Updated on March 04, 2025 03:58:03 PM
A Free Sale Certificate (FSC) for Medical Devices is an important document for legal selling of a medical device in the markets in India. The Free Sale Certificate for Medical Devices is issued by the Directorate General of Foreign Trade (DGFT) to the buyers in the international market as well as the regulatory agencies that the product is safe, quality and meets all regulatory standards. The Free Sale Certificate for Medical Devices is prominent for medical devices exports, to obtain market access, navigate customs more easily, and meet compliance requirements. A Free Sale Certificate for Medical Devices can provide Indian manufacturers with a means to showcase product credibility and compliance, and create opportunities for new markets. The global healthcare industry requires more confidence and trustworthy products to ensure its stability that is catered to by Free Sale and Commerce Certificate.
A Free Sale Certificate (FSC) for Medical Devices is a legal certificate by the Directorate General of Foreign Trade (DGFT) of India to affirm that a certain medical device conforms to the legal requirement. The Free Sale Certificate for Medical Devices ensures that the medical device being sold or exported in the domestic market of India meets the standard health safety and quality requirements. The Free Sale Certificate for Medical Devices is critical to export because it offers assurance to foreign Regulatory authorities that the particular medical device has met all the necessary domestic regulations on safety and standards. The Free Sale Certificate for Medical Devices helps to clear the customs procedures as well as medical device registration in a foreign country and also makes assurance to the importing country that the product that they are importing is safe, legally manufactured and permitted for sale in its country of origin.
The Free Sale Certificate (FSC) for Medical Devices provides various advantages to the organization that intend to sell the same products on foreign markets, include:
The Free Sale Certificate for Medical Devices in India can be applied for through an application form completed on the Directorate General of Foreign Trade (DGFT) website with all the mandatory and specified details.
There are some general details that a candidate has to provide, including their full name, address, and phone number, in the Free Sale Certificate application form.
In a Free Sale Certificate application, it is required to complete the product name, description of the product, and the category / classification of the product.
The Free Sale Certificate application form must contain information on the process of manufacture, manufacturer details and the location of the manufacturing unit.
Applicants must provide documents to the effect that the product conforms to the regulatory standards in India where the Free Sale Certificate for Medical Devices is required.
While filing the Free Sale Certificate application, applicants are required to upload documents like manufacturing license, product registration certificate, quality test reports, and more.
Online payment is to be done for payment of application fee for Free Sale Certificate DGFT.
To apply for the Free Sale Certificate DGFT, the following documents are to be submitted along with the application form to the Regional Authority:
Every application for the issuance of the Free Sale Certificate DGFT requires a flat charge of Rs 1,000 of registration fee in electronic mode. The Free Sale Certificate fee is charged on each individual application irrespective of the product and it has to be paid through the DGFT e-MPS (Miscellaneous Payment System) while filing the application. The proof of payment for the Free Sale Certificate fee should also be attached to the application when applying to the concerned Regional Authority of Directorate General of Foreign Trade (DGFT).
Note: Professional fees to apply for and obtain a Free Sale Certificate in Medical Devices is Rs 5000, exclusive of GST.
The Free Sale Certificate validity lasts for a period of 2 years or the time specified on the certificate. A Free Sale Certificate for export, once expired, cannot be renewed any more. To export the products, businesses must fill the forms provided by the customs and submit new documents and fees to obtain a new Free Sale and Commerce Certificate in India.
A Free Sale Certificate (FSC) for Medical Devices is vital in freighting out medical devices from India to overseas markets. The Free Sale Certificate for Medical Devices is issued by the Directorate General of Foreign Trade (DGFT), to demonstrate that a precise device is valid and, therefore, can lawfully be sold within India. Free Sale Certificate for Medical Devices avails businesses wide benefits like enhanced global market accreditations, conformity to International Standards and authenticity of Brands. Firms have to abide by the regulations of each Free Sale Certificate application as well as provide necessary and sufficient documents and make necessary payments to ensure they obtain their FSC. The Free Sale and Commerce Certificate validity is of 2 years, thereby guaranteeing its continual credibility; on the other hand, it is crucial to obtain a new Free Sale Certificate for Medical Devices as soon as possible to avoid interruption of exports.
At Professional Utilities, we leverage our industry knowledge and expertise to help businesses navigate complex regulations, minimize risks, and optimize operations for maximum efficiency and profitability.
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The Free Sale Certificate facilitates exports of medical devices from India by providing assurance that such devices meet the necessary regulatory standards and clearing customs processes and foreign buyers and regulatory authorities.
The Free Sale Certificate application can be done online on the DGFT website where you have to fill in some details such as personal details, product details, manufacturing details, documents in compliance with the regulations and pay the Free Sale Certificate fee.
The Free Sale Certificate fee for filing applications is Rs 1,000 for medical devices and it has to be paid online while filing the application on the Directorate General of Foreign Trade (DGFT) website.
The Free Sale Certificate for Medical Devices is valid for 2 years or as mentioned in the certificate. The Free Sale and Commerce Certificate cannot be renewed and a new application must be filed after the expiry of the set period to continue export.
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