ISSN: 2642-6315
Authors: Rao RJ* and Sutar GR
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). In China, the registration approval process is under NMPA (National Medical Product Administration) and requires complying with Chinese regulatory standard notice No. 218. Europe and Australian regulations are bit same and require a CE (Conformité Européenne) mark for manufacturing and marketing. U.S. regulations for approving medical devices are stringent and 510 (k) and PMA (pre-market authorization) is compulsory. In this review, the reader would get an idea about the evolution of medical devices and legislative changes in India and also about international standards and auditing programs. There is a comparison of Indian, Chinese, Australian, U.S., and European medical device registration processes for understanding the similarities and differences.
Keywords: Medical devices; Legislative changes; Registration process; Government initiatives; ISO; IEC
