CDSCO Medical Device Registration for Glucometer
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CDSCO Medical Device Registration for Glucometer - Process, Documents, Benefits
CDSCO stands for the Central Drugs Standard Control Organisation, which serves as India’s National Regulatory Body for cosmetics, pharmaceuticals, and medical devices.
The Indian Government has announced its intention to subject all medical devices, including implants and contraceptives, to a review by the Central Drugs Standard Control Organisation.
What is a Glucometer Medical Device?
A glucometer, also known as a glucose meter, is a medical device used for convenient at-home blood glucose testing. It is designed to measure blood sugar levels with just a single drop of blood. Glucometers are also referred to as self-monitoring of blood glucose devices.
Documents For CDSCO Medical Device registration for Glucometer
Important documents required in the process are as follows:
- Form MD 40
- Challan TR6
- ISO Certificate-13485
- Power of Attorney
- Covering Letter
- Device Master File
- Plant Master File
- Declaration of Conformity
- Certificate of Quality Assurance
- Device History
CDSCO Fee for Product
The taxvilla fee for the CDSCO certificate is INR 99,999/- only with taxvilla
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