CDSCO Medical Device Registration for Bone Marrow Cell Separator - Process, Importance, Fee

Updated on December 05, 2023 10:41:56 AM

CDSCO is the Central Drugs Standard Control Organisation, It is the National Regulatory Authority of India. CDSCO along with state regulators is responsible for granting the license of Medical Devices.

CDSCO comes under the Directorate General of Health services,Ministry of Health and Family Welfare and Government of India. The Indian government has announced its plans to bring all medical devices,including implants and contraceptives under a review of CDSCO.

Registration for Bone Marrow Cell

What is a Bone Marrow Cell Separator as a Medical Device?

A Bone Marrow Cell Separator is required to detect a disease or its Intensity. It is a general laboratory Medical Device to isolate target cells concentrated through blood and bone. A Bone Marrow Cell Separator is listed under Class B Medical Device Category depending on the risk type.

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What is CDSCO Registration for Bone Marrow Cell Separator?

CDSCO, the Central Drugs Standard Control Organisation, comes under the Directorate General of Health Services,Ministry of Health and Family Welfare and Government of India. Under the Drugs and Cosmetics Act,CDSCO is responsible for various activities of drugs,medical devices and cosmetics.

CDSCO Medical Device registration for Bone Marrow Cell Separator is a process of obtaining approval from the regulatory authority to ensure the efficiency and quality of the devices, accomplishing their main aim that is to safeguard public health.

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Procedure to do CDSCO Registration for Bone Marrow Cell-Separator

We can consider following steps of CDSCO Medical Device registration for Bone Marrow Cell-Separator;

Step 1:Signing Up

You need to Login/Sign Up on the registration portal which is ‘SUGAM’ on the official website of CDSCO.

Step 2:Registration Page

By clicking on the ‘Sign Up here’ option, the Registration purpose page will open. Select the ‘Registration Purpose page’ from the drop down box and click on ‘Submit’.

Step 3:Filling the details

You need to fill-in all the necessary details on the ‘Applicant Register’ page, by providing personal and organizational details. Complete the procedure by submitting it.

Step 4:Documentation

Required documents are asked to be submitted for the verification process from the CDSCO Officials in order to complete the process.

Step 5:Verification Process

To verify the registration, a confirmation link will be sent to your registered email Id. Click on the link to activate your account on the CDSCO SUGAM portal.

Step 6:Approval from the authority

After clicking on the confirmation link, the registration application will be sent to the concerned authority ‘officials of CDSCO’ for approvalIf 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.

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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Importance of CDSCO Registration for Bone Marrow cell Separator

Importance of CDSCO Medical Device Registration for Bone Marrow Cell Separator can be studied as follows:

  • Safety & Quality of Products: CDSCO registration ensures that cosmetic products don’t include any harmful preparations and are suitable for all, assuring that the products are safe to be consumed by the masses.
  • Ensuring Public Health: CDSCO is constantly striving to bring out transparency, accountability, and uniformity in its services in order to ensure safety, efficacy, and quality of medical devices manufactured, imported, and distributed in the country. The main job and objective of CDSCO is to safeguard Public Health.
  • Unlock Market Access: CDSCO Registration is required before dealing with Drugs, Medical Device, and Cosmetic Products; it makes sure that they are free of heavy metals and other toxins for being safe to be consumed by the masses. CDSCO provides new opportunities in the Market.
Benefits for Bone Marrow Cell
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CDSCO Fee for Product

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

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Documents required in the CDSCO Registration for Bone Marrow Cell-Separator

Documents for Bone Marrow Cell

Documents required in CDSCO Registration are as follows:

  • Form MD 40
  • Application Form 40
  • ISO Certificate
  • Actual Site Information
  • Full Quality Assurance Certificate
  • Undertaking that all the information provided is authentic
  • Brand Name (if registered under the Trade Marks Act, 1999)
  • Certificate of Marketability from GHTF
  • FSC/Certificate from the Foreign Government
  • Device Master File
  • Plant Master Report
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Conclusion

CDSCO Medical Device registration for Bone Marrow Separator is a mandatory step to be done as the Indian government has announced its plan to bring all medical devices including implants and contraceptives under a review of CDSCO. The application for registration certificate or import license can be made to the Licensing authority at CDSCO.

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Frequently Asked Questions

What does CDSCO stands for?

CDSCO refers to the Central Drugs Standard Control Organisation.

What is CDSCO registration for Bone Marrow Cell-Separator?

It is a process of obtaining approval from the regulatory authority to ensure the efficiency and quality of the devices, accomplishing their main aim that is to safeguard public health.

How to start the application process for CDSCO medical device registration?

You can start the application process by signing up on the ‘SUGAM’ portal on the official website of CDSCO.

What common documents are required for CDSCO for Medical Device?

Details and address proof of the applicant,description of the medical device,legal form,plant master file,device master file,other regulatory certificates.

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