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11 Steps to Obtaining CMDCAS Certification-Part 2

11 steps CMDCAS part2 11 Steps to Obtaining CMDCAS Certification Part 2

11 Steps to Obtaining CMDCAS Certification-Part 2″ focuses on the process of updating the quality system and preparing for your certification audit. The first 3 steps focus on classification and selecting a registrar. 

Steps 4: Writing a Licensing Procedure

Nowhere in the Canadian Medical Devices Regulations (CMDR), or in ISO 13485, does it require that you have a procedure for licensing or writing your technical documentation. However, most of the registrar auditors I have observed expect to see a procedure for this. You can reference Health Canada’s guidance documents (http://bit.ly/CanadianGuidance) and the CMDR (http://bit.ly/CanadianMDR), but that’s not enough. Typical audit questions I see on regulatory checklists include:

  • Is the company required to notify Health Canada of changes to the certificate within 30 days?
  • Is the classification rationale documented?
  • What is the procedure for maintaining technical documentation for Health Canada?
  • Is there a procedure for identifying significant changes that require notification of Health Canada (http://bit.ly/Canada-Significant-Change)?

Step 5: Mandatory Problem Reporting (MPR)

Some companies choose to have one procedure for adverse event reporting that covers all the countries that they distribute product(s) in. However, I recommend having a separate procedure for each country that is shorter and will require updates less often. It’s a personal preference, but I find people are intimidated by a longer, combined procedure. The following are the key elements for the MPR procedure:

  • decision tree for when to report
  • timescale for reporting deadlines
  • form references
  • address for reporting
  • reminder to report the event to the US FDA if the product is also sold in the USA

Step 6: Recall Procedure

Unlike the MPR procedure, I recommend having only one recall/advisory notice procedure to comply with Health Canada’s requirements and the rest of the worlds’ regulatory requirements. I typically choose this approach, because the recall/advisory notice procedure is less complex than the adverse event reporting procedures. The key element I look for in this procedure is the address for notifying Health Canada of a recall, because there is a different address in each region of Canada.

Step 7: Finding a Distributor

A Canadian Medical Device License is a license to distribute medical devices. Only Class I devices require an establishment license. Therefore, your company will be able to sell direct to physicians prescribing your device if you have a Class II, III or IV Medical Device License. If you choose to use a distributor in Canada, the distributor must meet the requirements for record keeping, and demonstrate the ability to conduct a recall, if necessary. Often, this is done by having a quality agreement in place which stipulates the retention of distribution records. Also, your company should conduct a mock recall once distribution has begun. This will ensure that the distributor is compliant the requirements for maintaining distribution records. The instructions for conducting a mock recall will be included in the revisions to the recall/advisory notice procedure described in Step 6.

Step 8: Training

The most common root cause of audit findings related to the CMDR is a lack of understanding with regard to the regulatory requirements. A better procedure can help, but there is no substitution for training on the CMDR. The CMDR is relatively easy to understand when compared to European Reglations, and the CMDR is shorter in length than US FDA regulations. However, most people have a lot of difficultly understanding the jargon of medical device regulations unless they are a regulatory expert. Therefore, it is important to develop training that summarizes the CMDR for anyone in your company that will be involved with complaint handling, adverse event reporting, recalls and regulatory submissions–including design changes.

Medical Device Academy has a recorded webinar specifically designed for company-wide training when companies are preparing for CMDCAS certification: http://bit.ly/CMDCAS-webinar. The cost of the webinar is $129 and there is a 10-question exam to verify effectiveness of training. The exam costs $49 to grade, correct answers are explained for each question and a certificate is issued for a passing grade of 70% or more.

Step 9: Internal Auditing

Your registrar will verify that you conducted an internal audit of the quality system for compliance with applicable sections of the CMDR. This can be performed by one of your internal auditors or a consultant. The audit can be completed on-site, but sometimes a remote desktop audit will suffice. Since there will be no records of distribution, licensing, complaints or recalls prior to the CMDCAS certification–there is little value in conducting an on-site audit prior to certification. The duration of the internal audit should not exceed a day, and typically can be completed in four hours by an experienced auditor–plus a couple hours of audit report writing.

Step 10: Conducting the CMDCAS Certification Audit

This step is conducted by your registrar. Any audit findings will require a corrective action plan that is accepted by the auditor before the new certificate can be issued. The new CMDCAS certificate will look very similar to the existing certificate, but there is typically an additional logo indicating compliance with CMDCAS. This is not the same as the SCC logo indicating accreditation by the Standards Council of Canada. Once the initial extension to scope is completed, the continued certification is evaluated as part of the normal surveillance audits and re-certification audits.

Step 11: License Application Submission

For a Class 2 device license application, you need to complete a form, send a check and include a copy of your new ISO 13485 Certificate with CMDCAS. The response from Health Canada is typically within 15 days or less–depending upon the current workload. Class III and IV device license applications are more complex and require technical documentation–including a clinical evaluation.

The timelines for approval of a Class III or IV device license is closer to the timeline for a 510(k) clearance letter from the US FDA. Health Canada’s Device Licensing Division is quite responsive to email inquiries, and they will respond to voicemail messages. Once a license is issued, it is typically faxed to the company and a hardcopy is mailed. I recommend a dedicated fax number for your regulatory affairs department.

Medical Device Academy, Inc. has a complete set of generic quality system procedures–including Canadian Medical Device Licensing and Mandatory Problem Reporting. Since the requirements for reporting adverse events is quite different in each country, it is not recommended to combine these procedures with other procedures. The cost of purchasing generic procedures from Medical Device Academy in a native MS Word Format is $300/procedure. Purchase grants your company a non-exclusive license to the content of the procedure for internal use. Please email Rob Packard if you are interested.

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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Canadian Medical Device Regulations (CMDR): Identifying New Changes

The author reviews a few methods to identify changes to the Canadian Medical Device Regulations (CMDR), including using the “compare” function in MS Word.

One of the most frustrating things about the Canadian Medical Device Regulations (CMDR), SOR/98-282, is the difficulty in identifying what has changed since the previous revision. There is no detailed revision history indicating what changed. This is surprising to me, because Canada was the first country to require ISO 13485 certification as a component of the regulatory approval process. Did the Therapeutic Products Directorate (TPD) overlook Clause 4.2.3?

Using MS Word to Compare CMDR Versions

Anyway, before I became an auditor, the way I determined what changed was to use the “compare” function in MS Word to compare the versions of the CMDR. The bottom of the first page indicates “Current to May 14, 2012.” This is our revision date, and it seems to change every month. Then below this, the document says, “Last amended on December 16, 2011.” This tells us that the last time TPD made a change was in December. Nowhere does CMDR tell us what changed.

On the second page of the CMDR, there is a note at the bottom of the page that supposedly clarifies the revision history:

“This consolidation is current to May 14, 2012. The last amendments came into force on December 16, 2011. Any amendments that were not in force as of May 14, 2012 are set out at the end of this document under the heading ‘Amendments Not in Force’.”

I have never seen a heading titled, “Amendments Not in Force.” So here’s what I do:

  1. “Select All” from the current PDF version of the CMDR and another version prior to the last amendment date: December 16, 2011.
  2. I copy and paste the text from each document into a separate MS Word document.
  3. I save each document with a different date code.
  4. I use the “compare” function to identify the revisions that were made to the pre-December version.
  5. Then I pound my forehead against my desk, because I just wasted 15 minutes to verify that the only changes made between August 8, 2011 and May 14, 2012 were as follows:
    • Date of revision throughout the document
    • Table of Provisions pagination was updated to reflect reformatting of Annex 3
    • Section 32.7 – changed wording from “may” to “shall,” and “giving” to “that gave”
    • Annex 3 was reformatted, so that the English and French versions appear side-by-side instead of on page 61 & 62 sequentially

Assessing the Impact of Change

So…the next time a third-party auditor asks you for objective evidence that you have assessed the impact of changes to the CMDR, show them this blog posting. If they force you to document the impact analysis of the change of the word “may” to the word “shall” in Section 32.7, request a new auditor quickly. If they ask for documentation of the impact of the tense change in Section 32.7, also request a new auditor quickly.

On a far less amusing note, the following new and revised regulatory requirements occurred on the TPD website:

  1. On May 31, 2012, there was an announcement by HC indicating “Categorization of Therapeutic Products at the Device/Drug Interface.”
  2. On October 19, 2011, the electronic submission pilot for Class IV devices was expanded to Class III devices: “Notice – Guidance for Industry: Preparation of a Premarket Review Document in Electronic Format for a Class III and Class IV Medical Device Licence Application”; this revised guidance document includes a table for Class III applications based upon the STED guidance document from GHTF.

You can also type in “What’s New” into the search engine for the TPD website. The search results can be narrowed down to a year, and postings are typically no more frequent than monthly (eight in 2011; one in 2012).

You should also be aware of the third-party auditor report guidance document (GD211):Guidance on the Content of Quality Management System audit reports. This was released in June 8, 2011. You can also get training on this GD211 format at the US FDA website. The webinars are at the bottom of the list. This is part of the FDA’s Medical Device ISO 13485:2003 Voluntary Audit Report Submission Pilot Program.

If you are interested in learning more about the CMDR or CMDCAS, please join my LinkedIn CMDCAS Group.

CMDCAS Group Logo Canadian Medical Device Regulations (CMDR): Identifying New Changes

LinkedIn CMDCAS Group Logo

Posted in: Health Canada

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