Free Sales Certificate (FSC) for Medical Devices in India
CDSCO Free Sale Certificate for Medical Devices in India
For manufacturers of medical devices operating in India, if you wish to export your products, then it is imperative that you have the FSC. What is the FSC, and how do I obtain it? The following guide will show you everything you need to know about applying for your FSC in India.
What Is A Free Sales Certificate (FSC)?
Free Sales Certificate (FSC) is a regulatory document issued by CDSCO that provides certification of the legal sale and distribution of the medical device in India. It also assists Medical Device Certification records in case an exporter needs any evidence of that for another country. It is required when exporting the medical device to other countries in order to prove that it is compliant with the Indian regulatory requirements and that it can be legally sold in the domestic market.
Who Needs A Free Sales Certificate (FSC)?
If you are a medical device manufacturer in India that is registered for manufacturing and would like to export any device you must obtain a free sale certificate.
This certificate is applicable to class c and class d medical devices that have been issued licenses under the medical devices rules 2017.
For class a and class b medical devices the application needs to be filed with the state licensing authority SLA and not central licensing authority CLA
Free Sale Certificate For Medical Devices: Application Process
The preparation of the certificate of free sale application process entails some steps which must be followed to ensure everything goes well. Below are the things you need to know.
Step 1: Application Preparation
The first step is that you should submit an application to CLA if handling class c and class d medical devices, or to SLA if your products come from class a and b medical devices.
Step 2: Documentation for Medical Device Certification
For Medical Device Certification, the application must be made online through the CDSCO website. The following documentation is required for Medical Device Certification:
Covering Letter: The covering letter should indicate the purpose of the application along with the list of documents being submitted.
Application Form: System generated form stating the manufacturing license number and list of the products for fsc.
Challan Receipt from Bharatkosh Portal: In this case, you have to make an online payment of Rs. 1000 per category of medical devices through the Bharatkosh portal.
Copy of Manufacturing License: Valid copy of manufacturing license, which enables the sale/distribution of your products.
Legal Undertaking: The notarized document on Rs. 100 stamp paper ensures no adverse action/market complaint/quality problems against your products/company.
In case you need, medical devices regulatory consulting will come in handy to review these documents prior to submission.
Step 3: Submit Your Application
The certificate of free sale application documents are now ready for submission. Submission is done online via the CDSCO portal.
Medical Device Registration In India - FSC Application Checklist
In case of registering medical devices in India, ensure that you have all your documentation requirements ready. Here is the checklist for the same:
Covering letter with all relevant details
Completed application form
Fee challan receipt of the bharatkosh portal
Copy of manufacturing license
Notarized legal undertaking
Ensure that all your documentation is properly signed and stamped as well as notarized wherever necessary.
Mistakes to be avoided in Applying for FSC
While applying for an FSC, one must note some of the most common mistakes which could lead to delays in the application process:
Incorrect Documentation: One must ensure that all the necessary documents have been supplied as per the checklist.
Incorrect Product Classification: One must make sure that the product has been properly classified as per the medical devices regulations 2017.
Issues with the Legal Undertaking: One must ensure that the legal undertaking has been notarized.
Important Points To Remember
FSC for Export Only Product: In case the product is an exclusive product for export then one is not eligible to apply for fsc.
Validity of Free Sale Certificate: The fsc that will be issued will be valid as long as the license to manufacture the product is valid and there is no pending regulatory action.
Fee for Certificate of free sales application: Fee is INR 1000 per category via bharatkosh portal.
Regulatory Actions Pending: There should be no regulatory action such as adverse events or market complaints initiated against the product for the application process to go smoothly.
Conclusion
Obtaining a free sale certificate for medical devices is an essential step to export products from India . by following CDSCO guidelines and having necessary documents you can streamline the process and avoid pitfalls. If you are ready, get started and ensure the application is complete, fees paid and documents submitted correctly . Once you have fsc you can proceed to international markets.
Medical Device Regulatory Consulting Support From Morulaa
Morulaa Health Tech offers assistance in medical devices registration in India and CDSCO compliance. With our medical device regulatory consulting, we can assist in FSC filings, market entry, and distribution assistance for manufacturers looking to enter the Indian market.
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