Challenges & Opportunities for Medical Device Manufacturers in India
The Indian medical device industry is expanding quickly because of the increased medical requirements, state programs such as “Make in India”, and the rise in demand for low-cost solutions. India has one of the largest emerging markets in the world, with industry reports suggesting that the medical device market will hit USD 50 billion by 2030. Although this potential is huge, medical device manufacturers in India still encounter numerous challenges, including stringent regulatory conditions, high costs of production, and modern technology.
Most companies are addressing these difficulties by outsourcing medical device contract manufacturing in India and partnering with established OEMs such as Cubit Medisurge to be more effective, compliant, and fast-track the market development. In order to overcome these challenges, nowadays numerous companies resort to Medical Device Contract Manufacturing in India, and this practice will enable them to concentrate on design, research and market expansion, and outsource manufacturing to special partners.
Regulatory Hurdles
Regulatory compliance is one of the most challenging.
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One of the initiatives by the Indian government is the Medical Device Rules (2017), which categorizes devices and imposes severe criteria on safety and quality.
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Lack of standardization between Indian and international standards increases the cost of compliance.
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Smaller manufacturing players cannot afford the investment in regulatory expertise.
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These rules are strengths to patient safety, but bottlenecks in product releases and global expansion are their side effects.
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Long approval procedures by CDSCO (Central Drugs Standard Control Organization).
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Conflict of Indian rules and overseas standards (FDA, CE, ISO).
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Policies are changing every minute, and manufacturers have to keep up.
These rules are strengths to patient safety, but bottlenecks in product releases and global expansion are their side effects. The companies that are involved in Medical Device Contract Manufacturing in India should also make sure that the contract partners adhere to the same standards, and compliance is a community effort involving a number of facilities.
Import/Export Issues
India imports more than 70 % of its premium medical equipment. This reliance on imports increases the manufacturing cost and competitiveness.
Major Import/Export issues:
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High-importation duties on essential raw materials.
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Difficult customs clearance regulations.
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Low availability of local suppliers of specialized components.
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Foreign exchange impacts on the prices of exports.
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Complying with worldwide export requirements.
This presents a challenging business climate to the domestic manufacturers who have to cut costs and expand internationally.
Quality of Standards in Healthcare Equipment Manufacturers in India
Quality is life-saving in the healthcare sector. Healthcare equipment manufacturers in India have to face a challenge that is also a necessity to meet the high-quality standards.
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The devices should be in conformity with ISO, CE, and WHO-GMP.
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It requires high levels of R&D investment in order to be accurate and reliable.
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Frequent tests and validation raise the cost of production.
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Hospitals and clinics require quality that is internationally competitive at a low cost.
The global standards of quality are a factor that makes companies fail to match the best medical device companies in India and other parts of the world.
Cubit Medisurge Comparative Note: Cubit Medisurge VS Other players
Most of the leading medical device companies in India put more attention on export, thus leaving a void in the affordability of solutions to local markets. Cubit Medisurge differs by:
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Striking the balance between the costs of production and global compliance.
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Providing products that cater to the needs of both the Indian and international hospitals.
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Forming healthy relationships with local health providers.
Such a balance gives Cubit Medisurge an opportunity to compete with the leaders of the industry without losing a specific place in the market.
How Cubit Medisurge Overcomes These Challenges
At Cubit Medisurge, a reputable medical equipment manufacturer in India.
We approach those challenges with innovation and commitment:
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Strict Compliance -The products are in compliance with ISO, CE, and Indian regulations.
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Quality First- A series of quality inspections will provide reliability and safety.
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Less Import Dependency -Domestic R&D and sourcing.
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International Presence - Certifications established in accordance with international standards in exports.
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Customer-Centric Approach - Providing safe, cost-effective, and effective devices.
Opportunities of Indian Medical Device Manufacturers
Nevertheless, medical device manufacturers in India have a bright future. Emerging growth opportunities are being offered by increased demand, state subsidies, and international collaborations.
By 2030, the medical device market in India is set to hit USD 50 billion
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Government Push to Localization: PLI Scheme (Production-Linked Incentives) is one of the initiatives that favor local manufacture.
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Rising Healthcare Demand: Healthcare in India is becoming older, and more hospitals are being constructed, which is leading to a rise in demand for cheap devices.
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Medical Tourism Development: India is a medical tourism destination and a global destination that provides low-cost healthcare services, which have escalated the number of devices sought.
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Export Opportunities: Indian medical devices are affordable and the developing African, Middle East, and Asian markets are willing to take them.
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Technological Advancement: AI, IoT-based systems, and digital health solutions are offering emerging business opportunities.
The Growing Scope of Medical Device Contract Manufacturing in India
Over the last few years, Medical Device Contract Manufacturing in India has become a viable option to numerous OEMs struggling with high costs of production, numerous compliance requirements, and inadequate infrastructure. Outsourcing of manufacturing to specialized plants allows companies to concentrate on innovation and marketing and provides uniform quality and scalability. Nevertheless, there are also some issues associated with contract manufacturing, including the maintenance of the high quality of product, intellectual property protection, and compliance with CE, ISO, and GMP regulations. Despite these challenges, the increasing ecosystem of certified contract manufacturers and advanced medical technology parks in India is propelling the country to become a global medical device production and export hub.
The Indian medical device industry is in a dynamic trend, but to emerge successfully, it must overcome the regulatory, quality, and market-related problems. Although compliance and relying on imports are challenges that many companies are not coping with, Cubit Medisurge is demonstrating that with the right innovation, quality, and customer confidence, the issue can also be turned into an opportunity.
Cubit Medisurge, being one of the credible and future-oriented medical device manufacturers in India, is determined to do its part in ensuring that better healthcare is achieved, in addition to making sure that India becomes a global hub of medical devices.
FAQs
Due to the strict international certifications (such as FDA and CE), and inconsistency with Indian regulations, several companies find it difficult to comply with export standards.
Important in quality and compliance are ISO 13485, CE Mark, and BIS certifications.
The government is offering subsidies and infrastructural support to manufacturers through several schemes such as the PLI Scheme, Make in India, and Medical Device Parks, among others.
Yes, as domestic production increases and the levels of R&D investments rise, the levels of import dependency will decrease from 75% in 2020 to approximately 40% in 2030.
Cubit Medisurge integrates quality that is both world-class yet affordable, global certifications, and a customer-first approach.