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:
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
South Africa
- LoA
- CoC
- ICASA Mark
America
Argentina
- Type Certificate – S Mark
- IRAM & S Mark
- AFTIC Approval
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
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)
Mexico
- NOM Certificate
- IFETEL Certificate
- CONUEE for energy efficiency
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)
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
India
- ISI Mark
- BIS registration for IT/AV products
- India local representative service
- WPC approval for telecom/radio
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)
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)
Mongolia
- CRC Approval
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
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
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
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)
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)
Middle East
Israel
- SII Standards Mark
- SII Type Approval
- Type Approval for PV
- MoC Approval for radio/telecom
- Energy Label Registration
Saudi Arabia
- SASO CoC Certificate
- Pre-shipment Inspection
- Energy Efficiency Label
United Arab Emirates (UAE)
- ECAS Registration Certificate
- TRA Approval for telecom/radio
- EESL (Energy Efficiency Standardization & Labeling)
- Testing and Certification Body for Civil Defense