What is a Free Sale Certificate?

A free sale certificate is a document issued for the export of medical equipment/devices, cosmetics and food items. These materials are not governed under the Drugs and Cosmetics act. The certificate states that the items mentioned in the certificate are safe. Further, they show these devices are sold without restrictions in the country of origin and therefore are permitted to be exported. In India, the Directorate General of Foreign Trade (DGFT) has a regional authority (RA) responsible for issuing the free sale and commerce certificate to the manufacturer/ exporter.

Need for Free Sale Certificate

It is mandatory for a trader to obtain a free sale certificate in India. The importance of the free sale certificate is listed below:

• Permit for the import and export of medical devices in the country:

It is obligatory for the trader to obtain the free sale certificate to import or export medical devices in the country.

• Validates the performance and use of Medical devices:

Medical devices are something of a highly sensitive nature. That’s why the governments importing or exporting them need a certain degree of assurance that the product is safe and performs tasks per its claims. The Free sale certificate acts as a document approved by the government/ medical authorities of the country of origin backing its claims.

• Shows adherence to GMP norms:

The free sale certificate also adheres to the Good Manufacturing Practice (GMP) norms. It is important for an exporter to make sure its product maintains international standards such as the CE marking for Europe. The exporting country validates that the product meets and follows the proper GMP norms to create these products.

• Verifies the Manufacturer:

A free sale certificate approves the importing country that the device manufacturer has a valid license, works as per the country of origin’s regulations, and complies with all the standards set by the government.

Documents required to obtain a Free Sale Certificate

The directorate general of foreign Trade had released a notification in which an applicant needs to produce the following documents along with the application for a free sale certificate these are:

• Receipt of the Fee paid to the Regional Authority of the DGFT
• Copy of valid manufacturing license of the product
• A detailed list of products for which the Free sale certificate needs to be issued

• Product permission letter for each of the above-mentioned products

• The letter from the concerned authority of the country demanding the Free Sale certificate

•   Copy of power of attorney
•  Copy of clearance letter

Process of application for Free Sale Certificate

The applicant must complete the following steps to get the free sale certificate for medical devices/ equipment:

Step 1: The applicant must visit the Directorate General of Foreign Trade’s^[1] (official website) and next select the ‘ECOM Application tab’ from the services column.

• Step 2: Under the ECOM tab, the applicant needs to access the e-MPS (miscellaneous payment system) and proceed to make the payment for the free sale certificate.
• Step 3: The applicant, under the e-MPS tab, needs to provide the following details such as – The permanent account number (PAN) of the firm and the individual and the name of the firm or individual (as applicable).
• Step 4: The applicant needs to click on the ‘Make a New Payment’ and fill in the information like mobile number (an OTP shall be sent to the mobile number), verify your mobile number and click on ‘pay now.’
• Step 5: Next, the applicant needs to again fill in the information for the Free sale certificate
  • IEC / PAN
  • Firm Name
  • ECOM Reference Number
  • Transaction Reference Number
  • DGFT RA office
  • Payment Amount in Rs. XXXXX
  • Subject
  • Scheme
  • Remarks
• Step 6: Click the submit button, and the website will move on to the next page with the payment details. The applicant should again click on proceed, and then he will be directed to the payment gateway.
• Step 7: The applicant can select from the various payment options such as UPI, Credit/debit cards, net banking etc.
• Step 8: once the payment is completed, the applicant needs to download a copy of the successful payment receipt. These documents shall be used for application.
• Step 9: The applicant needs to send an email with the application form and payment receipt to the RA’s mail id. This email id can be retrieved from the Director General of Foreign Trade’s official website.
• Step 10: If the application and the documents are as per the requirements, then the Free sale certificate shall be granted to the applicant.

What is the validity of a free sale certificate?

The Free sale certificate shall be valid for up to two years from the date of issue.

Conclusion

The Free sale certificate is a mandatory document for a trader to obtain if he wants to import or export medical devices in India. The certificate is granted to the applicant upon successful submission of the application and payment of the requisite fee to the Regional Authority of the Directorate General of Foreign Trade. This application acts as an instrument between the country of import and the country of origin stating that the device is safe and secure to use.

Read our Article:CDSCO Approval for Voluntary Registration of Medical Devices