Addendum No. 2 and Clarification to the Bidding Document for the Procurement Ref. No. ET-MOH- 400003-GO-RFB

Can you please confirm that Standards and Safety Requirements is Not Applicable for this Item?

Can you please confirm that Standards and Safety Requirements is Not Applicable for this Item?

Can you please confirm that Standards and Safety Requirements is Not Applicable for this Item?

Can you please confirm that Standards and Safety Requirements is Not Applicable for this Item?

Can you please confirm that Standards and Safety Requirements is Not Applicable for this Item?

Can you please confirm that Standards and Safety Requirements is Not Applicable for this Item?

Can you please confirm that Standards and Safety Requirements is Not Applicable for this Item?

The following is what it is mentioned:
9. Installation, Training and Commissioning: Not applicable
The supplier must provide installation, and commissioning of the device at health Facility
The supplier must provide on sight technical and end user training

As Installation, Training and Commissioning is not required for this Item, can you confirm that we can delete the description of the service to be provided?

ü   LOT 1- Screen Patient, Four Section- Utility Requirements

Can you please confirm that Utility Requirements is Not Applicable for this Item?;

Can you please confirm that the Requirement of operating environment is Not Applicable for this Item?

ü  LOT 1 – Screen Patient, Four Section- Installation / Training / Commissioning
Can you please confirm that the requirement of Installation/Training/Commissioning is Not Applicable for this Item?

In the Technical Specification at point 4 it is requested 4 casters with 2 castors lockable while at System Configuration Accessories at point 5 it is requested 4x caster with one lockable.
Could you please clarify if you want 1 or 2 lockable casters?

For Final Completion Date(s) of Services is mentioned the following

“As required within delivery time period”
Since the service required is the Warranty services, can you please confirm that the Warranty services must be performed within the period specified in the specification?

ü  Under Technical Specification posted for both trolley it requests shelve dimension of more than 60x45cm with Tray size: Min (705 x 445mm)(larger than shelf), Height &  Capacity: 70mm stainless steel trays (min. load 40.0kg per tray), Tray height Positions: in (210 & 845mm), are “shelf” and “tray” different for those trolley’s?

ü  Are both items the same or different, specifications posted for both items are similar?

Please confirm if only products certified by EFDA shall be allowed for supply

• the country or these certified product shall be given the first priority among a bidders..?

Obtaining this certification would require significant financial and time investment for bidders like us, who are interested to register our products with EFDA, once we will have any order in hand.

Considering the same, we request that bidders be permitted to apply for and obtain the necessary Product Certificate(s from EFDA after the intention to award issued and before the contract signing.

We believe this approach aligns with the tender’s objectives and kindly request confirmation that this will be acceptable to ensure our participation is not hindered.

2.       Second Priority: Valid Product Certificate from SRA Region; Based on the input received from our Manufacturers, it has been informed that A valid Product Certificate from an SRA Region typically applies to drugs and medicines, not for equipment like weighing scale.
Could you please confirm whether this certificate is required and compulsory for all equipment from Lot Two: Weighing Scale Equipment and Lot Four: Laboratory equipment, or If CE or ISI Certifications would also be acceptable?

3.       As per the Table 1 of Clause 3.1. Qualifications requirements you have listed the “valid product certificate from SRA region” We have contacted various reputable manufacturers in Europe, who are supplying the Medical Equipment, to the national/international hospitals and other reputable institutes like UNICEF/UNDP etc etc. Unfortunately, they told us that they do not have or require a certificate from the Stringent Regulatory Authority as specified in your tender documents to supply their equipment to Hospital or other institutions. As per their quality management system all manufacturers have been certified in accordance with ISO 9001 and or ISO 13485 as well as the CE marking to meet the requirement of Medical Device Regulation 2017/745/EU and others. Therefore kindly confirm that foreign Bidders and manufacturers are allowed to submit these certificates instead of “valid product certificate from SRA region”

4.       Most foreign Bidders and especially the manufacturers abroad do not have any “valid product Certificate from EFDA” Kindly confirm that the EFDA registration only applies for local Bidders.

5.       In case of a possible award kindly advise if the products supplied by the foreign bidder or manufacturer should be registered at EFDA or EPSS. If so than kindly advise ;

1) What will be the costs of the registration for each single item at EFDA or EPSS

2) Which documents need to be submitted in order to get this certificate

6.       3) How much time will it take to get the registration completed? We noticed that in some countries it takes months to complete a registration of a medical product. Keeping in mind that the Contractual delivery time is 120 to 150 days, it will be quite impossible to such a job in the Ethiopian registration (due to local bureaucracy) because it might take months to complete the registration, which is beyond the Suppliers control. Kindly advise.

ü  You also mentioned under point 5 System Configuration Accessories: 4 x castors with one lockable. 1) Should they be offered as optional or included in the total configuration unit price?

ü  2) In the original specs you ask for 4 castors with 2 lockable. Should the System Configuration Accessories also not be 2 x regular and 2 x lockable? Kindly confirm

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ü  As per ITB 19; please note that the bidder shall furnish the bid security as part of its bid.

1) letter of intent to form JV or JV agreement,

2) Legal and financial autonomy

3) Operation under commercial law

4) Establishing that the Bidder is not under the supervision of the Purchaser

5. As for Financial Capability in Section III – Evaluation and Qualification Criteria if the bidder is a new company less than 3 years, is Financial audit document from establishing OK?

6. We noticed that the voyage to Addis Ababa port has been cancelled by “Ethiopian Shipping Line S.C.” for several years, so it is hard for foreign bidders to transport goods to Addis Ababa, and you asked for FOB prices in last bid, but this time trade terms is CIP, so is there any possibility to accept CIF Modjo port (it is very near Addis Ababa) please?

7. Can we request extension of deadline of submission of biding document, as we need more time to prepare the competitive bidding document?

8. Can we offer the bid bond issued by Chinese bank directly? Or do you have the list of bank which can be accepted for issuing bid bond?

5.       The financial audit report must be submitted for the last three years and the new entrants are not acceptable.

6.       Kindly requested to give your quotation as per the requested INCOTERM: CIP (Addis Ababa, EPSS Warehouse)

7.       Kindly be informed that the bid closing date was extended to Oct. 29, 2024GC, 8:00PM

8.       Bidder can issue the bid security directly from their country bank: For details please refer to ITB 19.

d. Manufacturer’s authorization: A Bidder who does not manufacture an item/s where a manufacturer authorization is required in accordance with BDS ITB 17.2 (a), the Bidder shall provide evidence of being duly authorized by a manufacturer (Manufacturer’s Authorization Form, Section IV, Bidding Forms), meeting the criteria in (d) (i) and (ii) above, to supply the Goods;

d. Manufacturer’s authorization: A Bidder who does not manufacture an item/s where a manufacturer authorization is required in accordance with BDS ITB 17.2 (a), the Bidder shall provide evidence of being duly authorized by a manufacturer (Manufacturer’s Authorization Form, Section IV, and Bidding Forms).

Please delete the text “8. Standards & Safety Requirement” from each item specification indicated in all LOTS.

Please delete the text “6. Operating Environment”, “7. Utility requirements” and “9. Installation, Training and Commissioning” from each item specification indicated in LOT ONE.

“Mounted on 4 sturdy supports, finished with rubber feet and one adjustable section, with four lockable caster”

For LOT ONE: Item Couch-Examination; Give your quotation as of “4 castors with 2 castors lockable”.

– 6^th column: earliest delivery date from operable LC opening

– 7^th column: latest delivery date from operable LC opening

– 8^th column: bidder’s offered delivery date from operable LC opening

The dimension indicated on LOT 3 Item 1. Sterilizer-Drum, 240mm x 290mm is for Diameter x Height, respectively and

– Please omit “Height: approximately 160 to 180mm”.

The statement “1X drum for different size” is amended by the following

– one qty of Drum Sterilizer with size 340-350mm*180-200mm (Dia.* H),

– one qty of Drum Sterilizer with size 240-250mm*160-180mm (Dia. * H)  and

– One qty of Drum Sterilizer with size 165-175mm*100-120mm (Dia.* H)

– Thickness for all drums is 0.6mm-0.7mm

ü  Section VII – Schedule of Requirements; Under 3. Technical Specification; For LOT ONE: 9. Trolley – General Purpose; “Shall have shelve dimension of more than 60x45cm”.

ü  Section VII – Schedule of Requirements; Under 3. Technical Specification; For LOT ONE: 9. Trolley – General Purpose; “The tray/shelve dimension should be Minimum of 705mm x 445mm” and please remove the statement “Shall have shelve dimension of more than 60x45cm”.

ü  Section VII – Schedule of Requirements; Under 3. Technical Specification; The tray and shelves are similar so that they don’t have different meaning.

Both Items have different Dimension

Certificate Priority:

1. First Priority: Valid Product Certificate from EFDA (for Quoted Model) & Valid Product Certificate from SRA Region;

2. Second Priority: Valid Product Certificate from SRA Region;

Section III – Evaluation and Qualification Criteria: 3.1 Qualification Criteria (ITB 37.1) under (c). Documentary Evidence:

l  Product Certificate:

1.       Valid Product Certificate from SRA Region;

2.       EFDA registration is not mandatory at submission and evaluation stage, but the recommended bidder for award is required to get the EFDA registration prior to signing the Contract.

3.       For more EFDA Registration details please refer: https://eris.efda.gov.et/

Table 1 shows list of regulatory schemes under Stringent Regulatory Authority (SRA) regions (Certificate must include English Language with certification No. /Barcode).

From All Lots: Please delete the text “GMDN/UMDN Code/Name”

ü  Section VII – Schedule of Requirements; Under 3. Technical Specification; LOT ONE: Item Couch-Examination; “Mounted on 4 sturdy supports, finished with rubber feet and one adjustable section, with four lockable caster”

Please delete the text “Frame height: 130cm” and

Give your quotation as of “4 castors with 2 castors lockable” and please include its price in the total configuration unit price.

3.1 Qualification Criteria (ITB 37.1):

(b) Specific Experience: The Bidder shall demonstrate that it has successfully completed at least two contracts within the last five years prior to bid submission deadline,

3.1 Qualification Criteria (ITB 37.1):

(b) Specific Experience: The Bidder shall demonstrate that it has successfully completed at least one contract within the last five years prior to bid submission deadline,