| Services | - International Compliance Management |
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Basic Regulatory Facts - Canada
The more informed you are,
the better prepared you will be to gain share in the global market. The below
fact sheet provides general fundamentals on gaining product approval in the
targeted country.
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Total
Population: 31,281,092 (July 2000 est.) |
GDP per capita: $23,300 (1999 est.) |
|
|
Age
Structure: |
0-14 yrs
19 % |
Communication Status: Private |
|
|
15-64 yrs 68 % |
Health Care Status: National & Private |
|
|
65 yrs and over 13 % |
|
Sex Ratio: |
.98
male(s) /female |
Economic Status: Free market economy |
|
Official
Language: English 59.3% French 23.2% |
International
Organization Participation: |
|
|
Literacy
Rate: 97%(1986 est.) |
ISO,
ITU, NATO |
|
The three primary areas of Telecommunications, Medical
products, and Consumer products are addressed in this Fact Sheet. For detailed information on a specific
country or product, please contact the International Compliance Management Unit
at TÜV SÜD Product Service at icm@tuvam.com.
|
Telecom |
Medical |
Consumer
Products |
|
Regulatory Authority: Industry Canada |
Regulatory Authority: Ministry of Health Services |
Regulatory
Authority: Ministry
of Consumer and Business Services |
|
Approval Bodies: Industry Canada |
Approval Bodies: Health Canada |
Approval Bodies: Mechanical
and Electrical Hazards Section or Third Party |
|
EMC
& Safety: Industry Canada Certification & Engineering Bureau |
Safety: Health
Canada Medical
Devices Bureau |
EMC
& Safety: Requirements
according to product type & classification |
|
Radio: Industry Canada Radio Communications Regulatory Branch |
Radio: Spectrum assignments in place |
Radio: Spectrum
assignments in place |
|
Labeling:
Certification labels are obtained solely from Industry
Canada |
Labeling: Required
for all medical & surgical products |
Labeling: Safety
labeling per product type |
|
Residency
Requirements: No local
requirement |
Residency
Requirements: Local presence required |
Residency
Requirements: No local requirement |
|
Current
Trends: In
October, 2001 a change in labeling requirements will allow existing Technical
Acceptance Certificate (TAC) holders to mark certified terminal equipment
themselves. |
Current
Trends: In
January 2003, all medical device manufacturers selling in Canada will be
required to demonstrate compliance with Canadian Medical Device Regulations -
ISO 13485 for class II, III & IV devices. |
Current
Trends: High
consumer of U.S. and Asian products. |
For more information, contact us.