What Is The Registration Fee For CDSCO In India?

Central Drugs Standard Control Organisation (CDSCO) is the national regulatory body for pharmaceuticals, medical devices, cosmetics, and clinical trials in India. Any company that wants to manufacture or import medical devices in India needs to register with CDSCO and obtain the necessary licenses. In this article, let's understand the registration fee structure for CDSCO in India.

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How Much Does CDSCO Registration Cost?

The medical device registration fee for CDSCO varies depending on the type of application and the class of the medical device. There are four main classes of medical devices - A, B, C, and D based on the risk factor. Let's see the fee details:

• Class A medical devices: The registration fee for Class A medical devices is INR 5000. This includes both measuring/non-measuring sterile as well as non-sterile devices.
• Class B medical devices: For Class B devices, the registration fee is INR 10,000.
• Class C medical devices: The fee for Class C medical device registration is INR 15,000.
• Class D medical devices: The highest-risk Class D medical devices attract a registration fee of INR 20,000.
• Site Master File: To register a new manufacturing site, the Site Master File fee is INR 50,000.
• Product License fee: An additional INR 1000 fee is applicable for obtaining the product license.

So in summary, the CDSCO registration fee ranges from INR 5000 to INR 20,000 depending on the class of the medical device. There are additional fees for site master files and product licenses as well.

When Do You Need To Pay The CDSCO Registration Fee?

The registration fee needs to be paid at the time of applying for the CDSCO certificate. The payment can be made online via the SUGAM portal which is the online application system of CDSCO. You will have to generate a fee challan after filling out the application form and making the payment.

The application will not be processed until the fee payment is cleared. Make sure to retain the fee receipt as proof of payment which may be required later during the application processing or approval stage. The receipt is usually valid for 3 months from the date of issue.

Why Is CDSCO Registration Important?

CDSCO registration or license is mandatory for all medical devices being manufactured, imported, or sold in India. Here are some key reasons why obtaining CDSCO approval is important:

It ensures that quality, safety, and efficacy standards are met as per Indian regulations. This assures users.

Only medical devices with a valid CDSCO license can be legally imported or sold in India. Importing or selling without a license will attract legal penalties.

It helps in obtaining other regulatory approvals like import licenses, customs clearance, etc. smoothly.

CDSCO registration acts as a quality certificate that boosts credibility in the medical industry and with customers.

It is required to get product listings and reimbursements from government hospitals and insurance agencies.

Regular audits are conducted by CDSCO to ensure licensed products and companies adhere to quality norms.

So in summary, CDSCO registration provides regulatory compliance and acts as a seal of quality approval for medical devices in India. It is mandatory for doing business in this sector.

FAQs about the CDSCO registration fee

Here are some commonly asked questions about CDSCO registration fees:

What is the application fee for a new manufacturing site approval?

The application fee or Site Master File fee for a new manufacturing site approval is INR 50,000.

Is there a renewal fee after the initial registration?

Yes, the CDSCO registration needs to be renewed every 5 years. The renewal fee ranges from INR 5000 to INR 20,000 based on the device class.

What is the fee for making changes to a registered product?

The fee for product changes/modifications is INR 1000 per change or modification made to the registered product details.

Are there any late fees or penalties for delayed payments?

Yes, a late fee of INR 1000 per month is applicable if the payment is not made within the due date mentioned in the fee challan.