Recognition and Accreditation

For GMED: 

GMED is accredited under NF EN ISO/IEC 17021-1:2015 for quality management system certification under NF EN ISO 9001:2015 / ISO 9001:2015 and ISO 13485:2016 / NF EN ISO 13485:2016 for health care and medical devices.

Certificates are issued in accordance with international certification rules set out in ISO 17021 (French accreditation committee COFRAC accreditation no. 4-0608).

List of accredited sites and scopes available at www.cofrac.fr

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For LNE-GMED UK:

LNE-GMED UK is accredited under BS EN ISO/IEC 17021-1:2015 for quality management system certification under BS EN ISO 13485:2016 for healthcare and medical devices.

List of accredited sites and scopes available at https://www.ukas.com/find-an-organisation/

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GMED is notified by the French Health Authority (ANSM) and, as a notified body (ID no. 0459), performs all conformity assessment procedures covered by

• The European Regulation (EU) 2017/745 on Medical Devices (MD);
• The European Regulation (EU) 2017/746 on In Vitro Diagnostic Medical Devices (IVDMD).

GMED continues to carry out the activities required to maintain the certificates issued under the directives 93/42/EEC for Medical Devices (MD), 90/385/EEC for Active Implantable Medical Devices (AIMD) and 98/79/EC for In Vitro Diagnostic Medical Devices (IVDMD).

The scope of GMED’s notification is available on the European Commission website NANDO (New Approach Notified and Designated Organisations).

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GMED is recognized as an Auditing Organization (AO) by the MDSAP Regulatory Authority Council (the international MDSAP governing body) and has been performing MDSAP audits since April 2015. 

MDSAP is a program designed to allow medical device manufacturers to have their quality management system (QMS) assessed with regard to the regulations of five countries: Canada, Brazil, Australia, Japan, and the United States.

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LNE-GMED UK, GMED’s subsidiary, is an approved body by the Medicines and Healthcare products Regulatory Agency (MHRA) and, as an approved body (AB 8521), performs all conformity assessment procedures covered by the UK Medical Devices Regulations 2002 for medical devices, active implantable medical devices and in vitro diagnostic medical devices.

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The mutual recognition agreements signed between the European Union and Australia and New Zealand, implemented in 1998, allow manufacturers to obtain certificates after GMED completes its service as a designated body under these agreements.

The agreements cover medical devices under Directives 90/385/EEC and 93/42/EEC, with the exclusion of radioactive products, in vitro diagnostic devices, devices utilizing tissue of animal origin, devices incorporating medicinal substances, and devices with special risks.

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The TFDA (Taiwan Food and Drug Administration) has established a Technical Cooperation Program (TCP) aiming for the recognition of ISO 13485 quality management system audit reports. GMED has been participating in this program since November 2004.

With the evolution of the regulations, and under the aegis of the TFDA, the program has evolved to a 3rd version TCP III, requiring a new recognition of European organizations by the TFDA. GMED has successfully completed all the necessary steps for this recognition and can operate under this agreement as of January 1st 2022.

Are you a manufacturer located on the European territory? Are you planning to market your products in Taiwan?

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GMED’s certificates are recognized by some certification bodies in Ukraine.

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