Class I & II PPE: Masks, Gloves, and Gowns
Due to the Coronavirus disease (COVID-19) public health emergency, there has been an increase in the importation of personal protective equipment (PPE). Masks, gloves and medical gowns are in high demand to protect both essential workers and the general public.
While these products are highly sought after, the urgent need for them does not negate the regulations that ensure the safety and effectiveness of them. Health Canada is the government agency responsible for regulating PPE that make medical claims.
What You Need To Know Before Purchase
Is your item considered a medical device and how do you tell?
Items that make no medical claims and are not for use in a healthcare setting are not regulated by Health Canada. We recommend that the customs documents clearly indicate the masks are not for medical use and the product itself be marked with a notation such as “Not for Medical Use” or “For Industrial Use”.
Medical claims are words and statements such as "health care," "examination," "patient examination," "sterile" or "medical grade" or contain images or symbols that signify a medical use such as care, body, safe, guard, or cross.
If the products you intend to import make any of these claims they may be considered a medical device.
A medical device as defined by Health Canada is “Any article, instrument, apparatus or contrivance, including any component, part or accessory thereof, manufactured, sold or represented for use in the diagnosis, treatment, mitigation or prevention of a disease, disorder or abnormal physical state, or its symptoms, in human beings.”
Disposable face masks and gowns for use in preventing the transmission of infection are usually considered Class I medical devices. Class I devices are not required to be licenced but the manufacturer is responsible for ensuring the device complies with the remaining sections of the Medical Devices Regulations.
All medical or surgical gloves are class II medical devices in Canada. They are required to be registered with Health Canada and the manufacturer is issued a Medical Device Licence (MDL) for the gloves.
An Authorization Or Licence Is Required
In order to import and sell both Class I and II medical devices a Medical Devices Establishment Licence (MDEL) OR authorization from Health Canada under the COVID-19 Interim Order is required unless the Importer is also one of the following exempted parties:
- A Retailer;
- A Health Care Facility;
- Manufacturers of Class I devices if the manufacturer imports or distributes through a person who holds an Establishment Licence;
- A person who only imports a medical device for their own personal use (“ultimate consumer”)
- Establishments only importing or selling veterinary products;
- Dispensers; and
- Establishments that only import or sell custom-made devices, medical devices for Special Access, or devices for Investigational Testing involving human subjects.
- an interim order (IO) authorization holder
Definitions As Per Health Canada
Health Canada's guidance document on Medical Device Establishment Licensing and Medical Device Establishment Licence Fees (GUI-0016), defines of Retailers, Health Care Facilities and Ultimate Consumers as:
"Retailers are persons who sell a device, or a service utilizing a device, solely to the ultimate consumer/end user. Note: Many retailers may not be aware of whether devices are being purchased by ultimate consumers for their own use. However, where a sale occurs to those who are identifiable as not being the ultimate consumers, the seller is considered to be a distributor, not a retailer." (A Distributor of medical devices does require a MDEL)
Health Care Facilities
Health Care Facility "means a facility that provides diagnostic or therapeutic services to patients. It includes a group of such facilities that report to one common management that has responsibility for the activities carried out in those facilities."
Ultimate consumer “is the individual who purchases or receives a medical device for their own personal use (including use within their household) or receives treatment or diagnosis with a medical device from a health care facility or provider. Businesses that purchase medical devices solely for use by their employees during work activities (e.g. first aid kits, disposable gloves) or for incidental emergency use are also considered ultimate consumers as long as they are not in the business of offering healthcare services to employees or other individuals.”
If You Are Still Unsure How To Proceed
If you are unsure if you qualify for these exemptions, please contact Health Canada’s Medical Devices Directorate at email@example.com.
If you require a Medical Device Establishment licence or wish to apply for authorization to import under the interim order, information is found in our article “Getting COVID19 Medical Supplies Into Canada” and on Health Canada site “Optimizing the use of masks and respirators during the COVID-19 outbreak“
We hope this information is what you need. Please let us know 24/7 if you have any questions.