Cancellation of MDELs for Non-Compliance with Annual Licence Review Requirements

Cancellation of Medical Device Establishment Licence for A Non-compliance With Annual Licence Review Requirements

On May 27, 2021 Health Canada issued a bulletin about cancellation of Medical Device Establishment Licence (MDELs) for the sites that are not compliant with the annual licence review requirements. About 700 MDEL holders have not submitted an annual licence review application for the 2020/2021 fiscal year, and as a result Health Canada cancelled their MDELs. This means that these sites are not able to conduct their activities and must re-apply for a new establishment licence and pay the applicable fees. 

Annual Licence Review

An annual licence review (ALR) ensures that medical device establishment licence (MDEL) holders are complying with regulatory requirements associated with the Medical Devices Regulations. An ALR also ensures that their licence information is up-to-date.

As a courtesy, Health Canada sends an ALR application package to all active MDEL holders at the end of each calendar year. Health Canada also sends out 2 reminder notices to the licence contact person on file.

MDEL Holder Responsibilities

To continue doing business, active MDEL holders must submit an ALR application before April 1 of each year as per section 46.1 of the Medical Devices Regulations. Licence holders with a suspended MDEL do not need to apply.

Health Canada will cancel the MDEL for those licence holders who do not submit their ALR application within the required timeline. This authority is set out in section 51.1(b).

Under section 48, active MDEL holders must also notify Health Canada within 15 calendar days if they change their contact information. This includes changing the name or address of their establishment or the information of the establishment representative associated with their MDEL.

Cancellation of MDELs

Since the ALR deadline of April 1, 2021, about 700 MDEL holders have not submitted an ALR application for the 2020/2021 fiscal year. As this violates section 46.1, Health Canada have cancelled their MDELs and removed them from the active MDEL live listing.

MDEL holders whose establishment licence is cancelled are no longer authorized to conduct licensable activities (such as manufacturing, distributing or importing medical devices). They must cease their activities immediately once they receive their cancellation notice.

Resuming Licensable Activities

To resume licensable activities, companies whose MDEL has been cancelled must re-apply for a new establishment licence and pay the applicable fees. In line with the compliance and enforcement policy for health products (POL-0001), Health Canada carries out compliance monitoring activities. Cancelled MDEL holders may be subject to compliance and enforcement actions if Health Canada finds they are conducting non-compliant activities.

For more information on how to re-apply for a MDEL or if you need assistance filling your ALR please visit our website. Our Experts at Quality Smart Solutions continue to support your needs for medical devices, natural health products, foods, cosmetics and OTC drugs for North America. Contact us today to learn more about how we can support your compliance for Medical Device Establishment licence.

How We Can Help

Our Experts at Quality Smart Solutions also offer to support your needs for foods, cosmetics, OTC drugs and medical devices for North America.

Contact us today to learn more about how we can support your compliance needs during and after licensing!

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Cancellation of MDELs for non-compliance with annual licence review requirements – Health Canada.


Why You Should Consider a Third-Party NHP Importer of Record

Natural Health Products (NHPs) are regulated by Health Canada under the authority of the Food and Drugs Act and the Natural Health Products Regulations (NHPR) and must be licensed prior to marketing in Canada. Licensed NHPs are assigned an eight (8) digit Natural Product Number (NPN) or Homeopathic Medicine Number (DIN-HM). To be classified as an NHP, all of the medicinal ingredients in the product must be in Schedule 1 of the NHPR, not include any substances listed in Schedule 2 of the NHPR and be marketed for health reasons.

NHPs include traditional medicines; health supplements/vitamins; minerals; and bulk raw materials manufactured, sold or represented for use as NHPs. Cosmetics containing NHP ingredients and that meet both the function and substance components of the NHP definition are regulated as NHPs. 

Health Canada has an easy-to-follow policy on the importation of health products for commercial use. The Guidance Document on the Import Requirements for Health Products under the Food and Drugs Act and its Regulations (GUI-0117) outlines the requirements related to the importation of health products as defined by the Food and Drugs Act.

Health products commercially imported into Canada must meet all applicable requirements of the Food and Drugs Act and its Regulations including proper labelling, market authorization and establishment licenses. Here’s a summary of the licensing requirements for natural health products that are intended to be shipped to Canada for commercial purposes.

License Requirements for Natural Health Products:

Product license (NPN or DIN-HM) for each product.

All products, whether manufactured domestically or in a foreign site, must first undergo a pre-market review where it will be assessed for safety, efficacy, and quality. Evidence demonstrating this must be submitted to Health Canada by means of a product licence application (one for each product). Products, which meet the required criteria, will be authorized for sale and each issued a Natural Product Number (NPN) or Homeopathic Medicine Number (DIN-HM). Further information on this process is available in the Product Licensing Guidance Document.

Site license for each importer located in Canada.

The Natural Health Products Regulations require any Canadian site where natural health products are manufactured, imported, labelled, packaged, distributed, and/or stored to have a site licence. Businesses can choose to have a single site licence for all their operations (i.e. multiple sites) or an individual licence for each site. Site licences are obtained by demonstrating that the above-mentioned activities are conducted in a manner that is congruent with the requirements of the Canadian Good Manufacturing Practices (GMPs) for NHPs.

Quality Import Solutions (QIS) has a valid Site License to import Natural Health Products and can act as an importer of record into the Canadian market. We have collaboration with fist-class third-party warehouses annexed to our site license that can provides storage services of NHPs in compliance with Canadians GMPs if needed.

The foreign manufacturer must be listed on the importer’s site license.

While site licences are only issued to Canadian sites (none are issued to foreign sites). Foreign manufacturers as well as packagers, labellers of NHPs must be annexed to a Canadian importer’s site licence. In order to annex a foreign site to importer’s site licence, each foreign site must provide GMP evidence to demonstrate compliance with Part 3, GMP, of the Natural Health Products Regulations in full.  

Why Use Quality IMPORT Solutions (QIS) as a Third-Party NHPs Importer of Record 

Using QIS as a third-party NHPs Importer of Record will give you the benefits outlined below:

  1. Flexibility to use multiple distributors and/or brokers or sell direct in Canada
  2. Acting as a neutral third party which helps eliminating packaging liability (Our Importer’s name is required on your NHP label) if you were to use a distributor as your NHP importer and if down the line the relationship doesn’t work or if you decide to switch to a new distributor, you would be required to either over-sticker or destroy packaging 
  3. Multiple geographical choices as we have warehouse and fulfillment partners (annexed to Quality IMPORT Solutions site licence) located across Canada improving speed to market based on your preferred destination point 
  4. Having the option to either sell to traditional retail outlet or to online venues like Amazon, and others 
  5. Low resource cost as we have an experienced team of quality assurance who provide full product disposition to the Canadian market and manage your quality assurance obligations

More than 80% of Canadians consume natural health products (NHPs), so it’s a ripe market for brands that are willing to navigate the product registration and importation requirements outlined by Health Canada. Our team will help you navigate through the process of registration and importation of your NHPs. 

Our Experts at Quality Smart Solutions continue to support your needs for natural health products, foods, cosmetics, OTC drugs and medical devices for North America. Contact us today to learn more about how we can support your compliance for NHPs registration and importation.

How We Can Help

At Quality Smart Solutions, we provide you with the guidance to plan your Veterinary Health Products business, navigate the legal requirements, and acquire the appropriate license for your operations.

Quality Smart Solutions has a team of professionals to offer support from day one of starting your business, including formulation and label reviews, Veterinary Health Product notifications and more.

30 Minutes Free Consultation