Regulatory Requirements For Medical Devices In India As Per CDSCO Comparison with South Africa

ABSTRACT

The medical device market in India is a sunrise sector in the pharmaceutical industry and has achieved a milestone in the last few years securing 4th position in the medical device market in Asia with increasing foreign direct investments through governments. Make in India Campaign 2017 and PLI (Product linked incentive) schemes. To enter the medical device market in any country, one has to go through different procedures and regulatory requirements of that country. Medical devices are regulated in India by the DCGI (Drug Controller General of India) under the CDSCO (Central Drug Standard Control Organization). These rules and regulations covers various aspects of device related regulations, including classification, registration, manufacturing and import, labeling, sales, and post marketing requirements, etc. This study is aimed to review and compare the regulatory requirements of South African country with India. Harmonization of medical devices registration across the markets of these two country is essential to overlay way for their easy approval and also in dealing with the withdrawn issues related to quality, safety, and performance.

Keywords: CDSCO, SAPHRA, Notified devices, Medical device rules 2017, International regulations, Drug and Cosmetic act 1940 and rules 1945, Medical device