CDSCO Registration for Oncology Medical Devices
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CDSCO Registration for Oncology Medical Devices - Process, Documents
CDSCO is the Central Drugs Standard Control Organisation, India’s National Regulatory Body for Cosmetics, Pharmaceuticals, and Medical Devices.
The Indian government has announced its plan to bring all medical devices, including implants and contraceptives, under the review of CDSCO. Thus, it is mandatory to register under CDSCO for oncology medical devices. Within CDSCO, the Drug Controller General of India (DCGI) regulates pharmaceuticals and medical devices. It is positioned within the Ministry of Health and Family Welfare.
What are Oncology Medical Devices?
Oncology Medical devices are used in diagnosing, treating and mapping the severity of cancer and tumors such as MRI’s, Pet Scans, Ultrasound etc.
There are various types of Oncology Medical devices that needs to be registered with CDSCO in order to comply with the latest Medical Devices Rules in India, these are the legal framework for regulating the import, manufacture, distribution and sale of the medical devices, drugs and cosmetics in India under the Drugs and Cosmetics Act 1940 and Rules 1945.
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Documents required in the CDSCO for Oncology Medical Device process.
Documents required in the process are as follows
- Form MD 40
- Covering Letter
- Details of the Medical Device
- Copy of Authorization Letter issued by Director/Company Secretary
- Quality Assurance Certificates
- Instructions for Use
- Undertaking from Testing Laboratory
- Identity and Address Proof of the Applicant
- ISO Certificate-13485
CDSCO Fee for Product
The taxvilla Fee For CDSCO import Certificate for Cosmetic products is INR 99,999/- only with taxvilla.
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