R&Q's Blog

Medical device industry news and trends - and the resources to understand and act on them.


License Amendment Triggers in Canada

Sometimes changes in process can have a dramatic effect on product registration. There are several events that can cause a re-registration of a registered medical device. A new product name, part number, material, manufacturing site, country of origin, business name or manufacturing process are common re-registration triggers. It all depends on the specific regulations of the country involved.

I recently had to deal with a company that had changed contract manufacturers; the legal manufacturer and owner of design control remained the same. This move also involved a change in the country of origin. We were concerned specifically how this affected the current license in Canada. I read the Health Canada Guidance for Interpretation of Significant Change of Medical Device and the License Amendment Fax-Back Form from the Health Canada website. After reading these documents, I felt that an amendment to the license was necessary. I wasn't entirely sure. I asked a few colleagues for their opinion. After reading carefully, none of us were fully clear what path we needed to take in order to meet the requirements.

However, the one great thing about Health Canada is that the Medical Device Bureau is as polite and helpful as the rest of the country. We were quickly able to get clarification via email from the Device Licensing Services Division. Basically here is what we found out: If the products in question are Class II devices, then a License Amendment Fax-Back Application is not required (you can inform Health Canada when the product is renewed). However, if the devices in question are Class III or IV, then a License Amendment Fax-Back Application is needed.

Luckily, our devices were Class II, so we did not need to fill out the License Amendment Fax-Back Form. Thanks for your help, Canada!



Health Canada Guidance for Interpretation of Significant Change of Medical Device please see the following website:


License Amendment Fax-Back Form please see the following website:


FDA’s Guidance Document on Voluntary Submission of ISO 13485 3rd Party Audit Reports

I came across an FDA guidance document – not entirely recent; however, I found it very interesting and worth sharing. It is on voluntary submissions of audit reports done by auditing bodies outside of the FDA.

A QMS Outcast: Preventive Action

We in the medical device industry throw the term CAPA around like it's a word that is common-place in our society (though, here in Pittsburgh, you'll get a lot of confused looks if you tell someone you've opened a CAPA as it is a local performing arts school. That's a strange nightmare with future Broadway stars re-enacting a root cause analysis!).

Mistake, I Think Not!

As a native Clevelander and lifelong (i.e. 47 years) Northeast Ohio resident, I have heard my fair share of “Mistake on the Lake (Erie)” jokes. Yes, it’s true the Cuyahoga River caught fire in 1969, the city has suffered from loss of jobs due to de-industrialization, there have been numerous failed redevelopment efforts, and as far as sports teams go; well, I have yet to see a championship winning team. Jokes aside, I don’t think anyone can argue that the Northeast Ohio region has evolved into a world class leader in medical treatment, education and innovation in the health care industry.

Labels impact the device

During this holiday season, when presents are being packaged and shipped at high volumes, I thought it would be appropriate to talk about the importance of labeling.

Biocompatibility - Simple, Right?

I’ve been working in regulatory for a company in which biocompatibility of device materials has been pretty straightforward and understood by all for many years. Annex A in ISO 10993-1 and FDA General Program Memorandum - #G95-1 is all you need. Check the chart for our device intended use and see that irritation testing, sensitization testing and cytotoxicity testing are required for any new device materials prior to introducing them into the market. Not only did our regulatory folks clearly understand these requirements, but our project teams were also onboard. If engineering wanted to change materials or change the material color or tint, they would contact a toxicologist to perform these three necessary tests. End of story.

In Your Face

My teenager works at a local eatery – I thoroughly believe the saying, “A good teenager is a tired teenager”. Besides, there is a lot to be learned from being in the work force.

Mobile Medical Applications: Mobile Medical Device Design

Many medical devices are meant to be used while in mobile situations. These devices could be wearable, carried in a user’s pocket or by hand, pushed like a cart, etc. Users of mobile medical devices expect them to be safe, reliable, durable, and easy to use while in motion or when transported, so let’s look at some design considerations specific to this subset of devices.

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