Glucometer – U&T Standardisation Marks

CDSCO Medical Device Registration for Glucometer

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

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.

Overview

What is a Glucometer as a Medical Device?
What is CDSCO Medical Device Registration for Glucometer?
Procedure for doing CDSCO Medical Device registration for Glucometer
Importance of Medical Device CDSCO registration for Glucometer
Documents required in CDSCO Medical Device registration for Glucometer
Conclusion

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.

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.

Process for CDSCO Medical Device Registration for Defibrillators

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.hich is done by CDSCO officials.

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.

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.

Documents For CDSCO Medical Device registration 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

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.

LEGAL METROLOGY (LMPC)

UN MARK IP

Drug License

Cosmetics

Medical Devices