The following is a Q and A with Health Canada regarding chiropractic adjusting tables.
What are the device licensing regulations with respect to chiropractic
Health Canada: Chiropractic adjusting tables are classified as a medical device under Medical Devices Regulations. The Medical Devices Regulations set out a system for classifying medical devices into one of four classes – Class I represents the lowest risk devices and Class IV represents the highest risk devices. Chiropractic adjusting tables are classified as Class I or Class II medical devices.
Tables that are not powered in any way are considered Class I medical devices.
If a table is powered, it could be considered a Class II medical device or, more specifically, an "active therapeutic device.” “Active” just means that it is powered, and “active therapeutic” is defined in the Medical Devices Regulations as follows: “An ‘active therapeutic device’ indicates a powered device that, whether used alone or in combination with another medical device, is intended to support, modify, replace or restore a biological function or structure for the purpose of treating or mitigating an illness or injury or a symptom of an illness or injury.”
Devices imported into, or sold in, Canada must
meet eleven fundamental safety and effectiveness requirements and must be
labelled in accordance with specified labelling requirements. U.S. and
Canadian manufacturers must possess evidence that their devices meet those
There are two types of
licences issued by Health Canada:
one for medical devices (of Class II, III, or IV) and one for establishments
that import and sell devices.
1. Medical Device Licence
Every manufacturer of a Class II, III, or IV medical device must have a licence for that device before it can be imported into Canada, or sold in Canada.
2. Establishment Licence
An importer or distributor of a medical device of any class, (I, II, III, or IV) must have an establishment licence. The following are exempt from this requirement:
a. A retailer
b. A health care facility
c. A person who imports the device for personal use
d. A manufacturer of a Class II, III or IV device.
e. A manufacturer of a Class I device who sells only through an agent who holds an establishment licence.
Who is responsible to ensure that a given table has been licensed for
clearance and use in Canada?
Health Canada: Class I medical devices are exempt from medical device licensing requirements.
Every manufacturer of an adjusting table which is considered a Class II medical device must have a medical device licence for that table before it can be imported into, or sold in, Canada. Only the manufacturer can obtain this licence. The importer cannot do so on the manufacturer's behalf.
All importers and distributors of Class I, II, III and IV medical devices must obtain an establishment licence.
A manufacturer of a Class I device, who does not deal solely through an importer or distributor with an establishment licence –– that is, also deals with customers directly and/or through a distributor who does NOT have an establishment licence - must have an establishment licence.
The manufacturer is always responsible for the safety and effectiveness of this product.
C.C.: What should
the chiropractor know before purchasing a table from the U.S., in order
to ensure that his/her table doesn't get caught up at the Canadian border?
Health Canada: If buying a Class I table directly from the manufacturer, the chiropractor must inquire whether the manufacturer has a medical device establishment license in Canada.
If the adjusting table might be considered a Class II medical device, the chiropractor should ensure that the manufacturer has obtained a Class II medical device licence for it, prior to attempting to bring it into Canada.
The Health Products and Food Branch (HPFB) of
Health Canada, is
responsible for medical devices in Canada. The Health Products and
Food Branch monitors and evaluates the safety, efficacy and quality of
diagnostic and therapeutic medical devices.
The Medical Devices Bureau, a part of the Therapeutic Products directorate in HPFB, works closely with the HPFB Inspectorate to monitor medical devices for compliance with Canadian medical devices regulations and Health Canada guidelines, after they become available on the Canadian market.
If a medical device's safety or its effectiveness comes into question, the manufacturer may be asked to recall or refit the device. If necessary, the Bureau will suspend a product's license, or stop its sale in Canada.