SCHEDULE F

GMDN Membership Licence for use of the Global Medical Device Nomenclature (GMDN) database by a Translator

Membership - Licence Details:

Definitions

For the purpose of this schedule, the following definition applies: ‘Translator’ is an organisation that has been given permission by the Licensor to translate the original GMDN from English into another language for incorporation within the GMDN Agency website for eventual access by GMDN Members.
GMDN Agency will only licence a translation organisation which is recognized as a suitable body for this purpose by the appropriate regulatory body.


Specific Licence Restrictions

This Licence gives the Licensee permission to:

  • translate into a specified language and to become a recognized GMDN translator;
  • and, to have this translated version accessible via internet.
A Licence agreement for translators will be free of charge, will be valid for up to three years at a time, and the translator shall use every effort to ensure that the translated version does faithfully reproduce the construction, intentions and meaning of the original English version and shall comply with all agreed conditions. Full responsibility for the quality of the translated version resides with the Licensee.


Important

The GMDN recognized Translator shall use the specific additional GMDN Agency translation software and shall enter translated terms into the appropriate part of the GMDN database reserved for the particular language version, so that when released both the base English version and the translated version can be accessed by a Member/User.
There may be a charge for access to the GMDN Translation Software, subject to agreement.(This may be requested from the relevant Regulatory Body).
This Licence restricts access to the GMDN database to the Translator or those directly employed by the translator. No further rights are assigned to the Translator.


Access

The Translator will have access to the GMDN original English Terms, Definitions and Codes for specific categories as agreed (there are 14 specific categories) within which the GMDN and the main ‘P’ (Preferred) Terms with Definitions are the active terms.
These are used for generic identification of Medical Devices for all regulatory purposes.
There are approximately 9,000 ‘P’ Terms in GMDN plus approximately 10,000 other terms ‘S’ Terms (Synonyms) and ‘T’ Terms (Template Terms).

GMDN agency cannot accept responsibility for the accuracy of the translated versions of GMDN terms or for errors, omissions.
In case of doubt or dispute the original English language text only will be valid, subject to any necessary updates, corrections agreed.
The translator agrees to take all reasonable measures to ensure the accuracy of translated GMDN terms under the appropriate GMDN codes as applied in the reference English language text.

The Translator shall not distribute, or provide access to the GMDN database including the translated version of GMDN, to third parties without the agreement of GMDN Agency.
The translated version of GMDN, together with the original English version will be available to all GMDN Agency licenced Members.


Fees

Access to the GMDN database for recognized translators:
    - No charge during licence period.
Access and use of the dedicated GMDN Translation Software:
    - Subject to agreement between GMDN Agency and a recognized translator.


IMPORTANT NOTE

UNDER THIS LICENCE IT IS FORBIDDEN TO SUPPLY GMDN CODES TO ANY PERSON OR PARTY OUTSIDE THE CONFINES OF A MEMBERS LEGAL ENTITY, EITHER FOR PAYMENT OR FREE OF CHARGE, EXCEPT WHEN USE OR TRANSFER BY A GMDN MEMBER OF CODES AND TERMS, IS FOR PURPOSES AS IMPLIED WITHIN THE SCOPE OF THE LICENCE AS GRANTED.


FOR MEMBERS REQUESTING A FACILITY TO SUPPLY DATA WITH CODES TO A THIRD PARTY, PLEASE CONTACT gmdn_agency@btinternet.com FOR A DEDICATED LICENCE.


HOW TO BECOME A GMDN-RECOGNISED TRANSLATOR...
CONTACT: gmdn_agency@btinternet.com