CDSCO Medical Device Registration for Paediatrics and Neonatology
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CDSCO Medical Device Registration for Paediatrics and Neonatology | Process, Documentation, Fee
CDSCO, the Central Drugs Standard Control Organisation, serves as the National Regulatory Authority for India. Alongside state regulators, CDSCO is tasked with issuing licenses for medical devices.
CDSCO operates under the Directorate General of Health Services, Ministry of Health and Family Welfare, Government of India. The government has announced its intention to subject all medical devices, including implants and contraceptives, to CDSCO review.
What are Paediatrics and Neonatology?
Pediatrics is a branch of medicine that deals with the health and medical care of infants, children, and adolescents from birth up to the age of eighteen.
Neonatology, a subspecialty of pediatrics, focuses on the medical care of newborns, particularly those who are ill or born prematurely. It is primarily practiced in hospital settings, especially in neonatal intensive care units (NICUs).
Documents For CDSCO Registration for Paediatrics and Neonatology
Documents required in CDSCO Registration are as follows:
- Form MD 40
- TR6 Challan
- Undertaking from the Authority
- Quality Certificate
- ISO Certificate-13485
- FSC (Free Sale Certificate)
- Plant Master File
- Device Master File
- Power of Attorney
- Description of the Medical Device
CDSCO Fee for Product
The taxvilla fee for the CDSCO certificate is INR 99,999/- only with taxvilla.
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