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Global Regulatory Changes Prepared for TCBC Meeting – 09-Apr-14. Scope of Presentation. Introduction to PCS Global Regulatory Changes – Overview Country Specific Focus Eurasian Customs Union Indonesia India BIS Ukraine Summary on other Regulatory Changes. Introduction to PCS. - PowerPoint PPT Presentation
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Global Regulatory Changes
Prepared for TCBC Meeting – 09-Apr-14
Scope of PresentationIntroduction to PCSGlobal Regulatory Changes – OverviewCountry Specific Focus
Eurasian Customs UnionIndonesiaIndia BISUkraine
Summary on other Regulatory Changes
24 Apr 2023Product Compliance Specialists
Confidential 2
Introduction to PCS Dynamic UK based Company established in
2004 Specialists in managing certification of radio,
telecommunications and ITE products 12,000 Approvals obtained in 160 countries Multi-lingual team with 9 key languages spoken We specialize in international projects and
frequently manage projects for 50+ countries simultaneously
International blue chip customer base
24 Apr 2023Product Compliance Specialists
Confidential 3
Global Regulatory Changes - OverviewSignificant Regulatory Changes in
the following countriesArgentinaBoliviaMalaysia Pakistan
24 Apr 2023Product Compliance Specialists
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Regulatory Changes - ArgentinaSep 2013 - New standard affecting
2.4GHz and 5GHz WLAN releasedCame into effect on 4th November 2013All 2.4GHz and 5GHz devices tested under
previous standard must be retested at the time of renewal
5600 - 5650MHz portion of the 5GHz Band 3 no longer permitted
Bluetooth 2.1 exempt from retesting requirement
24 Apr 2023Product Compliance Specialists
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Regulatory Changes - BoliviaType Approval requirements enforced – June
2013Previously FCC Approval was sufficientTemporary Approvals issued during transition
period, invalidated – full Approval now requiredLocal applicant requiredPaperwork only processLead-time ~ 5 – 6 weeksValidity 5 years
24 Apr 2023Product Compliance Specialists
Confidential 6
Regulatory Changes - MalaysiaAdd-Host Approval Scheme for Modules
Abolished – Mar 2014No longer possible to add host models to
Approved modules via paperwork only processEach host now requires Approval in full, inclusive
of local testing / sample inspection. Products Approved prior to change in regulations
– not affected.
24 Apr 2023Product Compliance Specialists
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Regulatory Changes - PakistanApproval requirements for Mobile Phones
introduced. Jan 2014 – Pakistan Telecommunication Authority
(PTA) introduced Type Approval requirements for cellular mobile devices
New rules also apply to WWAN equipped tablets, and WWAN devices which are data only
24 Apr 2023Product Compliance Specialists
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EA Customs Union (EAC)
Approval Scheme
24 Apr 2023Product Compliance Specialists
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Customs Union Agenda Introduction
Scope and Limitations Differences to GOST, Advantages and Disadvantages
Overview of Approval Schemes Certification Declaration Exemption Letter Serial and Batch Approval
Product Categorization Labelling Requirements
Customs Union IntroductionOverview Harmonization of regulations for EMC (Electromagnetic
Compatibility) and LVE (Low-voltage equipment) across Customs Union member states of Russia, Belarus and Kazakhstan Implemented Feb 2013 as replacement to the
independent national GOST EMC / Safety Approval schemes previously enforced in these countries
EA Customs Union (EAC) Approval is a singular harmonized Approval Certificate for EMC and / or Safety that covers all member states in the union
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Customs Union IntroductionScope and LimitationsCustoms Union Approval does not cover
RF or TelecomFor RF or Telecom devices, separate
national Approval to cover RF / Telecom function must still be obtained in Russia and Belarus
Kazakhstan has no separate RF scheme so Customs Union Approval alone is sufficient.
24 Apr 2023Product Compliance Specialists
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Customs Union IntroductionKey Differences From GOSTChanges GOST Scheme Customs Union Scheme
Applicant Foreign Manufacturer or Local Company
Local Company
Route to Approval
Single route via accredited lab
Multiple routes and options – CoC, DoC, Exemption Letter
Local Testing
Requirement weakly enforced
Requirement much more rigidly enforced
Factory Inspection
No requirements / requirement weakly enforced
Requirement much more rigidly enforced
Certificate Validity
Maximum up to 3 Years Maximum up to 5 Years
Voluntary Approval
Voluntary Approval Possible No Voluntary Approvals Possible
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Customs Union IntroductionAdvantages and Disadvantages Advantages
Single EMC/ Safety Approval Certificate covering all customs union member states
Options for Longer Approval Validity Flexibility to apply for Approval in any of the member states
Disadvantages Increased complexity – multiple routes and schemes to Approval Stricter requirements – introduces local test and factory
inspection requirements. Stricter supervision and monitoring of Certification Bodies
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Customs Union IntroductionTransition from GOSTTwo Year Transition Period Allowed
Existing GOST Certificates remain valid until stated expiry date or 15th March 2015 (whichever comes first)
As of 15th March 2015, all GOST Certificates in circulation will cease to be valid and must be replaced with a Customs Union Approval
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Customs UnionApproval SchemesThree Approval Schemes
Certification (Certificate of Conformity) Declaration (Declaration of Conformity) Exemption Letter
Certification and Declaration scheme divided in to sub schemes Serial Approval Batch Approval
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Customs UnionApproval SchemesApproval Scheme
Certification, Declaration or Exemption Letter Determined by product type, function and HS
codeApproval Scope
Batch or Serial Applicant at liberty to select option that best
suits their needs and requirements
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Customs UnionApproval SchemesCertification Scheme
Third Party Certification – Certification Body takes responsibility for compliance
Required for devices ‘in scope’ of Customs Union Technical Regulations on EMC and LVE
Local Testing Required Physical Factory Audit / Inspection Required Family Approval Possible Local Approval Holder Required Lead Time ~ 12 weeks (FI ~ 12 weeks) Certificate Validity 1 - 5 Years
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Customs UnionApproval SchemesDeclaration Scheme
Applicant takes responsibility for compliance Required for devices ‘out of scope’ of Customs Union
Technical Regulations on EMC and LVE Local Testing Required Local Approval Holder Required Family Approval Possible Lead Time ~ 4 Weeks Certificate Validity 1 - 5 Years
24 Apr 2023Product Compliance Specialists
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Customs UnionApproval SchemesExemption Letter
Required for spare parts which are intended to be imported and sold in Customs Union Region as part of already Approved Host Device.
Foreign Manufacturer can hold Approval
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Customs UnionApproval Schemes Serial and Batch Approval
Serial Approval – For Serial Production – valid for import of unlimited quantity of stated product(s) during lifetime of Approval
Batch Approval – For Single Import Consignment Only. Max units unstipulated. Manufacturers expected to apply reasonable judgement.
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Customs UnionProduct CategorizationCategorization ‘In Scope’ and ‘Out of Scope’
– Determines which Approval scheme applies Products ‘In Scope’ of Customs Union EMC and LVE
Regulations are subject to Certification. Products ‘Out of Scope’ of EMC and LVE Regulations
subject to Declaration Rules can be open to interpretation. Lots of
scope for variation and differences of opinion between Customs Union Certification Bodies
24 Apr 2023Product Compliance Specialists
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Customs UnionProduct Categorization Key Factors Determining Product Classification
HS Code (Harmonised System Code) Model Name Power Supply and charging mechanism – i.e mains
A/C, DC Battery Only Input Voltage Rating Intended Use – Industrial or Consumer
HS Code is the chief determinant factor, however is rarely used in isolation alone. One or more of the above may also need to be considered
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Customs UnionProduct CategorizationGetting correct classification is crucialIncorrect classification can lead to:
Problems at import stageSevere penalties to manufacturer, local holder
and Customs Union CB including: Financial Penalties Confiscation of products Loss of accreditation status Imprisonment
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Customs UnionLabelling Customs Union Label Artwork
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Customs UnionLabelling Labelling Rules
Label should be placed on the product itself, the packaging and the user manual
If labelling product not feasible due to size restrictions label may be placed on packaging and user guide only
Label must be clear and visible to the naked eye
Minimum character height is 5mm
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Indonesia Regulatory Changes
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Indonesia AgendaGeneral Regulatory OverviewFocus on Regulatory Changes
Rules for Modular ApprovalApproval of Dual Band Access Points
Other Planned ChangesChanges to Type A / Type B ApprovalNew Application Prioritisation System
Indonesia Regulatory Overview Process and Requirements relatively stable at
current Potential for frequent regulatory changes of both
minor and major impact Often implementation of changes can be
disjointed and problematic due to lack of cohesion between Indonesian Government, Authority, Lab and Customs
Several notable and significant changes introduced in 2013
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IndonesiaRules for Modular ApprovalMultiple changes introduced during 2013
eroding strategic advantage previously conferred through Modular Approvals
Modular Approval now only advantageous if the module is imported in to Indonesia in it’s stand-alone state, not integrated in to any host
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IndonesiaRules for Modular ApprovalUnder new regulations - if module is imported
in to Indonesia installed inside a host then host Approval must be obtained again in full from scratch
Local testing on host must be repeated – not possible to leverage any modular level results.
Local importers no longer able to apply for Type B Host Approval, leveraging from Type A Modular Approval
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IndonesiaDual Band Access Points Previously WLAN Access Points could only be
Approved for single band use – either 2.4GHz or 5GHz only
New Regulations from Jan 2013 – WLAN Access Points may now be Approved for Dual Band Use
Indonesia Frequency Plan - Unchanged2.4GHz – Channels 1 – 135GHz – Band 4 Only – Channels 149 – 161
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IndonesiaDual Band Access Points Approval Process for Dual Band Operation is the
same as for Single Band Operation Two Accredited Laboratories
Authority Lab Accredited Lab
Sample Requirements - StrictSamples must be locked to Indonesian bands /
channels only
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IndonesiaProposed ChangesNumerous proposed changes planned for
Indonesia Regulatory processProposed changes currently still under
development and in consultation stageNo commitments at current time regarding
extent or timeframe of implementation
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IndonesiaProposed Changes Type A and Type B Approval format to be abolished
and replaced with new system Type A – Approval issued to manufacturer Type B – Approval issued to importer (Required to
Import Goods) Most common approach at current – manufacturer
obtains Type A Approval. Importer then obtains Type B Approval via paperwork only approach, leveraging local testing from manufacturers Approval
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IndonesiaProposed Changes Cont. Price structured – applicant selected
prioritization system for processing of Type Approval applications Standard Expedite VIPNew requirements for assessment of EMC,
Safety and Human Exposure For WWAN products – requirement for IMEI
letter from authorised body
24 Apr 2023Product Compliance Specialists
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India BIS Safety Approval
Scheme
24 Apr 2023Product Compliance Specialists
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India BIS Agenda Introduction
Background to India Approval Schemes Overview of new BIS Approval scheme
What and when Products requiring mandatory BIS Approval Organisations involved in scheme
Procedure Overview Registration and product testing Moving forward
Labelling Requirements
India Approvals Overview
Up until 2013 there have always been 2 Approval schemes in place in India specifically for this industry:
WPC (Ministry of Communications and IT Department of Telecommunications) covering Radio Approvals
TEC (Telecommunication Engineering Centre) covering Telecom Approvals
24 Apr 2023Product Compliance Specialists
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India BIS – What and when In September 2012, the Electronics and Information
Technology Goods (Requirements for Compulsory Registration) Order was introduced, and enforced in March 2013.
The Order requires that certain products imported to, manufactured in, stored, distributed or sold in India must conform to the Indian (safety) standards specified in the schedule. These products must then be registered as compliant with the Bureau of Indian Standards (BIS) Technical standards in interest of public health and safety Global quality standards for domestic manufacturers
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Products requiring mandatory BIS
24 Apr 2023Product Compliance Specialists
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Products requiring mandatory BIS
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Testing standards
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Product Indian Standard Title1. Electronic Goods IS 616:2010
(IEC 60065:2005)Audio, Video and Similar
Electronic Apparatus - Safety Requirements
2. Laptop/Notebooks/Tablets IS 13252:2010(ISO/IEC 60950-
1:2005)
Information Technology Equipment - Safety - General
Requirements
3. Plasma/LCD/LED Televisions of screen size
32" and above
IS 616:2010(IEC 60065:2005)
Audio, Video and Similar Electronic Apparatus - Safety
Requirements
4. Optical Disc Players with built in amplifiers of input power 2000W and above
IS 616:2010(IEC 60065:2005)
Audio, Video and Similar Electronic Apparatus - Safety
Requirements
Testing standards
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Product Indian Standard Title5. Microwave Ovens IS 302-2-25:1994
(IEC-60335-2-25:2010)
Safety of household and similar electrical appliances: Part 2
Particular requirements: Section 25 Microwave ovens
6. Visual Display Units, Video Monitors of screen
size 32" and above
IS 13252:2010(ISO/IEC 60950-
1:2005)
Information Technology Equipment - Safety - General
Requirements
7. Printers, Plotters IS 13252:2003(ISO/IEC 60950-
1:2005)
Information Technology Equipment - Safety - General
Requirements
8. Scanners IS 13252:2010(ISO/IEC 60950-
1:2005)
Information Technology Equipment - Safety - General
Requirements
Testing standards
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Product Indian Standard Title
9. Wireless Keyboards IS 13252:2010(ISO/IEC 60950-
1:2005)
Information Technology Equipment - Safety - General
Requirements
10. Telephone Answering Machines
IS 13252:2010(ISO/IEC 60950-
1:2005)
Information Technology Equipment - Safety - General
Requirements
11. Amplifiers with input power 2000W and above
IS 616:2010(IEC 60065:2005)
Audio, Video and Similar Electronic Apparatus - Safety
Requirements
12. Electronic Musical Systems with input 2000W
and above
IS 616:2010(IEC 60065:2005)
Audio, Video and Similar Electronic Apparatus - Safety
Requirements
Testing standards
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Product Indian Standard Title
13. Electronic Clocks with Mains Powers
IS 302-2-25:1994(IEC-60335-2-
25:2010)
Safety of household and similar electrical appliances: Part 2
Particular requirements: Section 25 Microwave ovens
14. Set top box IS 13252:2010(ISO/IEC 60950-
1:2005)
Audio, Video and Similar Electronic Apparatus - Safety
Requirements
15. Automatic Data Processing Machine
IS 13252:2010(ISO/IEC 60950-
1:2005)
Information Technology Equipment - Safety - General
Requirements
CB Test reports therefore play a pivotal role in the BIS Safety Scheme
Who is involvedDeity – Department of Electronic and Information
Technology Ministry of Communications & Information Technology, Government of India
BIS – Bureau of Indian Standards
Deity introduced and oversee the scheme, they update the mandatory list. Manufacturers also must register with Deity.
BIS write the Indian standards and responsible for Approval process.
No more extensions.
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Process Outline
24 Apr 2023Product Compliance Specialists
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Procedure OverviewManufacturer and Product Registration
Both Deity and BIS involvedPrior to product registration, each physical
manufacturer (final assembly factory) needs to register with Deity
Manufacturer registration and product local testing can proceed simultaneously
Tests can only be conducted at BIS approved labs in India (per manufacturer)
BIS allow for Approval of family/type on one certificate – all models must still be tested.
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Manufacturer Registration
Pre-requisites1. Full name and address of physical manufacturer (as per safety report)2. Business registration license (or other official government issued document)3. Contact details of the appointed member of factory manufacturer responsible for BIS registration4. English translation of above is essential5. Local nominee required6. Online process, 3-4 days.
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Accredited labs
24 Apr 2023Product Compliance Specialists
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Test Report requirements – CB Test reports and critical components CB Test Reports & technical documentation must be submitted
ahead of local testing All critical components must be declared and have evidence of
conformity to IEC standards Conformity of Critical Components to standards harmonised with IEC will
also be accepted. Where IEC standards are not available, test reports issued in compliance
with other international & national standards are accepted. “Various” cannot be listed on the Safety report. All sources
of manufacturers, models and brands of a component must be identified and verified (with supporting evidence of conformity)
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Product Registration Overview
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Summary:CB test reports still play an essential role and must
be submitted to the lab ahead of test startTest reports will be issued by accredited lab for
review at BIS Physical manufacturers must be registered before
products can be ApprovedOnce reports are issued, applicants can then file for
product Approval/registrationCertificates are issued for each physical
manufacturerApprovals are valid for 2 years – full renewal process
is yet to be confirmed
24 Apr 2023Product Compliance Specialists
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Procedure Overview – moving forward
24 Apr 2023Product Compliance Specialists
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Labelling requirements
“Self Declaration - Conforming to IS xxxxxx, R-xxxxxxxx”
IS xxx = standardR = registration number
On the product and its packaging
24 Apr 2023Product Compliance Specialists
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Ukraine Approval Scheme
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Ukraine Agenda Introduction
Background to Ukraine Approval Schemes Overview on current requirements
What and when Organisations involved in scheme
Procedure Overview Certification Declaration Moving forward
Labelling Requirements
Ukraine Approvals Background Beginning of 2011 - EMC standards and
regulations were released mandating requirement for Declaration on EMC standards in addition to Certification (CoC).
Beginning of 2012 - Safety standards and regulations were released mandating requirement for Declaration on Safety in addition to the CoC and EMC Declaration (if applicable)
24 Apr 2023Product Compliance Specialists
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Ukraine Approvals Background Beginning of 2013 - RF / Telecom standards
and regulations were released to mandate that all RF and Telecom devices would require an R&TTE Declaration, in addition to any applicable EMC and Safety Declaration.
End of 2013 – advised that Ukraine Certification (CoC) for RF/Telecom would be abolished. Declarations would remain.
24 Apr 2023Product Compliance Specialists
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What and whenChanges Before At present
Legacy Type Approval (RF / Telecom Certification)
Mandatory Failure to sign European Association Agreement in Nov. 2013 - still legally in place, however CAB opinion remains divided
Agreement in process for signature, however.
Route to Approval
Via bi-monthly Commissions Meeting at Authority for Certification
CABs now issuing Approvals directly for majority of products
Commissions Meeting now only takes place once a month and is for Access Point Declarations & Telecom Certifications only
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What and whenChanges Before At present
Local Testing Enforced CABs will follow paperwork only process while political unrest continues and customs issues encountered
Certification Validity
1 year No expiry for devices such as Short Range Devices, Access Points and Cellular devices.
Other products falling under Telecom Law will still have a validity of 1 year
Annual Technical Inspection
N/A Under discussion for all Certificates with no expiry. Nothing yet in place.
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Who is involved
National Commission for the State Regulation of Communications and Information (Authority)Mandate requirements for Certification and Declaration
State Service of Special Communication and Information Protection of Ukraine (Authority)Commissions Meetings and Technical Standards
Conformity Assessment Bodies (CABs)Local testingIssuance of Certification and Declaration
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Procedure Overview - CertificationAt present, Certification is still legally required for
all RF and Telecom devices
Still 2 routes to Approval:
Local testing still required*Manufacturer can still hold Approval
* At present, varies by CAB
24 Apr 2023Product Compliance Specialists
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Procedure Overview -Declaration (DoC)
24 Apr 2023Product Compliance Specialists
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EMC - most host devices
Safety – anything mains connected
R&TTE – all RF and Telecom
Self Declared or via CAB
Outline – Declarations Local testing required – 2 samples required* Local holder required*Manufacturer EU test reports can be leveraged to avoid testing forEMC & Safety Declarations. If R&TTE DoC process runs in parallel to CoC, testing does notneed to be repeated. A single DoC listing EMC and/or Safety and/or RF
standards can be obtained. No expiry – local holder must maintain DoC for 10 years Products which have obtained R&TTE DoC must also be
registered in the national Electronic Device Register of Ukraine – mandatory for import
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Procedure Overview – moving forward
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Labelling requirements
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Mandatory for all Products with Declaration(s)If processed via a CAB, CAB number should feature below logo
Voluntary only for CertificationCAB number should feature below logo
Product and/or its packaging, operation and accompanying documents or smallest consumer
packaging
Regulatory UpdatesCountry ChangeBelarus Early 2014 - Compulsory
certification requirement for all radio and telecommunication removed. Declaration now sufficient Removes the need for physical Factory Inspection, but local testing still required.
Vietnam New technical standards introduced affecting all RF devices. Additional EMC testing required to ensure its Compliance with QCVN18, full effects being investigated at present.
24 Apr 2023Product Compliance Specialists
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Regulatory UpdatesCountry Change
Gambia Changes to Type Approval guidelines introduced in July 2013.Certificates issued before 30th October 2013 will automatically expire on 31st December 2015. Renewal is then required.
Ghana New Type Approval guidelines implemented in January 2014.Now mandatory to submit samples for local testing.
Peru Portions of 902-928MHz band opened up again in 2013915-928MHz and 916-928MHz have now been assigned as unlicensed bands
Yemen Type Approval procedures and requirements introduced at the end of 2013Type Approval now mandatory.
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Thank you
[email protected]@productcompliancespecialists.com
Tel: +44 1844 273277Fax: +44 1844 273278
www.productcompliancespecialists.com
24 Apr 2023Product Compliance Specialists
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