CDSCO registration for Ophthalmic Medical Devices
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CDSCO registration for Ophthalmic Medical Devices - Procedure, Documents, Fees
CDSCO, short for the Central Drugs Standard Control Organisation, is a highly influential organization in India. It serves as the National Regulatory Body overseeing Cosmetics, Pharmaceuticals, and Medical Devices.
Given the Indian Government’s recent announcement to subject all medical devices, including implants and contraceptives, to CDSCO review, it has become mandatory for individuals dealing with Ophthalmic Medical Devices to obtain a CDSCO Certificate after registration in this domain.
What are Ophthalmic Medical Devices?
Ophthalmic Medical Devices are instruments used in Optometry and Ophthalmology for medical purposes. They are crucial for treating and preventing eye damage, diseases, or injuries.
Various types of Ophthalmic Medical Devices need to be registered with CDSCO to comply with India’s latest Medical Devices Rules. These rules establish the legal framework for regulating the import, manufacture, distribution, and sale of medical devices, drugs, and cosmetics in India under the Drugs and Cosmetics Act 1940 and Rules 1945.
Documents For CDSCO registration for Ophthalmic Medical Devices.
The following are the documents required in the CDSCO registration for Ophthalmic Medical Devices:
- Application Form MD 3 for application and MD 5 for license
- 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 fee for the import certificate for cosmetic products with Taxvilla is INR 99,999/- only.
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