Sent: Tuesday, November 13, 2018, 11:23 AM
Subject: RE: Questions re: medical devices from CBC, Radio-Canada, the Star
Health Canada is committed to providing Canadians with timely access to safe, effective and
high-quality medical devices. As part of the Department’s mission to help Canadians
maintain and improve their health, Health Canada evaluates and monitors the quality,
effectiveness and safety of medical devices throughout their lifecycle.
Product life cycle refers to all stages in the pre- and post-market "life" of a health product,
including:
● Investigational tests;
● Submission of product information to Health Canada for review and evaluation;
● Decision whether to authorize the sale of the product in Canada
● Public access to the product
● Post-market surveillance, inspection and investigation.
The Department’s work to minimize the risk of health products falls into three main areas:
● Review and Evaluation process to assess products against safety, quality and
effectiveness standards before allowing them onto the market in Canada, and to
determine whether products are suitable to use in medical device investigational
tests;
● Compliance and Enforcement activities to ensure that products and procedures
comply with the Food and Drugs Act and the Medical Devices Regulations; and
● Monitoring and Tracking to identify and address any problems and to assess the
effectiveness of products once they are on the market.
Health Canada assesses the risks of all health products and verifies their quality and
effectiveness before they are allowed to be used by Canadians. Regulations defining the
conditions for activities and materials associated with the testing, manufacture, preparation,
preservation, packaging, administration, storage and sale of any health product are set out in
the Food and Drugs Act, the Food and Drug Regulations and the Medical Devices
Regulations.
If the Department concludes that the benefits of a medical device outweigh the risks of the
device when used as intended, and that identified risks associated with the use of the device
can be mitigated or managed, we provide the manufacturer with a medical device licence.
Health Canada continues to monitor the safety, effectiveness and quality of medicines and
health products such as medical devices after they reach the marketplace. This provides
new and up-to-date information that becomes available only after people start using health
products under "real life" conditions. Once a product goes onto the market, we watch for
signals that there may be a problem.
Signals may come from many sources, including:
● Published studies
● Reports from other levels of governments and international organizations
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 ●
●

Domestic and international complaint and incident reports
Information received from manufacturers

A “signal” is an early indication that there may be an issue with a device. These signals go
through a process of analysis to determine whether there is a safety issue that requires
further action.
Some of the actions we may take to address safety issues for biotechnology-based health
products on the market include:
● Continuing to monitor the product
● Reassessing the risk-to-benefit profile of the product
● Asking the manufacturer to make changes to the labelling (e.g., changes to
directions for use, warnings about side-effects or interactions with other
products)
● Issuing advisories or warnings for healthcare professionals, hospitals and
consumers
● Removing the product from the marketplace (e.g., recalls).
For more information about the medical device regulatory system lifecycle, please consult:
https://www.canada.ca/en/health-canada/services/science-research/emerging-technology/bi
otechnology/health-products/product-life-cycle-medicines-health-products-biotechnology.htm
l
Q1. From 2008 to present, Health Canada has approved 93.7% of all the licence
applications it received for Class III and IV devices. During this time period, FDA
approvals of high-risk devices reportedly ranged from 59% to 98%. Why have Health
Canada’s approval rates been at times so much higher than those of the U.S. device
regulator?
The manufacturing and sale of medical devices is a global industry and Canadian approval
rates are similar to those in the United States. In fact, many medical device companies will
choose to launch in a large market such as the United States or Europe before coming to
Canada, meaning that many of the devices Health Canada approves have already been
approved by the FDA or EMA.
Health Canada licensed 92.5% of Class III applications and 95.2% of Class IV applications
in 2015, the latest year for which statistics are available from the US FDA for comparison
purposes. This compares with a 98% approval rating of applications for pre-market approval
by the FDA in 2015.
Please note that the statistics for authorizations in Canada do not take into account
applications withdrawn by manufacturers, recommendations made by Health Canada staff to
modify the indications for use or undertake additional testing of submitted devices, or the
withdrawal of specific models of devices during the review process. Medical device licence
applications that are grossly deficient—for example, lacking the required evidence of quality
systems—are not accepted for review and do not appear in the Canadian statistics. In
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 addition, companies applying for licensure of their medical devices work to ensure that they
have data to support the granting of a medical device licence before submission of an
application. All these factors could contribute to apparent high application approval rates in
general.
Q2. Using the number of Health Canada employees involved in the review and
approval of medical devices, we found that since 2013, each Health Canada evaluator
has been responsible for reviewing applications for anywhere from 52 to 90 high-risk
devices each year. This doesn’t even consider work involved in reviewing Class I and
II applications. How can Health Canada employees confidently evaluate high-risk
devices for safety and efficacy if they are in charge of reviewing as many as 90
devices each year?
Not all applications related to Class III and IV devices require an evaluator to perform a
scientific review. For example, some applications involve only administrative changes, and
these do not require a scientific review.
In 2017, an individual evaluator at Health Canada conducted, on average, 25 scientific
reviews for Class III and IV new and amendment applications (63 evaluators reviewing 1578
new and amendment Class III and IV applications requiring scientific review).
The number of reviews of medical devices done each year varies depending on the number
of submissions received, and the quality and complexity of the applications.
Q3. There are many implantable devices that were approved with minimal or no
clinical testing in humans. Some of these products were later subject to safety
warnings and pulled from the market. For example, at the time TVT Secur System was
approved in 2006, testing had only been done in animals and cadavers, according to
published research. The Sprint Fidelis leads, which were ultimately withdrawn from
the market and attributed to several deaths worldwide, was supported by animal and
bench testing compared to an earlier predicate when it was approved in several
countries in 2004, according to FDA documents. Why did Health Canada approve
products that were later subject to safety concerns based on no new evidence from
human clinical trials?
All Class III and IV medical device licence applications must be supported by evidence of
clinical effectiveness. The Canadian regulatory requirements to demonstrate clinical
effectiveness allow evidence in several forms, including clinical trials, clinical reviews,
meta-analyses and real-world evidence reviews.
In general, Health Canada requires randomized controlled trials where a proof-of-principle
study is used to demonstrate that a therapeutic product is safe and effective. This is true for
novel high-risk medical devices. In many cases, however, applications for new medical
device licences are based on an earlier generation of a similar device that was previously
licensed in Canada. In these cases, evidence of safety and effectiveness can be
demonstrated based on a comparison to currently licensed devices with similar designs and
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 performance characteristics.
With regard to the Sprint Fidelis lead, bench testing and animal studies provided evidence of
safety and effectiveness of the device based on the state of knowledge at that time. The
testing met internationally accepted standards for safety and effectiveness as outlined by the
International Organization for Standardization (ISO). The failures associated with the Sprint
Fidelis highlighted that the stresses applied to the leads were more severe than previously
assumed.
It wasn’t until there was a large number of Sprint Fidelis devices implanted, with follow-up for
approximately three years, that an initial signal was observed that the rate of failure was
higher than with other licensed devices. Based on this information, Health Canada, along
with other global regulators, halted sales of the Sprint Fidelis.
Q4. Roughly how many of the devices approved each year are not supported by
clinical testing in humans?
All applications for Class III and IV device licences are supported by evidence of clinical
effectiveness. The Canadian regulatory requirements to demonstrate clinical effectiveness
allow evidence in several forms, including clinical trials, clinical reviews, meta-analyses and
real-world evidence reviews. Health Canada’s database does not differentiate products
based on the type of evidence submitted, so the department is not in a position to provide
percentage estimates of the types of evidence submitted.
Q5. Surgeons and experts have told us that the lack of meaningful clinical testing for
devices means that patients getting implanted with approved devices are essentially
participating in “one big clinical trial.” Do you have any comment?
Health Canada requires applications for all Class III and IV device licences to be supported
by evidence of clinical effectiveness, including clinical data. Although these devices provide
significant benefits to the health of Canadians, all drugs and medical devices come with
some degree of risk. Health Canada licenses only those devices for which a risk-to-benefit
profile is favourable. Residual risks are disclosed through labelling information, which is
reviewed by Health Canada and is also to be disclosed to patients by their healthcare
professionals.
In addition, Health Canada oversees the clinical testing of medical devices through Part 3 of
the Medical Devices Regulations, which is referred to as Investigational Testing. These trials
involve medical devices that are in earlier phases of development and are not yet licensed in
Canada. They will provide additional clinical evidence to support a licence application for the
device in Canada. Such clinical trials are authorized only after careful consideration of the
risk-to-benefit ratio for patients and when the benefits outweigh the risks.
Q6. Based on Health Canada’s own figures, more than 75% of the medical device
bureau’s budget comes from application fees paid by manufacturers. How can Health
Canada make sure it remains independent when approving and monitoring devices if
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 it heavily relies on the industry financially?
As in many other countries, Health Canada’s regulatory activities are funded through both
public funds and revenues from user fees paid by industry. The fees support unbiased,
independent reviews, and are paid even if a drug or medical device is not approved.
Individual reviewers who make the decisions are not involved in collecting fees and have no
way of knowing whether fees have been paid or not. Fees paid by industry in no way
influence the independence of Health Canada’s review.
The overriding principle for all Health Canada activities is the health and safety of
Canadians. Health Canada’s approval of medical devices is based solely on the evidence of
a product’s safety, quality and effectiveness, and is subject to public scrutiny.
Health Canada has been charging fees to industry since the mid-1990s to recover a portion
of its costs for regulatory activities. Health Canada is in the process of updating its fees,
which were last updated in 2011, to reflect current costs of service delivery and to ensure
that the industry pays its share.
Q7. Clinical trial data, pre-market approval documents, post-approval studies,
post-market surveillance studies, inspection reports and warning letters sent to
manufacturers are publicly available in a number of developed countries, including
countries in the European Union, Australia, Japan and the United States. Why isn’t
that data publicly available in Canada?
Health Canada is committed to openness and transparency and does, in fact, make
information on medical devices public. Every regulator’s practices differ somewhat, and the
documents and other information they make available may differ as a result.
Health Canada conducts post-market approval safety reviews for medical devices when a
potential safety issue is identified. Once Health Canada completes a safety review, it
publishes a summary safety review, which highlights key findings. This summary safety
review informs Canadians of what was found and what actions were taken by Health
Canada if any. The full safety reviews are available from Health Canada by request. Results
of post-approval studies conducted by manufacturers, if available, are included as part of
Health Canada's safety reviews, along with other sources of information to help determine
risk mitigation measures and other regulatory actions, if required.
Health Canada may inspect anyone who has a medical device establishment licence
(MDEL) to ensure that they comply with the Food and Drugs Act (Act) and the Medical
Devices Regulations (Regulations). These inspections support Health Canada's national
compliance and enforcement program. Health Canada posts an Inspection Report Card on
its website as part of its commitment to openness and transparency. The report card
summarizes the findings of inspections of MDEL holders. Such report cards have been
available on Health Canada’s website since 2016. They include inspections dating back to
January 2012.

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 You
can
see
the
inspection
findings
at:
https://www.canada.ca/en/health-canada/services/inspecting-monitoring-drug-health-product
s/drug-health-product-inspections.html
Warning letters are a tool used by other regulators, such as the US FDA, to communicate
significant violations of their regulatory requirements found during an inspection. The report
card is our main transparency tool and serves as a comprehensive summary for disclosing
inspection outcomes to Canadians and notes where compliance action has been taken. In
some cases, compliance action has been prompted by Health Canada's compliance letters,
which are comparable to the US FDA's warning letters.
At this time, Safety recalls and safety alerts are issued online for individual product licence
suspensions that result from a finding that a medical device is unsafe. For product licence
suspensions and cancellations that are not the result of a safety alert, patients and
healthcare professionals can access Canada’s Medical Device Active Licence Listing, which
is an online database used to identify medical devices that are authorized for sale in
Canada. The database is updated on a daily basis.
Health Canada is striving to increase transparency and is continuously making
improvements to inform the public of the outcomes of inspections, including improving
web-based searchability tools and access to information for Canadians.
Q8. Medical device incidents (i.e. adverse events) are routinely released through a
public, searchable database in a number of developed countries, including Australia
and the United States. Why isn’t that data publicly available in Canada?
At present, Medical Device Problem Reports cannot be accessed through an online
database similar to the Canada Vigilance Adverse Reaction Online Database, although the
Department is examining options for online access to medical device reports.
In addition, through its Regulatory Transparency and Openness Framework, Health Canada
is pursuing initiatives to increase the regulatory health and safety information that is
available to Canadians. Currently, Canadians have access to Health Canada's Recalls and
Safety Alerts Database.
Q9. How is Health Canada using its own database to monitor potential trends and
risks? How much of that monitoring is done using foreign reports vs. domestic
reports? At what frequency is Canadian data analyzed to find possibly problematic
devices?
As per the Medical Devices Regulations, manufacturers and importers of medical devices
are required to submit to Health Canada reports concerning any incident that comes to their
attention whether inside or outside Canada and involving a device that is sold in Canada and
that: (a) is related to a failure of the device or a deterioration in its effectiveness, or any
inadequacy in its labelling or in the directions for use; and (b) has led to the death, or a
serious deterioration in the state of health, of a patient, user or another person, or could do
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 so, were it to recur. The requirement to report an incident that occurs outside Canada does
not apply unless the manufacturer has indicated, to a regulatory agency of the country in
which the incident occurred, the manufacturer’s intention to take corrective action, or unless
the regulatory agency has required the manufacturer to take corrective action.
With respect to frequency, on a daily basis, Health Canada performs the entry and initial
assessment of Canadian medical device incident reports in order to triage reports that may
require further assessment or immediate regulatory action. When monitoring the
risk-to-benefit profile of medical devices sold in Canada, Health Canada analyzes 100% of
the Canadian data of activities to identify and analyze potential trends and risks. Information
needed to understand the Canadian context is always prioritized, with information from
international sources used to supplement as appropriate. In particular, as Canada makes up
a small percentage of the global market, analysis related to identifying and assessing rare
incidents benefits from the inclusion of international medical device incident data shared with
Health Canada by other regulators. Health Canada has a systematic approach in place to
identify changes to the risk-to-benefit profile of medical devices sold in Canada. This
approach includes the regular review of information housed in the Medical Device System
(MDS) database, such as mandatory and voluntary problem reports, as well as recalls.
Foreign information housed outside the MDS database is also included, as appropriate, in
Health Canada's overall approach to monitoring potential safety risks.
This information includes:
● Scientific literature from international sources
● Safety communications issued by foreign regulatory agencies
● Foreign reports available through databases of the respective regulators
● Information-sharing reports received through the National Competent
Authority Report (NCAR) program or other information-sharing agreements
Q10. Health Canada does not require manufacturers to provide their sales numbers.
Data analysts and researchers we’ve spoken to argue that, this lack of a common
denominator makes any statistics about medical device incidents (MDIs) and injuries
all but useless. For example, 50 deaths among 100 insulin pump users is completely
different from 50 deaths for every 100,000 insulin pump users. How does Health
Canada account for that missing data when analyzing its adverse events data?
In fact, Health Canada does make use of sales information in its regulation of medical
devices and obtains this information in a number of ways.
In addition to using sales data for post-market activities, Health Canada requires the
marketing history of a device for the review of licence applications for Class III and IV
medical devices. This includes sales figures in major international jurisdictions, and any
reported recalls or other major post-approval events. The Department also receives
information on the predicate devices when amendment applications are received. The
Department considers that information in the context of the application. If concerns are
brought to light related to the post-market experience of the device (whether in Canada or
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 elsewhere) or if the device is novel without a strong history, Health Canada may request
additional information, further studies, and revisions to labelling, or it may refuse to issue a
licence.
Health Canada considers information related to the sales of medical devices to be an
important element in monitoring the safety and effectiveness profile once a device has been
marketed. As part of Health Canada's post-market medical device safety reviews, the
Department requests information from manufacturers, including sales numbers. The
information is used to estimate Canadian and international incident rates, and to further
guide risk mitigation measures and other regulatory decision-making.
Q11. Health Canada has said in the past that the medical device incidents are widely
underreported in our country. We have spoken with physicians who say they don’t
report, don’t have a clear sense of what qualifies as an MDI or find the reporting
process too complex. We’ve also spoken to patients who say they were never
informed that they could report. What is Health Canada doing to address this
underreporting?
Medical device problem reporting is an essential element in Health Canada’s assessments
of medical devices. Manufacturers and importers are required to report medical device
problems, and the Department encourages anyone purchasing, using or maintaining these
products to voluntarily report problems, including physicians and other healthcare
professionals. Health Canada also encourages consumers to report complaints involving
medical devices to the Department, including the sale of unauthorized devices. Healthcare
professionals and consumers are encouraged to report whatever information they may have,
even if they are uncertain of all the specific details needed. Health Canada takes a
risk-based approach in following up on voluntary complaints and will contact individuals who
report incidents to gather more information, as needed. An online form is available to
facilitate reporting of medical device incidents, or Canadians can call toll-free at
1-800-267-9675.
Underreporting of adverse reactions and medical device incidents is a challenge for all
regulators. Health Canada is addressing this issue in a few ways.
First, Health Canada has proposed regulations under the Protecting Canadians from Unsafe
Drugs Act (Vanessa’s Law) that would amend the Food and Drug Regulations and the
Medical Devices Regulations to require hospitals to provide reports of serious adverse drug
reactions (ADRs) and medical device incidents (MDIs) directly to the Department. This is to
improve the quantity of reports received and the quality of those reports to ensure sufficient
information is submitted to inform decision‑making. Mandatory reporting of MDIs by
Canadian hospitals is expected to increase the volume of incident reports, which would
address, in part, issues with underreporting; an increase in reporting would further inform
Health Canada on where additional analysis or action is required.
Second, as part of the implementation of mandatory reporting for hospitals, Health Canada
recognizes that increasing and improving the reporting of serious ADRs or MDIs will require
outreach and education as well as meaningful feedback to address reporting barriers beyond
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 the reach of regulations. The Department is developing education and tools as well as
information flow processes to support hospitals in meeting mandatory reporting
requirements. Those tools will be used to raise awareness among healthcare providers not
working in hospitals as well as Canadians in general about the benefit of reporting and how
and when to submit reports.
Third, Health Canada continues to optimize its partnership with the Canadian Medical
Devices Sentinel Network (CMDSNet). CMDSNet relies on a group of dedicated and trained
representatives from more than 16 acute or community-based healthcare facilities within
Canada to report high-quality data to Health Canada about adverse events associated with
medical devices. This successful active surveillance program has been in existence since
2009. CMDSNet provides a complementary data source for post‑market evaluations. Having
access to more information enables Health Canada to identify emerging safety issues in the
area of medical devices and to improve the safe use of medical devices. More
comprehensive incident data and earlier regulatory interventions also help to provide
Canadians with timely new safety information to make informed decisions on the appropriate
use of medical devices.
Q12. The number of medical device incidents reported as a death or an injury
quadrupled in the past decade - rising from roughly 400 incidents in 2006 to roughly
1,660 incidents reported in 2017. Those figures include 1,358 reports of domestic
deaths. How does Health Canada explain that rise?
In fact, while overall reporting of medical device incidents has increased, the proportion of
those reports indicating death or injury has remained relatively constant.
Specifically, while the total number of reports to Health Canada has increased approximately
fourfold between 2006 and 2017, the percentage of medical device incidents reported as a
death has remained at approximately 1% between 2006 and 2017 (1.14% in 2017 and
1.11% in 2006). Similarly, the percentage of medical device incidents reported as an injury
has also remained relatively stable (12.43% in 2017 vs. 11.33% in 2006). Year-to-year
variations during this time period may be due to changes in methodology including data
collection.
Percentage out of total cases received, by year
Year

DEATH

INJURY

TOTAL

2006

1.11%

11.33%

12.44%

2007

1.00%

7.56%

8.56%

2008

1.31%

8.81%

10.12%

2009

1.86%

11.16%

13.02%

2010

1.31%

8.21%

9.52%

2011

1.16%

6.90%

8.06%

2012

1.46%

8.31%

9.77%

9

 2013

1.37%

13.17%

14.54%

2014

1.27%

17.07%

18.34%

2015

1.11%

14.44%

15.55%

2016

1.19%

15.13%

16.31%

2017

1.14%

12.43%

13.57%

Per the Medical Device Regulations, manufacturers and importers must submit a report
within 10 days of an incident leading to the death or serious deterioration in the state of
health of a patient, user or another person, and within 30 days of an incident that has not led
to the death or serious deterioration in the state of health of a patient, user or other person
but could do so were it to recur. All 10-day reports (death and injury reports) are data
entered, assessed and coded as a high priority, and are also flagged for review by Health
Canada evaluators to determine their potential contribution to signal detection activities.
Health Canada considers the reporting of medical device incidents to be an important part of
our surveillance program, with reports coming from manufacturers, healthcare professionals
and patients. The increase in the number of medical device incidents received by Health
Canada since 2006 may be due to a number of factors, including the enhancement of Health
Canada's post-market surveillance and assessment program for medical devices; the
continuing commitment to greater transparency and openness to further strengthening trust
in our regulatory decisions by the public; the continuing efforts in outreach and engagement
of some key stakeholders such as healthcare professional associations; and the
establishment of the Canadian Medical Device Sentinel Network. The upcoming regulations
on the mandatory reporting of medical device incidents by Canadian hospitals as part of
Vanessa's Law are likely to further increase the number of incident reports for medical
devices in Canada.
Q13. In Canada, reporting of adverse events is only required by industry. Our analysis
of HC's MDI database shows manufacturers repeatedly flout mandatory 10- and
30-day timelines for those reports. Has Health Canada penalized manufacturers for
those breaches? If so, please provide details on the numbers and natures of those
actions. If not, why? Further, why would Canada not establish mandatory reporting of
medical device adverse health incidents for physicians and other healthcare
professionals whose observations could help inform the regulator, manufacturers,
physicians and the public? In other words, why limit the available body of knowledge
about potential medical device-related health risks?
Health Canada has been working on a robust Quality Control Framework to identify late final
reports to industry's mandatory 10- and 30-day reports. There is also an initiative underway
to replace the current database for medical device incidents. The updated database will
include increased quality checkpoints. This will assist in the enforcement of sections 59 and
61 of the Medical Devices Regulations.
The proposed regulations under Vanessa's Law would amend the Food and Drug
Regulations and the Medical Devices Regulations to require hospitals to provide reports of
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 serious adverse drug reactions and medical device incidents directly to Health Canada.
The mandatory reporting requirement would apply to the facility rather than individual
healthcare professionals working in the hospital. It is the hospital that is responsible for
determining clear internal roles and responsibilities for staff and the best operational
approaches to meet the mandatory reporting obligations.
Mandatory reporting by manufacturers and importers is one aspect that Health Canada
considers during an inspection of an MDEL holder. During the inspection, the inspector will
review the reports of the company to determine whether the process for identifying and
reporting problems is effective and whether the reports meet mandatory reporting criteria as
required in the Medical Devices Regulations (MDR).
During an inspection, should the inspector determine that a company is not following the
mandatory reporting requirements of the MDR, a deficiency observation would be assigned,
and the company would be required to submit a corrective action plan to address this
deficiency. This deficiency observation would be included in the company’s Inspection
Report Card posted on Health Canada’s website. Should Health Canada be made aware of
or suspect underreporting, it would follow up with the company and take compliance actions,
as appropriate.
Q14. In 2010, Health Canada closed its Medical Devices Laboratory facility. At the
time, former scientists who work in the labs warned the Health minister that the
closure undermined the agency’s capacity to monitor medical devices for defects or
other problems. Today, those in charge of testing devices suspected to have caused
health problems are the device makers themselves. Why does Health Canada rely on
industry to exclusively test products suspect of having problems? Is there a concern
that these companies have a conflict of interest?
The Food and Drugs Act and the Medical Devices Regulations place the onus on industry to
provide safe and effective products, with Health Canada stepping in, if necessary, to have
manufacturers correct problems as they arise.
Health Canada has never conducted independent testing of devices before their sale in
Canada. If Health Canada becomes aware of problems with a device through concerns
raised by practitioners, patients, researchers, etc., it investigates the problems, taking
appropriate actions, including laboratory testing, as necessary.
A review of Health Canada’s laboratory facilities determined that any necessary work could
be more efficiently secured by contracting independent laboratory capacity. Today, Health
Canada can and does seek independent laboratory insight to ensure public safety. This is
more cost-effective and allows the Department to access state-of-the-art facilities across all
areas, rather than maintain lab capacity related only to specific scientific domains.
Q15. Expert physicians in implants that we spoke to say a patient device registry for
all types of implantable devices could better protect patients than the status quo,
which leaves the onus on companies to contact patients via hospitals if there’s a
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 problem. Why does Health Canada continue to oppose a registry (as it did at Senate
hearing 27Mar/13 and in April 2018 in response to a petition about surgical mesh
oversight)? Many experts told us the current alert system and post-market monitoring
is ineffective, and a registry would be better. Do you have a comment?
Health Canada supports the development of patient registries for medical devices by key
stakeholders, such as professional associations and manufacturers, or through provincial or
territorial initiatives. In general, registries may help further epidemiological research and
provide advances in areas of scientific knowledge related to medical device complications.
However, the costs associated with the establishment and maintenance of registries are
considerable. Registries may also have quality or methodological limitations with regard to
the provision of valid and reliable safety and effectiveness information.
Health Canada consults with associations to obtain detailed information on adverse events.
The Department uses additional strategies, including leveraging international registries, such
as the International Collaboration of Breast Implant Registries (ICOBRA), to identify clinical
outcomes and complications. Health Canada is committed to exploring additional
post-market surveillance strategies and identifying additional approaches to filling gaps in
evidence.
Q16. We spoke to Toronto Dr. Jagmish Butany, who said he tried to raise concerns
about problems he was seeing with St. Jude’s Silzone heart valves in the late 1990s.
He said Health Canada was unresponsive to his concerns. The valves continued to be
implanted in Canadians until a worldwide recall in January 2000. Do you have any
comment on Dr. Butany’s characterization that Health Canada was unresponsive and
dismissive of his safety concerns?
Health Canada appreciates receiving information on any concerns or problems related to the
use of medical devices in Canada. We receive, and respond to, hundreds of pieces of
correspondence yearly and investigate information received as required. The Department
cannot comment on discussions held between Dr. Butany and Health Canada back in the
late 1990s.
Q17. Our reporting has found several cases where safety warnings or recalls have
been issued in other countries but it takes days, weeks, months and even years for
similar warnings to be made in Canada. For example, the FDA first issued a safety
advisory on a transvaginal mesh in October 2008, warning of rare but serious
complications. Health Canada’s first warning, spurred in part by international reports,
came in February 2010. On IVC filters, the FDA issued a warning in January 2010
about serious complications associated with these products. It followed that up in
2013 advising the filters be removed as soon as protection from a pulmonary
embolism is no longer needed. Health Canada’s first apparent safety notice about
these same products came in July 2016. Why does Health Canada lag behind other
regulators in notifying patients about potential problems?
Q18. More serious regulatory actions — such as suspending or removing products
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 from the market — have also been more swiftly and vigorously taken in other
countries. For example, Zimmer’s Durom Cup hip implants were suspended and
ultimately discontinued in the US, but continued to be implanted here. Transvaginal
meshes are the subject of suspensions or pauses in Australia and the UK but Health
Canada has said the mesh’s benefits continue to outweigh the risks. Why is it
acceptable for Canadians to be getting devices that are not available in other
countries because they've been deemed too risky?
Q19. We have found voluntary recalls or safety warnings initiated by a manufacturer
are sometimes disseminated in the United States days or weeks before they’re
distributed here. There are several examples of this with Medtronic insulin pump
warnings from 2009 to 2014. There is one case of a Canadian woman who received a
pump a day after the US recall but the Canadian recall had not yet been announced.
She alleges she was never told about the recall, which concerned a serious defect she
alleges later led to her having a hypoglycemic event. Why are companies’ recalls
announced in Canada days or weeks after they’re announced in the United States? Is
it acceptable that Canadians are potentially being left in the dark?
Q20. We have spoken to patients who have different types of products that have been
subject to recalls and market withdrawals -- including meshes, metal-on-metal hips
and Essure -- who say they were not notified the products were off the market until
months or even years later. Why aren’t patients immediately notified if an implantable
device they have has been subject to a recall or safety notice? Is Health Canada doing
anything to fix this?
Medical devices available in Canada have to comply with the regulatory requirements of the
Medical Devices Regulations. Health Canada takes very seriously the need to understand
what impact product suspension or removal could have on impacted patients. The
Department plays an active role in ensuring that Canadians have access to safe and
effective drugs and medical devices. It is important to understand the medical needs and
therapeutic options of current and future patients before taking regulatory action. The
Department does not make decisions on a product lightly, as some products that may not be
beneficial to some individuals are beneficial to others. The Department makes every effort to
ensure that it makes a decision appropriate to the Canadian context based on all available
sources of information, including Canadian incident reports received, the scientific literature,
and input from healthcare practitioners.
During the lifecycle of a medical device, as it moves from its testing phase through to
approval for market use, the manufacturer is required to maintain oversight of the device’s
performance in order to ensure it performs as expected and to maintain the safe use of the
device. In addition, Health Canada has established regulations and operational processes
for monitoring a device’s ongoing performance during its lifecycle in order to further gather
real-world evidence, strengthen the post-market safety of a medical device and ensure
healthcare professionals and consumers are informed of safety concerns or changes to
instructions for use related to the device.

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 Once Health Canada identifies a potential health or safety risk, it performs an assessment to
understand the risk associated with the use of affected devices within the Canadian context.
The availability, the use of the medical device and the potential impact may differ in Canada
compared to those in other countries. The Department makes every effort to ensure that the
appropriate decision is made relative to the Canadian context based on all available sources
of information, including Canadian incident reports received, the scientific literature, and
input from healthcare practitioners and patients. Health Canada strives to provide
information on health product risks to Canadians and to healthcare providers as soon as
possible, once a health or safety risk has been identified and examined.
The risks of a health product should never be considered in isolation. Instead, the balance
between possible risks and potential benefits needs to be taken into account. When Health
Canada determines that the risks associated with a medical device under its current
conditions of use are no longer acceptable, the Department takes regulatory actions, which
can include, but are not limited to, disseminating a risk communication, updating device
labelling, adding conditions to device licences, ensuring effective product recall strategies,
conducting product safety reviews, or suspending a product licence. Through increased
collaborations and better use of information related to medical devices in Canada, Health
Canada strives to develop strategies to increase the efficiency with which health and safety
risks are identified, assessed and communicated in Canada.
Recalls exist in regulation as one of the means to manage a product’s risk once on the
market. A recall is any action taken by a manufacturer, importer or distributor of a medical
device to recall or correct the device, or to notify its owners and users of its defectiveness or
potential defectiveness, after becoming aware that the device:
a)
may be hazardous to health;
b)
may fail to conform to any claim made by the manufacturer or importer relating to its
effectiveness, benefits, performance characteristics or safety; or
c)
may not meet the requirements of the Act or these Regulations.
A recall may include:
1. The removal of the medical device from the market and its consignees;
2. An on-site correction of the medical device;
3.
An advisory concerning a problem or potential problem with instructions to work around
the problem until an on-site correction can be implemented;
4. The supply of revised labelling related to corrective action;
5. A change or clarification in the Instructions for Use;
6.
The supply of instructions to stop using the medical device and to destroy remaining
units in stock.
The recalling company has primary responsibility for notifying the public in the interest of
protecting the health and safety of Canadians and are required to report recall actions to
Health Canada. Health Canada monitors a company’s recall compliance and will follow up
with companies to monitor the effectiveness of higher-risk recalls. Health Canada takes
appropriate regulatory actions when there is a suspected non-compliance in recall reporting.

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 In addition, some situations could result in Health Canada’s issuing a public notification in a
further attempt to reach patients and consumers.
More
information
on
medical
device
recalls
can
be
found
here:
https://www.canada.ca/en/health-canada/services/drugs-health-products/compliance-enforce
ment/problem-reporting/medical-devices-recall-guide-0054.html#a9
Foreign regulatory jurisdictions, such as the US FDA, approach medical device recalls in a
similar way. However, there are differences between the US FDA and Health Canada recall
requirements. It is the responsibility of every company, in the markets they serve, to
understand and tailor their recall strategy according to the requirements of each jurisdiction,
which vary and may contribute to the difference in the timeline for the notification of a recall
or the proposed mitigation strategy. Factors that could lead to variances in the need for and
timing of a recall could include:
●

●
●
●

Whether recalls in another jurisdiction, such as in the US, apply in the Canadian
market as there may be different conditions of use of the device within the healthcare
system
Variability of distribution channels for the devices
Impact of a recall on the healthcare system, including potential shortages
Whether recalls in another jurisdiction, such as in the US, apply in the Canadian
market as there may be different medical device lots, batches or models affected.

Under the Protecting Canadians from Unsafe Drugs Act (Vanessa's Law), a number of
post-market initiatives are being undertaken to strengthen the safe use of medical devices
once they are on the market. For example, the Food and Drugs Act has been revised to
provide Health Canada with the powers to order a mandatory recall in order to more rapidly
address unsafe health products when needed. Furthermore, Health Canada will be
strengthening recall reporting by further defining reporting requirements in regulations,
including timelines, and requiring manufacturers and importers to submit risk assessments
earlier in the notification process. This initiative is targeted for consultations in spring 2019.
More
information
is
available
here:
https://www.canada.ca/en/health-canada/corporate/about-health-canada/legislation-guidelin
es/acts-regulations/forward-regulatory-plan/2016-2018/regulatory-initiative-regulations-amen
ding-food-drug-regulations-medical-devices-regulations-recall-therapeutic-products.html
Q21. Your director general in 2013 acknowledged that Health Canada still hadn’t
assessed the efficacy of your ‘risk communications’ as called for by auditor in 2011.
What improvements if any have been made since then?
Working with outside consultant expertise, Health Canada has developed a standardized
methodology to evaluate the effectiveness of health product risk communications and made
changes to improve the reach, clarity, impact and timeliness of its communications products.
Health Canada has also streamlined its processes, modernized its tools and renewed its
focus on using plain language to enhance consumer uptake and increase engagement of
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 stakeholders (e.g., healthcare professional groups and associations). This helps Health
Canada to craft messaging and enhance the dissemination of risk communications.
Health Canada is modernizing information dissemination by expanding its use of social
media tools such as Twitter as well as mobile applications (e.g., Government of Canada
Recalls and Safety Alerts Mobile Application) to complement traditional communication
activities. These technologies allow the Department to reach more Canadians quickly and
efficiently and to leverage partner and stakeholder networks to promote important health and
safety information. Health Canada continues to explore new and innovative ways to help
evaluate and improve the effectiveness of risk communications, such as artificial intelligence,
to better understand the level of engagement with healthcare professionals and their
information needs and preferences.
Health Canada is also undertaking an external evaluation of its current methods for reaching
different target audiences with an eye towards continued improvement in our
communications and knowledge translation to stakeholders. The results of that evaluation
will inform a work plan for improvement in the coming year.
Health Canada continues to send email notifications directly to 28,500 subscribers through
its MedEffect e-Notice system. As a reminder to healthcare professionals, Health Canada
also publishes a monthly recap in the Health Product InfoWatch of all recent risk
communications.
Q22. Under Health Canada’s current inspection system, the regulator only physically
inspects facilities that have a device establishment licence -- often the Canadian
headquarters for larger device manufacturers. These inspections have been described
as administrative in nature. Inspections of the Canadian facilities that manufacture
high-risk devices are done by accredited, private companies hired by the
manufacturers themselves. The results of these audits are then given to the regulator.
Why does Health Canada do the administrative MDEL inspections while leaving the
physical inspections of facilities where high-risk devices are made to private
companies?
When the Medical Device Regulations were brought into force in 1998, the quality standard,
ISO 13485, was a requirement to obtain a medical device licence. At the time, Health
Canada did not have a medical device inspection program, and so the Department decided
to use a third-party auditor system to meet this requirement. Subsequent to that decision,
Health Canada created a medical device inspection program to oversee the post-market
aspects of the MDR, in order to oversee importers, distributors and Class I manufacturers, all
of whom were not captured under the third-party auditing system.
MDEL inspections are not an administrative process. Health Canada may inspect anyone
who has a medical device establishment licence to ensure that they comply with the Food
and Drugs Act (Act) and the Medical Devices Regulations (Regulations). These inspections
support Health Canada's national compliance and enforcement program. Health Canada
inspections of companies in Canada are conducted on location and include manufacturers of
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 Class I devices and importers and distributors of Class I-IV medical devices. Inspectors
check for compliance with regulatory requirements for complaint handling, labelling, recall
effectiveness, and device licensing to ensure that products are safe and that appropriate
oversight is taken to ensure the integrity of the supply chain in Canada. The Medical Device
Program has a comprehensive licensing and inspection program to ensure that each aspect
of the product lifecycle and distribution chain is accounted for and strengthens the overall
safe use of medical devices by Canadians.
It is important to note that Section 23 of the Act gives inspectors the power to examine and
take action against anything that is not compliant with the Act and Regulations. Inspectors
decide on the course of action to take based on risks, deviations from the Act and
Regulations, deficiencies or failures that could impact health and safety.
This two-system design of medical device establishment inspections, including MDEL
inspections by Health Canada inspectors and third-party auditors, provides effective
oversight of both manufacturing practices and quality of high-risk products, as well as
important controls for establishments conducting complaint handling or recalls.
Note that the third-party auditing system for higher-risk products facilitates market access to
medical devices for patients in Canada. The new Medical Device Single Audit Program
(coming into force January 1, 2019) is a single audit system that allows medical device
manufacturers to rely on a single recognized audit to satisfy the pre-market licensing
requirements for multiple countries and facilitates timely access to new and innovative
technologies. It is cost-effective for both the regulators and the manufacturers to leverage
the existing system and practices of third-party conformity assessment rather than to have
regulators independently inspect facilities multiple times, as manufacturing facilities already
undergo third-party audits (inspections) on an annual basis for other regulatory jurisdictions
(e.g., Europe). Having multiple regulators accepting the same third-party audits under the
Medical Device Single Audit Program (MDSAP) will create efficiencies.
The third-party auditors are companies subjected to an accreditation process and
recognized by Health Canada under section 32.1 of the MDRs as having sufficient training,
experience and technical knowledge in the design and manufacture of medical devices and
implementation of quality management systems. For more information, please consult this
web link. These registrars are recognized by Health Canada.
Globally, regulators such as Health Canada, the US FDA, Brazil’s ANVISA, the Australian
TGA and Japan’s Ministry of Labour Health and Welfare and Pharmaceutical and Medical
Devices Agency are increasingly harmonizing and cooperating on manufacturing inspections
through the joint recognition of third-party conformity assessment bodies such as MDSAP for
the routine inspection of manufacturing facilities. This approach is beneficial as it produces
more frequent and consistent inspections of manufacturing facilities.
Q23. Relying on the inspection results of private companies paid by the
manufacturers’ they’re inspecting raises the concern that the findings included in
these reports are favourable to the company footing the bill. What’s your response to
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 these concerns?
The system of third-party conformity assessment used by Health Canada (MDSAP) operates
under strict and specific requirements related to impartiality and objectivity, and all
conclusions and decisions must be supported by documented objective evidence that is
available to regulators.
More specifically, auditing organizations, their personnel and their auditors must meet
explicit criteria regarding objectivity and impartiality and are required to adhere to a code of
conduct, as well as to disclose any potential or apparent conflicts of interest. The regulators
participating in MDSAP verify adherence to these requirements on an annual basis as part of
the recognition of these third-party auditing organizations, in accordance with international
standards and program requirements.
In addition, auditors are not permitted to offer consulting services or advice to manufacturers
they audit (a cooling-off period exists) thus eliminating an additional risk of conflict of
interest.
Certification agreements between auditing organizations and manufacturers make no
guarantees (implied or explicit) about positive outcomes, and auditing organizations
generally include language in their certification agreements that clearly places the
responsibility for conformity on the manufacturer, and absolves the audit team and the
auditing organization from negative outcomes of the auditing/inspection process.
The system also has built-in safeguards to the effect that all audit results have to be
independently reviewed by a second person not involved in the audit to ensure that technical
requirements are met and that objective evidence is sufficient to support the conclusions
before the results are finalized.
Audit reports and results are also subject to review by regulators.
Although Health Canada routinely relies on private third-party inspections, Health Canada
inspectors have the authority to inspect manufacturers under Section 23 of the Food and
Drugs Act, including those audited by third parties under the MDSAP program. Should a risk
be identified, Health Canada would inspect these manufacturers to ensure compliance and
minimize any potential risk to the health and safety of Canadians.
Based on the structural safeguards built into the system, Health Canada is of the view that
the advantages of a third-party certification system such as MDSAP outweigh the potential
risk introduced by having manufacturers pay for audits/inspections to meet regulatory
requirements in any jurisdiction.
Q24. Unlike MDEL inspections, Health Canada does not disclose the results of these
inspections done by accredited auditors. Why aren’t these online? Do you plan on
making them available?

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 The results of audits performed by registrars recognized by the Health Minister (e.g.,
MDSAP Auditing Organizations) are not made public because they contain extensive
confidential business information. Making such information public would breach Health
Canada’s obligations to protect such third-party information in its possession.
While manufacturers are required to sign an agreement with their auditing organization
allowing the release of the results of audits to regulators, these agreements do not cover any
eventual public release of information. We are routinely seeking ways to enhance
transparency and to continue to review our practices in the interest of providing more
information to Canadians.

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