CDSCO registration for Cardiovascular Medical Devices - Meaning, Process, Fee

Updated on May 06, 2024 06:23:28 PM

CDSCO is the Central Drugs Standard Control Organisation, which is the Indian National Regulatory Body for Cardiovascular Medical Devices, Pharmaceuticals and Medical Devices. It comes under the Directorate General of Health services, Ministry of Health and Family Welfare and Government of India.

In India, import, manufacturing, sale and distribution of drug and medical devices and Cardiovascular Medical Devices are regulated under Drugs and Cardiovascular Medical Devices Act 1940 and rules 1945. CDSCO with state regulators are responsible for granting the license of specialized medical devices.

Registration for Cardiovascular Medical Devices

What are Cardiovascular Medical Devices?

A Cardiovascular Medical Device is a small device that has wires which are implanted in the heart tissue such as artificial heart waves, coronary stents, angioplasty balloon catheters etc to improve the quality of life of millions of people.

These are Implanted electronic devices that helps to control or monitor irregular heartbeat. There are different types of cardiovascular medical devices based on different requirements referring to the circulatory system.

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What is CDSCO registration for Cardiovascular Medical Devices?

CDSCO registration is a process of obtaining approval from the regulatory authority to ensure the efficiency and quality of cardiovascular medical devices.

The selection of applications varies according to the device type, applicant characteristics, operations and home country approval. The CDSCO grants license for device testing, import or manufacturing after carefully evaluating each application.

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Steps to be followed for CDSCO registration for Cardiovascular Medical Devices.

Following steps should be considered for CDSCO registration for Cardiovascular Medical Devices;

Step 1:SUGAM Portal

You need to visit the ‘SUGAM’ registration portal on the official website of CDSCO. Click on the ‘sign up here’ option to start the registration process.

Step 2:Filling up the Form

Fill up the space with required details. Fill the ‘Registered Indian Address Form’ by providing the necessary details.

Step 3:Documentation

Complete the application process by submitting the required documents for the verification process which is done by the officials of CDSCO.

Step 4:Confirmation of the Registration

A confirmation link will be sent to the registered email Id to verify the application. To activate your account in the SUGAM Portal you need to click on the confirmation link.

Step 5:Approval from the officials

Once the confirmation link is clicked, the application for registration will be sent to the concerned authority for an approval after the verification of the formal documents.

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Benefits of CDSCO Registration

The benefits acquired after CDSCO registration for Cardiovascular Medical Devices can be seen as follows:

  • Indian Market access: India has the largest Pharmaceuticals and medical device market in the world. CDSCO registration allows the manufacturers and importers to sell their products to the consumers in the Indian Market.
  • Ensuring Safety: The main aim of the Central Drugs Standard Control Organisation is to safeguard public health. The quality and efficiency of the device or product goes under a verification process done by the CDSCO officials. The safety and health issues of certain types of equipment are not a concern with registered Medical Devices as a finished product.
  • Brand Recognition: CDSCO registration enhances the manufacturer’s brand recognition and credibility, as it demonstrates that the products have met rigorous safety, efficacy, and quality standards.
Benefits for Cardiovascular Medical Devices
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CDSCO Fee for Product

The Professional Fee For CDSCO import Certificate for Cosmetic products is INR 99,999/- only with Professional Utilities.

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Documents For CDSCO Registration for Cardiovascular Medical Devices

Documents for Cardiovascular Medical Devices

Documents required in CDSCO Registration are as follows:

  • Covering Letter.
  • Form MD 40
  • Challan TR6
  • ISO Certificate-13485
  • Power of Attorney
  • Covering Letter
  • Device Master File
  • Plant Master File
  • Declaration of Conformity
  • Certificate of Quality Assurance
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Conclusion

Central Drugs Standard Control Organisation which is the National Regulatory Authority of India (NRA) issues licenses for specialized medical devices after checking the quality and efficiency of the device or product. Holding a CDSCO license enhances brand reputation and brings several benefits to the holder.

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Frequently Asked Questions

What is CDSCO?

CDSCO is the Central Drugs Standard Control Organisation which is the National Regulatory Authority of India.

Who is responsible for the approval of new drugs and conducting clinical trials?

Central Drugs Standard Control Organisation.

What is the objective of the Central Drugs Standard Control Organisation?

The main objective of CDSCO is to safeguard public health.

Who can apply for CDSCO Registration in India?

Manufacturers,authorized agents,corporates,subsidiaries of the manufacturer,any other importer.

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