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A Market Standing Certificate (MSC) is an essential regulatory document issued by the Central Drugs Standard Control Organization (CDSCO) in India. It confirms that a medical device—whether manufactured locally or imported—has been licensed and actively marketed in the Indian healthcare system, thereby meeting national regulatory standards.
At AccordMed Consultants, we assist medical device companies in obtaining MSCs quickly and efficiently—whether for government tenders, exports, or international registrations.
What is a Market Standing Certificate?
The Market Standing Certificate serves as evidence that a medical device:
- Holds a valid CDSCO license under the Medical Devices Rules, 2017
- Has been regularly marketed and distributed in India
- Meets CDSCO’s standards for safety, efficacy, and quality
This certificate is increasingly requested not just by foreign regulatory bodies, but also by Indian government agencies for public procurement and tender participation.
Why is an MSC Important for Medical Devices?
Required in Government Tenders
Several Indian government procurement agencies and hospitals require an MSC as part of their tender documentation to ensure that only established and compliant devices are supplied.
Essential for Export and Global Registration
For manufacturers and importers, an MSC supports product registrations abroad by demonstrating local market presence and regulatory compliance.
Proof of Market History
The certificate validates that the medical device has a track record of safe usage and consistent availability in the Indian market.
Who Can Apply for a Market Standing Certificate?
Both licensed manufacturers and importers of medical devices in India can apply for an MSC, provided the following conditions are met:
- The device holds a valid Manufacturing License (Form MD-5/MD-9) or Import License (Form MD-15)
- The product is being actively sold in India
The applicant can provide marketing history and supporting documents
Documents Required for Market Standing Certificate Application
How AccordMed Consultants Can Help
We offer complete support to streamline your Market Standing Certificate application process:
- Determining eligibility and preparing necessary documentation
- Drafting and formatting your application in line with CDSCO guidelines
- Liaising with the CDSCO Zonal/Sub-Zonal Office
- Handling follow-ups, clarifications, and additional queries
- Facilitating quick turnaround for urgent tender or export needs
Our in-depth understanding of India’s medical device regulatory framework ensures smooth and timely approvals.
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Medical Device Registration Services CDSCO
Get expert support for CDSCO medical device registration. Contact us for a free consultation call today!
Frequently
Asked Questions
Yes, many Indian government tenders, especially those issued by hospitals and public health agencies, require an Market standing certificate as proof of consistent market presence and regulatory approval.
Yes. Licensed importers holding a valid Form MD-15 Import License can apply for an MSC, provided the product is actively marketed in India.
Medical devices that are already licensed and distributed in India—especially those used in government procurement or intended for export—commonly require an MSC.
Timelines can vary, but with proper documentation and expert support, it can typically be completed in a few weeks.
Absolutely. We offer fast-tracked support for clients facing urgent deadlines for tenders, export submissions, or international registrations.
Get expert support for CDSCO medical device registration. Contact us for a free consultation call today!
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+91 9891232884
info@cdscoregistration.com