Market Standing

Medfins International > Services > Market Standing

What is a Market Standing or Non-Conviction Certificate?

A Market Standing Certificate (MSC) serves as proof that a medical device has been continuously available in the Indian market for a certain period. A Non-Conviction Certificate confirms that no regulatory action, adverse event, or Not of Standard Quality (NSQ) report has been issued against the product or company.

These certificates are often required for Class C & D notified medical devices when applying for government tenders or other regulatory processes.

Process for Obtaining a Market Standing Certificate (MSC) in India

In the regulated medical device industry, obtaining a Market Standing Certificate (MSC) or Non-Conviction Certificate is essential for manufacturers and importers, especially when participating in government tenders. This blog provides a step-by-step guide on how to apply for this certificate from the Central Drugs Standard Control Organization (CDSCO) in India.

Who Needs This Certificate?

  • Indian manufacturers with a valid manufacturing license for medical devices.
  • Importers holding a valid import license for notified medical devices.
  • Companies seeking government tenders or regulatory approvals requiring proof of market standing and compliance.

 

How to Apply for a Market Standing or Non-Conviction Certificate?

Step 1: Prepare a Covering Letter

  • Address it to CDSCO, specifying the purpose of the application.
  • Include an index listing the enclosed documents with page numbers.
  • Sign and stamp the letter with details of the authorized signatory (name, designation, company name, and address).

Step 2: Gather Required Documents

  1. Valid Manufacturing or Import License
    • A copy of the license issued by CDSCO for manufacturing/importing medical devices.
    • Attach the approved product list from CDSCO.
  2. Bills of Entry & Import Details (For Importers Only)
    • Submit import records for the last three years as proof of market standing.
  3. Legal Undertaking
    • Execute an undertaking on ₹100 registered notarized stamp paper, confirming that:
      • No regulatory action has been taken against the company.
      • No product complaints, adverse events, or Not of Standard Quality (NSQ) reports exist.
  4. Product List
    • Provide a list of all products for which the certificate is required.

Step 3: Submit the Application to CDSCO

  • Compile all documents and submit the hard copy along with the CD to the Central Licensing Authority at CDSCO.

Step 4: CDSCO Review & Verification

  • CDSCO reviews the submitted documents for completeness and accuracy.
  • If additional information is needed, applicants may be asked to provide clarifications.

Step 5: Issuance of Certificate

  • If the application meets all requirements, CDSCO issues the Market Standing or Non-Conviction Certificate.

Validity of the Certificate

  • The certificate is valid for 1 year from the date of issuance OR until the validity of the manufacturing/import license, whichever is earlier.

 

Why Is This Certificate Important?

  • Essential for government tenders requiring proof of continuous market presence.
  • Demonstrates regulatory compliance and a clean market record.
  • Strengthens credibility when applying for product registrations in India or abroad.

 

FAQs:

  1. Who needs an MSC?

Manufacturers or importers of drugs, medical devices, or IVDs applying for registrations, tenders, or regulatory approvals.

  1. Is an inspection required for MSC approval?

Usually, no physical inspection is required, but authorities may verify submitted documents.

  • Can an MSC be obtained for a newly launched product?

No, MSC requires proof of market presence for at least three years.

How can Medfins help you

As a regulatory consultant, we assist in obtaining a Market Standing Certificate (MSC) by:

  1. Document Preparation & Review – Drafting the covering letter, application, and verifying supporting documents (Bills of Entry, CA certification, sales invoices, legal undertaking).
  2. Regulatory Compliance – Ensuring adherence to state-specific requirements and regulations.
  3. Application Submission & Follow-up – Submitting the application to the State Drug Control Authority and tracking progress.
  4. Handling Queries & Inspections – Addressing authority queries and assisting in compliance checks.
  5. End-to-End Support – Guiding on related regulatory processes and renewals.