Public procurement notice: Contract Notice
Published: 2017-11-10
Buyer: PHI Clinical Hospital Tetovo
Country: MK
Contract type: Supplies
Procedure: Open procedure
CPV classification: 33000000
Estimated value: 4484100 MKD
Submission deadline: 2017-11-20
Award criteria: Lowest price

Technical requirements: Set for transfemoral approach, sterile, disposable that contains the following parts: arterial guide with dilator, mini wire and neddle for punction, for transfemoral approach length minimum 10 cm - 20 cm, diameter 5F-7F.
Guide catheters for PKI 5-8F left with internal lumen at least 0.070 for 6F length 90-110 cm (with an option to make separate curves needed).
Guide catheters for PKI 5-8F right with internal lumen at least 0.070 for 6F length 90-110 cm (with an option to make separate curves needed).
Coronary Cobalt Chromium Stent Tortuous Lesions with sinusoidal configuration, open cell design, with permanent polimer coated with cytostatic of LIMUS family (DES) for tortuous arteries (2.25 mm - 4.0 mm - minimum span of stent diameter)length minimum 8 mm - 38 mm.
Coronary Cobalt Chromium Stent with bioabsorptive polymer coated with cytostatic of LIMUS family (minimum 2.5 mm to 4.0 mm span of stent diameter) length minimum 8 mm to 30 mm.
Drugeluting stent (DES) - coated stents with platform PLATCRI active component everolimus, diameter (min. 2.25 mm - 4.0 mm) length (min. 8 mm - 38 mm).
Cobalt chromium stent without a polymer with Limus family in the reservoir. The stents on the stent are packed with an integral permanent film of a clean carbon black impregnated for metal ions responsible for possible allergic reactions. The minimum range of the stent of 2.25 mm to 4.5 mm and the minimum range of the stent of 8 mm to  38 mm.
Balloon Catheters — Non Compliant with low profile for focal and long lesions, for dilation and post dilation, with two markers, length min. 6 mm - 27 mm, balloon diameter min. 2.0 mm - 5.0 mm (between dimensions 0.25 mm in diameter) profile of the peak maximum 0.016’’.
Coronar Kobalt Kromium or Platinium Cromium Stent, open cell design, with a biodegradable polymer coated with an immunosuppressive drug from the LIMUS family, which stops the progression of the cell cycle by inhibiting m-TOR-a, a strut thickness of at least 60 μm 0.0024"), co pROBIO coating (amprphous silicon-carbid) with a stent diameter range of from minimum 2.25 mm to a maximum of 4.0 mm and a span of a stent length from a minimum of 9 mm to a.
The bidder shall submit a signed statement about the seriousness of the offer. Bidder should use the form — statement attached to the tender documentation.
The selected best bidder is obliged to provide performance guarantee of the contract in the amount of 5 % of the contract value.
Statement by the economic operator than it has not been sentenced, in the last 5 years, with effective court decision for participation in criminal organisation, corruption, fraud or money laundering — certificate that it is not subject to bankruptcy 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,

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 organisation, 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 nonregistered 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 nonregistered 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 nonregistered medical devices: — Economic operator offered goods should hold a document allowing imports (import approval for intervention) under the Law on Medicines and Medical Devices.