Tender Title:
3D Metal (Ti-6-Al-4-V-Eli) Printed Cranial Implant for Cranioplasty - GEM/2025/B/6147214
Issuing Authority:
Department of Military Affairs, Ministry of Defence
Scope of Work and Objectives:
The objective of this tender is to procure a 3D metal (Ti-6-Al-4-V-Eli) printed cranial implant designed specifically for cranioplasty procedures. The implant dimensions are approximately 11x7 centimeters, and it is expected to meet stringent quality and safety standards. This implant will be critical in restoring the cranial integrity of patients suffering from skull defects.
Eligibility Criteria:
To participate in this tender, bidders must meet the following eligibility requirements:
- Registration as a legal entity with relevant business licenses.
- Capability to manufacture 3D printed medical implants, specifically in titanium alloy.
- Proven track record of delivering similar medical implants in the previous projects.
- Compliance with applicable local regulations and standards regarding medical device production.
Technical Requirements:
The technical specifications for the cranial implant include:
- Use of Ti-6-Al-4-V-Eli, which is a titanium alloy recognized for its superior biocompatibility and mechanical properties.
- Compliance with ISO 13485, which pertains to quality management systems for medical devices.
- Ensuring the implant design is optimally customized for specific cranial defect measurements.
Financial Requirements:
Bidders will need to provide a comprehensive financial proposal that includes:
- Itemized costs of the cranial implants.
- Breakdown of developmental and manufacturing costs.
- Payment terms that comply with industry standards.
Document Submission Details:
All interested bidders should submit their sealed proposals, including technical and financial bids, to the Department of Military Affairs. The submission should include:
- Detailed specifications of the implant.
- Proof of eligibility and past performance.
- Certificates for quality compliance.
Special Provisions:
Micro, Small, and Medium Enterprises (MSEs) will be granted preferential benefits in line with government policies to encourage participation and competitiveness from smaller entities. Startups may also receive favorable considerations in this tender process, aligning with the government’s initiative to support new businesses in the medical manufacturing sector.
Evaluation Process:
Bids will undergo a thorough evaluation process based on:
- Compliance with technical specifications.
- Financial feasibility of the provided bids.
- Capacity to deliver within the required timeline.
- Overall experience and reputation in the industry.
Delivery Locations:
The implants will be delivered directly to designated medical facilities as per the directives from the Department of Military Affairs, ensuring adherence to regulatory standards of transport for medical devices.
Contact Information:
For further details regarding this tender, potential bidders should reach out to the Department of Military Affairs, under the Ministry of Defence.
General Information
Financial Information
Evaluation and Technical Information
Tender Documents
4 DocumentsDocuments Required from Seller
- Experience Criteria
- Past Performance
- Bidder Turnover
- Certificate (Requested in ATC)
- OEM Authorization Certificate
- OEM Annual Turnover
- Compliance of BoQ specification and supporting document *In case any bidder is seeking exemption from Experience / Turnover Criteria
- the supporting documents to prove his eligibility for exemption must be uploaded for evaluation by the buyer
Frequently Asked Questions
The eligibility requirements for this tender include being a registered legal entity capable of manufacturing 3D printed medical implants. Bidders must provide proof of previous experience in producing similar implants, along with compliance with local manufacturing regulations and quality standards.
The technical specifications for the cranial implants include manufacturing from Ti-6-Al-4-V-Eli titanium alloy, ensuring biocompatibility and strength. Compliance with ISO 13485 standards for medical devices is mandatory, alongside the need to customize the implant design to fit specific patient requirements.
Bidders are required to furnish a performance security guarantee, typically a specific percentage of the contract amount, which ensures compliance with delivery timelines and overall quality standards. This security may be forfeited should there be any non-compliance upon completion of the contract terms.
Bids for this tender must be submitted in sealed envelopes containing both technical and financial proposals. All required documentation, including proof of eligibility, should accompany the submission, adhering to the specified guidelines laid out by the Department of Military Affairs.
Yes, Micro, Small, and Medium Enterprises (MSEs) can expect to receive various benefits, including preferential treatment during the evaluation process. This encourages their participation and aids in making the tender more inclusive, supporting government initiatives aimed at empowering smaller businesses in the medical device manufacturing sector.
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