We assist some of the largest manufacturers of medical devices navigate regulatory complexities in India.
Medical Devices
India’s regulation of medical devices is marked by a combination of the pragmatic with the formulaic, making complying with medical devices regulations particularly challenging. Forged by a deep understanding of global regulations and business practices, our medical devices focus group has the capability to advise you on the law on the regulatory bent of mind and market practices.
Working seamlessly alongside our technology, data protection, intellectual property and M&A lawyers, our healthcare team has advised on many of the most complicated matters that haunt medical device manufacturers and distributors in India.
Work Highlights
Advised an AI/ML-powered telesurgery solutions provider on whether its product constitutes 'software as a medical device' under Indian laws on personal data protection that are applicable to its operations in India, and on import/export restrictions with respect to its expansion into India.
Advised a certified medical device manufacturer and the manufacturer of India’s first USFDA-approved hemostat, on regulatory licences, intellectual property law issues, government procurement contracts, employment law-related issues, and several commercial contracts.
Assisted a B2B health-tech platform on the patentability of its cardiac risk assessment solution – a portable ECG machine that would capture and transmit information through cloud to a remote doctor for real-time analysis at home.
Assisted a leading manufacturer of biopharma equipment and IVF medical devices on multiple trademark applications in India and in establishing distribution chains across the country.
Assisted Asia’s leading manufacturer of laboratory and biopharma equipment in restructuring its business, exiting a joint venture and protecting intellectual property.
Assisted a medical devices giant with a private equity fund raise of USD 200-Million.
Key Experts –
Mathew
Chacko
Chacko
Praveen
Raju
Raju
Aadya
Misra
Misra
Renuka
Abraham
Abraham
Shambhavi
Mishra
Mishra
