Albert Science International Organization

ARTICLE DESCRIPTION: 

Pranjal Sachan, An overview of Indian medical device laws, a comparison with EU laws, and future direction, ASIO Journal of Drug Delivery, 2022, 6(1): 14-20.

ARTICLE TYPE: REVIEW

DOI Link:: http://doi-ds.org/doilink/10.2016-21915953/ ;

DOI Link:: 10.2016-21915953/ ; DOI Link :: https://doi-ds.org/doilink/08.2022-83367123/ASIO-JDD/10.2016-21915953/2022/V6/I1/922

ABSTRACT:
A rapidly expanding area of an Indian economy, medical treatment is predicted by the year 2025, $280 billion. 1 of the 20 biggest marketplaces for medical devices worldwide is the one in India. By 2025, its worth, which is presently $5.2 billion, is anticipated to reach $50 billion. Though just over 70% of India's medical gadgets are still imported, the nation doesn't produce many of them domestically. The creation Proper upkeep of medical equipment highly regulated processes. The introducing new rules for medical devices in India, known as the Indian Medical Device Rules, 2017 India, were published on behalf belonging to the Central Drug Standard Control Organization to remedy this regulatory void. In order to keep up with the demands, they were modified Medical Devices (Amendment) Rules, 2020, for example went into effect 2020 April. These regulations include a number of facets of the laws governing medical devices, such as categorization, registration, production, importation, labeling, sales, and post-market procedures. The X-ray based diagnostics regulations are clearly defined in USA and Japan. In India, these diagnostic devices has been brought under ambit of MDR-2017 and the radiation emission are regulated by AERB, however there are no clear regulations manufacture of X-ray based diagnostic devices in India. Therefore to promote indigenous manufacturing & to reduce the dependency on import, Indian government should provide clear regulation comparable to the regulations of USA & Japan. This will boost Make in India initiative of Indian government.

Keywords: Medical devices, in-vitro diagnostics, Indian legislation, and medical device regulations 2017.

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