Public procurement notice: Contract Notice
Published: 2017-05-30
Buyer: PHI University Clinic of Otrinolaringology
Country: MK
Region: Poranešnata jugoslovenska Republika Makedonija
Contract type: Supplies
Procedure: Open procedure
CPV classification: 33000000
Estimated value: 73200 EUR
Submission deadline: 2017-06-22
Award criteria: Lowest price

Technical requirements: Lääketieteelliset laitteet, farmaseuttiset valmisteet ja henkilökohtaiseen hygieniaan liittyvät tuotteet
— Registered Activity Document — In order to prove its professional ability the economic operator needs to submit a DRD Form as a proof that it is registered as a physical or legal entity for performing the work related with the public procurement subject or evidence that it belongs to a suitable professional association in accordance with the regulations of the country where it is registered.
Proof 1 — Statement regarding engaged trained personnel, who will act as an intra-operative measurements support during surgery and will be present during postoperative inclusion and setup of the voice processor which conducts the cochlear implant work, inside the premises of the Contracting party.
Proof 2 — Statement regarding engaged trained personnel, who will be included in the rehabilitation process of the patients with built-in cochlear implant (who will continuously do the appropriate frequency tuning/setting of the voice processor depending on the improvement degree of the hearing-speech function of the patients), on the territory of the Republic of Macedonia.
— Resolution for medical device wholesale or temporary or permanent approval for parallel import, according to the Law on Medicines and Medical Devices.
— Import license (interventional import approval) according to the Law on Medicines and Medical Devices.
Condition 1      — The bidder should ensure the presence of trained personnel for surgical intervention (at least 1 person), trained by the manufacturer or other subject authorized by the manufacturer who will act as an intra-operative measurements support during surgery and will be present during postoperative inclusion and setup of the voice processor which conducts the cochlear implant work, inside the premises of the Contracting party.
Condition 2 — The bidder should ensure the presence of trained person who will be included in the rehabilitation process of the patients with built-in cochlear implant (who will continuously do the appropriate frequency tuning/setting of the voice processor depending on the improvement degree of the hearing-speech function of the patients), on the territory of the Republic of Macedonia.
— The Economic operator should have obtained approval for medical device wholesale or temporary or permanent approval for parallel import, according to the Law on Medicines and Medical Devices.
— The Economic operator should have obtained document which allows import (interventional import approval) according to the Law on Medicines and Medical Devices.
To be able to participate in procedure, it is necessary the Economic operator to be registered in ESJN and to possess a digital certificate. The economic operator is registered in ESJN by filling registration form which is an integral part of ESJN, after which the ESJN automatically processes the data from the registration form, generates a code and delivers it to the registered electronic mail o (...)

Eligibility requirements: — Registered Activity Document — In order to prove its professional ability the economic operator needs to submit a DRD Form as a proof that it is registered as a physical or legal entity for performing the work related with the public procurement subject or evidence that it belongs to a suitable professional association in accordance with the regulations of the country where it is registered. — Resolution for medical devices wholesale, according to the Law on Medicines and Medical devices.

Award value: 73200