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Medical Device Services

Quick Snapshot

  • Service / Form: Market Standing Certificate
  • Who Can Apply: Medical device manufacturers or importers in India who have a valid manufacturing license or import license under the Medical Devices Rules, 2017 and intend to obtain Market Standing.
  • Timeline: Approximately 7 to 15 days
  • Fee: INR 1,000 per application.

What is Market standing Certificate?

A Market Standing Certificate (MSC) is an official document confirming that a medical device is legally manufactured, marketed, and distributed in a country without major regulatory issues. It is used to demonstrate a product’s commercial and regulatory status to authorities, importers, distributors, hospitals, and international buyers. The MSC is often required for device registration, import/export approvals, government tenders, distributor onboarding, and international expansion. It enhances product credibility, supports compliance, aids regulatory reviews, and builds trust with stakeholders.

When Do You Need Medical Sales Certificate Support?

Assistance with preparing and coordinating Medical Sales Certificates (MSCs) for international registrations, import approvals, tenders, and market expansion.

When Do You Need MSC Support?
  • Applying for medical device registration abroad
  • Seeking import approvals for medical devices
  • Participating in government or institutional tenders
  • Appointing overseas distributors or agents
  • Expanding into international markets
  • Supporting regulatory submissions with market evidence
  • Demonstrating ongoing commercial sales of a device
  • Providing proof of product reputation and compliance
Key Challenges
  • Varying MSC format requirements across countries
  • Uncertainty about acceptable issuing authorities
  • Incomplete product and regulatory information
  • Delays in gathering supporting documents
  • Mismatches between licenses and product details
  • Regulatory delays due to incomplete or inconsistent declarations
  • Challenges aligning MSC wording with importing country rules
  • Requirements for notarization, apostille, or embassy legalization in some regions

Our Approach and What You Will Get

Comprehensive support for Medical Sales Certificate applications, supporting documentation, country-specific requirements, and regulatory submissions.

Our Approach
  • Understanding country-specific MSC requirements
  • Reviewing product classification and regulatory status
  • Assessing current licenses and approvals
  • Preparing supporting documentation and declarations required for MSC application
  • Coordinating supporting documents
  • Providing guidance on notarization and legalization if needed
  • Ensuring alignment with regulatory dossiers and submissions
What You Will Get (Deliverables)
  • Support with MSC application preparation and documentation
  • Review of regulatory documents
  • Verification of product information
  • Assistance with drafting declarations
  • Guidance on issuing authority or chamber requirements
  • Checklist of required supporting documents
  • Formatting to meet importing country standards
  • Consultation on legalization and apostille needs
  • Submission support for regulatory authorities

Why Choose Tacit Medtek and Case Example

Expert documentation and regulatory support for Market Standing Certificate applications and international medical device registrations.

Why Choose Tacit Medtek
  • Expertise in medical device regulatory documentation
  • Experience with international compliance standards
  • Professional support for startups and established companies
  • Comprehensive end-to-end documentation assistance
  • Timely coordination and regulatory communication
  • Knowledge of CDSCO and global medical device regulations
  • Customized documentation tailored to country-specific requirements
  • Practical, compliance-focused regulatory approach for efficiency
Case Example
  • Challenge: A medical device exporter planned to register surgical consumables in an overseas market but faced delays because the importing authority requested a properly structured Market Standing Certificate demonstrating commercial sale and regulatory standing of the products.
  • Our Approach: Prepared and supported submission of the MSC application through the applicable regulatory portal, aligned product information with regulatory documents, and guided the client on authentication requirements.
  • Outcome: Obtained the Market Standing Certificate with reduced documentation deficiencies and supported smoother progress in the overseas product registration process.

FAQ

Frequently Asked Questions

01
Who will issue certificates like Non-Conviction Certificate, Free Sale Certificate and Market Standing Certificate?

The Licensing Authority that issued the licence may issue such certificates.

02
What is the validity of a Market Standing Certificate issued by the Licensing Authority?

The Market Standing Certificate issued by the Licensing Authority is valid for one year from the date of issuance.

03
What is the mode of submission for applications for Free Sale, Market Standing and Non-Conviction Certificates?

Applicants may submit such applications online through the Medical Devices online portal (www.cdscomdonline.gov.in) to the concerned Licensing Authority.

04
Who will issue these certificates for Class A (non-sterile and non-measuring) medical devices?

As Class A medical devices are under the control of the State Licensing Authority, applicants may approach the concerned State Licensing Authority to obtain such certificates.

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