POST-QUALIFICATION REQUIREMENTS FOR MEDICAL EQUIPMENT

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POST-QUALIFICATION REQUIREMENTS FOR MEDICAL EQUIPMENT

Post by zeph03 on Thu Sep 07, 2017 4:14 pm

Hi good day!

I just want to ask your opinion if the listed Post-qualification requirements for Procurement of Medical Equipment are already enough and applicable to the equipment.
Here are the post-qua requirements:

1. Latest Annual Tax Return filed thru Electronic Filing and Payment Systems (EFPS) and must be duly validated with the tax payments made thereon for the preceding Tax Year be it on a calendar or fiscal year income (per Revenue Regulations 3-2005);
2. Latest Business Tax Return filed thru Electronic Filing and Payment System (EFPS) duly validated with the tax payments made thereon also refers to the Value Added Tax (VAT) or Percentage Tax Returns covering the previous six (6) months (per Revenue Regulations 3-2005);
3. Valid License to Operate issued by the Food and Drug Administration
4. Certificate of Compliance to ISO 13485 or its equivalent
5. Certificate of Product Registration or Exemption issued by FDA-Center for Device Regulation Radiation Health and Research (CDRRHR)
6. Certificate of Warranty on parts and services (at least three (3) years) upon acceptance by the Procuring Entity’s Inspection Committee or duly authorized representative, if applicable
7. (Applicable to Medical Electrical Equipment only) Sworn Affidavit of Undertaking as to the following if awarded the contract:
a. The Supplier will enter into a preventive maintenance service contract for the duration of the period of warranty without cost to the Procuring Entity except as otherwise stated in the Special Conditions of Contract
b. That the Supplier shall upon receipt of verbal/written notice, telephone calls or short messaging services the Supplier shall, within the period specified in the SCC and with all reasonable speed, repair or replace the defective Goods or parts thereof, without cost to the Procuring Entity
c. The Supplier shall be liable for loss of income that could have been made had the equipment been properly maintained or adequately and timely repaired
8. (Applicable to medical electrical equipment only) Sworn Affidavit of Undertaking that the Bidder shall provide the Procuring Entity during the warranty period Service Engineer/s for preventive maintenance/correction of defects within 2 days upon verbal notification. The affidavit must be supported by the Engineer’s, Curriculum Vitae with certificates of training specific to the specific to the type and brand of equipment with inclusive dates of training
9. (Applicable to medical electrical equipment only) Certification that the bidder will provide Certificate of Calibration with traceability to SI units as maintained by the National Metrology Institute or appropriate national, international, intrinsic, or manual consent standard, if awarded the contract. The certificate should indicate the measurement result and associated uncertainty of measurement.
10. Certification from the Manufacturer:
a. That the bidder has the capability for corrective and preventive maintenance of the unit;
b. That the equipment is brand new, unused and not a discontinued model or was never listed in any product recall worldwide
c. Certificate guaranteeing the availability of spare parts for five (5) years after the warranty period
d. That the terms and conditions stated in the contract shall be honored by the manufacturer in the event that a change of exclusive distributorship will occur during the duration of the said contract
e. Certification that the brand has been in the local market for at least ten (10) years or in the international market for at least twenty (20) years
f. Certificate from the bidder guaranteeing delivery of equipment and all accessories within the time period set by Procuring Entity
g. Certification that the bidder will provide training program for at least two (2) trainees from the end-users and at least two trainees from the Procuring Entity’s Biomedical Unit.
11. Location, contact number of the Service Center of the bidder
12. Certificate of exclusive distributorship/authorized distributorship from the unit manufacturer mentioning the name of the Philippine representative;
13. Certification from the bidder of the 95% uptime guarantee for the equipment offered within the warranty period. Accumulated downtime in excess of 5% shall be added to the warranty period
14. Certification that the bidder shall be responsible for the notification, transportation, delivery, installation and commissioning at no cost to the Procuring Entity
15. Copy of Operations Manual, if applicable

Listed are the following equipment requiring such post-qua req:
1. Baby's bassinet with 4 casters, mobile, stainless steel frame, forward tilting 0 degrees to 12 degrees, 80cm x 46cm x 86cm
2. Dermatome Air Power Surgical skin Grafting Instrument, thickness control adjustment range from .004-.02individual graft with 1 inch, 1.5 inches, 2 inches, 3 inches, 4 inches, self cooling rotary vane air motor, with accessories
3. Fiber Optic Light Cable Model 495 NB 4.8mm 180cm
4. Instruments stands, open type with 3 layers with 6" four (4) caster wheels with brakes; length = 35-36" x width = 19-20" x height = 44-45"
5. Light Prism (For esophagoscope use)
6. Stainless transport trolley for sterile packs, 2 layers; length = 35-36" x width = 19-20" x height = 34" with 8" four (4) caster wheels with brakes
7. Suction Machine, heavy duty, maximum vacuum 735mmHg, flow rate 50L/min, power consumption 250W, AC 220, 50/60 Hz to include two 3,000cc collection bottles, 1.5 silicone hose & foot switch, mobile, capable to use continuous suction
8. Transport stretcher with 3 cranks, stainless steel, adjustable height from 54cm - 85cm (include guard rail + 5%); capacity 150 kg; length of bed : 187cm(L) x 75cm(W); with oxygen tank older; IV pole (2 hooks);rubber bumper both side rails; side railes height = 30cm x length = 80cm; 4 caster wheels with brakes; with provision of rectangle stainless basket (for patient's medicine & supplies); manual; with calibration certificate

Hoping for your prompt reply. Thanks thanks thanks Laughing Laughing Laughing

zeph03
New Member
New Member

Male Number of posts : 11
Company/Agency : Zamboanga City Medical Center
Occupation/Designation : Admin Assistant 1/BAC Secretariat
Registration date : 2016-11-16

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