CDSCO Registration for Dermatology & Plastic Surgery Medical Devices- Process, Importance, Documents

Updated on March 01, 2024 12:07:21 PM

CDSCO is the Central Drugs Standard Control Organisation which is the National Regulatory Body for Cosmetics, Pharmaceuticals and Medical Devices.

Within the CDSCO, the Drug Controller General of India (DCGI) regulates Pharmaceutical and Medical Devices and its positioning with the Ministry of Health and Family Welfare.

Registration for Dermatology Plastic Surgery

What devices are needed for Dermatology and Plastic Surgery?

Dermatology and Plastic Surgery, these are two medical specialties that deals with body and skin appearance. Cautery, Diathermy, Dermatoscope etc are some of the Medical Devices needed.

CDSCO Registration is required for these Medical Devices in order to follow all the norms released by the government regarding Drugs, Cosmetics and Medical Devices under the Drugs and Cosmetics Act 1940.

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What is CDSCO Registration for Dermatology and Plastic Surgery Medical Devices?

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

The Registration for Dermatology and Plastic Surgery under CDSCO is an important step to be done to avoid any hindrances related to the activities involved in the domain. As in India, Import, Manufacturing, Sale and Distribution of Drugs, Cosmetics and Pharmaceuticals is regulated under Drugs and Cosmetics Act 1940.

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Process to do CDSCO Registration for Dermatology and Plastic Surgery Medical Devices.

Following steps should be considered for CDSCO registration for Cardiovascular Medical Devices;

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.

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Importance of CDSCO Registration for Dermatology and Plastic Surgery

Importance of CDSCO Registration can be seen as below;

  • 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.
  • Safety & Quality of Products: CDSCO registration ensures that cosmetic products doesn’t include any harmful preparations and are suitable for all assuring that the products are safe to be consumed by the masses under government regulations.
  • Unlock Market Access: CDSCO Registration is required before dealing with Drugs 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, it provides new opportunities in the Market.
Benefits for Dermatology Plastic Surgery
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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 Dermatology and Plastic Surgery Medical Devices.

Documents for Dermatology Plastic Surgery

Important documents required in the process are as follows:

  • Application Form COS 42
  • Covering Letter
  • Plant Master Report
  • Device Master Report
  • Constitution of Firm
  • Tenancy Agreement
  • Copy of Duly notarized valid copies quality Certificate
  • ISO Certificate-13485
  • Device Master File
  • Performance Evaluation Report
  • Undertaking from Government Authority
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Conclusion

Under the Drugs and Cosmetics Act and Rules, 1940 and 1945, CDSCO being the National Regulatory Body of India is the concerned authority for approving the license for Drugs, Cosmetics and Medical Devices. The process for the CDSCO Registration is quite lengthy and complex but you can rely on Professional Utilities at the amount of ₹99,999/- as a professional fee for complete procedure and guidance.

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Frequently Asked Questions

Why do Medical devices need CDSCO registration?

As the Indian Government has announced its plan to bring medical devices including implants and Contraceptives under a review of CDSCO.

What are the Drugs and Cosmetics Rules,1945?

The Drugs and Cosmetics Rules,1945,classify drugs under given schedules and present guidelines for the storage,sale,display and prescription of each schedule.

What is CDSCO?

CDSCO, Central Drug Standard Control Organisation is India’s National Regulatory Authority (NRA) for Cosmetics, Pharmaceuticals and Medical Devices.

How many types of classes are present for Medical Devices?

There are 4 classes (A,B,C,D) for Medical Devices based on the risk level they contain.

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