Recognition and Accreditation

GMED holds the authorizations, accreditations and international recognitions needed to support your certification projects in order to launch your medical devices on target markets.

1.Quality Management System Certification

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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2.CE Marking

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 (IVD MD);
The European Directive 98/79/EC – In Vitro Diagnostic Medical Devices (IVD MD);

Starting May 26th 2021, the activities that are required in order to maintain certificates issued per directives 90/385/EEC Active Implantable Medical Devices (AIMD) and 93/42/EEC Medical Devices (MD).

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

3.MDSAP Program

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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4.Mutual Recognition Agreements (MRAs)

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.

5.Technical Cooperation Program

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

6.Partnerships

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

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Our teams of experts, dedicated to the health care and medical devices industry, and our proven practices make GMED among the leading companies at an international level.

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