CDSCO Medical Device Alert: New Auto-Generated Workflow Requires Re-Submission

CDSCO Medical Device Alert

CDSCO Medical Device Division Updates Application Process — Fresh Submissions Now Mandatory for MSC and NCC

India’s medical device industry is seeing a notable shift in compliance procedures. The CDSCO medical device division has rolled out an upgraded online system for issuing two critical certificates — the Market Standing Certificate (MSC) and the Non-Conviction Certificate (NCC). With this move, companies must now submit fresh applications under the new, automated system starting April 9, 2025. 

This change is part of CDSCO’s broader push to simplify and digitize its regulatory workflows, making the process faster and more transparent for manufacturers and importers. 

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Here’s What You Need to Know: 

  • New System in Place: CDSCO has introduced an auto-generated certification workflow to replace the older manual system. 
  • Old Applications Voided: Any applications submitted under the previous system will be automatically cancelled. 
  • New Applications Required: All stakeholders must re-submit MSC and NCC applications using the updated portal from April 9 onward. 
  • Eligibility: Only manufacturers and importers with a valid CDSCO medical device license can apply. 

Understanding the Certificates

  1. Market Standing Certificate (MSC): 

This certificate validates a company’s regulatory track record and is often required for exports or when participating in public tenders. 

2. Non-Conviction Certificate (NCC): 

This certifies that the company hasn’t been convicted of any violations related to the quality or safety of medical devices. It serves as a declaration of legal compliance. 

Why This Matters for the Industry

The transition to an automated system marks an important step in improving efficiency within the CDSCO medical device framework. By reducing manual intervention, the process is expected to become smoother and more reliable. 

What you should do now: 

  • Review your current application status. 
  • Gather all necessary documents for re-submission. 
  • Submit fresh applications promptly through the upgraded CDSCO portal. 

With this digital shift, CDSCO is reinforcing its commitment to creating a more accountable and streamlined regulatory ecosystem for India’s medical device sector. 

Want to Know More In Detail?

Operon Strategist: Your Trusted Partner in CDSCO Medical Device Compliance

With India rapidly emerging as a key player in the global medical device space, keeping up with changing regulations—like CDSCO’s upgraded certification process—can be overwhelming. That’s where Operon Strategist brings real value.

Specializing in CDSCO medical device compliance and international certifications such as FDA 510(k), CE Marking, and UKCA, Operon offers comprehensive solutions tailored to the needs of device manufacturers. Whether it’s crafting regulatory strategies, compiling technical documentation, setting up quality systems, or planning compliant facilities, Operon supports clients at every step.

By teaming up with Operon Strategist, companies can confidently manage regulatory transitions, reduce delays, and accelerate their journey from development to market—ensuring innovative medical devices reach those who need them most.

Operon Strategist
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