CDSCO Medical Device Registration for BP Monitor
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CDSCO Medical Device Registration for BP Monitor - Meaning, Process, Fee
The Central Drugs Standard and Control Organisation (CDSCO) is India’s National Regulatory Authority for cosmetics, pharmaceuticals, and medical devices, making it a highly influential organization in the country.
Within the CDSCO, the Drug Controller General of India (DCGI) regulates pharmaceuticals and medical devices, aligning its position with the Ministry of Health and Family Welfare. The import, manufacturing, sale, and distribution of drugs in India are regulated under the Drugs and Cosmetics Act of 1940 and Rules of 1945.
What is CDSCO Registration for BP Monitor?
CDSCO Medical Device Registration is a process of obtaining approval from the regulatory authority to ensure the efficiency and quality of Pharmaceuticals, Medical Devices and Cosmetics.
The selection of applications varies according to the device type, applicant characteristics, operations and home country approval. The CDSCO grants license for device testing, import or manufacturing after carefully evaluating each application.
Documents required in CDSCO Registration for BP Monitor
Important documents required in the process are as follows:
- Application Form MD 40
- ISO 13485 Certificate
- TR6 Challan
- Power of attorney
- Undertaking that only authentic details are provided
- Full quality assurance certificate
- Declaration of conformity
- Device master file
- Plant master report
- Free sale certificate
CDSCO Fee for Product
The taxvilla fee for the CDSCO certificate is INR 99,999/- only with taxvilla
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