Compliance checklist for a medical device company to submit a tender
Download Medical Device Tender Compliance Checklist
Submitting a tender for a medical device company requires careful preparation to ensure compliance with various legal, technical, and financial requirements. These requirements vary depending on the region, tender authority, and the nature of the medical device. Below is a comprehensive compliance checklist for a medical device company to submit a tender, categorized into different areas:
1. Technical Compliance
a. Product Certifications
- ISO 13485: Quality Management System Certification
- Ensure your company has an ISO 13485 certificate demonstrating compliance with global quality management standards for medical devices.
- CE Mark (for EU countries) or FDA Approval (for the U.S.)
- Depending on the country, confirm that the medical device is certified by relevant regulatory bodies such as CE marking (Europe) or FDA approval (U.S.).
- Product Registration with Regulatory Authority
- Verify that the device is registered with national medical device regulators such as the Central Drugs Standard Control Organisation (CDSCO) in India or other relevant regulatory bodies in the tender-issuing country.
- Technical Specifications Documentation
- Submit a detailed product specification document that complies with the tender’s technical requirements.
- Provide the unique device identification (UDI) for the product, if applicable.
b. Clinical Evaluation Reports
- Provide clinical evaluation reports or evidence of clinical trials demonstrating the safety and effectiveness of the medical device.
c. Product Testing Certificates
- ISO 10993: Biocompatibility Testing
- For medical devices that come in direct contact with the human body, provide proof of biocompatibility testing.
- IEC 60601: Electrical Safety Compliance (if applicable)
- For electrically powered medical devices, ensure certification according to electrical safety standards.
d. Packaging and Labeling Compliance
- ISO 11607: Packaging for Terminally Sterilized Devices
- Ensure compliance with packaging and sterilization standards if applicable.
- Proper Labeling
- Submit labeling that complies with regional regulatory requirements, including UDI if applicable.
2. Financial Compliance
a. Financial Statements
- Audited Financial Statements
- Provide audited financial statements for the past 3-5 years to demonstrate the financial stability of the company.
- Turnover Certificate
- Submit a turnover certificate validated by a Chartered Accountant, showing that your company meets the turnover requirements specified in the tender document.
- Net Worth Statement
- Include a net worth statement if required, showing the company’s financial health.
b. Tax Compliance
- GST (Goods and Services Tax) Registration
- Ensure that the company is registered for GST (for Indian tenders), and provide the GST certificate.
- Tax Clearance Certificates
- Submit up-to-date tax clearance certificates to confirm the company’s compliance with tax obligations.
c. Bid Security or Earnest Money Deposit (EMD)
- Bid Security (if applicable)
- Deposit the required bid security amount or Earnest Money Deposit (EMD) as mentioned in the tender document.
- Bank Guarantee
- Provide a bank guarantee or a performance security deposit, which may be required as part of the financial compliance.
3. Legal and Regulatory Compliance
a. Company Registration
- Certificate of Incorporation
- Submit a copy of the company’s Certificate of Incorporation as proof of legal establishment.
- Memorandum of Association (MoA) & Articles of Association (AoA)
- Attach a copy of the MoA and AoA to show the company’s legal structure and authorized business activities.
b. Drug and Cosmetics Act Compliance
- Drug License (if applicable)
- For medical devices falling under the Drugs and Cosmetics Act, submit the necessary drug licenses.
- Import License (if applicable)
- For imported medical devices, provide an import license obtained from the relevant regulatory authority.
c. Statutory Compliance
- EPF/ESIC Registration
- Submit proof of registration for Employees’ Provident Fund (EPF) and Employees’ State Insurance Corporation (ESIC) for companies with employees under these schemes.
- Labour Law Compliance
- Provide documents proving compliance with applicable labor laws.
4. Expiry-Date and Validity-Based Compliance
a. Certificate Validity
- Ensure that all submitted certificates, including ISO 13485, CE Mark, FDA approval, and drug licenses, are up-to-date and valid.
- Annual Maintenance Contracts (AMCs)
- If offering post-sales support or services, ensure your AMCs are valid and comply with the tender requirements.
b. Product Shelf-Life
- Expiry Date of Medical Devices
- Provide information regarding the shelf life of the product, including expiry dates if the tender demands medical devices with specific usage periods.
5. General Tender-Specific Documents
a. Tender Form and Cover Letter
- Submit a properly filled tender form, including a cover letter summarizing your bid and how you meet the tender requirements.
b. Compliance Declaration
- Self-Declaration of Compliance
- Include a declaration of compliance, confirming adherence to all regulatory, financial, and technical requirements listed in the tender.
c. Manufacturer’s Authorization Form (MAF)
- For distributors or third-party representatives, provide an MAF from the manufacturer granting the authority to bid on their behalf.
d. Past Experience and Client References
- Previous Work Experience
- Submit documents showing relevant past projects or supply records of similar medical devices.
- Performance Certificates
- Include performance certificates from past clients or government bodies to demonstrate a track record of timely and satisfactory completion of contracts.
e. Compliance with Environmental and Safety Regulations
- RoHS Certification (Restriction of Hazardous Substances)
- For certain electronic medical devices, provide certification proving compliance with RoHS directives.
- Environmental Management (ISO 14001)
- Demonstrate that the company adheres to environmental management standards where applicable.
6. Compliance with Tender-Specific Requirements
a. Tender-Specific Technical Requirements
- Product Samples or Demonstrations
- Provide product samples or live demonstrations if required by the tendering authority.
b. Tender-Specific Service Requirements
- After-Sales Service Plan
- Submit detailed after-sales service and maintenance plans, including spare parts availability and technical support.
Conclusion
To successfully submit a tender for medical devices, a company must ensure compliance with a wide range of technical, financial, legal, and tender-specific requirements. Preparing these documents in advance and keeping them up to date will help streamline the tender submission process and increase the likelihood of winning the bid.
Here’s the tabular format for the compliance checklist. The data is organized with compliance categories, requirements, and applicable documents, including subpoints from points 1 to 6 mentioned earlier.
| Compliance Category | Compliance Requirement | Applicable Documents |
|---|---|---|
| Regulatory Compliance | Registration with GeM Portal | GeM Registration Certificate |
| Registration with National Health Portal | National Health Portal Registration Certificate | |
| Device Classification & Approval | Device Classification Document, CDSCO Certificate | |
| Technical Compliance | Adherence to Relevant Standards | ISO Certifications (e.g., ISO 13485, ISO 9001) |
| Warranty and Maintenance Commitment | Warranty Documents, Service Agreements | |
| Equipment Demonstration Requirement | Demo Reports, Technical Specification Sheets | |
| Financial Compliance | Valid GST and PAN Registration | GST Certificate, PAN Card Copy |
| Submission of Earnest Money Deposit (EMD) | Bank Guarantee, DD/Pay Order Copies | |
| Proof of Financial Stability | Audited Balance Sheets, Bank Statements | |
| Product Certification Compliance | BIS Certification | BIS Certification Documents |
| FDA/CE/ISO Certifications | FDA Certification, CE Marking, ISO Certifications | |
| Compliance with Tender Terms | Acceptance of Terms and Conditions | Signed Declaration Form |
| Submission of Tender-Specific Documents | Tender-Specific Formats, Authorizations, Compliance Declarations | |
| Legal and Statutory Compliance | Udyam Registration (if applicable) | Udyam Certificate |
| Adherence to Environmental Guidelines | Environmental Clearance Certificates | |
| Adherence to Labour Laws | Labour Law Compliance Certificates | |
| Proof of Establishment of Business | Company Incorporation Certificate, MSME/SSI Registration Certificate |
Downloadable Excel File
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Download Medical Device Tender Compliance Checklist
