| Services | - International Compliance Management |
Regulatory Facts - Argentina
The following
fact sheet provides general fundamentals on gaining product approval in Argentina.
|
Total
Population: 37,384,816
(July 2001 est.) |
GDP per capita: $12,900 (2000 est.) |
|
Age Structure:
|
0-14 years: 26.54% |
Communication
Status: Private |
|
15-64
yrs 63.04% |
Health
Care Status: Public & Private |
|
|
65 yrs
and over 10.42% |
||
Sex Ratio:
|
0.98
male(s) /female (2000 est.) |
Economic
Status: Free market economy |
|
Official
Language: Spanish |
International
Organization Participation: ISO, ITU, WTO, IEC |
|
|
Literacy
Rate: 96.2% |
|
|
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, contact
TÜV SÜD America at icm@tuvam.com
|
Telecom |
Medical |
Consumer Products |
|
Regulatory
Authority: National Commission of Communications (CNC) |
Regulatory Authority: Ministry of Health |
Regulatory
Authority: Secretary
of Industry and Commerce |
|
Approval Body: CNC |
Registration Body: National Administration
of Drugs, Foodstuffs and Medical Technology (ANMAT) |
Certification
Body: IRAM |
|
EMC:
Currently not in place Safety: Argentinean
Institute of Rationalization of Materials (IRAM) |
EMC:
Currently not in place Safety: IRAM |
EMC:
Currently not in place Safety: IRAM |
|
Radio: Spectrum assignment in place |
Radio: Spectrum assignment in place |
Radio: Spectrum assignment in place |
|
Labeling: IRAM safety mark, CNC identification number affixed to product. |
Labeling: Product
specifications & labeling information must be in Spanish. |
Labeling: IRAM’s
Safety Certification mark. |
|
Residency
Requirements: Local
presence required |
Residency
Requirements: Local presence required |
Residency
Requirements: Local presence required |
|
Current
Trends: CNC does not accept test reports from any other test lab
as part of an application for approval, nor does it recognize testing against
standards other than those adopted at a national level in Argentina. |
Currents
Trends: There is no legal mandate to retest products that have
already been approved in their country of origin. Medical products that incorporate
radio & telecom features must meet local requirements. |
Current
Trends: Electrical devices and equipment must comply with
Argentine electrical standards of 200 volts/50 cycles. |
For more information, contact us.