Senior Regulatory Affairs Executive
4 Years of Experience Medical device regulatory professional specializing in EU MDR 2017/745
Opportunities in Medical Device Manufacturing
The medical device manufacturing industry in India is in its nascent stage. The medical device industry encompasses everything from patient monitoring to pain management. As the pandemic hits us, industry is facing so many challenges at the global level in terms of disruption in the manufacturing sector. Certain products, like oximeters or temperature monitoring measures, were not in much demand previously, but suddenly there was an increase in demand. Eventually, medical device manufacturers got the opportunity. To boost production and encourage our manufacturers, governments are also taking initiatives like the Medical Device Park and launching schemes like PLI.
The vision of Atmanirbhar- Bharat “means self-reliant India is to that, India should produce the product not just for the Indian market but for the world. The advantages with these are like, it will create awareness that we are self- reliant and we can fulfill the market demand. Many industrialists have taken these initiatives positively and they started investing in the medical device manufacturing and we are assisting them as Turnkey project consultant for their regulatory and manufacturing requirement.
The Make in India move is helpful for the local manufacturer as it focuses on strengthening the economy through its own production. As the new disease and the pandemic continued to bob around, the demand for new equipment and quality-oriented monitoring systems increased. Presently, medical device manufacturers have significant growth opportunities. The government of India is putting efforts into research and development and 100% FDI for medical devices to boost the market. India is the land of many innovative and technically adapted entrepreneurs, which makes India a destination of choice for medical devices. Bringing innovative medical devices to meet the needs of the hour is the biggest challenge for the Indian medical device manufacturing industry. Technological dependency and dependency on international companies for medical devices and the hassles of importing them are the other challenges in the sector.
These challenges can be turned into opportunities for the betterment of the healthcare sector. The local manufacturing of these devices itself is a big opportunity to make qualitative diagnoses. The right combination of entrepreneurs and advanced technology can bring world-class healthcare and diagnostic facilities to citizens. The self-assessment devices witness heavy growth during a pandemic. Devices like home glucose testing equipment, blood pressure monitors, oximeters, etc. are the potential growth sector. The pandemic situation brought importance to immunization. Many manufacturers consulted with us for the syringe manufacturing unit, as we are medical device regulatory consultants and provide regulatory guidance to the medical device manufacturer. Medical device manufacturers need to be aware of updated regulations, and for that, we have launched the regulatory newsletter, which sheds light on regulatory changes.
Senior Regulatory Affairs Executive | 4 Years of Experience
Medical device regulatory professional specializing in EU MDR 2017/745 technical documentation, CE marking, risk management, clinical and biological evaluation, and post-market surveillance. His expertise includes SFDA MDMA submissions, CDSCO licensing, ISO 13485, MDSAP, US FDA regulatory requirements, and BIS certification.
