Updated on July 06, 2024 06:08:52 PM
CDSCO, being India’s most powerful Organization, refers to the Central Drugs Standard Control Organisation. It is the National Regulatory Body for Cosmetics, Pharmaceuticals and Medical devices.
To import medical devices into India, manufacturers have to fulfill all the standards of quality & efficacy to get access to the Indian market. In India, the Distribution, Sale, Manufacture and Import of Cosmetics, Drugs, Medical Devices are regulated under the provisions of the Drug & Cosmetics Act, 1940 and Rules, 1945.
A Medical Device is an article, instrument, apparatus or machine that is used in the prevention, diagnosis or treatment of illness or disease or for detecting, measuring, restoring, correcting or modifying the structure or function of the body for some health purpose.
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 |
CDSCO Registration is a process to obtain an approval from the Central Drugs Standard Control Organisation to ensure the efficiency and the quality of the Medical Devices to be used by the masses.
CDSCO along with state regulators are responsible for authorizing licenses for Medical Devices. It is a mandatory certificate to be obtained by the manufacturers who deals with medical devices especially in the Import activity in India. The Indian Government has announced its plan to bring all Medical Devices, including implants and contraceptives under a review of CDSCO.
The process for obtaining CDSCO Import License for Medical Device can be understood by following steps;
The first step is to Login/Sign up at SUGAM Portal on the official website of Central Drugs Standard Control Organisation.
By clicking on the ‘Sign Up here’, registration purpose page will open. Select the ‘Registration Purpose’ page from the drop down box and click on the ‘Submit”.
Fill all the necessary details on the ‘Applicant Registration’ page which is divided into 2 parts. You need to fill your personal details along with the organization's details.
Required documents needs to be submitted for the verification Process. Complete the procedure by submitting it.
To verify the registration,a confirmation link will be sent to your registered mail. Click on the confirmation link to activate your account on the SUGAM Portal.
After 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.
Medical Device Import License provides several benefits as:
The Professional Fee For CDSCO import Certificate for Cosmetic products is INR 99,999/- only with Professional Utilities.
Important documents required in the process are as follows:
CDSCO stands for Central Drugs Standard Control Organisation which is responsible for authorizing licenses for Medical Devices. For Importing, manufacturing,selling and distributing of Medical Devices, CDSCO license is important under the Drugs and Cosmetics Act,1945. The CDSCO License can also act as a Certificate of permission to deal with Medical Devices in India carrying several benefits with itself.
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.
.svg)
For any Medical Device which is imported to India, it is Mandatory to have a CDSCO Medical Import License.
SUGAM is an online portal of CDSCO, Central Drugs Standard Control Organisation.
The Drug Controller General of India regulates pharmaceuticals and medical devices and its positioning with the Ministry of Health & Family Welfare.
You can start the registration process on the official website of CDSCO at SUGAM Portal.
Speak Directly to our Expert Today
Reliable
Affordable
Assured
Call us on 011-45518998
+91 9821113117
[Mon - Sat, 10am - 7pm]
Write to us
809, 8th Floor, Madhuban Building,
Nehru Place, New Delhi - 110019
Reliable
Affordable
Assurity
They've been very helpful in our registration with ICEGATE. It was a small thing with a small amount paid which somehow escalated to a very painful procedure. Never did they say "You've only paid so much. It's too much effort for us.".
Very pleased with their service. Prompt, professional and great communication. Definitely recommend. Special mention for Ms. Razia - she handled our case.
Professional Utilities is fully professional in their work, Rates are too low and genuine. Services and satisfaction are high so I highly recommended Professional Utilities.
They are one of the most genuine and reasonable people. I applied for lmpc certificate through them and they charged me a very nominal amount as compared to what other firms asked .
