instructor that can teach effectively.

Four Prerequisites for a Great Instructor:

1. The instructor must be an expert

2. The instructor must inspire participation

3. The instructor must provide practical examples for each student

4. The instructor must get everyone’s attention–and keep it

The most important determining factor of training effectiveness, however, occurs after the course is over When you are teaching quality assurance and regulatory affairs, you must develop your ability to inspire and engage students to Olympic medalist proportions. “Blah, blah, blah…” and “Death by PowerPoint” will get you fired. Don’t read your slides, don’t turn your back on the audience (or they’ll attack) and PLEASE don’t ever ask someone to read the definition of nonconformity out loud to the rest of the group. When I teach a class, you demand my best. I’m six-foot, six inches tall and I have a loud booming voice. My mother has red hair and she was an opera singer. I’ve got the voice to fill any auditorium and stage presence to match. But if you even start to nod off in class, I may just have to throw a Snickers bar at you.

snickers Instructor Effectiveness and the Power of a SNICKERS

This is an essential tool for any instructor. It functions as a tool to prod sleeping students awake, is small enough to cause minimal injury when thrown, serves as an emergency food supply and is gluten free.

If legal counsel recommends against using projectiles to encourage class participation, you might also consider one of my all-time genius ideas. I was scheduled for a two-day course in Ottawa, but the day before I needed to perform an audit in Pennsylvania. Therefore, my flight was the last flight into Ottawa–arriving at approximately 1 a.m. My flight was delayed more than an hour, and the person in front of me was trying to smuggle an extra carton of smokes into the country. Just before 4 a.m. my taxi arrived at the Albert at Bay Suite Hotel. Class started at 8 a.m. I made it to class on time, and excessive consumption of several pots of black coffee helped get me to lunch. Then my legs started getting a little wobbly. Fortunately, there was a convenience store next door that sold my favorite chocolate–the Dark Aero bar! After four of these monstrous doses of cacao, and another pot of coffee, I could have listened to the lecture on Canadian Medical Device Regulations all night.

aero bar Instructor Effectiveness and the Power of a SNICKERS

Hershey’s copied them, but the result was a mere shadow of Nestle’s greatness. Canadians know how to make junk food, tell a joke and play hockey!

Lessons Learned

Despite the physical handicap of sleep deprivation, I still learned a ton from my course in Canada. Here’s why:

1. The instructors were experts. Both instructors were regulatory experts and Canadian. Both instructors taught this course twice a year for multiple years, and one of the instructors actually worked for Health Canada.

2. The instructors were blessed with the perfect audience that was hyper-motivated to pass the course. Everyone in the class worked for a Notified Body that had sponsored them to take the course. In order to stay employed and get a raise, I needed to pass that course. If I failed the exam, I had to absorb the cost to travel back to Ottawa and retake the course in February (BRRRR!).

3. Everyone has different experiences and therefore not every example makes sense to us. Therefore, instructors need to use practical examples that are actionable. In  this course, the instructors brought more than a dozen medical devices to the class. We studied the labeling and intended use of each device. Even students from Japan, Europe and Australia were familiar with some of the products. This was critical, because we all needed to be able to identify incorrect Canadian labeling.

4. The greatest asset of all was the humor of the instructor from Health Canada. He was hilarious. He had everyone laughing at his jokes for the entire course. Most of the jokes were not funny enough for a stand-up routine, but this was a mandatory regulatory course on Canadian regulations. Who would even expect a chuckle. Despite the strengths of these instructors, there is only one reason why I know the Canadian Medical Device Regulations (CMDR) as well as I do. I use them every single week.

Some Examples of How I Used the CMDR:

First, I had to audit 162 days for BSI in 2011. Ninety percent of those 162 days were for companies that required a Canadian Medical Device License. Therefore, I started auditing companies to the Canadian regulations immediately after the course. Second, I was also consulting for companies at the same time I was auditing for BSI. Consulting clients hired me to prepare and submit Canadian Medical Device License Applications for them. I also had to revise and create new procedures specific to the Canadian regulations. I spent another 60+ days in 2011 doing consulting. Finally, I was one of BSI’s instructors that taught the regulatory comparison course, which compared the regulations of the USA, Canada, Europe, Australia and Japan.

Therefore, at least once a month, I had a classroom of 6-20 people asking me challenging questions about how to interpret and apply regulations from each of these countries to their products. I used every bit of knowledge I learned in that course in Ottawa and I started using that knowledge immediately after the course. I had peers, superiors, clients and students challenging my knowledge of these topics every day. This is what makes you a subject matter expert. If you need to learn something about Quality Assurance or Regulatory Affairs, a one-hour webinar, reading a blog, taking a five-day, or shadowing another more experienced person is not enough. In the end, all of the above will get you to the level of barely competent!  If you want to learn, you need a great instructor. Then you need to use everything you learned at every opportunity for several years. Some say, “If you can’t do, teach.” I say, “Bring a SNICKERS bar and throw it at them for faking it.”

Posted in: ISO Auditing

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