CDSCO (INDIA)

Paediatrics is a speciality of medicine that is concerned with the health and medical treatment of babies, children, and adolescents from their birth until they reach the age of eighteen years.

Neonatology is a specialization of paediatrics that focuses on the medical treatment of newborn babies, particularly sick or born prematurely. It is primarily a hospital-based specialty most often seen in neonatal intensive care units (NICUs).

CDSCO, the Central Drugs Standard Control Organisation, comes under the Directorate General of Health Services, Ministry of Health and Family Welfare and Govemment of india. Under the Drugs and Cosmetics Act. CDSCO is responsible for various activities of drugs medical devices and cosmetics.

CDSCO is constantly bringing out the transparency, accountability and uniformity in its service in order to ensure safety, efficacy and quality of Medical Devices manufactured, imported and distributed in the country.

We can consider following steps of CDSCO Medical Device registration for Paediatrics and Neonatology :

Importance of CDSCO Medical Device Registration for Paediatrics and Neonatology can be studied as follows :

• Safety & Quality of Products : COSCO registration ensures that cosmetic products don't include any harmful preparations and are suitable for all, assuring that the products are safe to be consumed by the masses
• Ensuring Public Health : CDSCO is constantly striving to bring out transparency, accountability, and uniformity in its services in order to ensure safety, efficacy, and quality of medical devices manufactured, imported, and distributed in the country. The main job and objective of CDSCO is to safeguard Public Health.
• Unlock Market Access : CDSCO Registration is required before dealing with Drugs Medical Device, and Cosmetic Products. It makes sure that they are free of heavy metals and other toxins, ensuing they are safe to be consumed by the masses CDS00 provides new opportunities in the Market.

The Professional Fee For CDSCO Certificate is INR 99,999/- only with Cokion.

Documents required in CDSCO Registration are as follows :

Documents Required

• 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 Medical Device registration for Paediatrics and Neonatology is a mandatory step to be done as the Indian government has announced its plan to bring all medical devices including implants and contraceptives under a review of CDSCO. The application for registration certificate or import license can be made to the Licensing authority at CDSCO.