CDSCO Medical Device Registration for Bone Marrow Cell-Separator
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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.
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
CDSCO Fee for Product
The taxvilla fee for the CDSCO certificate is INR 99,999/- only with taxvilla
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