Personal protective equipment (COVID-19): How to get authorization
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- Regulatory authorization pathways for COVID-19 medical devices
- Responsibilities of authorization and licence holders
Authorization from Health Canada is required prior to the import or sale of personal protective equipment for medical purposes.
There are different routes to obtaining Health Canada authorization to supply COVID-19 medical devices. The routes depend on 2 things:
- whether the company bringing the product to market in Canada is a manufacturer, importer or distributor
- the risks associated with the medical device
Medical devices are classified based on their associated risks. Under the Medical Devices Regulations, N95 respirators, medical masks, face shields or medical goggles and medical gowns are Class I medical devices.
Medical gloves are Class II medical devices.
Regulatory authorization pathways for COVID-19 medical devices
- interim order authorization pathway
- Medical Device Establishment Licence (MDEL)
Applicants should carefully review the pathways below to select the most appropriate authorization route for their product.
Pathway 1: Interim order authorization for importing and selling medical devices
Interim Order No. 2 (IO No. 2) Respecting the Importation and Sale of Medical Devices for Use in Relation to COVID-19 was introduced on March 1, 2021. It allows Health Canada to expedite authorizations for the import or sale of medical devices related to COVID-19.
Important information about this pathway:
- This pathway is intended for manufacturers of all classes of devices, including Class I devices such as medical masks or gowns, that are not approved in Canada.
- Manufacturers wishing to sell 3D-printed swabs, sample collection devices, reprocessed respirators and KN95s as medical respirators in Canada are encouraged to use this authorization pathway.
- Manufacturers submit an abbreviated application to support the safety, effectiveness and quality of their medical device.
- Health Canada will conduct a scientific review before authorizing the sale of these devices.
- There are no application fees.
- Manufacturers that receive an authorization for Class I devices under this pathway are not required to obtain an MDEL.
- The application covers a single medical device product. Separate authorizations under IO No. 2 are required for each product.
- Medical devices authorized through this pathway are posted in the list of authorized medical devices.
- Two new requirements introduced by IO No. 2 are that importers and distributors must hold a medical device establishment licence (MDEL) and that manufacturers must comply with bilingual labelling requirements by September 1, 2021.
To submit an application for authorization under IO No. 2, follow these steps:
- Review the guidance document on how to apply for COVID-19-related medical devices under IO No. 2.
- Prepare your submission package and include enough information, such as device labelling, so that Health Canada can authorize the device.
- Make sure a senior official of the manufacturer has signed the application form.
- Include in the subject line of your email submission COVID IO Submission and email your application to the Medical Devices Directorate at firstname.lastname@example.org.
For information about the licensing or authorization of medical devices in Canada, please contact the Medical Devices Directorate at email@example.com.
Pathway 2: Expedited review and issuance of Medical Device Establishment Licences related to COVID-19
Health Canada is expediting the review and issuance of Medical Device Establishment Licences (MDELs) for companies asking to manufacture Class I, or import or distribute Class I to IV medical devices in relation to COVID-19.
Due to the high number of MDEL applications received, Health Canada issued temporary submission numbers (SN) in advance of the MDEL between April 22 and May 22, 2020. This was done to facilitate quicker access to products needed to help combat COVID-19.
SNs were issued to MDEL applicants that submitted the critical information required to ensure effective oversight of the activity being licensed. Companies conducting activities using a submission number are subject to all of the same safety requirements as MDEL holders. This temporary number can also be used at the border to allow importation.
Health Canada is contacting SN holders to either issue or refuse to issue an MDEL following the application review. Following this, the temporary submission number is no longer valid.
Important information about MDELs:
- Manufacturers, importers and distributors of medical devices must have an MDEL before they can import or sell in Canada. The exceptions to holding an MDEL are:
- manufacturers that have been granted an IO authorization under the IO authorization pathway
- importers or distributors that import or sell a medical device for which the manufacturer has been granted an IO authorization for that device
- manufacturers that import or distribute solely through a person that holds a MDEL
- retailers and health care facilities, as they do not need an MDEL
- An MDEL application form is required. No device label is required to be submitted.
- The fee to apply is $4,590, but the MDEL holder can qualify for a fee mitigation.
- MDEL holders can sell, import or distribute multiple types of medical devices under a single licence.
To submit an MDEL application:
- Review the guidance on medical device establishment licensing and medical device establishment licensing fees.
- Complete the MDEL application form (FRM-0292).
- Email the completed MDEL application form to firstname.lastname@example.org and put in the subject line of the email: URGENT – COVID-19 – MDEL application for - [name of company]
For any questions about the MDEL process, please email email@example.com.
Pathway 3: Exceptional importation and sale of certain medical devices to help prevent or alleviate shortages
A regulatory pathway has been created to facilitate access to PPE that may not fully meet the regulatory requirements, but are made to comparable standards. This is being done through an exceptional import and sale interim order.
This pathway includes medical devices that:
- may be past their expiry dates
- may not meet all labelling requirements under the Medical Devices Regulations
Important information about this access pathway:
- Medical devices included on the list of medical devices for exceptional importation and sale are called designated medical devices. They are eligible for the exceptional importation and sale provisions provided for in the IO.
- Manufacturers or importers must already have an MDEL or Medical Device Licence to use the exceptional importation and sale pathway.
To submit an application for exceptional importation or sale, manufacturers and importers should:
- complete the medical devices interim order request form
- email the completed form along with a copy of the product label to firstname.lastname@example.org
After reviewing the request, we will inform you of our decision to add the medical device to the list of medical devices for exceptional importation and sale.
Once a medical device is on the list:
- Importers must notify Health Canada by completing the exceptional importation and sale notification form to import a designated device at least 5 calendar days before the device is imported.
- Send your notification to email@example.com.
Responsibilities of authorization and licence holders importing and selling personal protective equipment
Applicants are responsible for ensuring that imported and sold products comply with the Medical Devices Regulations. This includes ensuring that:
- the necessary procedures are in place (for example, maintenance of distribution records, recall procedures)
- activities are conducted in accordance with the requirements set out under the Regulations
Health Canada will conduct site inspections and spot checks to verify compliance. We will take immediate action when non-compliance is confirmed. This includes stopping the importation and sale of any products that are found to pose a risk to the health to Canadians.
- Notice for industry: Ensuring predictability for interim orders relating to COVID-19
- Notice – Important regulatory considerations for the reprocessing of single-use N95 respirators during the COVID-19 response
- COVID-19 medical masks and N95 respirators: How to get authorization
- Personal protective equipment against COVID-19: Medical gloves
- Personal protective equipment against COVID-19: Medical gowns
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