Supply of N95 Respirator

New amendment added #3: Amendment - III (Dated. 20th September 2023)In section II & IV, the description “Surgical” is removed.In section III, Minimum 95% BFE (Bacterial Filtration Efficiency) according to ASTM F2101 and Fluid resistance according to ASTM F1862 are removed from UNOPS minimum technical requirements and see the revised as below.Lot No 1, Item 1- N95 Respirator without valve ,Small sizeN95 Respirators to prevent Mycobacterium TuberculosisNIOSH approved N-95Respirator contains no components made from natural rubber latex It covers approximately  4.5" (height) x 4.8" (width) of face (For the approx, the acceptable variation limit is +/- 3%)Non-oil aerosol type Collapse resistant cup shape design Braided headbands, cushioning nose foam and light weight comfortable wearSmall sizeUNOPS or end user may do fit test to see suitability for useLot No 1, Item 2 - N95 Respirator without valve ,Medium sizeN95 Respirators to prevent Mycobacterium TuberculosisNIOSH approved N-95Respirator contains no components made from natural rubber latex It covers approximately  4.825" (height) x 5.25" (width) of face (For the approx, the acceptable variation limit is +/- 3%)Non-oil aerosol type Collapse resistant cup shape design Braided headbands, cushioning nose foam and light weight comfortable wearMedium sizeUNOPS or end user may do fit test to see suitability for useIn section III & IV, TEC application period was revised as “UNOPS will apply for a Tax exemption certificate (TEC) which normally takes around 4 weeks’ time or more”.All other terms and conditions of the ITB document remain unchanged. 

New clarification added: Query  : FORM E states the following: "UNOPS will apply for a Tax exemption certificate (TEC). Once the TEC is received, UNOPS will provide the greenlight for the shipment. Please note that the TEC application period may take 8 weeks or more."We intend on making shipment by (3) 40 foot containers. As we understand it, we are required to provide UNOPS with draft BOL and all other shipping documents and wait for UNOPS approval to make shipment. UNOPS has advised that it will take at least 8 weeks to obtain the TEC and provide authorization to ship. Please be advised that once goods are delivered to Shanghai Port and vessel booked, and draft BOL provided, we cannot wait for 8 weeks to make shipment on the same vessel. UNOPS requirement in FORM E is very confusing. Please clarify.Answer : We will revise the TEC application to 4 weeks more or less. For the shipment, the supplier needs to wait for a greenlight from the UNOPS.

New clarification added: Query  : FORM E states the following: "UNOPS will apply for a Tax exemption certificate (TEC). Once the TEC is received, UNOPS will provide the greenlight for the shipment. Please note that the TEC application period may take 8 weeks or more."We intend on making shipment by (3) 40 foot containers. As we understand it, we are required to provide UNOPS with draft BOL and all other shipping documents and wait for UNOPS approval to make shipment. UNOPS has advised that it will take at least 8 weeks to obtain the TEC and provide authorization to ship. Please be advised that once goods are delivered to Shanghai Port and vessel booked, and draft BOL provided, we cannot wait for 8 weeks to make shipment on the same vessel. UNOPS requirement in FORM E is very confusing. Please clarify.Answer : We will revise the TEC application to 4 weeks more or less. For the shipment, the supplier needs to wait for a greenlight from the UNOPS.

New clarification added: Query : Request to make the Drive Supplier Sustainbility Questionnaire an optional document in the vendor submission. As this is a mandatory document without any documents for us to attach. Submission is not accepted or possible as the system locks us from submitting because of incomplete documentation. We have filled the sustainability questions in Supplier form. Kindly check and advise.UNOPS Reply : If you filled the DRIVE Supplier Sustainability Questionnaire in the“Supplier Forms"tab, we can download and access your file. No need to upload the file again.

New clarification added: Query : Can we quote for single item instead of both items?UNOPS Reply : As mentioned in Section I : Instruction to bidders , the bidder must offer 100% of the items specified for each lot  and 100 % of the quantities specified for each item of a lot. So quotation for both items is mandatory.

New clarification added: Query : Request to make the Drive Supplier Sustainbility Questionnaire an optional document in the vendor submission. As this is a mandatory document without any documents for us to attach. Submission is not accepted or possible as the system locks us from submitting because of incomplete documentation. We have filled the sustainability questions in Supplier form. Kindly check and advise.UNOPS Reply : If you filled the DRIVE Supplier Sustainability Questionnaire in the“Supplier Forms"tab, we can download and access your file. No need to upload the file again.

New clarification added: Query : In Vendor Submission, DRiVE Supplier Sustainability Questionnaire is a mandatory document. As the "Supplier Form" tab already addresses the Supplier Sustaainability questionnair, is this still required? Further there is no document for DRiVE Supplier Sustainability Questionnaire in the tender document, which is generally available in an excel file as we have seen in past tenders we have submitted.Please check and confirm how we can submit the DRIVE Supplier Sustainability Questionnaire.UNOPS Reply : If you filled the DRIVE Supplier Sustainability Questionnaire in the“Supplier Forms"tab, we can download and access your file. No need to submit the file again.

New clarification added: Question: Kindly clarify the penalty per day for failure of delivery, and the total number of days before the maximum penalty of 10% is reached.UNOPS Reply: It's not a penalty but Liquidated damages, which is compensation for loss occurred to buyer for delay, if any. The detail is provided in section IV - 2, UNOPS Special Conditions of Contracts.

New clarification added: Question : What are the documents to be provided by the supplier to UNOPS towards application for the TEC Certificate?Will the TEC request be placed as and when the order is placed by UNOPS, or only after confirmation of shipment readiness by the supplier?Once the shipment is ready and shipping documents have been provided, within how many days can the request for dispatch be expected? UNOPS Reply: For the documents, please refer to the GCC 4.1 under the Special Conditions of Contract. The TEC can be applied with the shipping documents provided by the supplier and the TEC application period may take 4 weeks more or less.

New clarification added: Question: We have already submitted our bid but a question has belatedly come up as follows: The minimum technical requirements state as follows:●        Surgical N95 Respirators to prevent Mycobacterium Tuberculosis●        NIOSH approved N-95●        Minimum 95% BFE (Bacterial Filtration Efficiency) according to ASTM F2101●        Fluid resistant according to ASTM F1862The Surgical N95 Respirators we have quoted already have a US FOOD& DRUG  (FDA) Premarket Notification, 510 (k) number  K 020474.  According to  the  manufacturer of the quoted products,the FDA standard is higher than the ASTM standard, therefore, if the quoted  Surgical N 95 facemasks have been approved by the US FDA, it means that the quoted products already meet the ASTM standard.  Please confirm.  thank you in advance.   Our quoted products are also NIOSH approved.UNOPS Reply: Requirement is for NIOSH approved N95 respirators and not surgical N95 respirators. If NIOSH approved, ASTM standard is not required to be submitted. If already submitted, you can withdraw and resubmit your bid, if required based on above clarification.

New clarification added: Question: We would like to know if we can offer an alternative that could work with FFP2. The N95 respirator is an FDA listed PPE AND the FFP2 is the European one which has similar standards and virtually the same applications for use. Although they are not the same. Is it possible to offer it?UNOPS Reply: We need only NIOSH Approved N-95 Respirator.

New clarification added: Query: For your tender number ITB/2023/48426,Will we deliver DAP to you at the port without doing customs clearance for the products?UNOPS reply - Pls submit as per the requested incoterm. We will do the custom clearance. Query: The requested ASTM certificate is a document in American standards.  We would like to present you the bacteria test certificate of the same document in Turkish standards.  Is this document accepted?We understand that you want to see ASTM on the boxes.  But this is not done according to Turkish standards.  Can you accept this situation?UNOPS reply - ASTM standard is required as mentioned in the document and pls offer accordingly.  Query: Following up on your answer regarding the location of DRIVE Supplier Sustainability Questionaire. Could you please clarify where the "Form Tab" is which you refer to? Under 'Vendor Submissions' --> 'Supplier Forms', one can find 7 parts of the DRIVE Supplier Sustainability Questionaire which are NOT downloadable, merely to be completed on the platform. This however, does not help when it comes to completing the 'Documents Checklist" where it is mandatory to upload a copy of the DRIVE Supplier Sustainability Questionaire. Please advise how to proceed here, ie how do we download the DRIVE Supplier Sustainability Questionaire? Thank youUNOPS reply -You can fill in the DRIVE Supplier Sustainability Questionnaire in“Supplier Forms" and no need to download. Query:   The delivery requirements under FORM E even after clarification by UNOPS are still uclear. PLEASE REPLY: Is the delivery requirement of 45 days of signing of the purchase order 45 days from the port of export OR 45 days at port of Yangon? Example: If he masks are being produced in China and shipped from Shanghai Port, is the delivery requirement 45 days from Shanghai Port OR 45 days at Yangon Port ?UNOPS reply - The shipment to be ready and shipping documents to be provided date within 45 days of signing Purchase Order. In case of air shipment, you have to provide shipping documents in advance of that date and shipment shall be made within 10 working days only after the dispatch clearance is issued by UNOPS. Pls refer details in the tender document form E. Query: The delivery reqUNOPS reply - The query is not relevant.

New clarification added: Query  -Can we apply to supply only one of the sizes not both? As our masks vary in terms of dimensions.The pricing to be provided will include the shipping to destination through sea or air? And do you need FOB prices without shipping?UNOPS Reply -As mentioned in Section I : Instruction to bidders , the bidder must offer 100% of the items specified for each lot  and 100 % of the quantities specified for each item of a lot. So, it is mandatory to offer both items. Please submit the mode of transport Air/Sea. In terms of incoterms, please submit as per our requirement mentioned in the delivery requirements and Form C Price Schedule form.

New clarification added: Query  -We have a question regarding the dimensions mentioned. As our masks have different ratios, would the dimensions below be acceptable?Medium N95 mask: 146mm /5.75” (height) x 117mm/4.61” (width)Small N95 mask: 144mm /5.67” (height) x 117mm/4.61” (width)UNOPS Reply - The acceptable variation is only +/- 3%. The acceptance of the offered product will be considered during the evaluation by the evaluation panels only.

New clarification added: Query  - About the samples, will they be sent 7 days after they are requested once a first evaluation is passed? Or when will the samples be sent? The issue of payment in dollars, how would it be? Could you explain me the issue of the third party as an intermediary?UNOPS Reply - We will let you know when the sample needs to be sent, which will be  during the evaluation time after bid closing. The third party payment is especially for the bidders from Myanmar having limited banking constraints and are unable to make the USD payment transfer due to the CBM limitations. The bank account name of the bidder has to be exactly the same name as their  company name. If it is not, we consider them  as a third party payment transfer and we need to run the third party payment process.

New clarification added: Query  -Can we quote for single item or quotation for both items is mandatory?UNOPS Reply - As mentioned in Section I : Instruction to bidders , the bidder must offer 100% of the items specified for each lot  and 100 % of the quantities specified for each item of a lot. Since,both items are in single lot, both items needs to be offered.

New clarification added: Query  -Can we quote for single item or quotation for both items is mandatory?UNOPS Reply - As mentioned in Section I : Instruction to bidders , the bidder must offer 100% of the items specified for each lot  and 100 % of the quantities specified for each item of a lot. Since,both items are in single lot, both items needs to be offered.

New clarification added: Query -We've filled in DRIVE Supplier Sustainability Questionnaire in“Supplier Forms". But in "Document Checklist", which still require upload the file. Pls help advise where the file of "DRIVE Supplier Sustainability Questionnaire" can be found?UNOPS Reply - If you filled the DRIVE Supplier Sustainability Questionnaire in the“Supplier Forms"tab, we can download and access your file. No need to upload the file again.

New amendment added #2: Amendment - II (Dated. 16th September 2023)The Quality assurance requirement is revised to NIOSH approved only and removed CDC guidelines in Packaging and Labelling Specifications, which appears in the bid document under Form D: Technical Quotation Format are amended as below.Lot No 1, Item 1- N95 Respirator without valve ,Small sizeN95 Respirators to prevent Mycobacterium TuberculosisNIOSH approved N-95Minimum 95% BFE (Bacterial Filtration Efficiency) according to ASTM F2101 Fluid resistant according to ASTM F1862 Respirator contains no components made from natural rubber latex It covers approximately  4.5" (height) x 4.8" (width) of face (For the approx, the acceptable variation limit is +/- 3%)Non-oil aerosol type Collapse resistant cup shape design Braided headbands, cushioning nose foam and light weight comfortable wearSmall sizeUNOPS or end user may do fit test to see suitability for useLot No 1, Item 2 - N95 Respirator without valve ,Medium sizeN95 Respirators to prevent Mycobacterium TuberculosisNIOSH approved N-95Minimum 95% BFE (Bacterial Filtration Efficiency) according to ASTM F2101 Fluid resistant according to ASTM F1862 Respirator contains no components made from natural rubber latex It covers approximately  4.825" (height) x 5.25" (width) of face (For the approx, the acceptable variation limit is +/- 3%)Non-oil aerosol type Collapse resistant cup shape design Braided headbands, cushioning nose foam and light weight comfortable wearMedium sizeUNOPS or end user may do fit test to see suitability for usePackaging and Labelling Specificationsa) Should be standard as per the regulations applicable.b) Special packaging and notification is required for easily breakable material.c) All Labelling and packaging inserts shall be in English.d) Special labelling is required for toxic and hazardous products shall indicate the necessary warnings as required.e)The required packaging is box packaging.All other terms and conditions of the ITB document remain unchanged.

New amendment added #1: The deadline for bid submission was extended to 22-Sep-2023 (5:30 UTC). The deadline for clarification was extended till 20-Sep-2023 (5:30 UTC).  The amendment will be issued regarding quality assurance requirement.

New clarification added: Query : Could you kindly provide us with an email address to which we may send an attachment pertaining to our inquiries concerning the fit testing of the requested Surgical N95 Cup style in sizes S and M for users in Myanmar regarding this project?UNOPS Reply - You can send via procurementmmoc@unops.org. 

New clarification added: Query  -Form E describes that the product needs to be ready and shipping docs provided within 45 days of signing the purchase order. Can you please clarify what you mean by 'ready'? Does this mean delivered and available or ready to be shipped? Production and delivery of the products to Yangon port would of course be tight within 45 days.UNOPS Reply - The product should be  available and ready to be shipped after  45 days of signing the purchase order.

New clarification added: Query  - Where can the 'DRIVE Supplier Sustainability Questionaire' be found?- Is there a template for the 'Document for Sustainability Requirement and Commitment to Gender Equality' or is it just a company statement which is required?UNOPS Reply - DRIVE Supplier Sustainability Questionnaire can be found in  “Form tab”. Document for Sustainability Requirement and Commitment to Gender Equality can be submitted as per company own statement. Regarding the mandatory attachments. 

New clarification added: Query  - I am unsure whether we must complete a supplier regiatration form or not. We have a UNGM account and number and have also sold goods to UNOPS previously. How can we readily find out if we are currently registered with you or not?UNOPS Reply - If you are already registered in oneUNOPS, have a supplier registration number and no need for further changes in the existing data, the form is not required.

New clarification added: Query  -The file named "Section III - Returnable Forms", for Packaging and Labelling Specifications, which mentioned "e)Meets the CDC guidelines for Mycobacterium tuberculosis exposure control must be mentioned on label and packing material of the product.". Could you please provide a file of CDC guidelines for reference?UNOPS Reply - We will delete the above labeling requirement in the amendment. 

New clarification added: Query  -The file named "Section III - Returnable Forms", for Packaging and Labelling Specifications, which mentioned "e)Meets the CDC guidelines for Mycobacterium tuberculosis exposure control must be mentioned on label and packing material of the product.". Could you please provide a file of CDC guidelines for reference?UNOPS Reply - We will delete the above labeling requirement in the amendment. 

New clarification added: Query :  In the UNOPS minimum technical requirements, it pointed out "NIOSH approved N-95", but in Quality Assurance Requirements "also pointed out "USFDA approved/cleared or CE mark or equivalent Quality management system recognized by one of the Regulatory Authorities of the founding members of the GHTF with documentary evidence that the product is being marketed in any one of these countries." , does it mean CE FFP2 mask is also acceptable for bidding?Thanks for your help and hope could get your reply ASAP.UNOPS Reply : Quality assurance requirement is revised to NIOSH approved only and the amendment will be issued along with the extension timeline of bid closing. 

New clarification added: Query: The answer on the quantity is not clear. Is it 220 336 packs of 20 or is it 220 660 pieces of masks.  Hello,UNOPS reply:  It is 220,660 pcs of masks.Query: We are contacting you from ABC company. We have a LTA with WHO supplying N95 masks. We are interested in this tender and want to clarify the folloiwng:1- Is there an estimation for the number of masks required to be purchased? 2- For current existing suppliers like us, is there a faster way we can apply for this tender? Any path for registered suppliers?UNOPS reply: 1.The required qty was mentioned in the solicitation documents.2. Since the UNOPS e procurement system is integrated with UNGM, the tender opportunities can be accessed from the UNGM through the Expression of interest button. https://www.ungm.org/.To share your company experience and product line introduction, you can send email to procurementmmoc@unops.org. Query: Our Small size N95 mask covers approximately  4.5" (height) x 5.24" (width) of face (For the approx, the acceptable variation limit is +/- 3%). Can it be accepted?UNOPS reply:  The equirement for a small size is 4.5" (height) x 4.8" (width) of face and the acceptable variation is only +/- 3%. 

New clarification added: Query: The total quanitity mentioned in the bid document is as below:1  Surgical N95 Respirator without valve ,Small size 20 pcs/pack  Pcs 220,660 2  Surgical N95 Respirator without valve, Medium size 20 pcs/pack  Pcs 659,140 A. We presume that for Small size we need 11033 packs and each pack will contain 20 pcs of Mask and for Medium size we need 32957 packs and each pack will contain 20 pcs of Mask,. Kindly confirmB. Do we need to quote on basis of each pack or each pcs?UNOPS reply: Yes, the mentioned qty is correct. Please quote on the basis of “pcs”. 

New clarification added: Query: The total quanitity mentioned in the bid document is as below:1  Surgical N95 Respirator without valve ,Small size 20 pcs/pack  Pcs 220,660 2  Surgical N95 Respirator without valve, Medium size 20 pcs/pack  Pcs 659,140 A. We presume that for Small size we need 11033 packs and each pack will contain 20 pcs of Mask and for Medium size we need 32957 packs and each pack will contain 20 pcs of Mask,. Kindly confirmB. Do we need to quote on basis of each pack or each pcs?UNOPS reply: Yes, the mentioned qty is correct. Please quote on the basis of “pcs”. 

New clarification added: Query 1- I have read the document and found small querries regarding the quantity, Here we read Packs of 20 No. Mask & quanity 220660. Is it No. of masks in total 11033 Packs or it is total pacs. Here we have slight confusion. Please correct meAnswer 1- The required qty for small size is 220,660 in smallest unit pcs. The pack size is 20 pcs/pack.

New clarification added: Query 1- Please confirm if the complete quantity is required in one single shipment?Answer 1- Yes, as mentioned in the Form E, 100% quantity needs to be shipped within 45 days of signing PO.