An export document is 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. Free Sale Certificate is required to sell products freely in the market.
The words “Your items are being freely offered and comply with all the laws and regulations of the state to which it belong” 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 complies with all legal requirements.
The National Regulatory Authority of the exporting nation issues a free sale certificate by local legal criteria.
This certificate is required by manufacturers who want to export their goods to other nations 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.
Free Sale Certificate Overview
A free sale certificate is a license issued by the CDSCO for the selling of products in the Indian market freely. If any of the sealer or distributor doesn’t want any kind of restriction while regulating products in the market then this free sale certificate is mandatory. This license gives you approval that you are allowed to sell a particular product in the market without facing any kind of restriction.
If you want this certificate then you can connect with the medical device regulatory consultant and we will guide you best and work on your behalf for the certificate approval.
What Is Free Sale Certificate CDSCO?
The FSC (Free Sale Certificate) is issued by the Central Drugs Standard Control Organization (CDSCO). This one if the approved document that shows that the product is regulatory and its sale in the country is allowed. It ensures that the product is verified and approved for sale in the domestic market. Also, this verifies the quality and safety of the product according to the guidelines required for export. For this apply online CDSCO Registration and get a free sale certificate.
What Is The Fee For a Free Sale Certificate?
The free sale certificate fee is not fixed. The fee varies as per the product. For the fees you can connect with us on call or you can search directly on the CDSCO website for more clearer vision regarding the fee of the Free Sale Certificate.
Responsibility Of Regional Authority Of Dgft In India
The Directorate General of Foreign Trade (DGFT) in responsible for facilitating the foreign trade of products. It also formulates the import & export policies. Regarding the free sale certificate, the DGFT is responsible for the verification and authentication for export purposes.
Free Sale Certificate Application Form
If you want the free sale certificate application form then you can simply obtain it from the CDSCO official website or through their offices. When you fill out the form it contains information on the exported, the manufacturer, the intended market, and other pertinent details.
Prerequisites Of Free Sale Certificate (FSC)
If as a seller you are willing to get a free sale certificate then your product must be legally marketed in India. Further, it also complies with the country’s regulatory requirements for safety, quality, and efficiency. To get this fSC the manufacturer and the exporter have to submit the necessary documents according to the guidelines of the CDSCO.
Vital Documents Required For A Free Sale Certificate
When you are going to fill out the form you have to add these further necessary documents:-
- Manufacturing license
- Product registration certificate
- Product testing reports
- Labeling and packaging details
- Authorization letter from the manufacturer
- Declaration of conformity to Indian standards
Procedures For The FSC
The procedure for a free sal;e certificate is very simple. You only have to fill out the form as per the given guidelines and attach the necessary documents to the CDSCO and the relevant authorities. Later the application is reviewed and verified by the compliance with regulations. Later the certificate is issued to you.
Free Sale Certificate Validity CDSCO
The free sale certificate by the CDSCO is valid for two years. It is issued to the manufacturer for the export of the particular product mentioned in the license.
What Is The Purpose Of Free Sale Certificate?
The free sale certificate works as an assurance from the foreign agency that the product is safe and listed on the certificate. It informed that the product is allowed to sell freely in the market.
Who Is Eligible To Apply For the Free Sale Certificate?
The Manufacturer Exporters and Merchant Exporters are eligible to apply for a free sale certificate.
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 several 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 permitted 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 that 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 the 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 For Getting The Free Sale Certificate?
Create and apply, 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 Export Certificate 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 license 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?
Rule number 91 of The Medical Devices Rules, 2017 published in the Official Gazette by the 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 like a free sale certificate or a certificate about quality, safety, and performance 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.