What Is A Free Sale Certificate?
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.
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:
Checking the Manufacturer
The manufacturer’s authorization can be confirmed in a number of ways, but the Certificate of Free Sale is unmistakable evidence that the manufacturer has a current license.
The company’s compliance with the CE labeling requirements is promptly verified by an authentication of the producer’s license.
Makes Product Verification Easier
The healthcare industry in importing nations must adhere to high health and safety standards.
Therefore, they won’t allow the use of a medical device, pharmaceutical, or other important goods by a producer if they can’t show that the product’s exporting country has given permission for it to be used there.
For this reason, a Certificate of Free Sale is a crucial document that certifies to the importing producer that a certain certified medical device is an approved health product in the nation in which it is produced.
Checking the GMP (Good Manufacturing Practice) Certification
It is a statement of free sale validates that the device in question complies with the International Society for Pharmaceutical Engineering’s (ISPE’s) Good Manufacturing Practice (GMP) standards. Another significant certification, in addition to the CE marking, supports the validity of any medical product.
As you can see, a medical device’s Certificate of Free Sale information 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 Certificate of Free Sale more significant.
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.
Required for authorization to import medical devices
A free sale certificate must be included with the MD-15 medical device import application in India.
What Does The Free Sale Certificate Look Like?
The free sale certificate looks as given below:
In the free sale certificate, the following things are mentioned:
- Certificate no.
- Exporting and importing country
- Registration no.
- Product license no.
- Classification of the product
What Is The Procedure Of Getting The Free Sale Certificate?
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.
What Are The Provisions For A Free Sale Certificate And Fee Payment?
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.