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

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

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  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 Product Compliance Specialists Confidential

  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 Product Compliance Specialists Confidential

  4. Global Regulatory Changes - Overview • Significant Regulatory Changes in the following countries • Argentina • Bolivia • Malaysia • Pakistan Product Compliance Specialists Confidential

  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 Product Compliance Specialists Confidential

  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 Product Compliance Specialists Confidential

  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. Product Compliance Specialists Confidential

  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 Product Compliance Specialists Confidential

  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 Product Compliance Specialists Confidential

  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 Product Compliance Specialists Confidential

  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. Product Compliance Specialists Confidential

  13. Customs Union IntroductionKey Differences From GOST Product Compliance Specialists Confidential

  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 Product Compliance Specialists Confidential

  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 Product Compliance Specialists Confidential

  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 Product Compliance Specialists Confidential

  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 Product Compliance Specialists Confidential

  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 Product Compliance Specialists Confidential

  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 Product Compliance Specialists Confidential

  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 Product Compliance Specialists Confidential

  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. Product Compliance Specialists Confidential

  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 Product Compliance Specialists Confidential

  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 Product Compliance Specialists Confidential

  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 Product Compliance Specialists Confidential

  25. Customs UnionLabelling • Customs Union Label Artwork Product Compliance Specialists Confidential

  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 Product Compliance Specialists Confidential

  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 Product Compliance Specialists Confidential

  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 Product Compliance Specialists Confidential

  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 it’s stand-alone state, not integrated in to any host Product Compliance Specialists Confidential

  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 Product Compliance Specialists Confidential

  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 Product Compliance Specialists Confidential

  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 Product Compliance Specialists Confidential

  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 Product Compliance Specialists Confidential

  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 Product Compliance Specialists Confidential

  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 Product Compliance Specialists Confidential

  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 Product Compliance Specialists Confidential

  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 Product Compliance Specialists Confidential

  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 Product Compliance Specialists Confidential

  41. Products requiring mandatory BIS Product Compliance Specialists Confidential

  42. Products requiring mandatory BIS Product Compliance Specialists Confidential

  43. Testing standards Product Compliance Specialists Confidential

  44. Testing standards Product Compliance Specialists Confidential

  45. Testing standards Product Compliance Specialists Confidential

  46. Testing standards CB Test reports therefore play a pivotal role in the BIS Safety Scheme Product Compliance Specialists Confidential

  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. Product Compliance Specialists Confidential

  48. Process Outline Product Compliance Specialists Confidential

  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. Product Compliance Specialists Confidential

  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. Product Compliance Specialists Confidential