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Marketing Standing Certificate

We specialize in Marketing Standing Certificate services to help your business meet compliance requirements and contribute to sustainable growth. Our services include the following:

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Overview

Marketing Standing Certificate for Medical Devices

A Marketing Standing Certificate (MSC) is an official document issued by the Central Drugs Standard Control Organization (CDSCO) that certifies that a medical device is legally marketed and sold in India. This certificate serves as proof that the product has been registered and is compliant with all regulatory requirements under the Medical Device Rules, 2017.

The Marketing Standing Certificate is essential for manufacturers and importers who wish to export medical devices to other countries or participate in international tenders. It demonstrates that the product meets Indian regulatory standards and is approved for sale in the domestic market.

Marketing Standing Certificate Services
Who Needs This Service

Is Marketing Standing Certificate the right fit for your business?

A Marketing Standing Certificate is essential for manufacturers and importers looking to export medical devices or participate in international tenders.

  • Medical device manufacturers
  • Medical device importers
  • Exporters of medical devices
  • Companies participating in international tenders
  • Businesses expanding to international markets
  • Any manufacturer with CDSCO registered products
Benefits

Benefits of Marketing Standing Certificate

A Marketing Standing Certificate provides several advantages for businesses in the medical device industry.

  • Export Facilitation: Enables export of medical devices to international markets by proving regulatory compliance
  • International Tenders: Required for participating in international procurement tenders
  • Regulatory Proof: Serves as official proof that the product is legally marketed in India
  • Business Credibility: Enhances business credibility and trust with international partners
  • Market Access: Facilitates market access in countries that accept CDSCO certification
Eligibility Requirements

Who can apply for Marketing Standing Certificate?

To be eligible for a Marketing Standing Certificate, the applicant must meet the following criteria:

  • Valid Business Registration: Must be a legally registered business entity in India
  • Valid CDSCO License: Must hold a valid CDSCO registration or license for the products
  • Product Registration: Products must be registered with CDSCO
  • Compliance: Products must comply with Medical Device Rules, 2017
Documents Required

Documents Required for Marketing Standing Certificate

To apply for a Marketing Standing Certificate, you need to submit the following documents to CDSCO:

Application Documents
  • Application form (Form MD-13)
  • Covering letter with company details
  • Identity and address proof of applicant
Regulatory Documents
  • Valid CDSCO registration certificate
  • Product license copies
  • ISO 13485 certification
Product Documents
  • Product list with details
  • Product specifications
  • Free Sale Certificate (if applicable)
Step-by-Step Procedure

How to Apply for Marketing Standing Certificate

The following is a concise description of the procedure for obtaining a Marketing Standing Certificate from CDSCO.

01
1–2 working days

Connect with First Auditor Team

Get in touch with our experts to discuss your Marketing Standing Certificate requirements and product list.

02
2–3 working days

Document Collection & Verification

Submit all necessary documents including application form, registration certificates, and product details.

03
3–5 working days

Application Preparation

Prepare the Marketing Standing Certificate application with all required documents and information.

04
1–2 working days

Application Submission on SUGAM Portal

Submit the application through the CDSCO SUGAM portal with all required documents and fees.

05
15–30 working days

Application Processing & Review

CDSCO reviews the application, verifies documents, and processes the Marketing Standing Certificate.

06
1–3 working days

Certificate Issuance

Upon approval, CDSCO issues the Marketing Standing Certificate and we send a copy to you via email or courier.

Authority, Timeline & Fees

Where the application goes, and what it costs

Government Authority

Central Drugs Standard Control Organization (CDSCO), Drug Controller General of India (DCGI), Ministry of Health and Family Welfare, Government of India.

Estimated Processing Period

Typically 15 to 30 working days from complete document submission, depending on application completeness and workload.

Certificate Issued

Marketing Standing Certificate (Form MD-13) with unique reference number, product list, and validity period.

Fee Structure

Government fee as prescribed by CDSCO. Professional fee quoted upfront by First Auditor.

ComponentPaid ToNature of charge
CDSCO Application Fee CDSCO / DCGI As prescribed by Medical Device Rules, 2017
Processing Fee CDSCO / DCGI As per applicable rules
Professional fee First Auditor Quoted upfront, one-time

Government fees are prescribed by CDSCO. Our team quotes both components separately before you proceed, with nothing added later.

Validity & Renewal

How long is the Marketing Standing Certificate valid?

The Marketing Standing Certificate is typically valid for a period of 1 to 2 years, subject to the validity of the underlying CDSCO registration. To maintain the certificate, businesses must:

  • Apply for renewal before the expiry date
  • Submit updated documents and fees
  • Ensure underlying CDSCO registration is valid
  • Maintain proper product records and documentation
  • Comply with all CDSCO regulations and guidelines
Common Reasons for Rejection

What causes CDSCO to reject a Marketing Standing Certificate application

  • Incomplete or incorrect application form submission
  • Missing or invalid CDSCO registration
  • Products not registered with CDSCO
  • Incomplete product list or specifications
  • Non-compliance with Medical Device Rules, 2017
  • Documents not properly signed or stamped
  • Outstanding government fees not paid
How First Auditor Assists

One team, from document collection to certificate issuance

We manage every step, document, and follow-up with CDSCO so you can focus on your export business.

Eligibility & Document Check

We verify your eligibility and ensure all required documents are complete and valid.

Application Preparation

Complete Marketing Standing Certificate application drafting and verification to ensure error-free submission.

Product List Compilation

Assistance in compiling and formatting the comprehensive product list for MSC application.

Application Filing

Complete CDSCO application filing through the SUGAM portal.

Query Handling

We respond to all queries from CDSCO on your behalf.

Dedicated Support

A single point of contact for questions throughout the entire process.

Timely Follow-up

Regular follow-up with CDSCO to ensure timely processing of your application.

Export Guidance

Assistance with understanding international market requirements for medical device exports.

Post-Certificate Compliance

Assistance with post-license compliance, renewals, and regulatory updates.

Frequently Asked Questions

FAQ

A Marketing Standing Certificate (MSC) is an official document issued by CDSCO that certifies that a medical device is legally marketed and sold in India. It serves as proof of regulatory compliance and is essential for export purposes.

Manufacturers and importers of medical devices who wish to export their products to international markets or participate in international tenders need a Marketing Standing Certificate.

The Marketing Standing Certificate is typically valid for 1 to 2 years, subject to the validity of the underlying CDSCO registration.

Key documents include application form (MD-13), valid CDSCO registration certificate, product list, product specifications, and ISO 13485 certification.

CDSCO typically issues the Marketing Standing Certificate within 15 to 30 working days from the date of complete application submission, provided all documents are in order.

Yes, a valid CDSCO registration or license for the products is mandatory for obtaining a Marketing Standing Certificate.

Yes, you can apply for a Marketing Standing Certificate for multiple products in a single application, provided all products are registered with CDSCO.

First Auditor provides end-to-end assistance for Marketing Standing Certificate applications including document verification, application preparation, SUGAM portal filing, and follow-up with CDSCO. We ensure error-free submission and timely issuance of your certificate.
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Disclaimer: This page is provided for general informational purposes only and does not constitute legal, tax, or professional advice. Government fees, processing timelines, and documentation requirements are prescribed by the Central Drugs Standard Control Organization (CDSCO) under the Medical Device Rules, 2017 and are subject to change without notice. First Auditor is an independent professional services firm and is not affiliated with, or an agent of, any government department. Please consult our team or a qualified professional for advice specific to your situation before making any registration decision.
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