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Regulatory Guide

  • EU CE Guide for Telecom Devi...

    EU CE Guide for Telecom Device -> In Europe the standards are set by the ETSI (European Standards Institute). These standards include TBR 4 (E1 ISDN PRI), TBR 12 (Unframed E1), TBR 13 (Framed E1), ETS 203 021 , TBR 21(analog equipment), TBR 38 (acoustic

  • EU RED Guide for Wireless De...

    EU RED Guide for Wireless Device -> Starting from June 2016 the Radio Equipment Directive (RED) is the new compliance requirement in Europe for wireless transmitters. The RED replaces the R&TTE Directive which previously covered radio transceivers an

  • Canada MDSAP Guide for Medic...

    Canada MDSAP Guide for Medical Device -> REGULATORY AGENCY Health Canada REGULATIONS A specific quality systems standard, ISO 13485, is required for Class II, III and IV medical devices as a prerequisite to obtaining device licensing.

  • Canada ISED Guide for EMC

    Canada ISED Guide for EMC -> REGULATORY AGENCY Innovation, Science, and Economic Development Canada (ISED) REGULATIONS Manufacturer's declaration is required for certain products according to ICES standards.

  • Canada ISED Guide for Teleco...

    Canada ISED Guide for Telecom Device -> Telecommunication approval The Innovation, Science and Economic Development Canada (ISED) is the government department responsible for regulating telecommunications equipment in Canada. The Radiocommunication Act

  • Canada ISED Guide for Wirele...

    Canada ISED Guide for Wireless Device -> Telecommunication approval The Innovation, Science and Economic Development Canada (ISED) is the government department responsible for regulating telecommunications equipment in Canada. The Radiocommunication Ac

  • USA FCC Guide for Wireless D...

    USA FCC Guide for Wireless Device -> In order to access the market of the USA, products must be approved according to the existing legislation and get the required document of conformity. Electrical and electronic equipment manufacturers planning to se

  • USA FDA Guide for Consumer &...

    USA FDA Guide for Medical -> REGULATORY AGENCY Food and Drug Administration (FDA) REGULATIONS Medical devices distributed in the United Sates are subject to general controls, pre-marketing and post- marketing regulatory controls.

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