Country Information:
India is one of the world’s most populous countries, with approximately 1.4 billion people. India’s healthcare system is a mix of public and private sectors, with a growing focus on improving healthcare access and quality.
Medical Devices Market Size:
India’s medical device market was valued at approximately USD 11 billion in 2023, with a robust growth trajectory. The market is growing due to rising healthcare needs, a shift towards preventive healthcare, and an increasing demand for diagnostic and imaging devices. The market is heavily reliant on imports, especially for high-end medical technologies.
Future Growth Potential:
The Indian medical device market is expected to grow at a CAGR of 10−12% over the next five years. Key growth drivers include:
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A large population with growing healthcare needs.
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Increased healthcare infrastructure investment.
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Government policies like «Make in India» promoting local manufacturing.
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Rising prevalence of chronic diseases and aging population.
Registration Process:
Medical device registration in India is regulated by the Central Drugs Standard Control Organization (CDSCO). The registration process involves:
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Classification: Devices are categorized into four classes (A, B, C, D) based on risk, with Class A requiring the least documentation.
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Required Documentation: Technical file, clinical trial data (for high-risk devices), manufacturing licenses, and GMP certification.
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Testing and Clinical Trials: Testing may be required for certain device categories, especially those that involve novel technology or high-risk features.
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Approval Timeline: Registration typically takes 6 to 12 months, depending on the complexity and class of the device.
Other Information:
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India presents a strong opportunity due to its large population and increasing demand for healthcare services.
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Manufacturers should be aware of regulatory changes, including the adoption of international standards and the new Medical Devices Rules 2017
India (CDSCO Registration Process) Flowchart:
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Classify Device
→ Class A, B, C, D -
Appoint Authorized Agent/Distributor
→ Required for foreign manufacturers -
Prepare Documentation
→ Technical file, clinical trial data (if needed), manufacturing licenses -
Submit Application to CDSCO
→ Submit through the online portal or through the agent -
Testing (if applicable)
→ Clinical trials, GMP compliance -
Approval by CDSCO
→ Issuance of Import License