Global Regulatory Changes Prepared for TCBC Meeting – 09-Apr-14

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

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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


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Global Regulatory Changes - OverviewSignificant Regulatory Changes in

the following countriesArgentinaBoliviaMalaysia Pakistan


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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


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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


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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.


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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


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EA Customs Union (EAC)

Approval Scheme


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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.


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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


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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


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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


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India BIS Safety Approval

Scheme


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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


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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


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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)


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)


Requirements

7. Printers, Plotters IS 13252:2003(ISO/IEC 60950-

1:2005)


Requirements

8. Scanners IS 13252:2010(ISO/IEC 60950-

1:2005)


Requirements

Testing standards


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Product Indian Standard Title

9. Wireless Keyboards IS 13252:2010(ISO/IEC 60950-

1:2005)


Requirements

10. Telephone Answering Machines

IS 13252:2010(ISO/IEC 60950-

1:2005)


Requirements

11. Amplifiers with input power 2000W and above

IS 616:2010(IEC 60065:2005)


Requirements

12. Electronic Musical Systems with input 2000W

and above

IS 616:2010(IEC 60065:2005)


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)


Requirements

15. Automatic Data Processing Machine

IS 13252:2010(ISO/IEC 60950-

1:2005)


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


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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


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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


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Procedure Overview – moving forward


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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


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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)


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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.


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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


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Procedure Overview -Declaration (DoC)


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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.


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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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Tel: +44 1844 273277Fax: +44 1844 273278

www.productcompliancespecialists.com


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Global Regulatory Changes Prepared for TCBC Meeting – 09-Apr-14