FDI In Medical Devices Sector— Procedure, Fees And Documents Required

100% FDI (Foreign Direct Investment) is allowed under FDI in the medical devices sector through automatic route.

Many documents are required for FDI in the medical devices sector which are as follows:

• List of names, addresses, and identification proof of all foreign collaborators of the investor company/entity
• From both investor/investee entities- Certification of Incorporation and MoA
• Copy of joint venture agreement/ shareholders agreement/technology
• Copy of downstream intimation
• Copy of relevant past FIPB/SIA/RBI joint with the current proposal
• Copy of Downstream Intimation
• An affidavit to ensure all documents are relevant
• Valuation certification approved by a certified chartered accountant
• CS Certificate
• Declaration by the Authorized Representative of the Indian Company/LLP
• Pre and post-shareholding pattern in the Indian company
• Copy of the order of the High Court on the scheme of merger/ demerger/ amalgamation (if applicable)
• RBI approval on the amount of refund concerning the amount of the issue (if applicable)
• Valuation certificate
• Approval letter (if non-compliant with the guidelines – if applicable)
• Relevant RBI approvals for an issue of equity shares against funds payable to the foreign investor
• FIRC/ Debit statement
• Know Your Customer (KYC)

Following are the key advantages for investors in India who invests in medical devices services:

1. Increasing Demand - The rising population in India gives the chance to raise demand for medical facilities and thus promotes the Indian Medical devices requirement in the country. Various government schemes nurtured the direct process of foreign investment in India in a less expensive way. It is being anticipated to reach over US$ 50 Bn by 2030 in the medical sector.
2. Increasing Investment - This sector has successfully attracted foreign capital to 98% YoY in the year 2020 at the worth of ₹2196 Cr. as against ₹1,108 Cr. in FY 2019. Hindustan Syringes & Medical Devices Ltd, accomplished another breakthrough of supplying 1.75 billion syringes of the total 13.3 billion COVID-19 vaccines administered globally. Wipro GE Healthcare proclaimed that it had collaborated with medical device maker Boston Scientific to offer a comprehensive, cutting-edge cardiac interventional care method in India.
3. Opportunities In Export - The goal for bilateral commerce between Russia and India is $30 billion USD by 2025. An extra US$ 5 billion in trade is anticipated annually, including prospects in chemicals, minerals, steel, medicines, and medical devices.
4. Policy Support - To guarantee and provide comprehensive legal safeguards to ensure that the medical products marketed in India are dependable, effective, and meet necessary requirements, the government introduced a draft of the new Drugs, Medical Devices, and Cosmetics Bill 2022 in July 2022.

Following are the benefits of FDI in medical devices which are as follows:

1. Healthcare diversification options - Establish the restorative approach towards healthcare units in building the better formulation of manifolds of Indian healthcare therapies, practices, and products.
2. Skill development and shaping capacity - FDI in the healthcare sector instills the elevation of skills by ensuring healthcare training and development research. This stimulates attention in healthcare professionals sectors and research in the natural medications sector.
3. Promoting global expansion - The marketing of traditional Indian approaches in the healthcare sector can promote product competition across global rivalry and create multiple phenomena for economic growth and employment opportunities for both local people and foreign investors.
4. Advent of technology - The strengthened healthcare education can generate knowledge within the human force, and the possibility of venting up innovation along with technology footprints can also be adopted in order to boost the effectiveness of medical products and practices.
5. Modernization and infrastructural development - Accessing high-quality medical products can directly affect the modernization input and shape infrastructural development in the country's quality control measures, healthcare institutions, and manufacturing segments.

FDI in the medical devices sector in India is the going up sector worldwide offering a diverse range of products at lower cost rates. The medical facility and services have evolved continuously in India by not only benefiting the economy to generate higher employment and revenue creation but also serve new offerings to add lifespan in human lives to achieve more dreams true.

For making one’s lifespan long, and to reduce ineffective productivity in the economy, the nation should achieve its first and foremost milestone in the health of the citizen. There are various other schemes, reforms and initiatives which continuously monitor to enhance the performance of the medical startup revolution in India.

Several other factors to consider for investors while investing in medical industries are listed below:

• Before involving huge investments, applicants must be prerequisites to check the kind of companies the government allows them to invest in. Because investment in the stock market is volatile and may not recover your loss, leading to unwriggled investment which will not recover at the time of redemption of company loss.
• Additionally, before application applicants need to inspect and ensure that all the requisite documents are submitted online without discovering any omissions and incorrect information within the documents. FDI is largely inspired to bring investors forth along with certain advantages that benefit sectors.