CDSCO Medical Device Registration for Bone Marrow Cell Separator - Process, Importance, Fee
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.
What is a Bone Marrow Cell Separator as a Medical Device?
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.
What is CDSCO Registration for Bone Marrow Cell Separator?
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.
Importance of CDSCO Registration for Bone Marrow cell Separator
Importance of CDSCO Medical Device Registration for Bone Marrow Cell Separator can be studied as follows:
- 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.
- Ensuring Public Health: CDSCO is constantly striving to bring out transparency, accountability, and uniformity in its services in order to ensure safety, efficacy, and quality of medical devices manufactured, imported, and distributed in the country. The main job and objective of CDSCO is to safeguard Public Health.
- Unlock Market Access: CDSCO Registration is required before dealing with Drugs, Medical Device, 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. CDSCO provides new opportunities in the Market.
CDSCO Fee for Product
The Professional Fee For CDSCO import Certificate for Cosmetic products is INR 99,999/- only with Monitrix.
Documents required in the CDSCO Registration for Bone Marrow Cell-Separator
Documents required in CDSCO Registration are as follows:
-
-
-
-
-
-
-
-
-
-
-
-
- Form MD 40
- Application Form 40
- ISO Certificate
- Actual Site Information
- Full Quality Assurance Certificate
- Undertaking that all the information provided is authentic
- Brand Name (if registered under the Trade Marks Act, 1999)
- Certificate of Marketability from GHTF
- FSC/Certificate from the Foreign Government
- Device Master File
- Plant Master Report
-
-
-
-
-
-
-
-
-
-
-
Conclusion
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.
Why Monitrix
At Monitrix, we leverage our industry knowledge and expertise to help businesses navigate complex regulations, minimize risks, and optimize operations for maximum efficiency and profitability.
