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CDSCO Medical Device Registration for Dialysis Machine

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CDSCO Medical Device Registration for Dialysis Machine - Process, Documents required, Fee

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 Dialysis Machine as a Medical Device under CDSCO?

The Dialysis Machine mixes and monitors the Dialysate. Dialysate refers to the fluid which helps to remove unwanted products from the blood. It also helps electrolytes and minerals to reach their proper levels in the body.

A Dialysis Machine is a Medical Device that filters out extra waste and fluid from the body. It also regulates the blood pressure and the blood flow in the body.

What is CDSCO Medical Device Registration for Dialysis Machine?

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 of doing CDSCO Registration for Dialysis Machine as Medical Device

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.

 

Importance of Medical Device CDSCO registration for Dialysis Machine

Importance of CDSCO Medical Device Registration for Dialysis Machine 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

Documents required in the CDSCO Medical Device registration for Dialysis Machine

Following are the important documents required in the CDSCO Medical Device Registration;

  • Form 40
  • ISO 13485 Certificate
  • Full Quality Assurance Certificate
  • CE Design Certificate
  • Undertaking that all details provided are authentic
  • Free Sale Certificate or Certificate from the Foreign Government
  • Plant Master Report
  • Device Master File

Conclusion

CDSCO Registration for Dialysis Machine as a Medical Device 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.