Gujarat Panchayats And Rural Housing Department Sterile Hypodermic Syringes Tender Surendranagar 2026 IS 10258 MDR 2017
N/a
SURENDRA NAGAR, GUJARAT
Progress
Quantity
87
Category
Single Use Sterile Hypodermic Syringes for Human Use Conforming to IS 10258 (Part 1)
Bid Type
Single Packet Bid
Central Government Health Scheme (CGHS) seeks supply of Single Use Sterile Hypodermic Syringes for Human Use conforming to IS 10258 (Part 1) with Q2 qualification, and Nitrile Coated/Nitrile Gloves (V2, Q3). The package involves syringes with needles included, needle caps or shields, and packaging details defined by the BOQ structure (pack size and residual shelf life). Compliance to the Drugs and Cosmetic Act 1940 and Medical Device Rules (MDR) 2017, plus a valid Medical Device license, are mandatory. Expected scope includes packaging details and on-demand test reports; no BOQ items are listed. The tender emphasizes quality conformance, licensing, and test documentation for buyer on demand.
Needle included in syringe
Syringe type varies by number of pieces
Needle cap/shield for safety
Nominal Capacity (ml) must be specified
Pack size per pack and residual shelf life required
Compliance to Drugs and Cosmetic Act 1940 and MDR 2017
Valid Medical Device license required
Test reports from NABL/ILAC accredited labs to prove conformity
EMD exemption for MSME/NSIC with certificate
Mandatory Medical Device license and MDR 2017 compliance
IS 10258 (Part 1) conformance and ISI/NABL testing as applicable
Payment terms to be as per buyer; EMD refundable as applicable; no advance without contract terms
Delivery timeline to be defined; ensure availability of stock for on-demand supply
Penalties for late delivery or non-conformance per procurement terms; LD applicable as specified
Vendor must hold valid Medical Device license for syringes or related accessories
MSME/NSIC registration entitles EMD exemption (certificate submitted)
Experience in supplying medical devices (syringes/gloves) with conformity to MDR 2017
Main Document
CATALOG Specification
CATALOG Specification
CATALOG Specification
CATALOG Specification
OTHER
OTHER
GEM_GENERAL_TERMS_AND_CONDITIONS
N/a
SURENDRA NAGAR, GUJARAT
N/a
PATAN, GUJARAT
Bhavnagar District Panchayat
BHAVNAGAR, GUJARAT
Directorate Of Animal Husbandry
AHMEDABAD, GUJARAT
Surat District Panchayat
SURAT, GUJARAT
Tender Results
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| Category | Specification | Requirement |
|---|---|---|
| PRODUCT INFORMATION | Needle included | Yes |
| PRODUCT INFORMATION | Syringe type based on number of pieces | Two Piece Syringe ( Barrel and Piston, plunger and plunger stopper form one component made of the same material) |
| PRODUCT INFORMATION | Needle cap or shield to protect the needle | Yes |
| PRODUCT INFORMATION | Nominal Capacity of Syringe (ml) | < 2 |
| PACKAGING | Number of pieces in a Pack | 100 |
| SHELF LIFE | Residual shelf life of the product | Agree to provide residual shelf life of atleast 75% of total shelf life at the time of delivery to the consignee |
| CERTIFICATIONS | Compliance to Drugs and Cosmetic Act 1940 and Medical Device Rules (MDR) 2017 as amended till date | Yes |
| CERTIFICATIONS | Availability of valid Medical Device license for the product issued from the competent authority | Yes |
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GST registration certificate
Permanent Account Number (PAN) card
Medical Device license (valid) for the product
Test reports from Central Govt/NABL/ILAC-registered labs
EMD payment proof or MSME/NSIC exemption certificate (if eligible)
Product technical compliance certificates
OEM authorization or authorized distributor certificate
Company profile and financial statements
Key insights about GUJARAT tender market
Bidders should verify Medical Device license validity, IS 10258 compliance, and MDR 2017 adherence. Prepare EMD as per MSME/NSIC eligibility, attach NABL/NILAC test reports, GSTIN, PAN, and OEM authorizations. Submit technical compliance documents and packaging details; ensure pack sizes and shelf life are clearly stated in the bid.
Required documents include GST certificate, PAN, Medical Device license copy, NABL/ILAC test reports, EMD proof or MSME exemption certificate, OEM authorization, company financials, and technical compliance certificates demonstrating IS 10258 conformity.
Syringe set must include needle, safety cap/shield, and be offered in specified nominal capacity (ml). Packaging must indicate number of pieces per pack and residual shelf life. Compliance with MDR 2017 and Drugs and Cosmetic Act 1940 is mandatory; test reports from NABL/ILAC labs are required on demand.
MSME vendors can seek EMD exemption by submitting an MSME/NSIC exemption certificate. If not exempt, standard EMD as defined by the tender must be paid. Exemption details are contingent on the declared registration status in the bid.
Delivery schedule will be defined in the contract; suppliers must ensure stock availability for on-demand supply. Payment terms follow buyer terms with potential milestone payments; specify delivery timelines and acceptance criteria in the commercial bid.
Confirm that the offered syringes and gloves have a valid Medical Device license and MDR 2017 conformity. Provide license numbers, issuing authority, and ensure test reports from NABL/ILAC labs accompany the bid or are available on demand during supply.
Gloves must satisfy V2 Q3 specifications with details on coating, powder content, material base (nitrile), size, and length. Include test reports and packaging details; ensure conformity with central government quality requirements and include OEM documentation if applicable.
Syringes must specify residual shelf life and pack size per unit. Packaging type should protect needle integrity, include needle shields, and be compliant with standard packaging practices for medical devices to ensure sterility during transport.
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Main Document
CATALOG Specification
CATALOG Specification
CATALOG Specification
CATALOG Specification
OTHER
OTHER
GEM_GENERAL_TERMS_AND_CONDITIONS