Скачать или смотреть Free Sale Certificate | How to Apply Free Sale Certificate For Export | Process | Swarit

A free sale certificate is a document issued for the export of medical equipment/devices and cosmetics. #These materials are not governed under the Drugs and Cosmetics act.# The certificate states that the items mentioned in the certificate are safe and secure. #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) which responsible for issuing the free sale and commerce certificate to the manufacturer/ exporter.

What is the Need for Free Sale Certificate?
it acts as a 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.

It 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.

It Shows adherence to GMP norms
The free sale certificate 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 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
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 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 visit the Directorate General of Foreign Trade’s (official website) and next select the ‘ECOM Application tab’ from the services column.
Under the ECOM tab, the applicant needs to access the e-MPSSection (miscellaneous payment system) and proceed to make the payment for the free sale certificate.
under the e-MPS tab, the applicant needs to provide details such as – The permanent account number (PAN) of the firm and the individual and the name of the firm.
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.’
Next, the applicant needs to again fill in certain details like Transaction number, DGFT RA office, subject scheme, etc.

Click on 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.
once the payment is completed, the applicant needs to download a copy of the successful payment receipt.

The applicant needs to send an email with the application form and payment receipt to the regional authority’s mail id.
If the application and the documents are as per the requirements, then the Free sale certificate shall be granted to the applicant.

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

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