Public procurement notice: Contract Notice
Published: 2016-02-02
Buyer: Public Health Institute University Digestive Surgery Clinic
Country: MK
Region: Skopski
Contract type: Supplies
Procedure: Open procedure
CPV classification: 33162000: Operating theatre instruments
Estimated value: 28999346 MKD
Submission deadline: 2016-02-09
Award criteria: Lowest price

Technical requirements: Implanted medical supplies: staplers, patrons staplers, laparoscopic, electrosurgical, ultrasonic surgical instruments according to technical specification.
Endoscopic staplers and cartridges with integrated blade in the cartridge, the same variable dimension of clips with diameter of 12 — 15 mm.
Linear staplers and cartridges with knife the stepler integrated and mechanism for consistant stepler formation 75 mm.
Linear staplers and cartridge with knife integrated in the cartridge and cartridges with rectangular stapler 100 mm.
Linear stapler with a two-sided mechanism of firing, the possibility of closing with one hand two rowed cartridge of titanium rectangular staples knife between them that is part of the cartridge, protector of knife 60мм х 4,8мм.
Linear stapler with a two-sided mechanism of firing, the possibility of closing with one hand two rowed cartridge of titanium rectangular staples knife between them that is part of the cartridge, protector of knife 60мм х 3,8мм.
Linear stapler with a two-sided mechanism of firing, the possibility of closing with one hand two rowed cartridge of titanium rectangular staples knife between them that is part of the cartridge, protector of knife 100 mm х 4,8 mm.
Linear stapler with a two-sided mechanism of firing, the possibility of closing with one hand two rowed cartridge of titanium rectangular staples knife between them that is part of the cartridge, protector of knife 100 mm х 3,8 mm.
Vertical curved staplers and cartridges for low rectum resection and colon with integrated knife 40 mm.
Endoscopic automatic clipser empty jaw and a possibility to descent the clips into the jaw before closing download prongs in the jaw before closing, front opening of the jaw, diameter of body of 5 mm.
Endoscopic automatic clipser empty jaw and a possibility to descent the clips into the jaw before closing download prongs in the jaw before closing, front opening of the jaw, diameter of body of 10 mm.
Automatic clipser for open surgery with the possibility of switching the mechanism for automatic closure.


Eligibility requirements: Document for registered activity. 1. List of main deliveries — of users in the EU, USA, RM, of the products that are subject of procurement, by providing minimum 3 confirmations of which one confirmation of completed deliveries in RM issued by the recipients or, if such confirmations cannot be provided for reasons beyond the control of the economic operator, then only its statement of completed deliveries should be submitted, 2. Submission of samples, descriptions and photographs of products subject to delivery and authenticity of which the economic operator is obliged to verify if requested by the contracting authority; 3. Decision that the products subject to procurement are registered on the territory of the Republic Macedonia issued by the Ministry of Health of RM, Approval for parallel import or temporary authorization for parallel import, 4. Certificates issued by the competent authorities for quality control, with recognized competence that test the conformity of products clearly identified by references to specifications or standard to these certificates or equivalent: Declaration of conformity, Free sale Certificate, FDA Certificate, EC/ CE Certificate. 1. The products subject to procurement to be used in the developed European countries, USA and R. Macedonia, 2. The offered products to correspond with the characteristics requested in the technical specification, 3. The products subject to procurement to be registered on the territory of the Republic of Macedonia in accordance with the law on drugs and medical devices, products or to be enrolled in the Register of Medical Devices of RM/to have an approval for parallel imports from the Agency for medicines., 4. The offered products to be manufactured in accordance with international standards for medical devices, quality standards, are approved for use/sale in the manufacturer country and abroad, the products are safe to use and sale and are approved to be used and sold on the market.
1. List of main deliveries — of users in the EU, USA, RM, of the products that are subject of procurement, by providing minimum 3 confirmations of which one confirmation of completed deliveries in RM issued by the recipients or, if such confirmations cannot be provided for reasons beyond the control of the economic operator, then only its statement of completed deliveries should be submitted, 2. Submission of samples, descriptions and photographs of products subject to delivery and authenticity of which the economic operator is obliged to verify if requested by the contracting authority; 3. Decision that the products subject to procurement are registered on the territory of the Republic Macedonia issued by the Ministry of Health of RM, Approval for parallel import or temporary authorization for parallel import, 4. Certificates issued by the competent authorities for quality control, with recognized competence that test the conformity of products clearly identified by references to specifications or standard to these certificates or equivalent: Declaration of conformity, Free sale Certificate, FDA Certificate, EC/ CE Certificate. 1. The products subject to procurement to be used in the developed European countries, USA and R. Macedonia, 2. The offered products to correspond with the characteristics requested in the technical specification, 3. The products subject to procurement to be registered on the territory of the Republic of Macedonia in accordance with the law on drugs and medical devices, products or to be enrolled in the Register of Medical Devices of RM/to have an approval for parallel imports from the Agency for medicines., 4. The offered products to be manufactured in accordance with international standards for medical devices, quality standards, are approved for use/sale in the manufacturer country and abroad, the products are safe to use and sale and are approved to be used and sold on the market.
1. List of main deliveries — of users in the EU, USA, RM, of the products that are subject of procurement, by providing minimum 3 confirmations of which one confirmation of completed deliveries in RM issued by the recipients or, if such confirmations cannot be provided for reasons beyond the control of the economic operator, then only its statement of completed deliveries should be submitted, 2. Submission of samples, descriptions and photographs of products subject to delivery and authenticity of which the economic operator is obliged to verify if requested by the contracting authority; 3. Decision that the products subject to procurement are registered on the territory of the Republic Macedonia issued by the Ministry of Health of RM, Approval for parallel import or temporary authorization for parallel import, 4. Certificates issued by the competent authorities for quality control, with recognized competence that test the conformity of products clearly identified by references to specifications or standard to these certificates or equivalent: Declaration of conformity, Free sale Certificate, FDA Certificate, EC/ CE Certificate.
1. The products subject to procurement to be used in the developed European countries, USA and R. Macedonia, 2. The offered products to correspond with the characteristics requested in the technical specification, 3. The products subject to procurement to be registered on the territory of the Republic of Macedonia in accordance with the law on drugs and medical devices, products or to be enrolled in the Register of Medical Devices of RM/to have an approval for parallel imports from the Agency for medicines., 4. The offered products to be manufactured in accordance with international standards for medical devices, quality standards, are approved for use/sale in the manufacturer country and abroad, the products are safe to use and sale and are approved to be used and sold on the market.