CDSCO Medical Device Registration for Paediatrics and Neonatology | Process, Documentation, Fee

Updated on March 05, 2024 11:15:57 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 Paediatrics and Neonatology

What are Paediatrics and Neonatology?

Paediatrics is a speciality of medicine that is concerned with the health and medical treatment of babies, children, and adolescents from their birth until they reach the age of eighteen years.

Neonatology is a specialization of paediatrics that focuses on the medical treatment of newborn babies, particularly sick or born prematurely. It is primarily a hospital-based specialty most often seen in neonatal intensive care units (NICUs).

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What is CDSCO Medical Device registration for Paediatrics and Neonatology?

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 is constantly bringing out the transparency, accountability and uniformity in its service in order to ensure safety, efficacy and quality of Medical Devices manufactured, imported and distributed in the country.

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Procedure For CDSCO Registration for Pediatrics and Neonatology

We can consider following steps of CDSCO Medical Device registration for Paediatrics and Neonatology;

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.

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Importance of CDSCO Registration.

Importance of CDSCO Medical Device Registration for Paediatrics and Neonatology 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, ensuring they are safe to be consumed by the masses. CDSCO provides new opportunities in the Market.
Benefits for Paediatrics and Neonatology
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CDSCO Fee for Product

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

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Documents For CDSCO Registration for Paediatrics and Neonatology

Documents for Paediatrics and Neonatology

Documents required in CDSCO Registration are as follows:

  • Form MD 40
  • TR6 Challan
  • Undertaking from the Authority
  • Quality Certificate
  • ISO Certificate-13485
  • FSC (Free Sale Certificate)
  • Plant Master File
  • Device Master File
  • Power of Attorney
  • Description of the Medical Device
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Conclusion

CDSCO Medical Device registration for Paediatrics and Neonatology 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 Paediatrics and Neonatology?

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,PMS report,plant master file,device master file,other regulatory certificates.

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