REGULATORY REQUIREMENTS FOR MEDICAL DEVICES IN INDIA AS PER CENTRAL DRUGS STANDARD CONTROL ORGANIZATION COMPARISON WITH SPAIN

*Dr. P. Ashok Kumar, Ashritha, Bhoomika K., Meghna S. R., Rathna N. R. and Trishmita Saha

ABSTRACT

Any Country’s Regulations and Processes Pertaining to the medical device industry must be followed in order to
get into the country Since ancient times, medical gadgets have been utilized for both diagnosis and treatment of
illness. Trephination has been documented in Neolithic times, and Jericho archaeological digs have revealed
instruments dating back as 2000 BC. The Central Drug Standard Control Organization (the CDSCO) is the
regulatory body in India for medical devices, overseen by the drug controller general of India (DCGI). These
guidelines address a number of device-related topics, such as post-marketing procedures, labelling, sales,
manufacturing and import, categorization, registration, and labeling.

Keywords: CDSCO, DCGI, DMF, PMF, AEMPS, GHTF.