REoI for global LTA for surgical sutures

UNICEF SUPPLY DIVISION is initiating a solicitation to establish long-term arrangements (LTA) for SURGICAL SUTURES FOR UNICEF WAREHOUSE REPLENISHMENT AND FOR UNICEF DIRECT DISTRIBUTION TO PROGRAMMES IN DEVELOPING COUNTRIES.

Procedure for submission of EoI:

Companies with experience in these products and interested in being considered for the tender should express their interest by completing this web form by 27 October 2024, 23:59 (Copenhagen time).

Potential suppliers:

This REoI is addressed to suppliers and manufacturers with experience in the sourcing, manufacturing, and supply of surgical sutures. 

Only suppliers and manufacturers* with a Quality Management System in conformity with at least one of the following standards are invited to express interest:  
(a)  ISO 9001:2015
(b) ISO 13485:2016+A11:2021

*Manufacturers should specifically have ISO 13485 to ensure compliance with the quality standards required for medical devices.

To be considered for the planned tender, it is preferable, though not required, for potential suppliers to have a website that provides access to product information.

Only products with at least one of the following pre-market approvals/market clearances will be considered in the planned solicitation exercise:

(a)   European Union: Regulatory agency in the European countries (manufacturers must either possess an Medical Device Regulation (MDR) certificate or, if the MDR certification process is ongoing, should have confirmation from the notified body that the transition from MDD (Medical Device Directive) to MDR is in process)
(b)   USA: Food and Drug Administration (FDA)
(c)   Canada: Health Canada
(d)   Japan: Pharmaceuticals and Medical Devices Agency (PMDA)
(e)   Australia: Therapeutic Goods Administration (TGA)

Expressions of Interest received will be screened based on the information provided. Only suppliers selected after the screening process will be invited to the tender.

Please note:

(a) This is NOT an invitation to submit a quotation. Do not send your prices or your products’ specifications at this stage. 

(b) This REoI does not constitute a solicitation. Submitting an EoI does not automatically guarantee receipt of the solicitation document when issued. 

(c) UNICEF reserves the right to require compliance with additional conditions as and when issuing the final solicitation document. 

(d) Questions about conformity of the supplier’s products will not be answered.

(e) UNICEF reserves the right to change or cancel the requirement at any time during the REoI and/or solicitation process.

Thank you.