CDSCO Medical Device Registration for Glucometer - Process, Documents, Benefits

Updated on July 06, 2024 06:14:01 PM

CDSCO refers to the Central Drugs Standard Control Organisation being India’s National Regulatory Body for Cosmetics, Pharmaceuticals and Medical Devices.

The Indian Government has announced its plan to bring all Medical Devices including Implants and Contraceptives under a review of the Central Drugs Standard Control Organisation.

Registration for Glucometer

What is a Glucometer Medical Device?

A Glucometer can also be referred to as a Glucose meter. It is a medical device that is used to check blood glucose at home in a convenient way. This device is designed and programmed to test blood sugar level with a single drop of blood. A Glucometer is also referred to as Self-monitoring of blood glucose.

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What is CDSCO Medical Device Registration for Glucometer?

CDSCO Medical Device Registration is a process of obtaining approval from the regulatory authority to ensure the efficiency and quality of Pharmaceuticals, Medical Devices and Cosmetics.

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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Procedure For CDSCO Medical Device registration for Glucometer

Following steps should be considered for CDSCO Medical Device registration for Glucometer;

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 registration

A confirmation link will be sent to the registered email Id to verify the registration. Click on the link to activate the account on CDSCO-portal.

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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Importance of Medical Device CDSCO registration for Glucometer.

The Importance of CDSCO Medical Device registration for Glucometer for 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 Glucometer
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CDSCO Fee for Product

The Professional Fee For CDSCO Certificate is INR /- only with Professional Utilities.

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Documents For CDSCO Medical Device registration for Glucometer

Documents for Glucometer

Important documents required in the process are as follows:

  • 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
  • Device History
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Conclusion

Under the Drugs and Cosmetics Act and Rules, 1940 and 1945, CDSCO being the National Regulatory Body of India is the concerned authority for approving the license for Drugs, Cosmetics and Medical Devices.

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Frequently Asked Questions

Why do Medical devices need CDSCO registration?

As the Indian Government has announced its plan to bring medical devices including implants and Contraceptives under a review of CDSCO.

What are the Drugs and Cosmetics Rules,1945?

The Drugs and Cosmetics Rules,1945,classify drugs under given schedules and present guidelines for the storage,sale,display and prescription of each schedule.

What is CDSCO?

CDSCO, Central Drug Standard Control Organisation is India’s National Regulatory Authority (NRA) for Cosmetics, Pharmaceuticals and Medical Devices.

How many types of classes are present for Medical Devices?

There are 4 classes (A,B,C,D) for Medical Devices based on the risk level they contain.

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