CDSCO Medical Device Import License
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CDSCO Medical Device Import License - Process,Types & Classification, Fee
CDSCO, or the Central Drugs Standard Control Organisation, is India’s most powerful organization and serves as the National Regulatory Body for Cosmetics, Pharmaceuticals, and Medical Devices.
To import medical devices into India, manufacturers must meet all standards of quality and efficacy to access the Indian market. The distribution, sale, manufacture, and import of cosmetics, drugs, and medical devices in India are regulated under the provisions of the Drug & Cosmetics Act of 1940 and its Rules from 1945.
What is a Medical Device, Types and Classification?
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.
Documents required for CDSCO Medical Device Import License Process
mportant documents required in the process are as follows:
- Covering Letter
- Form MD 14
- Description of Medical Letter
- Justification of Quantity
- Test Protocol
- Quality Certificate of the Manufacturer
- Instructions for use
- Undertaking (device will be imported exclusively for only specified purpose)
- Undertaking from the testing laboratory
- Fee Challan
- Copy of BA/BE site registration as approved by CDSCO in case of BA/BE approved sites registration
- Manufacturing license or wholesale license (in the case of Import)
CDSCO Fee for Product
The taxvilla fee for the CDSCO certificate is INR 99,999/- only with taxvilla
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