CDSCO Medical Device Registration for Pacemaker - Process, Documentation, Benefits acquired

Updated on November 27, 2023 04:26:34 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.

Registration for Pacemaker

What is a Pacemaker as a Medical Device?

A Pacemaker is a battery-powered small device that helps in preventing the heart from beating too slowly. A Pacemaker is also known as a Cardiac Pacing Device which is the size of a matchbox.

There are various types of Pacemakers; Single Chamber Pacemaker, Dual Chamber Pacemaker and Biventricular Pacemaker. The primary purpose of a pacemaker is to maintain an adequate heart rate.

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What is CDSCO Medical Device Registration for Pacemakers?

The Indian government has announced its plan to bring all the Medical Devices, including Implants and Contraceptives under the review of the Central Drugs Standard Control Organisation.

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

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Procedure of doing CDSCO Medical Device Registration for Pacemaker

Following steps can be followed for doing CDSCO Medical Device for Pacemaker;

Step 1:Online Registration

To apply for CDSCO Registration you need to visit the official website of CDSCO. Open the ‘SUGAM CDSCO Portal’ then Click on the ‘SIGN UP HERE’ option.

Step 2:Filling up the details

The Registration form is divided into two parts, ‘Applicant Details’- the applicant needs to submit his/her personal details, ‘Registered Indian Address'- the applicant needs to submit his/her organization's details.

Step 3:Document Submission

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

Step 4:Verification of the Registration

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

Step 5:Approval from Authority

After Clicking on the confirmation,the registration application will be sent to the concerned authority for approval. If the application got approved by the CDSCO Officials,an email of approval will be sent to the registered email Id, vice versa in the case of rejection.

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Benefits acquired after CDSCO Registration for Pacemaker

The benefits acquired after CDSCO registration for Pacemaker can be seen as follows:

  • 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.
  • Regulatory Compliance: CDSCO Registration provides Regulatory Compliance referring to a procedure of following relevant laws and regulations, CDSCO ensures that the Medical Devices that are used by the public are meeting the safety and quality standards set by CDSCO.
  • Safeguard 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.
Benefits for Pacemaker
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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 CDSCO Registration for Pacemaker as a Medical Device

Documents for Pacemaker

Important documents required in the process are as follows:

  • Application form MD 7
  • Challan TR6
  • ISO 13485
  • Power of Attorney
  • An Undertaking stating that only accurate information is provided
  • Certificate of quality assurance
  • C.E. Design accreditation
  • Declaration of conformity
  • Master Plant File
  • Device Master File
  • FSC
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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.

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Frequently Asked Questions

Is CDSCO registration required for Pacemaker?

Yes, CDSCO registration is required for any kind of Medical Device.

What is meant by CDSCO?

CDSCO stands for Central Drugs Standard Control Organisation.

What are the benefits acquired after CDSCO registration for Pacemakers?

Ensuring safety, Regulatory Compliance, Safeguard Public Health etc.

What is the process for CDSCO registration for Defibrillators?

Registration on SUGAM portal, Filling up the Form,Documentation, Confirmation of registration, Approval from the officials.

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