Updated on July 06, 2024 06:13:59 PM
CDSCO is the Central Drugs Standard Control Organisation, It is the National Regulatory Authority of India. CDSCO along with state regulators is responsible for granting the license of Medical Devices.
CDSCO comes under the Directorate General of Health services,Ministry of Health and Family Welfare and Government of India. The Indian government has announced its plans to bring all medical devices,including implants and contraceptives under a review of CDSCO.
A Bone Marrow Cell Separator is required to detect a disease or its Intensity. It is a general laboratory Medical Device to isolate target cells concentrated through blood and bone. A Bone Marrow Cell Separator is listed under Class B Medical Device Category depending on the risk type.
CDSCO, the Central Drugs Standard Control Organisation, comes under the Directorate General of Health Services,Ministry of Health and Family Welfare and Government of India. Under the Drugs and Cosmetics Act,CDSCO is responsible for various activities of drugs,medical devices and cosmetics.
CDSCO Medical Device registration for Bone Marrow Cell Separator is a process of obtaining approval from the regulatory authority to ensure the efficiency and quality of the devices, accomplishing their main aim that is to safeguard public health.
We can consider following steps of CDSCO Medical Device registration for Bone Marrow Cell-Separator;
You need to Login/Sign Up on the registration portal which is ‘SUGAM’ on the official website of CDSCO.
By clicking on the ‘Sign Up here’ option, the Registration purpose page will open. Select the ‘Registration Purpose page’ from the drop down box and click on ‘Submit’.
You need to fill-in all the necessary details on the ‘Applicant Register’ page, by providing personal and organizational details. Complete the procedure by submitting it.
Required documents are asked to be submitted for the verification process from the CDSCO Officials in order to complete the process.
To verify the registration, a confirmation link will be sent to your registered email Id. Click on the link to activate your account on the CDSCO SUGAM portal.
After clicking on the confirmation link, the registration application will be sent to the concerned authority ‘officials of CDSCO’ for approvalIf the application got approved by the officials, an email of approval will be sent to your registered email Id and vice versa for the case of rejection.
If the application got approved by the officials, an email of approval will be sent to your registered email Id and vice versa for the case of rejection.
Importance of CDSCO Medical Device Registration for Bone Marrow Cell Separator can be studied 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:
CDSCO Medical Device registration for Bone Marrow Separator is a mandatory step to be done as the Indian government has announced its plan to bring all medical devices including implants and contraceptives under a review of CDSCO. The application for registration certificate or import license can be made to the Licensing authority at CDSCO.
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)
CDSCO refers to the Central Drugs Standard Control Organisation.
It is a process of obtaining approval from the regulatory authority to ensure the efficiency and quality of the devices, accomplishing their main aim that is to safeguard public health.
You can start the application process by signing up on the ‘SUGAM’ portal on the official website of CDSCO.
Details and address proof of the applicant,description of the medical device,legal form,plant master file,device master file,other regulatory certificates.
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 .
