CDSCO Registration for Dermatology & Plastic Surgery Medical Devices
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CDSCO Registration for Dermatology & Plastic Surgery Medical Devices- Process, Importance, Documents
CDSCO is the Central Drugs Standard Control Organisation which is the National Regulatory Body for Cosmetics, Pharmaceuticals and Medical Devices.
Within the CDSCO, the Drug Controller General of India (DCGI) regulates Pharmaceutical and Medical Devices and its positioning with the Ministry of Health and Family Welfare.
What devices are needed for Dermatology and Plastic Surgery?
Dermatology and Plastic Surgery are two medical specialties that deal with body and skin appearance. Medical devices such as Cautery, Diathermy, and Dermatoscope are required for these procedures.
CDSCO registration is necessary for these medical devices to comply with government norms regarding drugs, cosmetics, and medical devices under the Drugs and Cosmetics Act 1940.
Documents required in the CDSCO Registration for Dermatology and Plastic Surgery Medical Devices.
Important documents required in the process are as follows:
- Application Form COS 42
- Covering Letter
- Plant Master Report
- Device Master Report
- Constitution of Firm
- Tenancy Agreement
- Copy of Duly notarized valid copies quality Certificate
- ISO Certificate-13485
- Device Master File
- Performance Evaluation Report
- Undertaking from Government Authority
CDSCO Fee for Product
The Taxvilla Fee For CDSCO import Certficate for Cosmetic products is INR 99,999/- only with Taxvilla
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