The regulatory landscape for medical device registration in India has undergone significant evolution, particularly following the Central Drugs Standard Control Organization (CDSCO)’s update in 2020. Initially, registration was mandatory for just 37 invasive devices. This scope expanded through a voluntary registration phase, ending on October 1, 2021, and transitioned into mandatory registration of medical devices in phases, concluding in October 2023. For manufacturers and suppliers, understanding the CDSCO’s Indian medical device regulation is not just beneficial — it’s essential. It helps determine applicable fees, documentation requirements, and form effective market entry strategies. The CDSCO employs a structured grouping mechanism that simplifies the medical device regulatory requirements in India and streamlines the process through the SUGAM portal and MD-14 guidelines.
Single Grouping:
Intended for individual devices marketed independently, Single Grouping applies to unique products that require specific licensing and documentation, regardless of packaging variations. A prime example includes condoms sold in different package sizes. Devices originally part of a group or system, if marketed separately, must undergo medical device registration under the MD-14 standards and through the SUGAM portal.
Family Grouping:
This category is ideal for devices that share similar characteristics and are managed by the same license holder. Devices in a Family Grouping must meet these criteria:
- Similar physical design and materials
- Comparable manufacturing processes
- Uniform intended use
- Matching risk classification
Examples include different types of gloves (powdered and powder-free), defibrillators (automatic and semi-automatic), and cardiac catheters. This category benefits from a single registration fee and a unified Device Master File (DMF), easing compliance under Indian medical device regulation via the SUGAM portal.
System Grouping:
System Grouping covers devices intended to work together under a proprietary system, like hip replacement kits. If components are marketed separately, each part must have distinct documentation and fees, even though they function together. This grouping is critical for medical device registration consultants in India to help manufacturers ensure compliance with CDSCO’s MD-14 framework.
Group:
The Group category includes different medical devices from various manufacturers bundled for a shared purpose — e.g., first aid kits. This classification uses a combined fee structure but requires individual documentation for each component. The SUGAM portal facilitates submissions in line with MD-14 guidelines.
Conclusion:
Understanding CDSCO’s medical device grouping system — Single, Family, System, and Group — is critical for navigating medical device regulatory requirements in India. These categories define documentation and fee requirements and influence your medical device registration strategy. Partnering with a medical device registration consultant in India like Morulaa helps streamline compliance and facilitate market entry. Morulaa’s team offers expert guidance in grouping, documentation, and SUGAM submissions, ensuring full alignment with Indian medical device regulation. Contact Morulaa at [email protected] to assess how your products should be grouped and registered.