CDSCO Medical Device Grouping Structure in India

All medical devices being imported into India need to be registered with the government body called the Central Drugs Standard Control Organization (CDSCO) and manufactures undergoing this registration process needs to be aware of India’s medical device grouping.  

In the complex landscape of medical device regulations in India, it is crucial for manufacturers and suppliers to understand the CDSCO grouping structure for medical devices. Each grouping has its own set of rules regarding fees and documentation, which impacts compliance and market strategy. 

CDSCO categorizes medical devices into four distinct groupings:

1. Single Grouping

2. Family Grouping

3. System Grouping

4. Group

This article gives a brief overview of each category, providing clarity and guidance for navigating these regulations. 

Understanding India Medical Device Grouping by CDSCO

1. Single grouping

The ‘Single’ category is designated for individual medical devices sold as distinct packaged entities. These devices do not qualify for other groupings like Family, IVD Test Kit, System, or Group. They require separate licensing and documentation and can include devices that are in a range of packaging sizes. This category includes products like condoms in various package sizes. Take the following scenario: 

A company assembles and licenses multiple medical devices as a kit/group but also chooses to sell each medical device in that kit/group separately. Under CDSCO rules, each medical device that is to be supplied individually must be licensed. For example: items from a first aid kit previously sold as a ‘kit’ are now planned for sale as distinct individual items. Taking this approach requires each item to have its own license under CDSCO rules the key takeaway is that to ensure regulatory compliance, each device needs to be classified on its own and have its own license for which specific fees and documentation are required. 

2. Family Grouping

Family grouping encompasses devices from the same registration or license holder that share characteristics like risk classification, intended use, design, and manufacturing process. The variations within a family must be within the scope of permissible variants. The characteristics of a medical device may be considered as a permissible variant if: 

• • the physical design and material of construction are the same or very similar 
  • the manufacturing processes are the same or very similar 
  • the intended purpose is the same 
  • the risk profile is the same 

Family grouping offers the advantage of a single fee for the entire family and a common Device Master File (DMF), simplifying the registration process. 

3. System Grouping

System grouping is for products intended to be used in combination to fulfill a specific purpose, sold under a single proprietary name. This grouping can include a hip replacement system with femoral and acetabular components or a glucose monitoring system comprising a meter, test strips, and solutions. Licensing and documentation requirements vary depending on whether these systems are sold as a single unit pack or as individual components. What is important to note is that if the system contains individual components which are sold separately then separate documentation and fees for each of these components must be done when applying for the CDSCO license.

4. Group

The Group category is a collection of two or more medical devices from different manufacturers, supplied in a single packaged unit for a common intended use. Each device in the group may have different proprietary names and intended purposes. An example is a first aid kit containing various medical devices like bandages and thermometers, assembled for a common medical purpose. This grouping requires a single fee and specific documentation for each device within the group. 

This table provides a visual representation on each grouping regarding criteria, fees and documents:

Medical Device Grouping by CDSCO with MedEnvoy

Understanding CDSCO’s medical device groupings is essential for navigating the regulatory landscape in India. Each category – Single, Family, System, and Group – has specific implications for fees and documentation. This grouping not only ensures regulatory compliance but also influences strategic decisions for manufacturers and suppliers in the medical device industry. By mastering these groupings, businesses can effectively manage their products’ lifecycle from development to market. 

MedEnvoy’s regulatory experts can help manufacturers in staying compliant with the latest requirements including assistance in how to group your products as per Indian Requirements. If you need additional help in making sure that  you are staying compliant don’t hesitate to contact us.

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