This is an un-official translation of Arabic text from Saudi Arabia Ministry of Commerce and Industry (MoCI) website:
http://www.commerce.gov.sa/test/a-1.asp
Mechanism for Consumer Products’ Sample Taking
and Referral to the Private Laboratories
The Mechanism of Consumer Products’ Sample Taking and Referral to the Private Laboratories which is being used for this purpose and the mechanism of receiving and resolving the results in implementation of Paragraph “Fifth” of the Decision of HE the Minister of Commerce and Industry No. 5817 dated 8/6/1428H (24/06/2007G).
1. Upon the arrival of consignments to the Kingdom’s inlets, they will be offloaded in the customs’ yards and inspected by the custom’s inspector.
2. The documentation of the consignment shall be referred to the offices of the branches of the Laboratories of the Ministry by the custom’s inspector.
3. The concerned technicians shall examine and study the documentation attached to the consignment.
4. The concerned technicians of the Branches of the Laboratories in the customs’ yards shall examine the consignment to insure the existence of complete explanatory information on the packages.
5. The Consignment Examination Form shall be completed and all the information required in the form filled up as well as the inclusion of all the items as per the invoice and actual inspection.
6. Consignments accompanied with a Conformity Certificate issued by approved authorities in the country of origin or have mutual recognition with the Saudi Arabian Standards Organization (SASO).
(Quality Mark or Certificate) shall be dealt with as follows:
A. The authenticity of the certificates and the approval authority shall be verified and random samples shall be taken in accordance with the scientific methods approved for sample taking.
B. Samples shall be secured and sealed with the seal of the laboratory and delivered to the representative of the outsourced laboratory accompanied with an official letter requesting their examination and testing to confirm their conformity to the approved standards and to verify the correctness of the attached Conformity Certificates.
C. The tests to be made shall be specified as determined by the Saudi Arabian Standards Organization (SASO) and the Directorate General for Laboratories and Quality Control as approved by the Ministry of Commerce and Industry.
D. The cost of tests shall be specified and the importer shall be asked to pay the cost of all the tests by a certified check in the name of the laboratory which shall be handed over to the representative of the private laboratory together with the samples referenced in Paragraph ‘B’.
E. Thereafter, those items shall be directly cleared in the customs’ yards.
7. Upon receiving the result of the tests, the following shall be made:
A. In case the result of testing all or some of the samples of the consignment (if the consignment contains several items) show their conformity to the approved standards, the importer shall be officially notified with the result, provided random samples may be taken from those items and for the importer itself if deemed appropriate by the Ministry.
B. In case the result of testing all or some of the samples of the consignment (if the consignment contains several items) show their non-conformity to the approved standards, the following actions shall be taken:
The importer will be officially informed with the result and asked to coordinate with the issuing (exporting) entity for the avoidance of such violations in the forthcoming consignments.
Providing the Directorate General for Laboratories and Quality Control with the result for circulation to all the laboratories of the Ministry.
The Directorate General for Laboratories and Quality Control will inform the Directorate General for the Quality Control of Saudi Arabian Standards Organization (SASO) to contact, in turn, the entity that issued the certificate and the approval authority in the country of origin to take the necessary action including the notification of the International Laboratory Accreditation Corporation (ILAC) if required and the Saudi Arabian Standards Organization (SASO) faces difficulty in solving this problem.
If the non-conforming items affect the health and the safety of the consumer with direct effect, the Directorate General for Commercial Fraud of the Ministry of Commerce shall be notified in order to take the necessary action for the withdrawal thereof from the markets using the appropriate methods deemed, along with the advertisement of the same in the Media at the expense of the importer and the issuance of a warning against having or using the same and the application of the regulatory penalties in this concern as well.
Upon the arrival of this consignment or some of its items for the same importer at a later date, it will not be directly cleared and the provisions of Item 6 (A, B, C and D) hereinabove shall be applied thereto.
8. Consignments not accompanied Conformity Certificates or their certificates are issued by a non-approved entity, shall be dealt with as following:
A. Consignment for which testing there is no private laboratory to be used for testing, the same shall not be cleared, provided such shall be applied after the lapsing of six months after the announcement of the same in the read media.
B. Consignments for which there is a private laboratory to be used for the purpose of testing them, shall not be directly cleared and the provisions of Paragraph 6 (A, B, C and D) shall be applied with respect thereto.
C. In case the result of testing all or some of the samples of the consignment (if the consignment contains several items) show their conformity to the approved standards, the importer shall be officially notified with the result and the Customs will be asked to clear them.
D. In case the result of testing all or some of the samples of the consignment (if the consignment contains several items) show their non-conformity to the approved standards, the importer shall be officially notified with the result and the Customs will be asked not to clear them.
9. The representative of the private laboratory to which the sample(s) is referred shall transport the same to the laboratory in accordance with the scientific methods of sample transportation within a maximum period of three (3) days as of receiving the sample(s) together with the official letter and the test fees.
10. The Private laboratory for which the sample(s) is referred shall examine/test the same in accordance with the approved standards in strict compliance with the performance of the tests specified to be done by it pursuant to the contents of Paragraph No. 6 (C).
11. The laboratory shall send the results of the test to the originating entity together with the remaining sample(s) or whatever proves the usage thereof for testing within fifteen (15) days as of receiving the sample(s) and for a maximum period of twenty five (25) days for the sample(s) which testing takes more than 15 days.
12. The originating entity shall notify the customs and the importers with the result of the test after studying the result by the conformity section.
13. The following consignments shall be exempted from the conformity certificates and from the referral to the private laboratories.
A. Consignments that have no entities for the issuance of conformity certificates including original auto spare parts, computer accessories and everything excepted by the Ministry of Commerce and Industry is are manufactured by the original manufacturers provided that a certificate issued by the manufacturer (factory) shall be attached thereto certifying that the spare parts and computer accessories are original (genuine) and manufactured by the factory and that the manufacturer bears full responsibility for the damages that might happen as a result for their utilization.
B. Consignments imported for personal use and of little quantities, a written undertaking shall be taken to the effect of not offering them in the market.
C. Consignments bearing quality mark issued by the Saudi Arabian Standards Organization (SASO), provided that the importer shall submit what proves the validity of the quality mark.
D. Consignments imported under contracts with government entities, registered companies or licensed factories intended for those entities exclusive use and not for sale, provided that the original contract or a copy certified by the contracting entity shall be presented and the quantities imported shall be conforming to those stated in the contracts.
E. If so desires, the contracting entity may request the testing of those merchandise by a private laboratory used for the purpose of their conformity with the approved standards.
F. Used cars shall be referred to the Saudi Arabian Standards Organization (SASO) for testing to ensure their conformity to the approved standards even if conformity certificates are attached thereto issued by approved entities in the issuing (exporting) country in implementation of what is agreed upon between the Ministry (MOC&I) and the Saudi Arabian Standards Organization (SASO) in this regard.
PETER S. MERGUERIAN
peter@goglobalcompliance.com
GO GLOBAL COMPLIANCE, INC.
Tel: (408) 416-3772
Fax: (408) 416-3224
Cell: (925) 487-4640
Skype: petermerguerian
twitter: marketaccess
Global Regulatory Compliance
Tuesday, May 27, 2008
ATEX FAQs
Q: What does ATEX mean?
A: ATEX is French for ATmosphere EXplosible.
Q: Where is the ATEX Directive applicable?
For equipment intended for entry or use in the European Union.
Q: Where can I find the text of the ATEX Directive 94/9/EC?A: http://europa.eu.int/smartapi/cgi/sga_doc?smartapi!celexapi!prod!CELEXnumdoc&lg=en&numdoc=31994L0009&model=guichett
Q: How does one determine if the ATEX Directive applies to a product?A: The Manufacturer is responsible for determining whether the product will be used in a potentially explosive atmosphere. This may be driven by a requirement from the end-user or an engineering decision based on the target market(s).
For instance, a manufacturer would like to design a pressure sensor that will be used in a gas turbine. It is very likely that ATEX approval will be required.
Similarly, an end-user would like to have a pump system that will be located in a process chamber that uses Hydrogen gas. ATEX approval would definitely apply.
Q: What are the various ATEX classifications?
A: Products are divided into Groups and further into Categories.
GROUP I is reserved for products intended for use in underground mines
GROUP II covers the rest of the products with the exception of certain excluded products.
GROUP II is broken into Categories as follows:
Category 1 is for products ensuring a very high level of protection intended for use where explosive environments are very likely to occur and for long periods of time.
Category 2 is for products ensuring a high level of protection intended for use where explosive environments are likely to occur and may be sustained for short durations.
Category 3 is for products capable of maintaining normal operation intended for use where explosive environments are less likely to occur and are for short durations only.
Q: What are Zones and how do they relate to the Classification system?
A: Zones represent the intended areas of use for the equipment and define the intended environment and/or level of severity. Products approved for Category 1 can be used in any Zone, however products approved for Category 3 can only be used in Zone 2. =
Zone 0 is a direct hazard or continuous environment.
Zone 1 is a highly potential environment.
Zone 2 is a likely environment.
Q: Is ATEX compatible with North American Hazardous Locations?
A: Haz-Loc in the US are evaluated according to the NEC 500 or NEC 505. There are correlations between the classification systems, but no direct conversion.
Q: What is involved in an ATEX project?
A: The scope of an ATEX project is determined by the classification being pursued by the client. This is listed by Category for clarity:
Category 1 – EC type examination + Production QA (or) Product Verification + Notified Body Certification(s). Notified Body involvement is mandatory.
Category 2 – For electrical equipment, same process as Category 1. For mechanical equipment, Internal Production Control system + Communication of TCF to Notified Body is required.
Category 3 – Self Declaration is possible if Internal Production Control system is in place.
Audit or type examination.
Q: What type of documentation is involved in an ATEX project?
A: Much of the same type of documentation is required for ATEX as for any other CE type project. The manufacturer is required to issue a Declaration of Conformity, compile a TCF or CDF, and furnish documentation related to their Quality System (if necessary). The TCF should include Certificates for components that are ATEX approved and used in an assembly. The engineer will assist the client in compiling the appropriate documentation.
Q: Is IEC Ex the same as EU EEx approval?
A: No. IEC Ex is notation for the IEC CB scheme for electrical equipment intended for use in explosive atmospheres.
Q: How is the product marked and what are all those symbols?
A: The ATEX Directive calls for marking of products beyond the typical CE Mark. The most recognizable symbol is the Ex within the hexagon, which indicates the equipment is intended for use within an ATEX environment.
The remaining symbols typically communicate the Group, Category, Temperature Class, and other specifics. This allows for a visual inspection at the point of use to ensure the equipment meets minimum requirements for the application. The marking is the responsibility of the manufacturer; however we typically provide assistance in deciphering the required symbols.
Q: Where can I get help with ATEX?
The text of the Directive, along with other resources, can be found at: http://europa.eu.int/comm/enterprise/atex/infor.htm
In particular, the guide is a useful tool to help understand the nuances of the Directive:
http://europa.eu.int/comm/enterprise/atex/guide/guide_en.pdf
PETER S. MERGUERIAN
peter@goglobalcompliance.com
GO GLOBAL COMPLIANCE, INC.
Tel: (408) 416-3772
Fax: (408) 416-3224
Cell: (925) 487-4640
Skype: petermerguerian
twitter: marketaccess
A: ATEX is French for ATmosphere EXplosible.
Q: Where is the ATEX Directive applicable?
For equipment intended for entry or use in the European Union.
Q: Where can I find the text of the ATEX Directive 94/9/EC?A: http://europa.eu.int/smartapi/cgi/sga_doc?smartapi!celexapi!prod!CELEXnumdoc&lg=en&numdoc=31994L0009&model=guichett
Q: How does one determine if the ATEX Directive applies to a product?A: The Manufacturer is responsible for determining whether the product will be used in a potentially explosive atmosphere. This may be driven by a requirement from the end-user or an engineering decision based on the target market(s).
For instance, a manufacturer would like to design a pressure sensor that will be used in a gas turbine. It is very likely that ATEX approval will be required.
Similarly, an end-user would like to have a pump system that will be located in a process chamber that uses Hydrogen gas. ATEX approval would definitely apply.
Q: What are the various ATEX classifications?
A: Products are divided into Groups and further into Categories.
GROUP I is reserved for products intended for use in underground mines
GROUP II covers the rest of the products with the exception of certain excluded products.
GROUP II is broken into Categories as follows:
Category 1 is for products ensuring a very high level of protection intended for use where explosive environments are very likely to occur and for long periods of time.
Category 2 is for products ensuring a high level of protection intended for use where explosive environments are likely to occur and may be sustained for short durations.
Category 3 is for products capable of maintaining normal operation intended for use where explosive environments are less likely to occur and are for short durations only.
Q: What are Zones and how do they relate to the Classification system?
A: Zones represent the intended areas of use for the equipment and define the intended environment and/or level of severity. Products approved for Category 1 can be used in any Zone, however products approved for Category 3 can only be used in Zone 2. =
Zone 0 is a direct hazard or continuous environment.
Zone 1 is a highly potential environment.
Zone 2 is a likely environment.
Q: Is ATEX compatible with North American Hazardous Locations?
A: Haz-Loc in the US are evaluated according to the NEC 500 or NEC 505. There are correlations between the classification systems, but no direct conversion.
Q: What is involved in an ATEX project?
A: The scope of an ATEX project is determined by the classification being pursued by the client. This is listed by Category for clarity:
Category 1 – EC type examination + Production QA (or) Product Verification + Notified Body Certification(s). Notified Body involvement is mandatory.
Category 2 – For electrical equipment, same process as Category 1. For mechanical equipment, Internal Production Control system + Communication of TCF to Notified Body is required.
Category 3 – Self Declaration is possible if Internal Production Control system is in place.
Audit or type examination.
Q: What type of documentation is involved in an ATEX project?
A: Much of the same type of documentation is required for ATEX as for any other CE type project. The manufacturer is required to issue a Declaration of Conformity, compile a TCF or CDF, and furnish documentation related to their Quality System (if necessary). The TCF should include Certificates for components that are ATEX approved and used in an assembly. The engineer will assist the client in compiling the appropriate documentation.
Q: Is IEC Ex the same as EU EEx approval?
A: No. IEC Ex is notation for the IEC CB scheme for electrical equipment intended for use in explosive atmospheres.
Q: How is the product marked and what are all those symbols?
A: The ATEX Directive calls for marking of products beyond the typical CE Mark. The most recognizable symbol is the Ex within the hexagon, which indicates the equipment is intended for use within an ATEX environment.
The remaining symbols typically communicate the Group, Category, Temperature Class, and other specifics. This allows for a visual inspection at the point of use to ensure the equipment meets minimum requirements for the application. The marking is the responsibility of the manufacturer; however we typically provide assistance in deciphering the required symbols.
Q: Where can I get help with ATEX?
The text of the Directive, along with other resources, can be found at: http://europa.eu.int/comm/enterprise/atex/infor.htm
In particular, the guide is a useful tool to help understand the nuances of the Directive:
http://europa.eu.int/comm/enterprise/atex/guide/guide_en.pdf
PETER S. MERGUERIAN
peter@goglobalcompliance.com
GO GLOBAL COMPLIANCE, INC.
Tel: (408) 416-3772
Fax: (408) 416-3224
Cell: (925) 487-4640
Skype: petermerguerian
twitter: marketaccess
Monday, May 26, 2008
Saturday, May 24, 2008
Trinidad and Tobago: Equipment Standardization and Certification Framework for the Telecommunications and Broadcasting Sectors
http://www.tatt.org.tt/ddocs/Equipment_Standardization_Framework%20Feb2008.pdf
EU Harmonized Standards for the R TTE Directive
http://ec.europa.eu/enterprise/rtte/mandates/m284en.pdf
Frequently asked questions (FAQs) concerning EU Directive R&TTE 1999/5/EC
http://ec.europa.eu/enterprise/rtte/faq.htm
Thursday, May 22, 2008
SAFETY LINK: COMPREHENSIVE COLLECTION of ELECTRICAL PRODUCT SAFETY & STANDARDS
For Immediate Release:
Contact:
Arthur Michael
Product Safety Int'l
166 Congdon St. East
Middletown, CT 06457 USA
A COMPREHENSIVE COLLECTION of ELECTRICAL PRODUCT SAFETY & STANDARDS
RESOURCES
Middletown, Connecticut, USA, May 21, 2008: Product Safety
International, an electrical product safety compliance consultancy, publishes the Safety Link, the web's most comprehensive collection of electrical product safety
and standards resources. Online since 1995 and recently revamped, the Safety Link
provides ready access to the World's electrical product safety approval
test labs including BSI, CSA International, FM Approvals, Intertek, the
NRTLs, the TUVs, UL, VDE and 100's more; standards bodies such as ANSI, CENELEC,
IEC, EIA, and ETSI; government links such as BERR, CPSC, FCC, OSHA, NIST and the
EU. CE marking information can also be found here along with links to many EU
Directives and associated resources regarding electrical product safety.
Links to related compliance resources, including those in the fields of
EMC/RFI, Telecommunications, Quality, EHS, WEEE/RoHS and the Environment, are
also provided. The Safety Link is of utility to professionals responsible for
electrical or electronic regulatory compliance efforts. Please click on the
"Optimize Your Safety Link Visit" tab to gain full benefit of the
redesign and the new search and translation options available. Each month the Safety
Link provides critical resources to electrical product safety professionals
from more than 90 countries; it is referenced by more than 1,000 sites in
60+ countries.
The Safety Link is at: http://www.safetylink.com
ABOUT: The Safety Link is provided by Product Safety International(established
in 1982); Arthur E. Michael, the principal consultant of Product Safety International, has 40+ years of diverse design experience, ranging from
reactor controls and space vehicle guidance systems to consumer products. He is
the Editor of "International Product Safety News" founded in 1988 (ISSN
1040-7529), a founding member & past President of the Northeast Product Safety
Society, Inc. and consults and lectures thoughout the U.S., Europe, and Asia.
Mr. Michael is a Charter Member of the IEEE's Product Safety Engineering
Society and a Life Member of the IEEE.
PETER S. MERGUERIAN
peter@goglobalcompliance.com
GO GLOBAL COMPLIANCE, INC.
Tel: (408) 416-3772
Fax: (408) 416-3224
Cell: (925) 487-4640
Skype: petermerguerian
twitter: marketaccess
Contact:
Arthur Michael
Product Safety Int'l
166 Congdon St. East
Middletown, CT 06457 USA
A COMPREHENSIVE COLLECTION of ELECTRICAL PRODUCT SAFETY & STANDARDS
RESOURCES
Middletown, Connecticut, USA, May 21, 2008: Product Safety
International, an electrical product safety compliance consultancy, publishes the Safety Link, the web's most comprehensive collection of electrical product safety
and standards resources. Online since 1995 and recently revamped, the Safety Link
provides ready access to the World's electrical product safety approval
test labs including BSI, CSA International, FM Approvals, Intertek, the
NRTLs, the TUVs, UL, VDE and 100's more; standards bodies such as ANSI, CENELEC,
IEC, EIA, and ETSI; government links such as BERR, CPSC, FCC, OSHA, NIST and the
EU. CE marking information can also be found here along with links to many EU
Directives and associated resources regarding electrical product safety.
Links to related compliance resources, including those in the fields of
EMC/RFI, Telecommunications, Quality, EHS, WEEE/RoHS and the Environment, are
also provided. The Safety Link is of utility to professionals responsible for
electrical or electronic regulatory compliance efforts. Please click on the
"Optimize Your Safety Link Visit" tab to gain full benefit of the
redesign and the new search and translation options available. Each month the Safety
Link provides critical resources to electrical product safety professionals
from more than 90 countries; it is referenced by more than 1,000 sites in
60+ countries.
The Safety Link is at: http://www.safetylink.com
ABOUT: The Safety Link is provided by Product Safety International(established
in 1982); Arthur E. Michael, the principal consultant of Product Safety International, has 40+ years of diverse design experience, ranging from
reactor controls and space vehicle guidance systems to consumer products. He is
the Editor of "International Product Safety News" founded in 1988 (ISSN
1040-7529), a founding member & past President of the Northeast Product Safety
Society, Inc. and consults and lectures thoughout the U.S., Europe, and Asia.
Mr. Michael is a Charter Member of the IEEE's Product Safety Engineering
Society and a Life Member of the IEEE.
PETER S. MERGUERIAN
peter@goglobalcompliance.com
GO GLOBAL COMPLIANCE, INC.
Tel: (408) 416-3772
Fax: (408) 416-3224
Cell: (925) 487-4640
Skype: petermerguerian
twitter: marketaccess
Wednesday, May 21, 2008
Tuesday, May 20, 2008
Mexico NOM-ANCE logo
PETER S. MERGUERIAN
peter@goglobalcompliance.com
GO GLOBAL COMPLIANCE, INC.
Tel: (408) 416-3772
Fax: (408) 416-3224
Cell: (925) 487-4640
Skype: petermerguerian
twitter: marketaccess
South Korea ROHS - Effective Date July 1, 2008
Mandatory Product List for Korea ROHS
1. TV (CRT, LCD, PDP etc.)
2. Refrigerators
3. Washing machines (Household)
4. Air conditioner
5. PC (including monitor, keyboard)
6. Audio (excluding portable equipment)
7. Mobile phone (including battery and charger)
8. Printer
9. Copier
10. Facsimile
Limits:
Electric, Electronics appliances:
Pb, Hg, Cr6+, PBB : below 0.1%/wt
Cd: below 0.01%/wt
Overseas manufacturer must self declare compliance and South Korean importer must register ROHS product information to “Korea Environment & Resources Corporation (www.ecoas.or.kr)” within a month of import declaration date. Manufacturer and importer are responsible to submit required information for recycling upon request.
PETER S. MERGUERIAN
peter@goglobalcompliance.com
GO GLOBAL COMPLIANCE, INC.
Tel: (408) 416-3772
Fax: (408) 416-3224
Cell: (925) 487-4640
Skype: petermerguerian
twitter: marketaccess
1. TV (CRT, LCD, PDP etc.)
2. Refrigerators
3. Washing machines (Household)
4. Air conditioner
5. PC (including monitor, keyboard)
6. Audio (excluding portable equipment)
7. Mobile phone (including battery and charger)
8. Printer
9. Copier
10. Facsimile
Limits:
Electric, Electronics appliances:
Pb, Hg, Cr6+, PBB : below 0.1%/wt
Cd: below 0.01%/wt
Overseas manufacturer must self declare compliance and South Korean importer must register ROHS product information to “Korea Environment & Resources Corporation (www.ecoas.or.kr)” within a month of import declaration date. Manufacturer and importer are responsible to submit required information for recycling upon request.
PETER S. MERGUERIAN
peter@goglobalcompliance.com
GO GLOBAL COMPLIANCE, INC.
Tel: (408) 416-3772
Fax: (408) 416-3224
Cell: (925) 487-4640
Skype: petermerguerian
twitter: marketaccess
Saturday, May 17, 2008
South Korea KCC Mark Logo
Link to S. Korea KCC Mark logo with elements around the
http://www.rrl.go.kr/eng/approval/process/sign.jsp
PETER S. MERGUERIAN
peter@goglobalcompliance.com
GO GLOBAL COMPLIANCE, INC.
Tel: (408) 416-3772
Fax: (408) 416-3224
Cell: (925) 487-4640
Skype: petermerguerian
twitter: marketaccess
http://www.rrl.go.kr/eng/approval/process/sign.jsp
PETER S. MERGUERIAN
peter@goglobalcompliance.com
GO GLOBAL COMPLIANCE, INC.
Tel: (408) 416-3772
Fax: (408) 416-3224
Cell: (925) 487-4640
Skype: petermerguerian
twitter: marketaccess
Thursday, May 15, 2008
Australia and Medical Devices
All medical devices placed on the market in Australia must have a sponsor for the goods, resident in Australia, who takes responsibility for the products, compliance with regulatory obligations and any postmarket action, such as regulatory reporting to the TGA (Therapeutic Goods Authority), distribution, product recall, etc.
Here are a number of links to the TGA website:
Medical Devices home page - http://www.tga.gov.au/devices/devices.htm
Roles and responsibilities of medical device sponsors and manufacturers -
http://www.tga.gov.au/docs/html/devguid20.htm
Prior to you supplying medical devices in Australia, the device(s) must be entered on to the Australian Register of Therapeutic Goods (ARTG). This is done using an e-business account which a device sponsor establishes with the TGA, using the Devices Electronic Application Lodgement (DEAL) system established by the TGA.
Guidance on establishment of an e-business account and lodgement of applications can be found at - http://www.tga.gov.au/devices/dealfaq.htm#q7
The above document also has links to a number of other guidance documents, available from the website, which will provide you with further information on key elements of the regulatory framework and application process.
Fees are payable for most applications, and an annual fee is payable for each entry held by a sponsor on the ARTG.
Summary of fees and charges - http://www.tga.gov.au/fees/fees06.htm
Search the Australian Register of Therapeutic Goods
- https://www.tgasime.health.gov.au/SIME/ARTG/ARTGPublicWeb.nsf/DEVpublic?OpenView
PETER S. MERGUERIAN
peter@goglobalcompliance.com
GO GLOBAL COMPLIANCE, INC.
Tel: (408) 416-3772
Fax: (408) 416-3224
Cell: (925) 487-4640
Skype: petermerguerian
twitter: marketaccess
Here are a number of links to the TGA website:
Medical Devices home page - http://www.tga.gov.au/devices/devices.htm
Roles and responsibilities of medical device sponsors and manufacturers -
http://www.tga.gov.au/docs/html/devguid20.htm
Prior to you supplying medical devices in Australia, the device(s) must be entered on to the Australian Register of Therapeutic Goods (ARTG). This is done using an e-business account which a device sponsor establishes with the TGA, using the Devices Electronic Application Lodgement (DEAL) system established by the TGA.
Guidance on establishment of an e-business account and lodgement of applications can be found at - http://www.tga.gov.au/devices/dealfaq.htm#q7
The above document also has links to a number of other guidance documents, available from the website, which will provide you with further information on key elements of the regulatory framework and application process.
Fees are payable for most applications, and an annual fee is payable for each entry held by a sponsor on the ARTG.
Summary of fees and charges - http://www.tga.gov.au/fees/fees06.htm
Search the Australian Register of Therapeutic Goods
- https://www.tgasime.health.gov.au/SIME/ARTG/ARTGPublicWeb.nsf/DEVpublic?OpenView
PETER S. MERGUERIAN
peter@goglobalcompliance.com
GO GLOBAL COMPLIANCE, INC.
Tel: (408) 416-3772
Fax: (408) 416-3224
Cell: (925) 487-4640
Skype: petermerguerian
twitter: marketaccess
Tuesday, May 13, 2008
Vietnam Telecom / Radiocom Standards
THE LIST OF PRODUCTS SUBJECT TO SPECIALIZED MANAGEMENT BY THE MINISTRY OF
POSTS AND TELEMATICS AND COMPULSORY TO BE TYPE-APPROVED
(Promulgated together with the Decision No. 45/2006/QD-BBCVT dated November 3, 2006 of the Minister of Posts and Telematics
1. Fixed, mobile network elements
1.1. Large Digital Exchange TCN 68 – 179 : 1999
1.2. Small Digital Exchange TCN 68 – 146 : 1995
1.3. Network Access Equipment (including digital subscriber concentrator, pair-gain equipment)
TCN 68 - 163 : 1997
TCN 68 - 163A : 1997
TCN 68 - 163B : 1997
TCN 68 - 169 : 1998
TCN 68 - 179 : 1999
TCN 68 - 184 : 1999
TCN 68 - 185 : 1999
TCN 68 – 188 : 2000
1.4. Cardphone equipment TCN 68 – 166 : 1997
2. Transmission Equipment
2.1. Optical fiber transmission equipment TCN 68 - 173 : 1998
TCN 68 - 175 : 1998
TCN 68 – 177 : 1998
2.2. Digital microwave transmission equipment TCN 68 - 137 : 1995
TCN 68 - 156 : 1996
TCN 68 - 158 : 1996
TCN 68 – 234 : 2006
3. Transmission Cable
3.1. Optical fiber cables TCN 68 - 160 : 1995
3.2. Metallic cables TCN 68 - 132 : 1998
4. Terminal Equipment
4.1. Terminal equipment to be connected to an analogue subscriber interface in the PSTN TCN 68 - 188 : 2000
TCN 68 - 190 : 2003
TCN 68 - 193 : 2000
TCN 68 - 196 : 2001
TCN 68 - 211 : 2002
4.2. Terminal equipment to be connected to ISDN using basic rate access BRA TCN 68 - 189 : 2000
TCN 68 - 190 : 2003
TCN 68 - 193 : 2000
TCN 68 - 196 : 2001
TCN 68 - 212 : 2002
TCN 68 - 213 : 2002
4.3. Cordless telephone equipment TCN 68 - 143 : 2003
TCN 68 - 188 : 2000
TCN 68 - 190 : 2003
TCN 68 - 192 : 2003
TCN 68 - 196 : 2001
TCN 68 - 211 : 2002
4.4. Public Land Mobile Network Terminals TCN 68 - 138 : 1995
TCN 68 - 221 : 2004
TCN 68 - 222 : 2004
TCN 68 - 223 : 2004
TCN 68 - 245 : 2006
4.5. Terminal equipment to be connected to Public Telecommunications Network via leased-lines TCN 68 - 190 : 2003
TCN 68 - 193 : 2000
TCN 68 - 196 : 2001
TCN 68 - 216 : 2002
TCN 68 - 217 : 2002
4.6. PABX TCN 68 - 136 : 1995
TCN 68 - 188 : 2000
TCN 68 - 190 : 2003
TCN 68 - 193 : 2000
TCN 68 - 196 : 2001
4.7. xDSL Terminal Equipment TCN 68 - 190 : 2003
TCN 68 - 193 : 2000
TCN 68 - 196 : 2001
5. Radio frequency transmitters, tranceivers having frequency band in the range from 9 kHz to 400 GHz, and transmitted power from 60 mW upwards
5.1. Radio frequency transmitters, tranceivers used in land fixed or mobile communications systems TCN 68 - 192 : 2003
TCN 68 - 219 : 2004
TCN 68 - 220 : 2004
TCN 68 - 229 : 2005
TCN 68 - 230 : 2005
TCN 68 - 231 : 2005
TCN 68 - 232 : 2005
TCN 68 - 233 : 2005
TCN 68 - 235 : 2006
TCN 68 - 236 : 2006
TCN 68 - 237 : 2006
TCN 68 - 238 : 2006
TCN 68 - 242 : 2006
TCN 68 - 251 : 2006
TCN 68 - 252 : 2006
***
5.2. Radio frequency transmitters, tranceivers exclusively used for television broadcasting TCN 68 - 192 : 2003
TCN 68 - 246 : 2006
***
5.3. Radio frequency transmitters, tranceivers exclusively used for radio broadcasting TCN 68 - 192 : 2003
***
5.4. Radio frequency transmitters, tranceivers exclusively used for standardization (of time, frequency) TCN 68 - 192 : 2003
***
5.5. Radio frequency transmitters, tranceivers exclusively used for positioning and remote measuring (excluding offshore equipment used for oil and gas industry). TCN 68 - 192 : 2003
TCN 68 - 243 : 2000
***
5.6. Radio frequency transmitters, tranceivers exclusively used for satellite communication (except mobile equipment used in marine and aviation) TCN 68 - 180 : 1999
TCN 68 - 192 : 2003
TCN 68 - 215 : 2002
TCN 68 - 214 : 2002
***
5.7. Radio Amateur transmitters, tranceivers TCN 68-244: 2006
***
5.8. Radio frequency transmitters, tranceivers exclusively used for marine mobile services (including support and satellite equipment) TCN 68 - 192 : 2003
TCN 68 - 198 : 2001
TCN 68 - 199 : 2001
TCN 68 - 200 : 2001
TCN 68 - 201 : 2001
TCN 68 - 202 : 2001
TCN 68 - 204 : 2001
TCN 68 - 205 : 2001
TCN 68 - 206 : 2001
TCN 68 - 239 : 2006
TCN 68 - 240 : 2006
TCN 68 - 241 : 2006
TCN 68 - 247 : 2006
TCN 68 - 248 : 2006
TCN 68 - 249 : 2006
TCN 68 - 250 : 2006
***
5.9. Radio frequency transmitters, tranceivers exclusively used for aviation mobile services (including support and satellite equipment) TCN 68 - 192 : 2003
***
6. Radio frequency support equipment
6.1. Radar equipment TCN 68 - 192 : 2003
***
6.2. Guiding equipment using radio frequency TCN 68 - 192 : 2003
***
6.3. Warning equipment, remote control equipment using radio frequency TCN 68 - 192 : 2003
TCN 68 - 243 : 2006
***
6.4. Reading equipment using radio frequency TCN 68 - 192 : 2003
TCN 68 - 243 : 2006
***
Note:
- *** Application of National radio frequency planning, Decision No. 478/2001/QĐ-TCBĐ dated June 15, 2001 of the General Director of the Department General of Posts and telecommunications on promulgating “Technical specifications applied for type approval of radio frequency equipment”, International regulations on radio frequency of International Telecommunications Union (ITU)
PETER S. MERGUERIAN
peter@goglobalcompliance.com
GO GLOBAL COMPLIANCE, INC.
Tel: (408) 416-3772
Fax: (408) 416-3224
Cell: (925) 487-4640
Skype: petermerguerian
twitter: marketaccess
POSTS AND TELEMATICS AND COMPULSORY TO BE TYPE-APPROVED
(Promulgated together with the Decision No. 45/2006/QD-BBCVT dated November 3, 2006 of the Minister of Posts and Telematics
1. Fixed, mobile network elements
1.1. Large Digital Exchange TCN 68 – 179 : 1999
1.2. Small Digital Exchange TCN 68 – 146 : 1995
1.3. Network Access Equipment (including digital subscriber concentrator, pair-gain equipment)
TCN 68 - 163 : 1997
TCN 68 - 163A : 1997
TCN 68 - 163B : 1997
TCN 68 - 169 : 1998
TCN 68 - 179 : 1999
TCN 68 - 184 : 1999
TCN 68 - 185 : 1999
TCN 68 – 188 : 2000
1.4. Cardphone equipment TCN 68 – 166 : 1997
2. Transmission Equipment
2.1. Optical fiber transmission equipment TCN 68 - 173 : 1998
TCN 68 - 175 : 1998
TCN 68 – 177 : 1998
2.2. Digital microwave transmission equipment TCN 68 - 137 : 1995
TCN 68 - 156 : 1996
TCN 68 - 158 : 1996
TCN 68 – 234 : 2006
3. Transmission Cable
3.1. Optical fiber cables TCN 68 - 160 : 1995
3.2. Metallic cables TCN 68 - 132 : 1998
4. Terminal Equipment
4.1. Terminal equipment to be connected to an analogue subscriber interface in the PSTN TCN 68 - 188 : 2000
TCN 68 - 190 : 2003
TCN 68 - 193 : 2000
TCN 68 - 196 : 2001
TCN 68 - 211 : 2002
4.2. Terminal equipment to be connected to ISDN using basic rate access BRA TCN 68 - 189 : 2000
TCN 68 - 190 : 2003
TCN 68 - 193 : 2000
TCN 68 - 196 : 2001
TCN 68 - 212 : 2002
TCN 68 - 213 : 2002
4.3. Cordless telephone equipment TCN 68 - 143 : 2003
TCN 68 - 188 : 2000
TCN 68 - 190 : 2003
TCN 68 - 192 : 2003
TCN 68 - 196 : 2001
TCN 68 - 211 : 2002
4.4. Public Land Mobile Network Terminals TCN 68 - 138 : 1995
TCN 68 - 221 : 2004
TCN 68 - 222 : 2004
TCN 68 - 223 : 2004
TCN 68 - 245 : 2006
4.5. Terminal equipment to be connected to Public Telecommunications Network via leased-lines TCN 68 - 190 : 2003
TCN 68 - 193 : 2000
TCN 68 - 196 : 2001
TCN 68 - 216 : 2002
TCN 68 - 217 : 2002
4.6. PABX TCN 68 - 136 : 1995
TCN 68 - 188 : 2000
TCN 68 - 190 : 2003
TCN 68 - 193 : 2000
TCN 68 - 196 : 2001
4.7. xDSL Terminal Equipment TCN 68 - 190 : 2003
TCN 68 - 193 : 2000
TCN 68 - 196 : 2001
5. Radio frequency transmitters, tranceivers having frequency band in the range from 9 kHz to 400 GHz, and transmitted power from 60 mW upwards
5.1. Radio frequency transmitters, tranceivers used in land fixed or mobile communications systems TCN 68 - 192 : 2003
TCN 68 - 219 : 2004
TCN 68 - 220 : 2004
TCN 68 - 229 : 2005
TCN 68 - 230 : 2005
TCN 68 - 231 : 2005
TCN 68 - 232 : 2005
TCN 68 - 233 : 2005
TCN 68 - 235 : 2006
TCN 68 - 236 : 2006
TCN 68 - 237 : 2006
TCN 68 - 238 : 2006
TCN 68 - 242 : 2006
TCN 68 - 251 : 2006
TCN 68 - 252 : 2006
***
5.2. Radio frequency transmitters, tranceivers exclusively used for television broadcasting TCN 68 - 192 : 2003
TCN 68 - 246 : 2006
***
5.3. Radio frequency transmitters, tranceivers exclusively used for radio broadcasting TCN 68 - 192 : 2003
***
5.4. Radio frequency transmitters, tranceivers exclusively used for standardization (of time, frequency) TCN 68 - 192 : 2003
***
5.5. Radio frequency transmitters, tranceivers exclusively used for positioning and remote measuring (excluding offshore equipment used for oil and gas industry). TCN 68 - 192 : 2003
TCN 68 - 243 : 2000
***
5.6. Radio frequency transmitters, tranceivers exclusively used for satellite communication (except mobile equipment used in marine and aviation) TCN 68 - 180 : 1999
TCN 68 - 192 : 2003
TCN 68 - 215 : 2002
TCN 68 - 214 : 2002
***
5.7. Radio Amateur transmitters, tranceivers TCN 68-244: 2006
***
5.8. Radio frequency transmitters, tranceivers exclusively used for marine mobile services (including support and satellite equipment) TCN 68 - 192 : 2003
TCN 68 - 198 : 2001
TCN 68 - 199 : 2001
TCN 68 - 200 : 2001
TCN 68 - 201 : 2001
TCN 68 - 202 : 2001
TCN 68 - 204 : 2001
TCN 68 - 205 : 2001
TCN 68 - 206 : 2001
TCN 68 - 239 : 2006
TCN 68 - 240 : 2006
TCN 68 - 241 : 2006
TCN 68 - 247 : 2006
TCN 68 - 248 : 2006
TCN 68 - 249 : 2006
TCN 68 - 250 : 2006
***
5.9. Radio frequency transmitters, tranceivers exclusively used for aviation mobile services (including support and satellite equipment) TCN 68 - 192 : 2003
***
6. Radio frequency support equipment
6.1. Radar equipment TCN 68 - 192 : 2003
***
6.2. Guiding equipment using radio frequency TCN 68 - 192 : 2003
***
6.3. Warning equipment, remote control equipment using radio frequency TCN 68 - 192 : 2003
TCN 68 - 243 : 2006
***
6.4. Reading equipment using radio frequency TCN 68 - 192 : 2003
TCN 68 - 243 : 2006
***
Note:
- *** Application of National radio frequency planning, Decision No. 478/2001/QĐ-TCBĐ dated June 15, 2001 of the General Director of the Department General of Posts and telecommunications on promulgating “Technical specifications applied for type approval of radio frequency equipment”, International regulations on radio frequency of International Telecommunications Union (ITU)
PETER S. MERGUERIAN
peter@goglobalcompliance.com
GO GLOBAL COMPLIANCE, INC.
Tel: (408) 416-3772
Fax: (408) 416-3224
Cell: (925) 487-4640
Skype: petermerguerian
twitter: marketaccess
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