Updated on July 06, 2024 06:14:02 PM
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.
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.
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.
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.
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.
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 |
The Procedure to acquire CDSCO Registration can be understood by following steps:
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.
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.
Complete the application process by submitting the required documents for the verification process.
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.
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.
CDSCO Registration provides several Benefits that are as follows:
The Professional Fee For CDSCO import Certificate for Cosmetic products is INR 99,999/- only with Professional Utilities.
Documents required in CDSCO Registration are as follows:
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/- |
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.
At Professional Utilities, we leverage our industry knowledge and expertise to help businesses navigate complex regulations, minimize risks, and optimize operations for maximum efficiency and profitability.
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CDSCO stands for Central Drugs Standard Control Organisations.
Central Drugs Standard Control Organisation is India’s national regulatory body for Cosmetics, Pharmaceuticals and Medical Devices.
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.
You can contact Professional Utilities for the whole procedure with complete documentation.
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