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CDSCO Registration for Defibrillators

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CDSCO Medical Devices Registration for Defibrillators - Process, Fee, Documentation

The Central Drugs Standard Control Organisation is one of the powerful organizations in India. CDSCO is India’s National Regulatory Body for Cosmetics, Pharmaceuticals and Medical Devices.

Within the CDSCO, the Drug Controller General of India (DCGI) regulates pharmaceuticals and medical devices and its positioning with the Ministry of Health and Family Welfare.

 

Overview

What is a Defibrillators Medical Device?

A defibrillator is a Medical Device that sends an electric shock to the heart for restoring or correcting a normal heartbeat. It is used to treat life threatening conditions that affects the heart rhythm,such as ventricular fibrillation and ventricular tachycardia.

There are various kinds of Defibrillators as Automated external defibrillators (AEDs),Implanted cardioverter defibrillators (ICDs),Wearable cardioverter defibrillators (WCDs) which requires CDSCO registration.

What is CDSCO Medical Device registration for Defibrillators?

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

CDSCO registration process is required to ensure the quality of the Medical Device as the main job and objective of CDSCO is to safeguard Public’s Health.

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 personal and organizational details.

Step 3 – Documentation

Complete the application process by submitting the required documents for the verification process which 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.

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.

 

Importance of CDSCO Registration for Defibrillators Medical Device

Importance of Oncology Medical Device CDSCO Registration can be studied as follows;

  • Regulatory Compliance: CDSCO Registration provides Regulatory Compliance referring to a procedure of following relevant laws and regulations. CDSCO ensures that the Drug and Cosmetic Products that are used by the public shouldn’t be hazardous to them.
  • 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.
  • Access to Indian Market: In India, the responsibility of Import, manufacturing, sale & distribution of Medical Devices is managed by Central Drugs Standard Control Organisation under the Drugs and Cosmetics Act, 1940. CDSCO Registration is required to get access to the Indian Market for Medical Devices for the consumers, making sure to fulfill their requirements while following all the rules and regulations of the government.

Documents required in the CDSCO for Defibrillators process

Documents required in the process are listed below;

  • Form MD 40
  • ISO Certificate-13845
  • Fee Challan
  • Power of Attorney
  • Quality Assurance Certificate
  • Device Master File
  • Plant Master File
  • FSC (Free Sale Certificate)
  • Details and Address Proof of the Applicant
  • Medical Device Description

Conclusion

CDSCO registration is required for all kinds of Medical Devices as they contains a risk level.There has definitely been significant market growth in the medical device industry because of various factors, which is a necessary and profitable domain for the country. As the Indian government has announced its plan to bring all Medical Devices under a review of CDSCO thus it is important to complete the registration process on the official website of CDSCO.