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Medical Device License (MDL) Renewals

As a Canadian medical device license (MDL) holder, you are subject to an annual license renewal procedure. The renewal process has two purposes, the first is to verify that the MDL will remain active and will continue to be sold in Canada. The second reason is to collect and analyze the appropriate information prior to invoicing for the right to sell fee.

Process 

The renewal process involves manufacturers of medical devices that are licensed for sale in Canada, to inform Health Canada each year before November 1st, that the information on their license has not changed. Health Canada will send each manufacturer who is marketing a licensed class II, III or IV medical device an annual license renewal package in early August. This package will allow the manufacturer to fulfil their regulatory obligation and contains the Renewal Form with instructions. The Renewal Form contains the following information:

  • Regulatory correspondence address of the manufacturer
  • Name of the regulatory correspondent and their contact information
  • Attestation page
  • Section 43 of the MDR
  • Name of the manufacturer
  • A listing of all the manufacturer’s licensed devices, their license number and class that are currently on the market

Instructions 

Health Canada has provided the following instructions for the completion of the Renewal form:

  • Correct any changes to the name of the contact person or their contact information in the space provided to the right of the contact information
  • A senior official of the Manufacturer or their designated regulatory correspondent must sign the attestation
  • Indicate medical device licenses that should be discontinued by placing an [X] beside the medical device license number in the discontinue column. This means that the manufacturer has stopped marketing the device or family of devices in Canada
  • If all the products for which medical device licenses that are listed are to remain on the Canadian market, place an [X] in the appropriate column

Failure to Comply 

Please be advised, that any changes to the MDL other then changes to contact information and notification of discontinuation will not be accepted via the Renewal Form. All other changes must be addressed by submitting the appropriate amendment form to Health Canada. The Renewal Form is required to be emailed to the Bureau of Device Licensing Services Division of the Medical Devices Directorate before November 1 of the year it is received license_renewal@hc-sc.gc.ca. Failure to renew by the November 1st deadline may result in the cancellation of existing medical device licenses by the Medical Devices Directorate.  

Invoicing and Payment

Renewal applications are processed on receipt. Therefore, invoices are mailed in December for payment within 30 days. The invoice documentation confirms renewal of the medical device license(s), describes the license(s) and the associated fee(s). 

Additional Fee Information 

Health Canada carries out post-market monitoring and assessment of medical devices. The fee for the right to sell a licensed medical device is used to pay for a portion of these activities. The fee is charged annually for the twelve-month period beginning on November 1 of each year. These fees will increase annually to keep up with inflation. 

Conclusion 

Need help filing your MDL Renewal Form or have questions about the renewal process? Our experts at Quality Smart Solutions would be happy to assist! Please Contact us today or call us at 1-800-396-5144.

References

https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices/application-nformation/guidance-documents/medical-device-licence-renewal-fees-right-sell-licensed-2019/document.html

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What You Need to Know – Software as a Medical Device (SaMD)

The advancement of technology is rapidly progressing, and the evolution can be observed all around us. As cutting-edge technology becomes more available, there appears to be a shift with regard to how work is carried out across several industries. Within the last decade, the healthcare field has seen an increased amount of software being utilized in medical devices. Software has become an important aspect of medical devices and is proving to benefit both patient and provider. 

What is Software as a Medical Device (SaMD)

There are various types of medical device software, but an emerging software of interest is known as Software as a Medical Device’ or SaMD. As defined by several regulatory bodies, SaMD “is software intended to be used for one or more medical purposes and it performs these purposes without being part of a hardware medical device.” In other words, SaMD is a type of software that works independently from another device. 

For example, a mobile application that takes input from a blood glucose meter to provide insulin dosage recommendations for diabetes is considered SaMD. But the software used to take the blood glucose meter reading is not considered SaMD, as this is software that supports the medical device and therefore can not function without it. Other examples include software that analyzes physiological signals that are collected from sleeping, software that uses digital mammograms to calculate breast density percentages and even software that permits smartphones to view images captured from a computerized tomography (CT) scan. 

Advantages of Using (SaMD) in Healthcare 

SaMD offers numerous opportunities and has the potential to refine integral systems in a healthcare setting. This is due to the possibility of automating certain aspects that can lead to better treatment for patients. SaMD’s main advantages include improving healthcare outcomes and faster response times. 

There are several intended uses for SaMD that can benefit both the patient and the provider, 

  • Treat or diagnose– information provided by SaMD can be used to accurately detect a disease or condition and help reduce the time from diagnosis to treatment.
  • Drive clinical/patient management– SaMD can help better identify early warning signs and provide real time recommendations. Also, can aid clinicians with making a definitive diagnosis, by analyzing relevant information.
  • Inform clinical/patient management- SaMD allows clinicians to better advise their patients regarding options for personalised treatment plans. 

Compliance Measures 

The FDA and Health Canada have similar SaMD classification guidelines based on risk categorization. The class and/or category of SaMD is determined by the state of the healthcare situation and the significance of information provided by SaMD to make a healthcare decision. Other factors of consideration include the degree of invasiveness in the body, duration of contact and local versus systemic effects. Both regulatory bodies have stated that as the medical device software field evolves, policy reform will follow to prioritize patient safety and clinical effectiveness. 

Aligned Interests 

Are you a company operating in the medical device software space and need help navigating the complex classification system or want to enter the medical device software market? Our team of knowledgeable subject matter experts can provide the necessary regulatory support with respect to preparing and submitting SaMD applications. Contact us today or call us at 1-800-396-5144!

References

www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices/application-information/guidance-documents/software-medical-device-guidance-document.html  

www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices/application-information/guidance-documents/software-medical-device-guidance-document.html  

www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices/application-information/guidance-documents/software-medical-device-guidance-document.html  

www.selecthub.com/medical-software/software-medical-device-samd/

www.torys.com/insights/publications/2018/11/software-as-medical-devices-and-digital-health-in-canada.

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Important Notice Regarding the Transition of COVID-19 Site Licenses

In March 2020, Health Canada introduced interim measures to expedite the issuance of site licences for alcohol-based hand sanitizers, to address the shortage of these products due to the COVID-19 pandemic. Alcohol-based hand sanitizers are considered natural health products (NHP) and all Canadian companies engaged in manufacturing, packaging, labelling, or importing a natural health product for sale, require a natural health product site licence.

However, as the demand for alcohol-based hand sanitizers stabilizes, the interim order is approaching an end. The Natural and Non-Prescription Health Products Directorate (NNHPD) of Health Canada has set forth that temporary COVID-19 site licences (COVID-19 SL) for manufacturing, packaging, labelling and/or importing alcohol-based hand sanitizers will expire on September 30, 2021. Health Canada issued a bulletin to all temporary COVID-19 SL holders that gave a 60-day notice period in advance for the end of interim measures.

Therefore, COVID-19 SL holders are presented with two options prior to licence expiry:

  1. Stop manufacturing, importing, packaging, labelling, or distributing alcohol-based hand sanitizers.
  2. Apply for a valid SL to continue producing hand sanitizer until you receive a decision on your application.

If the SL holder would like to continue activities beyond September 30, 2021, then a complete site licence application (SLA) must be submitted, as per Section 28 of the NHPR, by September 30, 2021, at 11:59 pm PST. The applicant will be required to complete the web SLA form and must select the “COVID-19 SL Transition” option. The applicant will also be required to demonstrate compliance with the Good Manufacturing Practices (GMPs) (i.e. Quality Assurance Report (QAR), and applicable testing, release, and batch records).

Once the SLA form is completed and GMP evidence documents are collected, the applicant then must retrieve the ePost Connect conversation thread. If the applicant does not have a COVID Applications conversation, Health Canada has recommended to contact the following e-mail address: hc.nnhpd-dpsnso.sc@canada.ca with the subject line “COVID transition – No applications conversation”. It is worth noting that any applications submitted through other means will not be accepted.

If Health Canada deems that the application requires more information to be sent, then an Information Request Notice (IRN) may be sent. The IRN will state a timeline and define the additional information required. Failure to respond adequately or on time will result in an application refusal.

The service standards normally in place for new applications will not apply to COVID-19 SL transition applications. Therefore, temporary COVID-19 SL holders will be allowed to continue activities under the temporary licence, until a decision is issued. The NNHPD is striving to issue an acknowledgement within 30 days of receiving the application. Please be advised, if you receive a site licence, you will be required to renew it within one year.

Alternatively, if you wish to discontinue activities under the COVID-19 SL licence, Health Canada has requested that you send an email to the following e-mail address; hc.nnhpd-dpsnso.sc@canada.ca ahead of the September 30, 2021, end date. The email will need to include a cover letter, reference your COVID-19 SL number and the discontinuation date.  

It is important to understand that if you choose to discontinue activities, you may liquidate the remaining stock that was imported or manufactured while the interim COVID-19 SL was valid. You will be asked to confirm that you have ceased licensable activities. Also, you must retain samples of your products and records to enable a recall should the need arise.

In the event you have already stopped or never carried out activities under your interim COVID-19 site licence, you can notify the NNHPD that you wish to discontinue your license ahead of the September 30 deadline, following the same directions as above.

If you take no action, the activities listed on your interim COVID-19 SL will no longer be allowed after September 30, 2021.

 

How Quality Smart Solutions can help:

We offer site license application services that consist of preparing and submitting applications, as well as handling communication with Health Canada. Also, our sister company, Quality IMPORT Solutions, can be your importer of record. Our team of experts can handle all site licencing matters and are happy to help you with future projects or questions! Please find our contact information here: Contact our Compliance Experts to get a Permanent Site License.

30 Minutes Free Consultation
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Consultation Period Extension: Proposal to Improve Natural Health Product Labelling

On June 26, 2021, Health Canada launched a consultation on a proposal to improve natural health product labelling. Health Canada held extensive pre-consultation with a wide array of stakeholders in the development of the policy and prior to publication in Canada Gazette, Part I. The Canada Gazette, Part I consultation period process allows all stakeholders to review the proposed regulations and comment on the analysis of the potential positive and negative effects of a proposal on the health, safety, security, the social and economic well-being of Canadians, businesses and on the environment.

Recognizing that the timing of this consultation coincides with the summer holiday period and that there are a number of consultations underway at Health Canada, which may also be of interest to industry, the Canada Gazette, Part I public comment period is extended to 90 days and will now close on September 24, 2021. The details of how you can provide your feedback on the proposed amendments to the Natural Health Products Regulations can be accessed on Consulting with Canadians web page.

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Proposal to Improve Natural Health Product Labelling

Natural Health Product Labelling

On June 25, 2021, Health Canada published a news release that announced proposed changes to the Natural Health Products Regulations. The proposed changes would directly affect natural health product (NHP) labelling requirements.

What are Natural Health Products?

As defined by Health Canada, natural health products are naturally occurring substances that are used to restore or maintain good health. They are often made from plants, but can also be made from animals, microorganisms, and marine sources.

A wide variety of NHP’s, such as vitamins, probiotics, and minerals, are used daily by many Canadians. The COVID-19 pandemic has increased the demand for these products, as consumers are becoming progressively self aware and are wanting to take more control of their own health.

Why Are Changes Being Proposed?

Health Canada is conscious of the growing usage of NHP’s among Canadians and is therefore trying to improve the understanding of NHP’s by proposing an amendment that will enhance plain language labelling. The goal of the amendment is to improve representation of key information on product labels to help consumers make more informed decisions.

The importance of labelling can be demonstrated by an online poll that was published by the Office of the Auditor General. The poll asked participants to rate different factors that influence the purchasing of NHP’s. The results of the poll identified that a product label was the second most important factor that influences consumer decisions, among other strong factors that were rated less significant, such as recommendations from family, and pricing.

What Are the Proposed Amendments?

The proposal by Health Canada includes four key elements that can be summarized below:

  1. A Product Facts Table:

    Includes important product information, such as warnings and directions for use, that would be presented in a standardized table.

  2. Clearly and prominently displayed label text:

    Rules would be introduced to improve NHP label legibility and readability (ie. minimum font size requirements).

  3. Labelling of food allergens, gluten, and aspartame:

    Priority food allergens, gluten and aspartame would be identified in the warning section of the label.

  4. Modernized contact information:

    A manufacturer may display either an e-mail address, telephone number or website instead of a postal address, as currently required.

 

If the proposal were to be registered as part of the Natural Health Products Regulations, there would be a transitional period of 3 years to allow NPN license holders to make the appropriate changes to product labels.

How to Participate in the Consultation

The public consultation for the proposal to improve natural health product labelling opened on June 26, 2021 and will close on September 4, 2021. Health Canada welcomes comments and feedback on the regulatory proposal from all interested parties.

Sources:

www.canada.ca, www.oag-bvg.gc.ca

How We Can Help

Quality Smart Solutions offers a Canadian natural health product label compliance service. This service includes a complete review of your NHP label to determine if all regulatory requirements are implemented. The label compliance service utilizes a collaborative approach between the experts and our clients to ensure a compliant label is produced for the Canadian market.

Our team of experts at Quality Smart Solutions are continuously staying educated on the evolving NHP labelling requirements. Please contact us to learn more about NHP labelling or about how we can help with your NHP label!

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