- It serves as proof that your medical device company, as a manufacturer, holds a valid manufacturing license and has been actively manufacturing and selling your products in the Indian market.
- It is often required by foreign regulatory bodies and importers during tender processes or product registration in other countries.
- You must have a valid manufacturing license issued by the Central Licensing Authority (CLA) or a State Licensing Authority (SLA) in India.
- You must have been actively manufacturing and selling the specific medical device(s) in the Indian market for which you're requesting the MSC.
How to Obtain a Market Standing Certificate:
- The application process is now streamlined through the Online System of Medical Devices portal (https://cdscomdonline.gov.in).
- You'll need to create an account and submit the application with the necessary documents and fees.
- A cover letter stating the reason for the MSC application.
- Government-prescribed fees.
- A copy of your valid manufacturing license.
- List of products for which you're requesting the MSC.
- An undertaking (a formal declaration) that there are no pending adverse reports, recalls, or Not of Standard Quality (NSQ) actions against you in India regarding any of the products on your list.
- The licensing authority that issued your manufacturing license (CLA or SLA) will issue the MSC.
Additional Considerations:
- Validity: The validity of the MSC is typically one year from the date of issue or aligned with the expiration of your manufacturing license (whichever is earlier).
- Use: MSCs are commonly used for export purposes and when participating in tenders in other countries.
