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Global Regulatory Changes Prepared for TCBC Meeting

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Title: Global Regulatory Changes Prepared for TCBC Meeting


1
Global Regulatory ChangesPrepared for TCBC
Meeting 09-Apr-14

2
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

3
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

4
Global Regulatory Changes - Overview
  • Significant Regulatory Changes in the following
    countries
  • Argentina
  • Bolivia
  • Malaysia
  • Pakistan

5
Regulatory Changes - Argentina
  • Sep 2013 - New standard affecting 2.4GHz and 5GHz
    WLAN released
  • Came into effect on 4th November 2013
  • All 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

6
Regulatory Changes - Bolivia
  • Type Approval requirements enforced June 2013
  • Previously FCC Approval was sufficient
  • Temporary Approvals issued during transition
    period, invalidated full Approval now required
  • Local applicant required
  • Paperwork only process
  • Lead-time 5 6 weeks
  • Validity 5 years

7
Regulatory Changes - Malaysia
  • Add-Host Approval Scheme for Modules Abolished
    Mar 2014
  • No longer possible to add host models to Approved
    modules via paperwork only process
  • Each host now requires Approval in full,
    inclusive of local testing / sample inspection.
  • Products Approved prior to change in regulations
    not affected.

8
Regulatory Changes - Pakistan
  • Approval 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

9
EA Customs Union (EAC) Approval Scheme

10
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

11
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

12
Customs Union IntroductionScope and Limitations
  • Customs Union Approval does not cover RF or
    Telecom
  • For 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.

13
Customs Union IntroductionKey Differences From
GOST
Changes 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
14
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

15
Customs Union IntroductionTransition from GOST
  • Two 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

16
Customs UnionApproval Schemes
  • Three 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

17
Customs UnionApproval Schemes
  • Approval Scheme
  • Certification, Declaration or Exemption Letter
  • Determined by product type, function and HS code
  • Approval Scope
  • Batch or Serial
  • Applicant at liberty to select option that best
    suits their needs and requirements

18
Customs UnionApproval Schemes
  • Certification 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

19
Customs UnionApproval Schemes
  • Declaration 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

20
Customs UnionApproval Schemes
  • Exemption 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

21
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.

22
Customs UnionProduct Categorization
  • Categorization 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

23
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

24
Customs UnionProduct Categorization
  • Getting correct classification is crucial
  • Incorrect classification can lead to
  • Problems at import stage
  • Severe penalties to manufacturer, local holder
    and Customs Union CB including
  • Financial Penalties
  • Confiscation of products
  • Loss of accreditation status
  • Imprisonment

25
Customs UnionLabelling
  • Customs Union Label Artwork

26
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

27
Indonesia Regulatory Changes

28
Indonesia Agenda
  • General Regulatory Overview
  • Focus on Regulatory Changes
  • Rules for Modular Approval
  • Approval of Dual Band Access Points
  • Other Planned Changes
  • Changes to Type A / Type B Approval
  • New Application Prioritisation System

29
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

30
IndonesiaRules for Modular Approval
  • Multiple 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 its
    stand-alone state, not integrated in to any host

31
IndonesiaRules for Modular Approval
  • Under 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

32
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 - Unchanged
  • 2.4GHz Channels 1 13
  • 5GHz Band 4 Only Channels 149 161

33
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 - Strict
  • Samples must be locked to Indonesian bands /
    channels only

34
IndonesiaProposed Changes
  • Numerous proposed changes planned for Indonesia
    Regulatory process
  • Proposed changes currently still under
    development and in consultation stage
  • No commitments at current time regarding extent
    or timeframe of implementation

35
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

36
IndonesiaProposed Changes Cont.
  • Price structured applicant selected
    prioritization system for processing of Type
    Approval applications
  • Standard
  • Expedite
  • VIP
  • New requirements for assessment of EMC, Safety
    and Human Exposure
  • For WWAN products requirement for IMEI letter
    from authorised body

37
India BIS Safety Approval Scheme

38
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

39
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

40
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

41
Products requiring mandatory BIS
42
Products requiring mandatory BIS
43
Testing standards
Product Indian Standard Title
1. Electronic Goods IS 6162010 (IEC 600652005) Audio, Video and Similar Electronic Apparatus - Safety Requirements
2. Laptop/Notebooks/Tablets IS 132522010 (ISO/IEC 60950-12005) Information Technology Equipment - Safety - General Requirements
3. Plasma/LCD/LED Televisions of screen size 32" and above IS 6162010 (IEC 600652005) Audio, Video and Similar Electronic Apparatus - Safety Requirements
4. Optical Disc Players with built in amplifiers of input power 2000W and above IS 6162010 (IEC 600652005) Audio, Video and Similar Electronic Apparatus - Safety Requirements
44
Testing standards
Product Indian Standard Title
5. Microwave Ovens IS 302-2-251994 (IEC-60335-2-252010) 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 132522010 (ISO/IEC 60950-12005) Information Technology Equipment - Safety - General Requirements
7. Printers, Plotters IS 132522003 (ISO/IEC 60950-12005) Information Technology Equipment - Safety - General Requirements
8. Scanners IS 132522010 (ISO/IEC 60950-12005) Information Technology Equipment - Safety - General Requirements
45
Testing standards
Product Indian Standard Title
9. Wireless Keyboards IS 132522010 (ISO/IEC 60950-12005) Information Technology Equipment - Safety - General Requirements
10. Telephone Answering Machines IS 132522010 (ISO/IEC 60950-12005) Information Technology Equipment - Safety - General Requirements
11. Amplifiers with input power 2000W and above IS 6162010 (IEC 600652005) Audio, Video and Similar Electronic Apparatus - Safety Requirements
12. Electronic Musical Systems with input 2000W and above IS 6162010 (IEC 600652005) Audio, Video and Similar Electronic Apparatus - Safety Requirements
46
Testing standards
Product Indian Standard Title
13. Electronic Clocks with Mains Powers IS 302-2-251994 (IEC-60335-2-252010) Safety of household and similar electrical appliances Part 2 Particular requirements Section 25 Microwave ovens
14. Set top box IS 132522010 (ISO/IEC 60950-12005) Audio, Video and Similar Electronic Apparatus - Safety Requirements
15. Automatic Data Processing Machine IS 132522010 (ISO/IEC 60950-12005) Information Technology Equipment - Safety - General Requirements
CB Test reports therefore play a pivotal role in
the BIS Safety Scheme
47
Who is involved
  • Deity 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.

48
Process Outline
49
Procedure Overview
  • Manufacturer and Product Registration
  • Both Deity and BIS involved
  • Prior 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.

50
Manufacturer Registration
  • Pre-requisites
  • 1. 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
    registration
  • 4. English translation of above is essential
  • 5. Local nominee required
  • 6. Online process, 3-4 days.

51
Accredited labs
52
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)

53
Product Registration Overview
54
Summary
  • CB test reports still play an essential role and
    must be submitted to the lab ahead of test start
  • Test reports will be issued by accredited lab for
    review at BIS
  • Physical manufacturers must be registered before
    products can be Approved
  • Once reports are issued, applicants can then file
    for product Approval/registration
  • Certificates are issued for each physical
    manufacturer
  • Approvals are valid for 2 years full renewal
    process is yet to be confirmed

55
Procedure Overview moving forward
56
Labelling requirements
  • Self Declaration - Conforming to IS xxxxxx,
    R-xxxxxxxx
  • IS xxx standard
  • R registration number
  • On the product and its packaging

57
Ukraine Approval Scheme

58
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

59
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)

60
Ukraine Approvals Background
  • Beginning of 2013 - RF / Telecom standards and
    regulations were released to mandate that all RF
    and Telecom devices would require an RTTE
    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.

61
What and when
Changes 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
62
What and when
Changes 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.
63
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 testing
  • Issuance of Certification and Declaration

64
Procedure Overview - Certification
  • At 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

65
Procedure Overview -Declaration (DoC)
  • EMC - most host devices
  • Safety anything mains connected
  • RTTE all RF and Telecom
  • Self Declared or via CAB

66
Outline Declarations
  • Local testing required 2 samples required
  • Local holder required
  • Manufacturer EU test reports can be leveraged to
    avoid testing for
  • EMC Safety Declarations.
  • If RTTE DoC process runs in parallel to CoC,
    testing does not
  • need 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 RTTE DoC must also
    be registered in the national Electronic Device
    Register of Ukraine mandatory for import

67
Procedure Overview moving forward
68
Labelling requirements
Mandatory for all Products with Declaration(s) If
processed via a CAB, CAB number should feature
below logo
Voluntary only for Certification CAB number
should feature below logo
Product and/or its packaging, operation and
accompanying documents or smallest consumer
packaging
69
Regulatory Updates
Country Change
Belarus 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.
70
Regulatory Updates
Country 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 2013 915-928MHz and 916-928MHz have now been assigned as unlicensed bands
Yemen Type Approval procedures and requirements introduced at the end of 2013 Type Approval now mandatory.
71
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  • Kathryn_at_productcompliancespecialists.com
  • Tel 44 1844 273277
  • Fax 44 1844 273278
  • www.productcompliancespecialists.com
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