In:
Pharmaceutical Drug Regulatory Affairs Journal, Medwin Publishers, Vol. 4, No. 1 ( 2021)
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). 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.
Type of Medium:
Online Resource
ISSN:
2642-6315
Uniform Title:
Evolution of Medical Device Sector in India and Comparison of Registration Processes of Medical Devices in India with Countries like China, Australia, U.S. and Europe
DOI:
10.23880/pdraj-16000127
Language:
Unknown
Publisher:
Medwin Publishers
Publication Date:
2021
Permalink
