Medical devices are essential for effective and safe diagnosis, treatment, rehabilitation, and prevention of illness and diseases. The achievement of healthcare goals depends upon proper manufacturing, planning, assessment, regulation, acquisition, management, and use of medical devices that are of the best quality and compatible with particular settings in which these are used. The involvement of market entry strategy firms helps medical devices-oriented businesses and investors to contribute to making the world healthier at a lower price.

Growth Prospects for Medical Device Industry in India:

India is ranked among the top 20 international medical device markets; it is the 4^th largest market (Medical Device Industry in India) in Asia after China, South Korea, and Japan. At present, India has almost 800 medical device manufacturers with an average investment of Rs 200 million at an average turnover of Rs 500 million. The Medical Device Industry in India is of USD 5.2 Billion worth; still, it is growing at 15.8% CAGR. According to present trends, the Indian medical devices industry is expected to be USD 50 billion worth by 2025. At present, the medical device industry in India contributes just 4-5% to USD 96.7 billion worth Indian healthcare industry leaving many areas still untapped. Indian medical devices marketplace offers enormous growth opportunities not only because of the market size but also because of supporting policies and regulations recently introduced by the Indian Government.

According to Deloitte report, Medical Device Industry in India has a growth rate is around 15 %; it is more than the double of the global medical device industry growth rate.

Government’s Support for Medical Device Industry:

• The key strategic changes are introduced to ‘the regulatory framework for ‘medical devices in 2017’ with the intention to make it at par with the latest international norms.
• The concept of ‘risk-based’ regulation is introduced.
• The regulatory licenses for import, manufacturing and sale of medical devices are made perpetual to reduce unnecessary time-consuming, paperwork.
• Foreign direct investment (FDI) for the medical device manufacturing sector is allowed without any pre-approval.
• The processes are simplified to encourage the investors to infuse capital in strategic time-sensitive acquisitions.
• Within the couple of years, Indian Govt. has introduced number of measures to support research & development projects, manufacturing units and importers of medical devices.
• The intellectual property rights regime is strengthened by changing the rules for patent and trademark grant.

Role of Healthcare Consulting Firm For Medical Devices Businesses in India:

The well noticed active presence of top healthcare consulting firms in India confirms that the never before supporting conditions are inviting investors for medical devices business in India. Like in any other country, the new businesses also face some challenges in setting up medical devices business in India.

The import constitutes almost 75% sales of medical devices in

You might be having years’ experience in medical devices industry but the regular change in working conditions, demographics and regulations makes the hiring of a specialist consulting firm imperative. The healthcare consultancy firm plays key roles to help you move ahead passing one milestone than the other on the strategically structured roadmap:

• Drug, Medical Device & Cosmetic Registration with Drug Authority of India
• Identification & Selection of Partner (s) for CRAMS, Distribution, Clinical Trials & others
• In and Out-Licensing of Products
• Setting up R&D labs in India
• Market research to formulate Indian market entry strategy
• Acquisitions
• Performance improvement by conducting trainings
• Project management for set up
• Sourcing of API’s, formulations & intermediates
• Connecting decision makers & influencers
• Competitive assessment to ensure long-term growth

The involvement of a market entry specialist agency helps you in all the key domains like – Regulatory Affairs; Quality Management; Risk Management; Device Vigilance; Track & Trace Technologies; Combination of Medical Devices; Unique Medical Device Identification; Complaint Handling; Continual Training & Development.

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Seven Things You Must Know To Plan Medical Devices Business In India:

1. Registration Certificates last for 5 years
2. Application fees are higher than ever before
3. Not all the medical devices need clinical investigation
4. Medical devices new to the Indian market are subjected to special regulations
5. Medical devices approved for import, sale and distribution in India must essentially have device identifier and production identifier by 2022.
6. Foreign medical devices manufacturing sites are subjected to inspection by India’s Central Licensing Authority.
7. The old 10-medical devices list has been replaced by the four classes to categorize all the medical devices to be sold in India

Concluding Note:

Indian government has made several encouraging and inviting changes in regulations for the foreign and Indian investors interested in medical devices business; but, the stiff global competition, ever-changing marketing scenario, changing trade regulations, changing buyers’ expectations etc put some challenges across to medical device industry. The partnership with a top healthcare consulting firm with proven experience and expertise in formulating Indian market entry strategy puts aside all the hurdles making the roadmap for sustainable growth rate safe and smooth.

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