Registration routes in India
Medical approval process in India
The registration of medical devices in India has become mandatory, effective 1 October 2023. The registration applies to all new Class A (measuring or sterile), Class B, Class C, and Class D devices. Considering that registration before the application date of 1 October 2023 was voluntary, CDSCO allowed for an enforced transition until 1 October 2023.
Manufacturers are expected to provide comprehensive technical documentation, including clinical evidence, on their products. By utilizing similar technical documentation, manufacturers can benefit from their existing market approvals. However, compared to other countries, CDSCO India Medical Device Regulations focuses on predicate devices on the market, which will benefit the registration process.
Abridged routes to the Indian Market
Two types of registration pathways
Option 1: Predicate device and approval in a GHTF* country.
India recognizes certain countries’ regulatory approvals to decrease overall review timelines and complete a simplified assessment process. The FDA follows a faster assessment pathway for devices approved under the scope of a CE mark than those without. Conformity to ISO 13485:2016 is a recognized quality management system in India.
Option 2: Predicate device and no approval in a GHTF country.
The Special Expert Committee (SEC) will execute the technical assessment process. The review lead times depend on the type of device and associated risk class. The device falls under an ‘Investigational Medical Device.’ The SEC focuses on the requirements for clinical evidence and the performance of the devices remaining unchanged in the Indian population.
GO-TO-MARKET STRATEGY AND REGISTRATION SUPPORT
Do you need assistance with your strategy with the India Medical Device Regulations?
Qserve is your trusted partner for market access in India.
Contact us
Expand your knowledge
On-demand webinar
The free webinar series on Medical Device Registration will cover interesting topics on how to enter the Asia-Pacific (APAC) and Latin-American (LATAM) markets and how to meet regulatory compliance. Learn more about the regulatory framework in India, Australia, New Zealand, and Malaysia, presented by our regulatory affairs associates.
Webinar
Regulatory timelines and fees
How long does it take to enter
the Indian medical device market?
Class A (non-sterile and non-measuring) devices are immediately approved. For higher-risk classes (Notified devices), depending on the approach, the turnaround time is 6-9 months* or 18+ months (in case of no predicate device, clinical trials are required for approval).
Explore your journey
Understanding the regulations
Making informed choices
Understanding the pros and cons of the various pathways for market access in India is essential to making informed choices. To understand the most feasible and cost effective approach to enter the Indian market, Qserve can help you in determining your regulatory roadmap.
Free introductory call