// FSc for medical products

FSC Role in Medical Device Registration?

The Free Sale and Commerce Certification System (FSC) plays a significant role in relation to medical device products by serving as a declaration that these items are legally manufactured and freely sold in the country of origin, confirming they do not fall under the Drugs and Cosmetics Act.

Who Can Apply?

Manufacturer or Exporter Status

The applicant must be a manufacturer or an authorized exporter of medical devices with the required licenses and certifications.

Valid Manufacturing License

The manufacturer must possess a valid license to manufacture medical devices, issued by the relevant authority in their country.

Registration with DGFT

The applicant's profile must be linked to an Importer Exporter Code (IEC) issued by the Directorate General of Foreign Trade (DGFT).

Digital Signature Certificate

A valid DSC must be registered in the DGFT system to enable secure digital transactions and authentication.

No Legal Issues

The manufacturer should not have any ongoing legal actions related to product quality or compliance issues.

Why is a Free Sale Certificate essential for Medical Device products?

1. A Certificate of Free Sale (CFS) is essential for medical device products because it serves as official proof that the device is legally marketed and sold in the manufacturer’s country.

2. This certification assures importing countries that the product meets safety and efficacy standards, confirming compliance with local regulatory requirements.

3. Additionally, the CFS facilitates market entry into international markets, enhances product credibility, and builds trust among foreign regulatory authorities and consumers. Without a CFS, manufacturers may face significant barriers when exporting their medical devices.

4. Many regulatory bodies and distributors require a CFS as part of the approval process, making it a crucial document for smooth international trade and regulatory compliance.

What should I do if my medical device is not covered under the Drugs and Cosmetics Act when applying for a Free Sale Certificate in India?

If you are looking to obtain a Free Sale Certificate (FSC) for a medical device in India, it’s essential to understand the distinction between notified and non-notified devices under the Drugs and Cosmetics Act.

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Notified vs / Non-Notified Devices

Notified Medical Devices

1 .These devices are regulated under the Drugs and Cosmetics Act.
2. To export these devices, manufacturers can apply for an FSC from the Central Drugs Standard Control Organization (CDSCO), which confirms that the device is legally marketed in India and complies with regulatory standards.

Non-Notified Medical Devices

1. These devices do not fall under the regulations of Drugs and Cosmetics Act.
2. For non-notified devices, you cannot apply for an FSC from CDSCO. Instead, you must obtain a Free Sale and Commerce Certificate from the Directorate General of Foreign Trade (DGFT).

// Medical Devices Covered by FSC

What type of medical devices products are covered by the Free Sale Certificate (FSC)?

The Free Sale Certificate (FSC) is specifically for notified medical devices that are regulated under the Drugs and Cosmetics Act in India. Here’s a breakdown of the types of medical devices that require an FSC and information about non-notified devices:

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Notified Medical Device

These are devices that have been classified and approved under the Drugs and Cosmetics Act.

∙ They include various categories such as

1. Class A Devices: Low-risk devices (e.g., bandages, examination gloves).

2. Class B Devices: Moderate-risk devices (e.g., infusion pumps, surgical drapes).

3. Class C and D Devices: Higher-risk devices (e.g., implantable devices, diagnostic imaging equipment).

Manufacturers of these devices must have a valid manufacturing license and can apply for an FSC to export these products.

Non-Notified Medical Device

For non-notified medical devices, the process differs:

∙ Free Sale and Commerce Certificate:

1. Non-notified devices do not require an FSC. Instead, they need a Free Sale and Commerce Certificate, which is issued by the Directorate General of Foreign Trade (DGFT).

2. This certificate indicates that the product is freely sold in the country of origin but is not regulated under the Drugs and Cosmetics Act.

Examples of Non-Notified Devices

While specific product names may vary, typical examples of non-notified medical devices could include:

1. Certain types of diagnostic kits that are not classified as notified.

2. Basic medical supplies like certain types of bandages or dressings that do not require regulatory oversight.