Health Canada

HC, TPD, CMDR, CMDCAS and MDALL

Medical Device Shortage Reporting

1 Comment / FDA, Health Canada / By / ,

The FDA and Health Canada both have executive-level orders requiring medical device shortage reporting or supply-chain disruptions.

In a previous article, we discussed supply-chain disruptions and mentioned that there might be medical device shortage reporting requirements if that disruption causes a market shortage of the manufactured device. Both the United States and Canada have reporting requirements for supply disruptions or the market’s ability to meet the demand of specific types of devices.

Both the U.S. FDA and Health Canada have executive-level orders that require reporting of shortages or disruptions to the supply of medical devices deemed necessary for the COVID-19 Health Emergency. There is some overlap, but each country is monitoring and experiencing shortages and disruptions of different devices.

Where did medical device shortage reporting responsibilities come from?

Check 21 CFR 820, ISO 13485:2016, and even peek at SOR 98-282 and see if you can find your obligations for reporting. Go ahead. I’ll wait… Not much in there, right? Adverse events, complaints, etc., but not market shortages.
Medical device shortage reporting is specific to health emergencies. The U.S. FDA and Health Canada happen to be two authorities having jurisdiction with reporting requirements for shortages concerning the COVID-19 Health Emergency. However, there may be others, so having your organization’s regulatory affairs manager verify the reporting requirements for the markets in which you are engaged might not be bad.

U.S. FDA 506J reporting-

fda logo Medical Device Shortage Reporting
U.S. FDA logo


In the United States, an Amendment to the U.S. Food, Drug, and Cosmetics Act requires regulatory reporting by medical device manufacturers to the U.S. FDA. It is sometimes called 506J reporting for the Section of the U.S. FD&C Act where it is located.

You will find the statutory requirements outlined within 21 USC 356J.

21 USC 356j screenshot from uscode.house .gov cropped title Medical Device Shortage Reporting
21 USC 356J Discontinuance or interruption in the production of medical devices

For the full text read, 21 USC 356j: Discontinuance or interruption in the production of medical devices. (Interestingly enough, the website where this information is available is not an HTTPS site, so visit at your own discretion).

http://uscode.house.gov/browse.xhtml

What devices are subject to 506J reporting?

There are two types of devices that the FDA is monitoring. “Critical” devices and an FDA-published list of devices for which COVID-19 is causing a higher than expected demand.

The FDA has released a guidance document that contains criteria for what is considered to be a “Critical Device”. This includes devices such as those used during surgery, emergency medical care, and those intended to treat, diagnose, prevent, or mitigate COVID-19.

fda guidance criteria for 506j critical devices Medical Device Shortage Reporting
Screenshot of the Critical Device Criteria for 506J reporting

There is also a published list of concerned devices that the FDA is specifically monitoring. The FDA website lists these devices by product code, but include the following device types;

  • Clinical Chemistry Products
  • Dialysis-Related Products
  • General ICU/Hospital Products
  • Hematology Products
  • Infusion Pumps and Related Accessories
  • Microbiology Products
  • Needles and Syringes
  • Personal Protective Equipment (PPE)
  • Sterilization Products
  • Testing Supplies and Equipment
  • Ventilation-Related Products
  • Vital Sign Monitoring
fda 506j shortage list screenshot Medical Device Shortage Reporting
Screenshot of the FDA Shortage List

Understandably this process may not be intuitive, and for this, the FDA has released a guidance document that addresses;

  • Who must make the notification
  • When you should make a notification
  • What information needs to be included within your 506J notification
  • How to make a notification, and
  • Penalties for failure to make a notification

The referenced product codes may not be an all-inclusive list or entirely up to date. The best suggestion for full compliance is to go straight to the source of the regulation, in part because noncompliance can result in enforcement action from the FDA. If you think that your device might require notification to the FDA but isn’t in the reference table, you should contact the FDA for notification clarification. Below is the quote from the FDA website, and it includes the contact email for asking these specific questions to ‘the agency.’

“If a device type is not included in this table, but you believe it requires a notification under section 506J of the FD&C Act, or if you have questions regarding the device types in this table, you should contact FDA at CDRHManufacturerShortage@fda.hhs.gov and include “Question” in the subject line of the email.”

Link to the FDA Guidance Document for 506J Reporting- HERE

How to make a 506J report to the U.S. FDA?

The FDA accepts 506J reports in multiple ways. For example, you may use the 506J Reporting web form or submit a notification by email directly to (Include Email Here). In addition, Medical Device Academy has developed a Work Instruction and Form to determine if your company is experiencing a reportable discontinuance or meaningful disruption in manufacturing a medical device as well as compiling the report for submission.

There are a few methods of notification, a web form for individual notifications and spreadsheet options for multiple notifications at once, or emailing a report directly to the FDA reporting email included below;

CDRHManufacturerShortage@fda.hhs.gov

fda 506j webform screenshot Medical Device Shortage Reporting
Screenshot of the FDA 506J reporting Webforms from https://fdaprod.force.com/shortages

It is for this process that Medical Device Academy developed WI-010 506J Shortage Reporting to the U.S. FDA. This work instruction and associated form, FRM-053 506J Reporting Form are designed to walk you through the process of determining reportability and compiling the information necessary to either complete the webform or email the report directly to the shortage reporting email.

Medical Device Shortage Reporting to Health Canada

health canada logo sante canada 1024x224 1 Medical Device Shortage Reporting
Health Canada logo

Rather than discontinuance and disruption of manufacture, Health Canada is monitoring for shortages of specific devices. Therefore, Health Canada wants Medical Device Shortage Reports regardless of the reason for the shortage. It also shows that this is not identical reporting of the same conditions to two different authorities. Health Canada will also accept reports from Importers because the frame of reference is Canada’s supply of medical devices concerning Canada’s needs.

As an Authority Having Jurisdiction, Health Canada also has reporting requirements for medical device shortage reporting of specific types of medical devices. Health Canada is also an independent authority that uses a different device classification system than the U.S. FDA.

The table below shows the device types by their classification level that HC requires supply chain disruption notifications for. This information is current as of September 5th, 2021, and the link below will take you to the HC website page for the most up-to-date list.

https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices/shortages/covid19-mandatory-reporting.html

Class I Medical Devices
Masks (surgical, procedure or medical masks) – Level 1, 2, 3 (ATSM)
N95 respirators for medical use
KN95 respirators for medical use
Face shields
Gowns (isolation or surgical gowns) – Level 2, 3 and 4
Gowns (chemotherapy gowns)
Class II Medical Devices
Ventilators (including bi-level positive airway pressure or BiPAP machines, and continuous positive airway pressure or CPAP machines)
Infrared thermometers
Digital thermometers
Oxygen Concentrators
Pulse Oximeters (single measurement)
Aspirators/suction pumps (portable and stationary)
Laryngoscopes
Endotracheal tubes
Manual resuscitation bags (individually or part of a kit)
Medical Gloves – Examination and Surgical (Nitrile, Vinyl)
Oxygen Delivery Devices
Class III Medical Devices
Ventilators (including bi-level positive airway pressure or BiPAP machines)
Pulse Oximeters (continuous monitoring)
Vital Signs Monitors
Dialyzers
Infusion Pumps
Anesthesia Delivery Devices
Class IV Medical Devices
Extracorporeal Membrane Oxygenation (ECMO) Devices
List of ‘Specified Devices’ that Health Canada is monitoring for shortage reporting

One of the things that Health Canada does an excellent job of is defining its expectations. In the Second Interim Order Respecting Drugs, Medical Devices and Foods for a Special Dietary Purpose in Relation to COVID-19, it is explained the Manufacturers or Importers should report to the Minister actual or expected shortages of the device, OR components, accessories, or parts. These notifications must be made within 5-days of becoming aware of the shortage or the anticipated shortage date. Update reports must be made within 2-days of becoming aware of new information regarding the shortage, and a closing report must be made within 2-days of the end of the shortage.

(This link is to the HC website for the 2nd Interim Order referenced above)

https://www.canada.ca/en/health-canada/services/drugs-health-products/covid19-industry/drug-medical-device-food-shortages/interim-order-2021.html

How to make a shortage report to Health Canada?

These reports are submitted online through the Health Canada Website. They have an entire section dedicated to medical device shortages, and the reporting links can be found there (Link here). If you have any questions or are on the fence about notification, you can email Health Canada at MD.shortages-penurie.de.IM@canada.ca.

Inkedhc reporting shortages overview screenshot edited LI 1024x384 Medical Device Shortage Reporting
Health Canada Webforms for reporting a shortage and the end of a shortage

The webform for reporting a shortage is the same webform that is used for providing update reports to Health Canada as well. This is both for manufacturers of specified medical devices as well as importers.

Medical Device Shortage Reporting Read More »

Obtaining a Health Canada Medical Device License (Case Study)

7 Comments / Health Canada / By / , , ,

This article explains the process for obtaining a Health Canada Medical Device License through a hypothetical case study. Canadian Medical Device Licensing is generally a more straightforward process than the 510(k) submission process for the US FDA and the European CE Marking Process. Therefore, launching a new product in Canada is one of the fastest ways for start-up medical device companies to achieve initial cash flow.

case study canada Obtaining a Health Canada Medical Device License (Case Study)

For this case study, I chose the maker of Krazy Glue® as a hypothetical new client. The company wants to start selling their products as medical devices. Fortunately for them, companies have been selling cyanoacrylate (e.g., – Krazy Glue®) as a medical device for years. Therefore, my client needs to decide if they want to sell the product as 1) a liquid bandage, 2) a topical adhesive to replace sutures, or 3) a vascular repair device for use inside the body during surgery. The client indicates that they want to sell cyanoacrylate as a medical device all over the world. Therefore, after a little homework, the client decided that a “topical adhesive” application will give the company higher margins of a medical device for prescription use. Still, it will also avoid the costly Pre-Market Approval (PMA) process at the FDA. I recommend that the client try a pilot launch in Canada first to evaluate their new packaging ideas on a smaller market than the USA or Europe.

Even though I have submitted multiple-device license applications to Canada, my first job in Regulatory Affairs taught me the most valuable lesson of all: “Always check the source.” Therefore, I went to the “helpful links” (http://bit.ly/RA-Resources) page of my website to find the Canadian Medical Device Regulations (CMDR), but for those of you that just don’t want to work that hard, here’s the direct link: http://bit.ly/SOR-98-282. The CMDR was most recently updated on December 8, 2014, but there have been no amendments to the regulations since December 16, 2011. If you want to know what the difference is between the current version and the previous version, I wrote an entire blog posting on just that topic (http://bit.ly/CMDRChange). The posting is 701 words long, but the two-word answer is: “Not much.”

Once I find the most recent version of the CMDR, I skip ahead to the bottom of page 54. Rule 4 states that “all non-invasive devices that are intended to come into contact with injured skin are classified as Class 2.”  This is the applicable rule for a topical adhesive, but with device classifications, I always verify the Classification by looking up the license for a competitor product. The competitor product I selected was “Surgiseal.” I wasn’t sure who the manufacturer was for Surgiseal™, so I used Health Canada’s Medical Device Active License Database and searched by “Device Name.” In this case, I quickly found the license information I needed. Still, sometimes I use the US FDA website’s Registration and Listing Database (http://bit.ly/CDRH-Registration-Listing-Database) to identify device names and the name of manufacturers. The Canadian Device License information for Surgiseal™ is shown below:

fig. 1 canada Obtaining a Health Canada Medical Device License (Case Study)

After verifying, this is a Class 2 device in Canada, I reviewed the Canadian Licensing Process for Class 2 devices. Starting on page 16 of the CMDR, Section 32, I reviewed the process of applying for a Medical Device License. I also reviewed the Guidance Document for “How to complete a new medical device license application.” The location of that Health Canada Guidance Document is http://bit.ly/Canadian-Device-License. Fortunately, this is a Class 2 device, and the requirements are primarily to complete the application form for a new Class 2 device license (http://bit.ly/Canadian-Device-License-Form), sign attestations regarding compliance with the safety and effectiveness requirements (Section 10-20 of the CMDR) and compliance with the labeling requirements (Section 21-23 of the CMDR). The application form has a new section requiring information about the phthalate content of the device in the application. However, this tissue adhesive would only have phthalates if it was contained in the packaging.

Obtaining a Health Canada Medical Device License: The Process

After reviewing all the requirements for a device license application, I meet with the client to explain the next steps of the process:

  1. The client needs to upgrade its existing ISO 9001:2008 Quality Management Certificate to an ISO 13485:2003 Certificate with CMDCAS. “CMDCAS” is the Canadian Medical Device Conformity Assessment System (http://bit.ly/CMDCAS-Certification-Part2). The Quality System Auditor from the registrar will look for additional requirements specific to the CMDR, but all of these requirements are identified in GD210—another guidance document from Health Canada. This will only require a one-day external audit to upgrade the scope of the current certification.
  2. The labeling needs to be revised to meet the requirements for Sections 21-23 of the CMDR. Since this product will be used by Medical Professionals, rather than an over-the-counter product, the labeling requirements are similar to Europe and the U.S. The most important thing to do will be to implement the use of appropriate symbols found in ISO 15223:2012—an Internal Standard for Labeling and Symbols.
  3. The client will need to conduct an internal audit to the CMDR requirements before the certification upgrade audit. If I make revisions to the client’s quality system, then another auditor on my team will conduct the internal audit remotely. If the client makes the changes to the quality system themselves, then I can conduct the internal audit myself.
  4. Finally, once the new CMDCAS Quality System Certificate is received, we can complete the medical device license application and submit the application with a copy of the new certificate.

In my proposal to the client, I estimate that the entire process will require less than 60 days. When the client gets an upgrade quotation from their registrar, the earliest date available is in 10 weeks, but their annual surveillance audit is already scheduled for 13 weeks. Therefore, the client decided to combine the upgrade audit and the annual surveillance audit to save money on the travel costs and to give themselves more time to prepare for the upgrade to CMDCAS certification.

Not all applications are this easy. For higher-risk devices (i.e., Class 3 and 4), Summary Technical Documentation (STED) must be submitted in both paper and electronically. Health Canada provides guidance documents for this, and there is a Global Harmonization Task Force (GHTF) document that explains how to prepare these documents. Depending upon the Classification and complexity of the device being submitted, this documentation can take weeks or months to prepare. 

The STED documents described above meet the European CE Marking requirements for the content of a Technical File, and most of the STED documents can be modified to meet 510(k) submission requirements of the US FDA. Preparation of STED documents, including STEDs for biocompatibility testing and sterilization validation, can be prepared in parallel with obtaining ISO 13485:2003 certification. The only item that should require additional time is the clinical summary–if clinical studies are required.

If your company needs help with Canadian Medical Device Licensing, please contact Rob Packard.

Obtaining a Health Canada Medical Device License (Case Study) Read More »

11 Steps to Obtaining CMDCAS Certification-Part 2

2 Comments / Health Canada / By / , ,

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 three steps focus on classification and selecting a registrar. 

Steps 4: Writing a Licensing Procedure

Nowhere in the Canadian Medical Devices Regulations (CMDR), or 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 the 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 directly 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 with 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 Regulations, 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 essential 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 designed explicitly 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 the 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 before the CMDCAS certification–there is little value in conducting an on-site audit before certification. The duration of the internal audit should not exceed a day. It typically can be completed in four hours by an experienced auditor–plus a couple of hours of audit report writing.

Step 10: Conducting the CMDCAS Certification Audit

Your registrar conducts this step. 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 the 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.

11 Steps to Obtaining CMDCAS Certification-Part 2 Read More »

11 Steps to Obtaining CMDCAS Certification: Part I

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  • 11 steps CMDCAS partI 11 Steps to Obtaining CMDCAS Certification: Part I“11 Steps to Obtaining CMDCAS Certification-Part I” focuses on the process of verifying the classification, selecting a registrar, and more.

Step 1: Verify Classification

There are four device risk classifications in Canada: I, II, III, and IV. If your device is Class I, then you can work with a distributor in Canada that has an establishment license. However, if your device is Class II, III, or IV, then ISO 13485 certification with CMDCAS is required as a prerequisite for a Canadian Medical Device License Application. Therefore, before you waste time and money on upgrading your ISO 13485 certification to include CMDCAS, you should ensure that your device is Class II-IV.

Each country has slightly different regulations. Often the risk classification is different between the two countries. However, in the following example, the classification is identical. If a device is an active, therapeutic device, then the device is typically classified as Class 2, as per Rule 9 of the CMDR. The rule and the rationale are identical to the EU classification of Class IIa, per rule 9 in Annex IX of the MDD. A manufacturer can confirm this classification by sending an email to the Device Licensing Division, asking them to confirm the classification rationale. Including a copy of the draft, IFU is recommended, so that Health Canada is aware of the intended use when they are verifying your classification rationale. Verification typically is completed within ten days, and there is no charge. If you need help determining the classification, please contact Rob Packard.

Step 2: Health Canada recognizes a verified Registrar

The process for becoming a CMDCAS auditor is one of the most challenging examinations that I have ever taken (http://bit.ly/Instructor-Effectiveness). However, the process of becoming a recognized registrar for CMDCAS is even more challenging. Health Canada acknowledges only 15 registrars. Therefore, ensure that your registrar is on the list first http://bit.ly/RecognizedRegistrars.

If you are selecting a critical subcontractor (i.e., “subcontractors in charge of processes which are essential for ensuring compliance with legal requirements”), you should verify that the company has a registrar that is recognized by Health Canada, as well. If not, this may result in the need for additional scrutiny of the critical subcontractor by the registrar–including the potential for an audit. If you need help selecting a registrar from the 15 recognized registrars, you should read our blog on this topic: http://bit.ly/SelectingRegistrar.

If your registrar is not one of these 15, then you will either need a second registrar, or you will need to transfer to a new registrar. The transfer process is a little different from each registrar. Still, generally, the new registrar must review previous audit reports, your certificate, and any corrective actions that are associated with the previous regulatory audit. This is typically completed in a one day audit that may be on-site or remotely conducted. The next step is to obtain a quote.

Step 3: Obtaining a Quote for CMDCAS Certification

Every registrar I know has a long application form that needs to be completed before they can provide a quote for CMDCAS certification. You will need company information about the various locations for each site covered by the quality system certificate–including the number of people, shifts, and types of activities conducted at each location. If you already have ISO 13485 certification, the quotation will be for an extension to the scope of the original quality system certification. An extension to scope audit is typically one day in duration. Upon successful completion of the audit, your company is recommended for CMDCAS certification, and the existing ISO 13485 certificate is replaced with a CMDCAS Certificate. For some companies, the scope of activities requires that you maintain your original certificate and the new CMDCAS certificate.

Once you obtain your quote(s) for upgrading to CMDCAS, then you must schedule your audit. Typically, auditors are booked at least 90 days in advance. Since the process of making upgrades to your quality system takes no more than 90 days, I don’t recommend waiting to make changes. Just go ahead and schedule the audit, and now you have a real deadline for everyone to work toward.

Part 2 of this article will explain the changes you need to make to the quality system to prepare for your CMDCAS audit.

11 Steps to Obtaining CMDCAS Certification: Part I Read More »

How to Identify New and Revised Canadian Medical Device Regulations

1 Comment / Health Canada / By / , , , ,

Four steps for identifying new and revised Canadian medical device regulations and guidance documents for a 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 every quarter and to perform a systematic review of new and revised medical device regulations just before 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, which 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 (https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices/legislation-guidelines.html). This link tells you how to search for the Medical Device Regulations on the Justice Canada website (https://laws-lois.justice.gc.ca/Search/Search.aspx). 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; https://laws-lois.justice.gc.ca/eng/regulations/SOR-98-282/index.html). 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: https://medicaldeviceacademy.com/cmdr-new-changes/. 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 changed 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: https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices/application-information/guidance-documents.html. There have only been four new guidance documents in the past two years:

1. Medical device license – The final guidance document for Class III and IV medical device license applications was released on July 5, 2012.

2. UltrasoundLicenseApps – Updated guidance license applications for ultrasound systems and transducers were published on September 13, 2013.

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

4. 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 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 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.

How to Identify New and Revised Canadian Medical Device Regulations Read More »

Risk Classification Process for Health Canada Device Licensing

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Author reviews considerations of the risk classification process for Health Canada device licensing, including a review of Health Canada guidance documents.

Last week, I was visiting a client who was told that their device is a higher risk device classification (i.e., – Class IV) in Canada than it is in Europe (i.e., – Class IIa). Although Canada has its own device classification rules, there are many similarities with European Classifications for CE Marking. A few months ago, I posted a gap analysis (http://bit.ly/gapanalysiscmda) comparing the classification rules in the current MDD (http://bit.ly/M5MDD) to the new classification rules in the proposed European Device Regulations (http://bit.ly/EUProposal). Now, let’s review the Canadian classification rules versus the current European classification rules.

Overview of the European and Canadian Medical Device Classification Rules

There are four European and Canadian medical device classifications. Class I, IIa, IIb, and III are the European classifications, while Class I, II, III, and IV are the Canadian classifications. The Canadian classification rules are located on pages 54-57 of the Canadian Medical Device Regulations (http://bit.ly/FindCMDR).

canada class blog Risk Classification Process for Health Canada Device Licensing

There are 16 risk-based classification rules, with a similar format and organization to the 18 risk-based classification rules in the MDD. Just a glance at the table above reveals that the classification rules for Europe and Canada are similar. However, a closer comparison between the two regulations shows that Rules 1-14 in the CMDR match-up with part or all of a corresponding European classification. Only rules 15 and 16 do not have a corresponding European classification rule.

How to Write a Classification Rationale for Health Canada

Two weeks ago, I wrote a blog (http://bit.ly/riskclass) on how to write a classification rationale for CE Marking of Medical Devices. That blog made use of the European guidance document for the classification of medical devices (http://bit.ly/EUClassification). For Canadian Medical Device License Applications, there is a different guidance document (http://bit.ly/CMDRClassificationGuidance). However, if you already have a European device classification, I recommend the following strategy:

  1. Identify the equivalent classification rule in the CMDR
  2. Write a classification rationale using the rule you identified in the CMDR
  3. Send your classification rationale to the Canadian Medical Device Licensing Division for verification (http://bit.ly/CanadianMDL)

If you have any trouble with step 1, you might try doing a keyword search of an electronic version. For example, the word “gases” in rule 2 of Annex IX in the MDD only appears once in the CMDR classification rules—in rule 5. An alternate approach to identifying the classification is to search Health Canada’s MDALL (http://bit.ly/CanadianMDALL) medical device licensing database for a competitor’s equivalent product. If you don’t know the name of competitor products, you can also use Health Canada’s keyword index (http://bit.ly/CanadianKeywordIndex).

Get Health Canada’s Input

Once you have written your classification rationale, then you should email the classification rationale to Health Canada’s licensing division (http://bit.ly/CanadianMDL). Help with identifying the proper device classification in the CMDR does not require paying a consultant thousands of dollars, because Health Canada will not charge you for this service, and they typically respond within 7-10 days. Their response will confirm you have identified the correct classification for your product, or you will receive an explanation of why another rule is a better choice.

Regulatory Pathway Identification

Medical Device Academy offers a standardized service for identifying the regulatory pathway for device submissions to the United States, Europe, and Canada. We recommend that companies prepare a regulatory pathway document during the initial design planning stage (ISO 13485, Clause 7.3.1) because the harmonized standards identified will become your design inputs (ISO 13485, Clause 7.3.2). The Canadian pathway is always the easiest and least expensive of the three markets mentioned.

Do Not Ask Your CMDCAS Registrar

Your company’s ISO 13485 registrar should NOT attempt to participate in the above classification process. Health Canada specifically tells all CMDCAS (http://bit.ly/CMDCAS) auditors to instruct companies to contact Health Canada directly. The CMDCAS auditor is only supposed to verify that the company has a documented licensing process and documented classification rationale. Health Canada’s Device Licensing Division assesses the accuracy of the rationale.

You may also be interested in joining the LinkedIn Group I manage on this topic (i.e.,- CMDCAS): http://bit.ly/CMDCASLinkedInGroup.

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Canadian Medical Device Regulations (CMDR): Identifying New Changes

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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 before 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 on 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. 

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

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