info@medicaldeviceregistration.com
+91 9891-998-002

      Apply For Free Sale Certificate CDSCO

      Apply For Free Sale Certificate CDSCO

      • Quick Response
      • Easy Registration Process
      • Complete Online Process
      • Free Documentation Review
      Call Now
      Apply For Expert Advice

      What Is A Free Sale Certificate?

      The free sale certificate is an export document required by some nations for specific goods like medical devices or other items, as well as to certify that the product is freely sold in the markets of the exporting country and, as such, can be freely sold in the market of the importing country.

      In other words, it is proof that the goods you seek, buy, or possess are openly distributed and sold in the nation where you are requesting this document. It is also proof that the product complies with all legal requirements. The National Regulatory Authority of the exporting nation issues a free sale certificate based on local legal criteria.

      This certificate is required by manufacturers who want to export their goods to other nations to demonstrate that the product is not restricted or illegal to export. It is widely available there without indicating that it has been tested for safety and efficacy and is approved for nationwide use.

      Why Is A Free Sale Certificate Required?

      Medical equipment imports and exports into and out of India require a Free Sale Certificate. Free Sale Certificate also has the following advantages:

      1. Checking the Manufacturer
      2. The manufacturer’s authorization can be confirmed in several ways, but the Certificate of Free Sale is unmistakable evidence that the manufacturer has a current license.
      3. The company’s compliance with the CE labelling requirements is promptly verified by authenticating the producer’s license.
      4. Makes Product Verification Easier
      5. The healthcare industry in importing nations must adhere to high health and safety standards.
      6. Therefore, they won’t allow a producer to use a medical device, pharmaceutical, or other essential goods if they can’t show that the product’s exporting country has permitted it to be used there.
      7. For this reason, a Certificate of Free Sale is a crucial document that certifies to the importing producer that a specific certified medical device is an approved health product in the nation in which it is produced.
      8. Checking the GMP (Good Manufacturing Practice) Certification
      9. It is a statement of free sale validating that the device complies with the International Society for Pharmaceutical Engineering’s (ISPE’s) Good Manufacturing Practice (GMP) standards. Another significant certification, besides the CE marking, supports the validity of any medical product.
      10. As you can see, the information on a medical device’s Certificate of Free Sale can be very significant. The fact that it is essentially a guarantee given by the importing country to the exporting country as to the validity of the manufacturer and its product makes the Certificate of Free Sale more significant.
      11. We can offer manufacturers who want to export their medical device products the services necessary to apply for and obtain a Certificate of Free Sale from the Ministry of Exports. Additionally, we offer the examinations required for CE certification and other pertinent certifications.
      12. Required for authorization to import medical devices
      13. A free sale certificate must be included with India’s MD-15 medical device import application.

      Who Can Apply for a Free Sale Certificate?

      The medical companies’ manufacturers and authorized representatives also want to export can apply for free sale certificate.

      What Does The Free Sale Certificate Look Like?

      The free sale certificate looks as given below:
      1 . Certificate no.
      2. Date
      3. Exporting and importing country
      4. Registration no.
      5. Product license no.
      6. Classification of the product

      Free Sale Certificate
      Free Sale Certificate

      What Is The Procedure for Getting Free Sale Certificate?

      1. Create and apply a cover letter and any necessary attachments.
      2. Provide a list of the goods that need the free sale certificate.
      3. Pay the stipulated fee in line with the second schedule of the Rules for Export Certificate for Medical Device. Each medical device’s fee must be paid using an electronic challan from a bank approved by the Ministry of Health and Family Welfare.
      4. Share a legal copy of the license for the sale or distribution of medical devices, along with the list of items approved by the appropriate body, as soon as it has been issued (State Licensing Authority or Central Licensing).

      An assurance that no legal action has been taken against the applicant due to unfavourable occurrences, market complaints, or Not of Standard Quality (NSQ) reports of any product in India must be submitted with the application.

      Important Documents for Free Sale Certificate

      Here is the list of essential documents anyone requires for a free sale certificate:-

      1. Valid Manufacturing Certificate
      2. Power of Attorney Copy
      3. IEC/PAN
      4. Certificate of Free Sale
      5. DGFT ra Office
      6. Product Approval
      7. Concerned Authority Letter
      8. Remarks

      Can I Create a Copy of an Existing Application for a Free Sale Certificate?

      Yes, you can create a copy of an existing application of a free sale certificate by following these steps:-

      • My Dashboard>Submitted Application.
      • Enter Type of Certificate>Type of Sub Scheme.
      • Tap to Search.
      • Click on Action>Make a Copy.

      Then, try the following steps to retake an existing application certificate for a free sale copy. If you want to connect with the regulatory consultancy directly, tap medicaldeviceregistration.com.

      Can the CDSCO provide FSC for Non-Notified Products?

      Typically, FSC is issued for products regulated under Indian law if the product is not notified or regulated. If the product is not notified or regulated, CDSCO may not issue an FSC. It’s best to check with them directly.

      What is the FSC Application Number & Where can you find it?

      When an application is created and saved, the number gets made by itself, as all the drafted applications have its number. You can check application no. through dashboard>draft applications.

      The fee is specified in the Medical Device Rules 2017. Pay using an electronic challan through a bank approved by the Ministry of Health and Family Welfare.

      Getting FSC from the Central Drugs Standard Control Organization usually takes months. 

      Yes, you can export multiple products under a single free sale certificate to export it to foreign buyers.

      There is no extension of the time limit available for export & most importantly, it can only be extended up to 2 years.

      You can visit the official CDSCO website to track your status.

      The Free Sale Certificate is valid for two years from the date of its issuance.

      In the free sale certificate application, choose the branch code of the previous branch where the certificate is used.