CDSCO Registration - Online Procedure, Documentation, Benefits, Fee etc.

Updated on December 07, 2023 11:36:21 AM

CDSCO full form is 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, specializing in CDSCO Registration.

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, Import, manufacturing, sale and distribution of drugs is regulated in India.

Registration for CDSCO Medical Device

What is the Central Drugs Standard Control Organisation?

CDSCO, the Central Drugs Standard Control Organisation, is India's National Regulatory Body for Cosmetics, pharmaceuticals, and medical devices. It is a highly powerful organization in India and operates under the Directorate General of Health Services, Ministry of Family Welfare & Health, and the Government of India.

The Indian Government has announced its plan to bring all medical devices, including implants and contraceptives, under the review of the Central Drugs Standard Control Organisation. CDSCO, along with state regulators, is responsible for granting licenses for certain specialized categories of critical drugs, such as Blood and Blood Products, I.V Fluids, Vaccine & Sera.

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What is CDSCO Registration?

CDSCO Registration is the pivotal approval process from the Central Drugs Standard Control Organisation, assuring the quality and efficacy of Pharmaceuticals, Medical Devices, and Cosmetics. It guarantees that these products are devoid of harmful elements, ensuring no harm to animals during production, and certifies their safety for public use.

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Drugs and Cosmetics Act,1940 & Rules 1945

The Drugs and Cosmetics Rules,1945 are the rules which were established by the government of India through the Drugs and Cosmetics Act,1940. These are the legal framework for regulating the Import, manufactures, distribution and sale of Drugs and Cosmetics in India.

The act and rules aims to ensure the safety, efficacy and quality of the Drugs and Cosmetics, it also classifies the medicines into different schedules and provides guidelines for their storage, sale, display and prescription.

  • Medical Devices: Any Article, Instrument, Apparatus, Machine, Implant or Reagent that is manufactured, sold, represented for use in the diagnosis, treatment, mitigation, prevention, or care of a human or animal disease, disorder, condition or pregnancy.
  • Cosmetic: Referring to several preparations that are applied to the human body for beautifying, preserving, or altering the appearance or for cleansing, coloring, conditioning, or protecting the skin, hair, nails, lips, eyes, or teeth.
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Types and Classifications of Medical Devices

A medical device is any device that is used for medical purposes. It can be any Article, Instrument, Implant, Reagent etc.

Types of Medical Devices

There are two types of Medical Devices.

  • Notified Devices: Notified Devices are the Medical Devices that are regulated under the Medical Devices Rules, 2017 by the CDSCO.
  • Non-Notified Devices: Non-Notified Devices are Medical Devices that have not been mentioned under Notified Devices in the official gazette released by the government of India.
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Classifications of Medical Devices

The commodity that is packaged needs to have a plain, conspicuous, and definite declaration. There are a required declarations that needs to be mentioned on the each package as mentioned below-

Category Amount of Risk
A Low risk
B Low moderate risk
C Moderate high risk
D High risk
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Who can Apply for CDSCO Medical Registration In India?

  • Manufacturer having a registered office in India.
  • The Authorized Agent of the Manufacturer.
  • Foreign Enterprises holding Indian Subsidiary.
  • Corporates.
  • Any other Importers.
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Procedure to acquire CDSCO Registration

The Procedure to acquire CDSCO Registration can be understood by following steps:

Step 1:Online Registration

To apply for CDSCO Registration you need to visit the official website of CDSCO. Open the ‘CDSCO SUGAM 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 for the case of rejection.

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Benefits of CDSCO Registration

CDSCO Registration provides several Benefits that are as follows:

  • 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 don't include any harmful preparations and are suitable for all, assuring that the products are safe to be consumed by the masses.
  • 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, ensuring they are safe to be consumed by the masses and providing new opportunities in the Market.
Benefits for Bone Marrow Cell
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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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Necessary documents required CDSCO Registration

Documents for Bone Marrow Cell

Documents required in CDSCO Registration are as follows:

  • Form MD 1.
  • Identity and Address Proof of the Applicant.
  • Covering Letter.
  • Description of the Product.
  • Test Protocol.
  • Quality Certificates.
  • Instructions for Use.
  • Undertaking from the Government Authority.
  • Fee Challan.
  • Legal Form.
  • ISO-13485.
  • PMS Surveillance
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Fees required in CDSCO Registration for License

Manufacturing of Medical Equipment

Device Type Governmental Fee Professional Fee
Class A and Class B 5000 (one site), 1000 (each distinct medical device) ₹99,999/-
Class C and D 50000 (one site), 1000 (each distinct medical device) ₹99,999/-

Import of Medical Equipment

Device Type Governmental Fee Professional Fee
Class A $1000 (one site), $50 (each distinct medical device) ₹99,999/-
Class B $2000 (one site), $1000 (each distinct medical device) ₹99,999/-
Class C and D $3000 (one site), $1500 (each distinct medical device) ₹99,999/-
Class A and B in vitro diagnostic $1000 (one site), $10 (each distinct) ₹99,999/-
Class C and D in vitro diagnostic $3000 (one site), $500 (each distinct) ₹99,999/-

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Conclusion

CDSCO, the Central Drugs Standard Control Organisation is the national regulatory body for Cosmetics, Pharmaceuticals & Medical Devices. It is responsible for the approval of new drugs, conduct of clinical trials, laying down the standards for drugs etc under the Drugs and Cosmetics Act, 1940. CDSCO along with state regulators is responsible for granting the license for specialized categories of drugs. It Provides numerous benefits as being safe for the users to consume, ensures quality etc.

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Frequently Asked Questions

What is the full form of CDSCO?

CDSCO stands for Central Drugs Standard Control Organisations.

What is CDSCO?

Central Drugs Standard Control Organisation is India’s national regulatory body for Cosmetics, Pharmaceuticals and Medical Devices.

What is DCGI?

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

What is the process of CDSCO registration?

You can contact Professional Utilities for the whole procedure with complete documentation.

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