Medical Device Approval in India with Regulatory Expertise



India’s medical device market is one of the fastest growing in the world, According to Invest India, India’s medical device market valued at around USD 11 billion in 2022–23, is projected to reach USD 50 billion by 2030, growing at a CAGR of approximately 16.4% [Report]. As global manufacturers and startups set their sights on this high-potential market, regulatory compliance becomes the pivotal differentiator between accelerated market entry and lengthy delays.

But navigating India’s regulatory framework overseen by the Central Drugs Standard Control Organization (CDSCO) requires more than just documentation. It demands strategic expertise, local intelligence, and proactive lifecycle management. Here’s how partnering with seasoned regulatory experts can fast-track your approvals, mitigate risk, and position your product for long-term success.

Understanding the Indian Regulatory Landscape for Medical Devices

India regulates medical devices under the Medical Device Rules (MDR), 2017, governed by CDSCO under the Ministry of Health and Family Welfare. As of October 1, 2023, nearly all medical devices are notified and regulated as drugs under the Drugs and Cosmetics Act, a move that signals tighter scrutiny, increased documentation, and mandatory licensing.

Key Regulatory Components For Medical Device Approvals in India:

  • Classification-based Requirements: Devices are categorized into Class A (low risk) to Class D (high risk), aligned with GHTF principles.
  • Import Licenses (Form MD-15) and Manufacturing Licenses (Form MD-5/MD-9)
  • Notified Bodies approval for Class A/B devices
  • Clinical Investigation or Performance Evaluation Reports (PER) for Class C/D devices
  • Post-market Surveillance, PMSRs, and Adverse Event Reporting
  • QMS (ISO 13485:2016) compliance is mandatory

For foreign manufacturers, appointing an Indian Authorized Agent (IAA) is a legal prerequisite to interact with CDSCO and carry out device registrations.

How to Register a Medical Device in Egypt: Regulatory Pathways with the EDA

Read more here: Achieve Faster Medical Device Approval in India with Regulatory Expertise — DDReg pharma

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