SCHEDULE H(ex) Membership

Individual Membership for Designated Experts

These are the selected device/product experts that work with the GMDN Core Expert Group

Membership - Licence Details:

Applicants for GMDN Schedule ‘H’ membership, to obtain internet access to the GMDN database, herewith commit themselves to use and promote the use of the GMDN nomenclature for regulatory purposes when there is a need for generic descriptors for identification purposes, including for example: -

• Registering of specific Medical Devices placed on the market
• Identification of device involved in reportable-incidents, to identify other similar devices
• Statistical purposes
• Data exchange between Regulatory Bodies
• Where generic descriptors form the basis for commercial use
• For reimbursement identification purposes.

For the purpose of this membership schedule, the following definition applies: - “GMDN Expert” is an individual, recognised by GMDN Agency to possess knowledge and understanding relating to Medical Devices in specific areas (GMDN categories) so that such skills may be applied to assist GMDN Agency to update and develop appropriate generic descriptors.

Relevant skills may be required to assist in the translation of GMDN into other language versions.

Schedule ‘H’ Members will be able to access the GMDN database within which there are at present approximately 20,000 generic terms. This includes some 10,000 Preferred Terms with full Definitions and these ‘P’ terms indicate the codes under which devices should be identified for regulatory purposes. The remaining 10,000 terms include ‘T’ terms which are Template terms and ‘S’ terms which are Synonym terms, both of which provide valuable search information to locate the appropriate ‘P’ term.

There is an obligation not to release, in full or in part, the GMDN data file to any party, except in pursuance of specific investigations when access to individual terms may be necessary.

Such specific requests for GMDN terms/codes will be notified to gmdn_agency@btinternet.com and the party concerned may be invoiced accordingly by GMDN Agency

When a non GMDN Member requests the identification of a term (or terms) and codes for his own use, then the Expert shall request payment for this service, by completing the GMDN invoice “Invoice for requested GMDN codes/terms” and copying GMDN Agency accordingly.

It is understood that GMDN Agency will assist Regulatory Bodies in developing countries to take advantage of the GMDN to the best of its ability, without imposing monetary barriers, and will provide user-instruction and other assistance to facilitate the usage and benefits to be obtained.

The Member shall contact the GMDN Agency when there is a suggested need to change, add, or correct an entry to ensure consistency of term and definition within the base Nomenclature (English version) for each coded entry.

Only the GMDN Agency can make changes, additions, or corrections to the nomenclature codes, terms and definitions.

Proposals for new terms will only be accepted for consideration when submitted through the established GMDN Agency application form route. Administrative charges may apply.

Irrespective of the way the base Nomenclature is presented, the definition for a given coded term shall be that in the base Nomenclature (English Language).

Distribution of the base English language version of GMDN shall only be available through the Agency.

GMDN Agency will, with the advice of specific Regulatory Bodies, recognize bodies appropriate to translate the English base Nomenclature into other languages.
Such translated versions will be made available through the GMDN Agency.
See “Translation Software”.

Schedule H Members have full access to all GMDN terms and definitions, and immediate access to a pack of 500 GMDN codes.
Further packs will be provided on request.

When a Member already has a device code and wishes to identify the appropriate GMDN generic term, this is always available and may be found by using the “Search” facility in the GMDN database.

TO BECOME A MEMBER PLEASE CLICK HERE TO COMPLETE THE REGISTRATION FORM