Trilegal is a market leader offering legal expertise in regulatory, corporate, commercial, disputes and intellectual property matters in the medical devices industry. We have helped clients navigate clinical trials, product development, manufacturing, labelling, marketing, product liability, and investigations and anti-bribery issues in the sector.
From disposables to implantables, India now manufactures a range of medical devices. The industry has seen exponential growth since 2014, when the government recognised the sector as a focus area during the Make-In-India campaign. According to the India Brand Equity Foundation , the Indian medical devices market, which includes large multinationals as well as small and mid-sized companies, is the fourth-largest market in Asia after Japan, China, and South Korea. The export of medical devices from India is likely to touch USD 10 billion by 2025 from USD 2.53 billion in 2021.
Driven by the sector’s growth, the regulatory regime governing medical devices has tried to keep pace. In 2017 and 2020, the Drugs and Cosmetics Act, 1940, sought to separately regulate medical devices, which were previously being treated as ‘drugs’. The 83-year-old law simply could not keep up with the technological progress of the sector, and the Indian government released a draft Drugs, Medical Devices and Cosmetics Bill, 2022 for public comments.
Owing to its broad industry knowledge, experience in healthcare regulations, and an extensive understanding of compliance regimes, Trilegal is a market leader in this sector and offers legal expertise in regulatory, corporate, commercial, disputes and intellectual property matters. Trilegal helps clients navigate clinical trials, product development, manufacturing, labelling, marketing, product liability, and investigations and anti-bribery issues in the sector. Trilegal’s expertise also extends to M&A transactions in the sector.
Some of our clients in this space include –
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