CDSCO Medical Device Registration for BP Monitor - Meaning, Process, Fee

Updated on January 30, 2024 01:17:19 PM

CDSCO stands for The Central Drugs Standard and Control Organisation. It is India's National Regulatory Authority (NRA) for Cosmetics, Pharmaceuticals and Medical Devices, being a highly powerful organization of India.

Within the CDSCO, the Drug Controller General of India (DCGI) regulates Pharmaceuticals & Medical Devices and its positioning with the Ministry of Health and Family Welfare.Under Drugs and Cosmetics Act 1940 and Rules 1945, import, manufacturing, sale and distribution of drugs is regulated in India.

Registration for BP Monitor

BP Monitor as a Medical Device

A Blood Pressure monitor is a digital medical device that is used to check the blood pressure of human beings and to track their readings. It is also known as Digital BP Monitor, It is a diagnostic tool to check the blood pressure levels in the body.

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What is CDSCO Registration for BP Monitor?

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 of doing CDSCO Medical Device Registration for BP Monitor.

Following steps should be considered for CDSCO Medical Device registration for BP Monitor;

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.

If the application got approved by the officials, an email of approval will be sent to your registered email Id and vice versa for the case of rejection.

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Benefits acquired after CDSCO Registration for BP Monitor.

The Benefits of CDSCO Medical Device registration for BP Monitor 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 BP Monitor
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CDSCO Fee for Product

The Professional Fee For CDSCO Medical Device Registration for BP Monitor is INR 99,999/- only with Professional Utilities.

Note: The aforementioned Fees is exclusive of GST.

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Documents required in CDSCO Registration for BP Monitor

Documents for BP Monitor

Important documents required in the process are as follows:

  • Application Form MD 40
  • ISO 13485 Certificate
  • TR6 Challan
  • Power of attorney
  • Undertaking that only authentic details are provided
  • Full quality assurance certificate
  • Declaration of conformity
  • Device master file
  • Plant master report
  • Free sale certificate
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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. The process for the CDSCO Medical Device Registration for BP Monitor is quite lengthy and complex but you can rely on Professional Utilities for complete procedure and guidance.

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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 the fee for doing CDSCO Registration for BP Monitor?

The fee for doing CDSCO Registration for BP Monitor is ₹99,999 + additional fee of the medical device at Professional Utilities.

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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