An export document required by some nations for specific goods like medical devices or for other items as well 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.
The words “Your items are being freely offered and comply with all the laws and regulations of the state to which it belongs” are part of a legal document. In other words, it is proof that the goods you are looking for, buying, or possessing are openly distributed and sold in the nation where you are requesting this document. It is also proof that the product is in compliance with all legal requirements.
The National Regulatory Authority of the exporting nation issues a free sale certificate in accordance with local legal criteria.
This certificate is required by manufacturers who want to export their goods to other nations in order to demonstrate that the product in question is not restricted or illegal to export and is widely available there without any indication that it has been tested for safety and efficacy and is approved for use in the nation.
Medical equipment imports and exports into and out of India require a Free Sale Certificate. Free Sale Certificate also has the following advantages:
The free sale certificate looks as given below:
In the free sale certificate, the following things are mentioned:
Create and submit the application, a cover letter, and any necessary attachments.
Provide a list of the goods that need the free sale certificate.
In line with the second schedule of the Rules for Certificate to Export Medical Device, pay the stipulated fee. Each specific medical device’s fee must be paid using an electronic challan from a bank that has been approved by the Ministry of Health and Family Welfare.
Share a legal copy of the licence for the sale or distribution of medical devices, along with the list of items that have been 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 as a result of unfavorable occurrences, market complaints, or Not of Standard Quality (NSQ) reports of any product in India must be submitted with the application.
The rule number 91 of The Medical Devices Rules, 2017 published in the Official Gazette by Government of India vide G.S.R. 78(E). dated 31.01.2017 says, “Where a person intends to export any medical device made in India and for that purpose requests a certificate in the nature of a free sale certificate or a certificate about quality, safety, and performance in relation to that medical device as required by the authority concerned of the importing country, such person may apply to the Central Licensing Authority for the purpose along with a fee as specified in the Second Schedule and the said authority shall issue such certificate,” the Central Licensing Authority states.
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