CDSCO Certifications

CDSCO license for import of device and manufacture of medical device .We Provide CDSCO license for category C and D . CDSCO is mandatory for all types of imported medical devices and all types of manufatured medical devices in india.CDSCO Certificte will be Provided with in 3-4 months

• Delivery Time: 3 months

The Central Drugs Standard Control Organisation(CDSCO)under Directorate General of Health Services,Ministry of Health & Family Welfare,Government of India is the National Regulatory Authority (NRA) of India. Its headquarter is located at FDA Bhawan, Kotla Road, New Delhi 110002 and also has  nine zonal offices,seven sub zonal offices,eighteen Port offices , seven central laboratories and six mini labs spread across the country.
The Drugs & Cosmetics Act,1940 and rules 1945 have entrusted various responsibilities to central & state regulators for regulation of drugs & cosmetics.It envisages uniform implementation of the provisions of the Act & Rules made there under for ensuring the safety, rights and well being of the patients by regulating the drugs and cosmetics. CDSCO is constantly thriving upon to bring out transparency, accountability and uniformity in its services in order to ensure safety, efficacy and quality of the medical product manufactured, imported and distributed in the country.

For import of Cosmetics products into India, the cosmetic products and manufacturing site are to be registered with Central Drugs Standards Control Organization by submitting an application in Form COS-1 to obtain a Registration Certificate in Form COS-2.

• MD 5 License is issued by the State Licensing Authority of the concerning state to manufacturers of Class A and Class B medical devices. The MD 5 License is a mandatory requirement for the manufacture, sale, and distribution of Class A and Class B medical devices in India.
• The MD 5 Medical Device Manufacturing License is issued by the State Licensing Authority (SLA) to manufacturers of Class A and Class B medical devices in India. Class A medical devices are those that are considered to be low risk, while Class B medical devices are those that are considered to be of low-moderate risk.