Moldova – Medical equipment – regarding the conclusion of the framework agreement - Purchase of cochlear implants required by the PMSI Institute of Mother and Child and the PMSI “Timofei Moșneaga” Republican Clinical Hospital for the years 2026-2029

Opportunity description

Public tender for the conclusion of a framework agreement regarding the purchase of cochlear implants required by the PMSI Institute of Mother and Child and the PMSI “Timofei Moșneaga” Republican Clinical Hospital for the years 2026-2029. The procedure contains 2 lots. The framework agreement has a duration of 48 months and is not renewed. Subsequent contracts are awarded, as a rule annually, through reopening of competition; an electronic auction in 3 rounds is organized for their award. Evaluation is carried out per lot, at the lowest price, with compliance with all requirements. Lot no. 1: Cochlear implant system Beneficiary: PMSI “Timofei Moșneaga” Republican Clinical Hospital Estimated value of the lot: 66613830.00 MDL 1.1 – Cochlear implant system (internal component) The thickness of the implant must not be greater than 6.0 mm, thus ensuring a rapid intervention and minimal drilling. The implant must have a hermetically sealed titanium casing. The implant must not weigh more than 10 g. The electrode tip must have a diameter of no more than 0.5 mm at the apical end Basal diameter of minimum 0.6mm- maximum 1.3mm The active length of the implant must be a minimum of 25mm, maximum 32mm from the apical tip. Intracochlear portion with a minimum of 12 independently stimulated electrodes Straight electrode array Possibility of performing magnetic resonance imaging (MRI) up to 3.0 T Possibility of temporary removal of the magnet from the receiver / stimulator in order to perform magnetic resonance imaging (MRI) of the head. U/m: piece Maximum estimated quantity: 178 Minimum estimated quantity: 40 Estimated value of the item: 43396400.00 MDL 1.2 – Cochlear implant system Audio processor (external part) The processor must be offered in the OTE (off-the-ear) option. (OTE is defined as a single-piece processor fixed by magnet above the implant) Electric or electro-acoustic stimulation is possible Advanced sound pre-processing technology that allows the user clear perception in various listening situations. At least one omnidirectional microphone. Possibility of storing at least four different listening programs in the processor. It must have an LED indicating functional status It is available in at least 4 available colors It has a water accessory that ensures protection of the processor, according to the IP68 standard Watertight construction, resistance to splashing water, atmospheric humidity or excessive perspiration according to the IP68 standard Possibility of locating the sound processor in case of loss. The processor has a remote control that makes setting the programs easier Verification of the processor’s operating status through messages that are easy for the patient to understand Compatibility with cochlear implants from previous generations The processor allows connection to a wide range of Wireless/Bluetooth devices U/m: piece Maximum estimated quantity: 178 Minimum estimated quantity: 40 Estimated value of the item: 23217430.00 MDL Delivery: DDP - Delivered Duty Paid, Incoterms 2020, within up to 60 days from the beneficiary’s written order. Lot no. 2: Cochlear implant system for children (older than 36 months) Beneficiary: PMSI Institute of Mother and Child Estimated value of the lot: 10891160.00 MDL 3.1 – Cochlear implant system (internal component) • Intracochlear portion with a minimum of 12 independently stimulated electrodes • Straight electrode array • The implant casing maintains complete hermeticity even in the event of a severe impact • Detachable magnet or magnet with rotating technology for safely performing MRIs and reducing image distortions. • The implant is fully compatible with and approved as such for magnetic resonance procedures with values up to 3.0T with the magnet in position, as well as with temporary surgical removal of the magnet. • Includes fully integrated electrophysiological telemetry modes • The thickness of the implant must be a maximum of 4.5 mm, thus ensuring a rapid intervention and minimal drilling. • The implant allows various common surgical approaches, including through the round window and cochleostomy. • The electrode tip must have a diameter between 0.3mm-0.5mm at the apical end, which has been proven to reduce insertion trauma. • The active length of the implant must be a minimum of 25mm, maximum 32mm from the apical tip. • Basal diameter of minimum 0.8mm- maximum 1.3mm • For impact resistance, the implant casing must be made of titanium. • The weight of the implant must be a maximum of 10 g, including the electrode filament. • The electrode must have markings indicating the insertion depth U/m: piece Maximum estimated quantity: 28 Minimum estimated quantity: 7 Estimated value of the item: 6374760.00 MDL 3.2 – SPEECH PROCESSOR (external component) • The processor must be offered in the OTE (off-the-ear) option. (OTE is defined as a single-piece processor fixed by magnet above the implant) • Electric or electro-acoustic stimulation is possible • Advanced sound pre-processing technology that allows the user clear perception in various listening situations. • At least one omnidirectional microphone. • Possibility of storing at least four different listening programs in the processor. • It must have an LED indicating functional status • It is available in at least 2 available colors • The offered processor configuration allows dual power supply, both with batteries and rechargeable batteries. • Integrated protection against changing settings by accidentally touching the control buttons according to the IP68a standard. • It has a water accessory that ensures protection of the processor, according to the IP68 standard • Watertight construction, resistance to splashing water, atmospheric humidity or excessive perspiration according to the IP68 standard • Possibility of locating the sound processor in case of loss. • The processor has a remote control that makes setting the programs easier • Verification of the processor’s operating status through messages that are easy for the patient to understand • Compatibility with cochlear implants from previous generations • The processor allows connection to a wide range of Wireless/Bluetooth devices • Possibility of listening at a distance, with the help of an accessory with an external microphone U/m: piece Maximum estimated quantity: 28 Minimum estimated quantity: 7 Estimated value of the item: 4516400.00 MDL 3.3 – Programming System • Possibilities for quickly performing certain intraoperative and postoperative tests • Auditory nerve response telemetry • Customization of listening programs • Compatibility with cochlear implant systems from previous generations • Possibility of programming and adjustment. U/m: piece Maximum estimated quantity: 28 Minimum estimated quantity: 7 Delivery: DDP - Delivered Duty Paid, Incoterms 2020, within up to 60 days from the beneficiary’s written order. Procedure: open. Estimated value: 77,504,990 MDL. Review the original TED notice for the complete requirement, lots, amendments and attachments.