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Canadian Medical Device Classification (MDALL, MDL & MDEL Listing)

medical device classification in canada

How Medical Devices are Classified in Canada

Regulatory Classification Basics for your Medical Device: 

There are certain rules that apply to a medical device classification, and it varies between different regulatory agencies. The classifications are related to the perceived risk of the product type. Medical device manufacturers selling internationally need to familiarize themselves with the applicable regulations within the Canadian market.

Why does Regulatory Classification even matter for my Medical Device?

Knowing how your medical device is classified matters so that we can determine what is required to be done before the medical device is sold in Canada. Furthermore, the classification determines how the product is to be designed and what controls are required. Lastly, timelines around what it would take to bring your device to market and costs can be estimated once the device class is determined.

Medical Device Classification in Canada

The medical devices regulations in Canada are established by the Government of Canada and regulated by Health Canada. There is a risk-based classification system defined by Health Canada for non-in vitro diagnostic (non-IVDDs) medical devices:

  1. Invasive Devices (Rules 1-3)
  2. Non-Invasive Devices (Rules 4-7)
  3. Active Devices (Rules 8-12)
  4. Special Rules (Rules 13-16)

For each of the broad categories, there are a set of rules that apply.  Manufacturers should follow these rules to determine the risk classification of their medical devices. For example, you are interested in marketing a percutaneous catheter in Canada. After reviewing the Risk-Based Classification System for non-IVDDs, we would determine for you that the percutaneous catheter is an invasive device. To classify the device, we’d review all the options and conclude that Rule 1 applies for you. Further, based on the intent of use, the medical device is classified as a Class II medical device in Canada. There are similar risk-based classification systems for in vitro diagnostic medical devices and Software as a Medical Device (SaMD).

Medical Device Licence (MDL) in Canada

Overall, there are four levels of medical device classifications based on the level of risk (low to high) in Canada: Class I, Class II, Class III, and Class IV.  Before going to market in Canada, a manufacturer must first apply for a medical device license (MDL).

Class, I medical devices do not require a license. There are different applications for Class II, Class III, and Class IV medical devices, and the application complexity increases as the risk classification increases.

There is a keyword index document available to assist manufacturers in verifying the class of medical devices is an alphabetical listing of all the short descriptors for devices that are entered into the medical devices system. This document contains synonyms and industry words that are used to describe these devices, along with their respective classifications.

Looking to license your medical device?

 

Manufacturers of Class II, III, and Class IV medical devices can receive their MDL license by submitting a premarket application.  This can be in either the ToC or Health Canada formats, for entering the Canadian market. Additionally, the manufacturers should obtain an ISO 13485 certification with Medical Device Single Audit Program (MDSAP).

Medical Device Active Licence Listing (MDALL)

Once Health Canada approves the Medical Device Licence, the device information is maintained in the Medical Devices Bureau database for Class II, Class III, and Class IV devices. Class I medical devices do not require an MDL as they are monitored by the Health Products and Food Branch Inspectorate through establishment licensing.

The MDALL online query allows you to search for medical devices with an active MDL. A search can be done by company name, company ID, license name, license number, device name, and device identifier.  A device identifier is a unique series of letters or numbers or a combination of both, assigned by the manufacturer to identify the device. The catalog number of the device is often selected for this purpose.

Medical Device Licence Renewal in Canada

The medical device license renewal process in Canada has two purposes.  The first is to confirm whether the medical device will continue to be sold in Canada and whether the medical device license will remain active.  The second is to collect information that must be assessed prior to invoicing for market authorization.

Manufacturers of medical devices that are licensed for sale in Canada are required to inform Health Canada each year before November 1 that the information submitted with their license application and any subsequent amendments have not changed. This is referred to as the medical device license renewal process. Manufacturers of licensed Class II, III, and IV medical devices are charged an annual fee, payable at the time of license renewal, for the right to sell their devices in Canada. The fee is charged annually for the twelve-month period beginning on November 1 of each year. Manufacturers must notify Health Canada if there is a change regarding the regulatory correspondent or contact information previously submitted. Failure to do so may result in the cancellation of your medical license.

How Quality Smart Solutions can help

Our experts at Quality Smart Solutions are here to help and offer medical device-related regulatory advice and support on successfully securing your medical device license.  We can help you by responding to potential information requests, keeping your license updated, and reviewing your device labels. Contact us today to learn more about how we can support your compliance needs during and after licensing! Please find our contact information here: https://qualitysmartsolutions.com/contact/

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Health Canada Marketing Authorization Update – Increased Vitamin D

On January 19, 2022, Health Canada announced a marketing authorization (MA) to permit manufacturers to voluntarily increase the amount of Vitamin D in cow’s milk, goat’s milk and margarine.  This was decided in order to facilitate alignment and compliance with the Regulations Amending the Food and Drug Regulations (Nutrition Labelling, other Labelling Provisions and Food Colours).

Background

Vitamin D is a key nutrient that helps the body use calcium and phosphorus to maintain strong bones and teeth. Vitamin D can be obtained from food and supplements and can be made by the body after exposure to sunlight. Vitamin D deficiency can lead to rickets in children and Osteomalacia (softening of the bones) in adults.

The Food and Drug Regulations (FDR) set out the daily value (DV) for vitamin D (i.e. a value that would meet the vitamin D requirements of almost all Canadians) as well as the amount of vitamin D required in cow’s milk and margarine, and permitted in goat’s milk. Manufacturers cannot increase the amount of vitamin D in foods beyond what is currently set out in the FDR.

However, Health Canada has made plans to increase Vitamin D intake with the public health objective of promoting adequate bone health among Canadians without excessive Vitamin D intake. As a first step, Health Canada proposed increases to the amount of Vitamin D required in cow’s milk and margarine and permitted in goat’s milk, as these are the biggest contributors of Vitamin D in the Canadian diet.

Benefits of this change

This marketing authorization will have the following benefits:

  • Helping to promote adequate bone health among Canadians by permitting an increased amount of vitamin D in cow’s milk, goat’s milk and margarine;
  • Allowing for the possibility of financial savings for manufacturers who have not already updated their product labels to comply with the 2016 nutrition labelling regulations. For these manufacturers, the MA enables a single label change (rather than multiple changes) to account for an increase to vitamin D amounts and meeting the requirements set out in the 2016 nutrition labelling regulations
  • Allowing manufacturers to continue to market cow’s milks and goat’s milks as an “excellent source” of vitamin D, thus providing a marketing benefit to manufacturers and
  • Helping to reduce the risk of illness related to certain bone diseases and therefore potentially reduce health care spending on the treatment of these diet-related diseases

Need help with food compliance in Canada or the USA?

 

Implementation

Public education efforts to help Canadians understand how best to use nutrition labelling to make informed food choices is ongoing. In addition, Health Canada will post information about the marketing authorization on its website and will notify stakeholders. Industry is not required to submit a premarket notification or a Temporary Marketing Authorization application in order to apply the increased vitamin D levels for cow’s milk, goat’s milk or margarine. Therefore, action can be taken immediately, but must follow the applicable rules and regulations.

Compliance and Enforcement

Compliance and enforcement of the marketing authorization will be incorporated into existing activities carried out by the Canadian Food Inspection Agency (CFIA). The CFIA is responsible for the enforcement of the Food and Drugs Act as it relates to food. While it is the responsibility of the industry to comply with regulatory requirements, compliance will be monitored as part of ongoing domestic and import inspection programs. Appropriate enforcement action will be taken based on risk.

How Quality Smart Solutions can help

Quality Smart Solutions can help your business with food label compliance (Canada & USA), food importing, GRAS, food quality and much more. Our specialists are here to help!  

30 Minutes Free Consultation
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Health Canada’s Annual Adjustment of Fees for Drugs & Medical Devices

On December 11, 2021, Health Canada issued a notice regarding the annual adjustment of fees for drugs and medical devices in the Canada Gazette, Part I.

Each year Health Canada’s fees for drugs and medical devices are subject to an annual fee adjustment. The fee adjustment is a cost-recovery practice by the federal government.  Cost recovery as defined by Health Canada is “fees charged to recoup a portion, or the entirety, of costs incurred to deliver regulatory programs and ensure businesses pay their fair share.”

The annual fee adjustment is viewed as a common practice amongst international regulators of health products and Health Canada aims to provide license holders with sufficient notice, to allow companies to plan accordingly.

Starting April 1, 2022, Health Canada will be adjusting its human and veterinary drugs and medical devices fees for the fiscal year of 2022–2023 by the Consumer Price Index (CPI), 3.4%. Most of the CPI-adjusted fees are currently being phased in over 4 to 7 years and will therefore be different than those stipulated in the fees order.

Veterinary Drug Dealer’s Licence fees will also be adjusted by the Consumer Price Index.  Fees for other regulatory and non-regulatory activities and services, including but not limited to Human Drug Dealer’s Licences, Certificate of Supplementary Protection and Drug Master File, will be subject to the established annual fee for drugs and medical devices increase of 2%.

The associated fee web pages and application forms will be updated to reflect the adjusted fees on the Health Canada website by April 1, 2022.

Furthermore, Health Canada made a prior commitment to engage with stakeholders annually to discuss key elements of cost recovery including performance, costs and program efficiencies. Originally, the Annual Cost Recovery Stakeholder meeting was scheduled to take place in spring 2020.

Looking to obtain a Medical Device Establishment Licence?

However, due to the COVID-19 pandemic, the meeting was postponed. The meeting will now take place in February and will consist of four virtual sessions, articulated around specific health products and services. The sessions will take place over Zoom with simultaneous translations available.

How Quality Smart Solutions can help

Our team at Quality Smart Solutions will be attending all the virtual sessions to keep updated with the changing regulations and attend on behalf of our clients, to be able to provide guidance and feedback regarding the adjusted fees for drugs and Medical Devices.

Please reach out to our team if you have any questions about the annual fee adjustment. Please Contact us today or call us at 1-800-396-5144. We look forward to serving you!

30 Minutes Free Consultation

Resources:

Government of Canada, P. W. and G. S. C. (2021, December 10). Government of Canada. Canada Gazette, Part 1, Volume 155, Number 50: Index. Retrieved February 11, 2022, from https://canadagazette.gc.ca/rp-pr/p1/2021/2021-12-11/html/index-eng.html

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5 Tips to Successfully Secure your NPN Number in 2022

Top 5 Tips to Successfully Secure an NPN Number

In order to sell a Natural Health Product  (NHP) in Canada you’ll require an NPN.  NPN stands for Natural Product Number, which is a product license that is issued by the Natural and Non-prescription Health Products Directorate (NNHPD) of Health Canada. The NNHPD oversees all NHP applications submitted in accordance with the Natural Health Products Regulation (NHPR). Here are our top 5 tips to successfully secure an NPN number:

  • Determine the Correct NPN Classification

For starters, obtaining an NPN can take anywhere between 60 days to 210 days depending on the class of the application. There are 3 different classes of an NPN applications, Class I, II or III. Determining the correct class of NPN application is extremely important, if the class is not identified correctly the application may be refused. Learn more about the different NHP application classes here: The Difference between a Class I, II and III NHP Application

  • Knowing the Risk of each NPN

The NNHPD has developed what is known as a Compendium of Monographs.  These monographs are used to support NPN applications and can speed up the evaluation of safety and efficacy for certain medicinal ingredients.  Class I and II NPN applications are supported entirely with NNHPD monographs, which makes them very low risk when complying strictly to these monographs. Class III NPN applications often have the most risk.  This is because these NPN’s usually fall outside of these monographs and therefore require additional safety and efficacy studies.

  • Having Enough NPN Evidence – Class III Only

For Class III applications additional safety and efficacy studies are required for any new novel ingredients or claims. Class III NPN’s also includes partially referencing monograph information but they go beyond the parameters established in the monographs.  This ensures that there is enough high-quality evidence to really assist Health Canada in evaluating and approving the NPN.

  • Prompt Responses to Information Request Notices (IRNs) – Class II and III

For Class II and III NPN applications Health Canada will sometimes require additional information during their review. These requests are called IRNs which are time sensitive and comes with a specific deadline, if the information is not provided to Health Canada by the specific deadline the NPN application will be refused. Ensuring all necessary information is provided to Health Canada in a timely manner will prevent avoidable refusals.

  • Proper NPN Administrative Documents

Finally, making sure to have all the proper administrative documents prior to submitting an NPN application.  This is immensely important as having insufficient documents can lead to an NPN administrative refusal.  This will require you to re-submit an entirely new NPN application which can cause further delays in getting an NPN insurance.

How Quality Smart Solutions can help

Our Experts at Quality Smart Solutions are here to help and offer any NHP-related regulatory advice and support on successfully securing your NPN.  We provide help by responding to potential IRNs, keeping your product license updated, and reviewing your NHP labels. Contact us today to learn more about how we can support your compliance needs during and after licensing! Please find our contact information here: https://qualitysmartsolutions.com/contact/

30 Minutes Free Consultation
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Interim Order No. 3 The Sale of Medical Devices for COVID-19 use

Interim Order No. 3 Respecting the Importation and Sale of Medical Devices for Use in Relation to COVID-19 (the third interim order) was made by the Minister of Health on February 21, 2022, in accordance with subsection 30.1(1) of the Food and Drugs Act. This third interim order maintains all the flexibilities of the second interim order, including the consideration of urgent public health needs. These flexibilities are needed to assess evidence that demonstrates the safety and effectiveness of medical devices. The third interim order also continues to allow the importation and sale of COVID-19 medical devices that were authorized under the previous interim orders.

Overview

The third interim order supports Canada’s ongoing focus on dealing with the significant risk that COVID-19 continues to pose to the health and safety of Canadians. It contributes to securing Canada’s COVID-19 medical devices supply chain by:

  • providing an expedited pathway for authorizing COVID-19 medical devices
  • helping to facilitate access to safe and effective COVID-19 medial devices for health care workers and other Canadians

From the outset, the COVID-19 pandemic has created challenges in global supply chains, including an unprecedented demand for certain medical devices. Medical device manufacturers and importers adapted quickly to meet demands for COVID-19 medical devices. New manufacturers also stepped in to create additional capacity.

Combined global efforts continue to identify ways to contain the pandemic and prevent further spread as well as find effective treatments and cures against this disease.

Requirements carried over from the previous interim order

As was the case under the second interim order, the third interim order provides for an expedited authorization pathway for COVID-19 medical devices. This contributes to ensuring Canadians have continued access to COVID-19 medical devices.

The third interim order continues to apply to all classes of medical devices and provides 3 authorization mechanisms:

  1. an expedited authorization pathway for importing and selling new COVID-19 medical devices
  2. expanded use indications for devices authorized under the Medical Devices Regulations or the third interim order without requiring the manufacturer to apply
  3. authorization of new COVID-19 medical devices that have been approved by a trusted foreign regulatory authority

The third interim order still allows the Minister to determine the level of evidence required to demonstrate the safety and effectiveness of devices authorized through the interim order, considering the urgent public health need. This new interim order continues to:

  • provide flexibility and regulatory oversight to enable ongoing importation, sale, and distribution of COVID-19 medical devices, including personal protective equipment
  • incorporate by reference the existing list of licensed or authorized medical devices for which an expanded use has been approved
  • ensure that all authorizations for medical devices issued under the previous interim order, including any terms and conditions on those authorizations, will remain in effect
  • require importers and distributors of all COVID-19 medical devices to hold a medical device establishment licence
  • maintain bilingual labelling requirements for manufacturers, importers, and distributors of all COVID-19 medical devices

Looking for assistance with your COVID-19 related medical device?

Further, any applications that are outstanding when the previous interim order expires will still be considered under the third interim order.

All authorized COVID-19 devices are subject to post-market requirements. These include incident reporting, reporting of a voluntary recall and record-keeping requirements related to distribution.

The Minister also maintains the ability, at any time, to:

  • impose or amend terms and conditions on authorizations
  • ask for more information or materials about a COVID-19 medical device submission, existing authorized device or expanded use

Health Canada will continue to monitor the safety and effectiveness of authorized COVID-19 medical devices. This includes taking immediate action, such as cancelling authorizations if required, to protect people’s health and safety.

Manufacturers of Covid-19 medical devices authorized under the third interim order will not be subject to evaluation, amendment, and right-to-sell fees.

What this means for manufacturers and applicants?

The intention of Interim Order No. 3 is to maintain the same flexibilities offered under Interim Order No. 2. All COVID-19 medical device application requirements remain the same as those in the second interim order, unless communicated otherwise. As such, all Interim Order No. 2 active authorizations and expanded use indications will continue under Interim Order No. 3. No action will be required from the manufacturer.

Manufacturers of authorized medical devices under Interim Order No. 2 may continue to import and sell their devices in Canada under Interim Order No. 3.

Any terms and conditions placed on an interim order authorization issued under Interim Order No. 2 remain in effect under Interim Order No. 3. Manufacturers are to continue to operate under those existing terms and conditions.

All applications that were made under Interim Order No. 2 and are still in process will be evaluated under Interim Order No. 3. These include amendment applications. No action is required from the manufacturer.

What this means for COVID-19 medical device purchasers and users?

There is no impact as devices authorized under Interim Order No. 2 may continue be sold under Interim Order No. 3.

Anyone, other than the device manufacturer, who imports or distributes an interim order-authorized device for human use in Canada must obtain a medical device establishment licence (MDEL). Health care facilities and retailers are exempt from holding an MDEL.

Next steps

We expect that Interim Order No. 3 will remain in place for up to 1 year. Future updates for this project will be available in the following document:

Resources:

Health Canada, February 21, 2022. Interim Order No. 3 Respecting the importation and sale of medical devices for use in relation to COVID-19. Retrieved from

https://www.canada.ca/en/health-canada/services/consumer-product-safety/cosmetics/regulatory-information.html

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