Public procurement notice: Contract Notice
Published: 2017-03-17
Buyer: PHI Clinical Hospital Tetovo
Country: MK
Contract type: Supplies
Procedure: Open procedure
CPV classification: 33730000
Estimated value: 5084745 MKD
Submission deadline: 2017-04-03
Award criteria: Lowest price

Technical requirements: Fragmatome ultrasound handpiece for CONSTELLATION device or equivalent, multi use, for 20 Gauge tip with range 30-60KHz.
Fragmatome ultrasound pak for handpiece for CONSTELLATION device or equivalent, single use, with 20Gauge ultrasound tip, straight.
Automatic set for gas injection for CONSTELLATION device or equivalent 20/23/25 gauge, single use, with syringe 40-60cc and a filter.
Automatic set for injection/exctaction of silicone oil for CONSTELLATION device or equivalent 20/23/25 gauge, single use, with syringe 12-25cc, with included cannulas with size 20/23/25 gauge.
Vitrectomy handpiece for CONSTELLATION device or equivalent, multiple use, with size 20/23/25/27 gauge.
Pneumatic handpiece for CONSTELLATION device or equivalent, single use with size 20/23/25/27 gauge, with plastic ergonomic handle, with included control from footswitch, with proportional actuation for forceps and scissors.
Aspheric macular lens, no stitching, with minimum 30 degree visual field, -59-65D, minimal corneal contact from 200mm2, 6-8 stabilization tabs.
Purufied Perfluorocarbon — Perfluoro-n-octane luquid for tamponade, from 6-8ml, viscosity from 0.65 — 0.75 cSt (centistoke).
Balances salt solution for infusion for vitrectomy, from 400-600ml, glass container, CONSTELLATION device or equivalent.
Sterile drape set for patient with dimensions from 90-110 x 110-120 cm, with opening with size 10-15 x 8-12cm, with plastic drainage bag with minimal volume of 100mg, single use.
Ophthalmic suture 6-0, white, braided, polyester, with double needle, 40-50cm length, needle 1/4 with 7-8mm size.
SF6 intraocular gas, in cylinder tank from 110-130g, with active connection for CONSTELLATION device or equivalent.
C3F8 intraocular gas, in cylinder tank from 110-130g, with active connection for CONSTELLATION device or equivalent.
Glaucoma implantation device, with dimensions 2-3mm length, and 0.mm width, made from non corrosive medical steel with a cannula for drainage of aqueous humour, with preventing edge of implant extrusion, packed in special extruder, single use.
Cassette for posterior segment for vitrectomy for CONSTELLATION device or equivalent, with trocar system 23 gauge, with 3-5mm infusion cannula, single use syringe 15cc-25cc, with 3way stopcock, tubing for aspiration with length min. 40cm, with auto infusion valve connected to the infusion cannula with dimension min. 40cm.

Eligibility requirements: Statement by the economic operator than it has not been sentenced, in the last 5 years, with effective court decision for participation in criminal organization, corruption, fraud or money laundering — certificate that it is not subject to bankruptcy procedure issued by competent authority — certificate that it is not subject to liquidation procedure issued by competent authority — certificate for paid taxes, contributions and other public duties by the competent authority in the country where that economic operator is established — certificate from the Legal Entities Penal Registry that it is not being imposed a side sanction – prohibition to participate in public competitions, contract award procedures and PPP award procedures — certificate from the Legal Entities Penal Registry that it is not being imposed a side sanction — temporary or permanent prohibition to perform certain professional activity — certificate that it is not being sanctioned for misdemeanor with an effective court decision, resulting in prohibition for pursuing professional activity or duty, i.e. temporary prohibition for performing professional activity Document for registered activity — Document for registered activity ( DRA form) issued by the Central Registry of the Republic Macedonia Decision of the Ministry of Health — Bureau of medicines for performing trade of drugs on the territory of Macedonia. — Decision on registration of medical device in the register of medical resources available in the country or Temporary approval or final approval for parallel import of medical devices, issued by the Agency for Medicines and Medical Devices. — for non registered medical devices: — Import license ( authorization for intervention import) under the Law on Medicines and Medical Devices. For the registered medical devices: — The proposed goods to be recorded in the register of medical devices available to the Republic of Macedonia or have temporary approval or final approval for parallel import of medical device. For the non-registered medical devices: — Economic operator offered goods should hold a document allowing imports ( import approval for intervention ) under the Law on Medicines and Medical Devices.
— Decision on registration of medical device in the register of medical resources available in the country or Temporary approval or final approval for parallel import of medical devices, issued by the Agency for Medicines and Medical Devices. — for non registered medical devices: — Import license ( authorization for intervention import) under the Law on Medicines and Medical Devices. For the registered medical devices: — The proposed goods to be recorded in the register of medical devices available to the Republic of Macedonia or have temporary approval or final approval for parallel import of medical device. For the non-registered medical devices: — Economic operator offered goods should hold a document allowing imports ( import approval for intervention ) under the Law on Medicines and Medical Devices.
— Decision on registration of medical device in the register of medical resources available in the country or Temporary approval or final approval for parallel import of medical devices, issued by the Agency for Medicines and Medical Devices. — for non registered medical devices: — Import license ( authorization for intervention import) under the Law on Medicines and Medical Devices.
For the registered medical devices: — The proposed goods to be recorded in the register of medical devices available to the Republic of Macedonia or have temporary approval or final approval for parallel import of medical device. For the non-registered medical devices: — Economic operator offered goods should hold a document allowing imports ( import approval for intervention ) under the Law on Medicines and Medical Devices.