Introduction

All medical devices imported into India must be registered with the Central Drugs Standard Control Organization (CDSCO). Initially, only 37 types of invasive medical devices required registration. However, in 2020, the CDSCO revised the regulations, mandating that all other medical device manufacturers complete “voluntary” registration by October 1, 2021. Subsequently, compulsory registration was required in a phased manner, concluding in October 2023. Navigating the regulatory environment for medical devices in India involves understanding the CDSCO’s categorization structure, which is crucial for compliance and strategic market entry. CDSCO categorizes medical devices into four groups: Single, Family, System, and Group. This article provides an overview of each category, offering insights to help manufacturers and suppliers comply with these regulations effectively.

1. Single Grouping

The ‘Single’ category applies to individual medical devices sold in separate packages. These devices are not eligible for other groupings such as Family, IVD Test Kit, System, or Group. Each item in this category requires its own licensing and documentation, regardless of the packaging size. This includes products like condoms in different package sizes.

If a company assembles a kit or group of medical devices and later decides to sell each item separately, each item must be individually licensed. For instance, if items from a first aid kit are to be sold both as a kit and individually, each item needs separate licenses and documentation. The essential point is that each product requires distinct licensing and documentation to ensure regulatory compliance.

2. Family Grouping

Family grouping covers devices under the same registration or license holder that share similar characteristics like risk classification ,intended use, material of construction and design. The variations within a family must adhere to permissible variants. A medical device qualifies as a permissible variant if:

Family grouping advantages include a single fee for the entire group and the use of a common Device Master File (DMF), which simplifies the registration process.

Examples of devices in this category include defibrillators (automatic or semi-automatic), dental brackets with different materials, gloves (powdered or powder-free), and cardiac catheters available in various lumens, lengths, and diameters.

3. System Grouping

System grouping pertains to products designed to work together for a specific purpose and sold under a single proprietary name. Examples include a hip replacement system with femoral and acetabular parts or a glucose monitoring system with a meter, test strips, and solutions. Licensing and documentation requirements differ based on whether these systems are sold as a single unit pack or as individual components. If individual components are sold separately, each component requires its own documentation and fees when applying for the CDSCO license.

4. Group

The Group category comprises multiple medical devices from different manufacturers, packaged together for a common intended use. Each device within the group may have distinct proprietary names and purposes. For example, a first aid kit may include various medical items like bandages and thermometers, all assembled for a common medical purpose. This category requires a single fee but mandates specific documentation for each device within the group.

Below is a table that provides examples of medical devices for each CDSCO grouping category, This is only an indicative representation and for accurate grouping please contact Morulaa Team to reconfirm updated data:

Conclusion

Understanding the CDSCO’s medical device groupings is crucial for navigating India’s regulatory landscape. Each category—Single, Family, System, and Group—has specific requirements for fees and documentation. These groupings not only ensure regulatory compliance but also impact strategic decisions for manufacturers and suppliers in the medical device industry. By using these groupings, businesses can efficiently manage their products from development to market.

In India, the registration process on the SUGAM portal is a critical step for medical device manufacturers. The MD-14 form is one of the essential documents required for registration. Morulaa assists manufacturers in correctly filling out and submitting the MD-14 form, ensuring all regulatory requirements are met. With expertise in CDSCO regulations and the SUGAM portal, Morulaa supports manufacturers and importers in navigating India’s medical device registration process efficiently. By partnering with Morulaa, manufacturers can ensure compliance with CDSCO regulations, streamline the registration process, and achieve successful market entry in India.