GMA Service Scope

Our market access services at a glance

Click on the links below for an overview of the services offered by our GMA team by region:

  1. Africa
  2. America
  3. Asia
  4. Australia
  6. Middle East

The scopes below cover the following product categories:

  • Automotive components
  • Commercial products
  • Consumer products
  • Healthcare and medical devices

Our GMA services cover additional product categories that are not listed in the above. For more information, plesae contact us.

Africa

  1. America

Argentina

  • Type Certificate – S Mark
  • IRAM & S Mark
  • AFTIC Approval
  1. Click for Argentina market access information

Brazil

  • INMETRO homologation for household appliances
  • INMETRO homologation for electrical components
  • INMETRO certification for electrical medical devices
  • Quality Management System Audits within the scope of the  Medical Device Single Audit
  • Program (MDSAP)
  • INMETRO homologation for toys
  • INMETRO Voluntary S mark
  • Brazil local representative service
  • Automotive Management System Certification for ISO/TS 16949
  • INMETRO homologation for automotive components
  • ANATEL Approval
  1. Click for Brazil market access information 

Canada

  • Audits for ISO 13485 CMDCAS
  • NRTL for the standard CAN/CSA-C22.2 Nr. 601.1
  • Quality Management System Audits within the scope of the  Medical Device Single Audit Program (MDSAP)
  1. Click for Canada market access information

Mexico

  • NOM Certificate
  • IFETEL Certificate
  • CONUEE for energy efficiency
  1. Click for Mexico market access information

USA

  • 510(k) Third Party Review under the FDA Modernization Act of 1997     
  • Routine inspections on behalf of FDA according to QSR 21 CFR 820
  • Mock-Inspections according to QSR 21 CFR 820
  • TÜV SÜD Product Service is a National Recognized Testing Laboratory (NRTL) (i.e. UL 60601-1)
  • Quality Management System Audits within the scope of the  Medical Device Single Audit Program (MDSAP)
  1. Click for USA market access information

  1. Asia

China

  • CCC Certificate
  • CQC Certificates
  • SRRC (State Radio Regulatory Committee) Certificate
  • NAL (Network Access License) Certificate
  • China Energy Label (CEL) Registration
  • Voluntary China certificate for Energy Conservation Product (CECP)
  • CFDA Medical Devices Registration and Testing services
  1. Click for China market access information

India

  • ISI Mark
  • BIS registration for IT/AV products
  • India local representative service
  • WPC approval for telecom/radio
  1. Click for India market access information

Japan

  • TÜV SÜD Diamond PSE
  • TÜV SÜD Circle PSE
  • S-JQA Mark for LED and Battery
  • MIC approval
  • JATE approval
  • Voluntary VCCI mark
  • JET approval for PV modules
  • Top Runner Program
  • Certification of Class II/III Medical Devices and In vitro Diagnostics reagents
  • Quality Management System Audits (JGMP)
  1. Click for Japan market access information

Malaysia

  • SIRIM Label or Certification Mark
  • Medical devices certification of registration
  • Quality management system audits according to ISO 13485 (Good Distribution Practice of Medical Device - GDPMD)
  1. Click for Malaysia market access information

Singapore

  • Certificate of Conformity for Electrical Safety
  • IDA Equipment Registration
  • NEA Registration
  • HSA Medical Device Certification
  • Review and certification of medical device manufacturers according to ISO 13485 and GDPMDS
  1. Click for Singapore market access information

South Korea

  • KC Mark for Electrical Appliances Safety
  • KC Mark for EMC/Telecom/Radio
  • KCs Mark & S Mark for Industrial Machinery & Equipment
  • Technical File Review for 8 categories of class II Medical Devices
  1. Click for South Korea market access information

Taiwan

  • BSMI Certificates
  • NCC Approval
  • Energy Efficiency Label
  • Audits of medical device manufacturers according to Taiwanese Good Manufacturing Practice (TGMP)
  • Issuance of confirmation letters detailing the products which are covered under the scope of a valid ISO 13485 or MDD certificate
  1. Click for Taiwan market access information

  1. Australia

Australia

  • Certificate of Approval for declared electrical household appliances
  • Certificate of Suitability for non-declared electrical appliances
  • C-tick
  • A-tick
  • RCM registration supplier service
  • GEMS registration (MEPS and Energy Labeling)
  • MRA Certification within the European / Australian Mutual Recognition Agreement for medical devices
  • Quality Management System Audits within the scope of the  Medical Device Single Audit Program (MDSAP)
  1. Click for Australia market access information

  1. Europe

Custom Union (Russia, Belarus & Kazakhstan)

  • Custom Union Safety Approval for low-voltage equipment (CU TR 004/2011)
  • Custom Union EMC Approval for low-voltage equipment (CU TR 020/2011)
  • Declaration of Conformity in Customs Union
  • Russian GOST-R Certificate of Conformity  
  • Customs Union Ex-Proof Certificate
  • Russian Radio Frequency Approvals
  • Russian Fire Safety Certifications
  • Russia: Registration of Medical Devices
  • Russia: Declaration of Conformity for Medical Devices
  • Pattern Approval Certificate of Measuring Instruments
  • Permit for Use of ROSTEKHNADZOR (RTN – Industrial Safety)
  1. Click for Custom Union market access information

  1. Middle East

Israel

  • SII Standards Mark
  • SII Type Approval
  • Type Approval for PV
  • MoC Approval for radio/telecom
  • Energy Label Registration
  1. Click for Israel market access information

Saudi Arabia

  • SASO CoC Certificate
  • Pre-shipment Inspection
  • Energy Efficiency Label
  1. Click for Saudi Arabia market access information

United Arab Emirates (UAE)

  • ECAS Registration Certificate
  • TRA Approval for telecom/radio
  • EESL (Energy Efficiency Standardization & Labeling)
  • Testing and Certification Body for Civil Defense
  1. Click for UAE market access information