500+ Clients
20+ Years Experience
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Pan India Support
Medical Device Services

Quick Snapshot

  • Service / Form: Non-conviction Certificate
  • Who Can Apply: Medical device manufacturers, importers, or other eligible applicants requiring NCC for regulatory, export, tender, or compliance purposes.
  • Timeline: The Non-Conviction Certificate (NCC) application is submitted through the CDSCO Online System along with the required legal undertaking and supporting documents. The certificate is issued after verification of applicable license details and regulatory requirements, subject to CDSCO processing timelines.
  • Fee: Official Fee: ₹300 per certificate.

What is Non-conviction Certificate?

A Non-Conviction Certificate (NCC) is a regulatory certificate issued by the applicable Licensing Authority confirming that there are no convictions recorded against the applicant/license holder as per regulatory records. Under the Medical Devices Rules, 2017, such certificates may be required for regulatory submissions, export-related documentation, tenders, or other compliance purposes.

When Do You Need Regulatory Status Certificate Support?

Support for demonstrating legal, licensing, and compliance status during regulatory submissions, partnerships, procurement, and market expansion activities.

When Do You Need Support?
  • Regulatory submissions requiring confirmation of legal and compliance status
  • Import license applications under MDR 2017
  • Manufacturing and distribution partnerships
  • Hospital and government procurement tenders
  • Vendor qualification and due diligence
  • International regulatory submissions and market expansion
  • Supplier qualification and regulatory due diligence activities
  • Business collaborations in regulated healthcare products
  • Regulatory audits and compliance reviews
Key Challenges
  • Navigating system upgrades and re-applications
  • Ensuring data consistency across the regulatory ecosystem
  • Maintaining the underlying license
  • Ensuring eligibility and compliance per regulatory requirements
  • Gathering the correct supporting documentation

Our Approach and What You Will Get

Professional support for NCC applicability, documentation verification, attestation, legalization, and regulatory submission readiness.

Our Approach
  • Assess NCC requirement for medical device activities
  • Support document preparation and review
  • Guide notarization, legalization, apostille, and attestation
  • Coordinate international documentation and verification
  • Review records for accuracy and consistency
  • Align NCC documentation with applicable CDSCO requirements and regulatory submissions
  • Verify documents to prevent discrepancies and delays
  • Ensure consistency across submissions and licenses
  • Advise on submission readiness and compliance
  • Reduce the risk of document rejection
  • Provide professional coordination throughout the process
What You Will Get (Deliverables)
  • Regulatory guidance on NCC applicability
  • Documentation checklist preparation
  • Application drafting support
  • Review of identity and address documents
  • Guidance on regulatory verification requirements
  • Support for notarization and attestation
  • Apostille and embassy legalization advice
  • Coordination for international submissions
  • Compliance review per applicable medical device regulations
  • Query and clarification assistance

Why Choose Tacit Medtek and Case Example

Structured support for Non-Conviction Certificate documentation, authentication, legalization, and medical device import compliance.

Why Choose Tacit Medtek
  • Expertise in medical device regulatory compliance and documentation
  • Knowledge of MDR 2017 and global regulations
  • End-to-end consultancy for healthcare businesses
  • Experience with import, manufacturing, and agent documentation
  • Support for attestation, legalization, and compliance
  • Fast, structured document review
  • Dedicated help for startups, importers, and foreign manufacturers
  • Integrated support with medical device licensing services
Case Example
  • Challenge: A medical device company required a Non-Conviction Certificate as part of regulatory and export documentation and faced delays due to documentation preparation and authentication requirements.
  • Our Approach: Tacit Medtek evaluated the regulatory and documentation needs, prepared a detailed checklist, guided the applicant through authentication, notarization, and apostille processes, and ensured the final Non-Conviction Certificate package met medical device import compliance standards.
  • Outcome: The client completed the documentation and verification successfully, enhancing compliance readiness, reducing errors, and streamlining the medical device import licensing process.

FAQ

Frequently Asked Questions

01
Who will issue the certificates like Non-Conviction Certificate, Free Sale Certificate, Market Standing Certificate etc. which are required on request of procurement / tendering agencies or for export purpose?

The Licensing Authority who has issued license may issue such certificates.

02
What is the mode of submission of application for Free Sale Certificate/ Market Standing Certificate/ Non-Conviction Certificate etc. to the Licensing Authority?

The applicant may submit all such applications through Online mode in Medical Devices online portal (www.cdscomdonline.gov.in) to concerned Licensing Authority.

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