Canadian Chiropractor

Features Business Management
Chiropractic Tables and Canada Customs


May 7, 2008
By Maria DiDanieli

Topics

What you need to know

Recently, there have been questions asked –
and some problems arising – with respect to purchasing chiropractic adjusting
tables from manufacturers and/or distributors in the United
States and, subsequently, having those tables delivered
into Canada.
The problem seems to stem from whether or not the tables have proper approval
and licensing, as medical devices, with Health Canada, and has resulted in these
expensive, and necessary, purchases becoming stuck at the U.S./Canada border.

Canadian Chiropractor thanks the personnel within the Health Canada Medical
Devices Bureau, as well as Health Canada
media relations officer, Paul Spendlove, for their assistance in bringing
chiropractors the following helpful information for purchasing tables from
manufacturers, or distributors, in the United States. 

The following is a Q and A with Health Canada
regarding chiropractic adjusting tables.

 

C.C.: 
What are the device licensing regulations with respect to chiropractic
adjusting tables?

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
requirements.

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.

 

C.C.: 
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.

For more information on this topic,
chiropractors are invited to contact the Medical Devices Bureau through the
Therapeutic Devices directorate at

613-957-1909 or device_licensing@hc-sc.gc.ca
.  (Visit the website at: www.healthcanada.gc.ca/medicaldevices.)