Navigating CDSCO's Medical Device Grouping Structure in India
All medical devices imported must undergo medical device registration in India with the Central Drugs Standard Control Organization (CDSCO) by an India Authorized Importer. Initially, only 37 types of invasive medical devices required registration in India. However, in 2020, the CDSCO revised the regulations, mandating that all other medical device manufacturers complete “voluntary” registration by October 1, 2021. Subsequently, Indian Authorities have required compulsory registration in a phased manner, concluding in October 2023. Navigating the regulatory environment for medical devices involves understanding the CDSCO’s categorization structure in India, which is crucial for compliance and strategic market entry. In India medical devices are categorized 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 grouping by CDSCO regulations effectively.
The Medical Device Rules, 2017, provide the regulatory framework under which the CDSCO operates, outlining the medical device registration in India requirements for various categories. Keeping abreast of these regulatory changes and updates is crucial for successful market access and compliance in India. Moreover, understanding the approval time and ensuring notified regulations are met can streamline the process.
CDSCO Registration Requirements and India Medical Device Grouping Structure
Medical Device Grouping Categories
The ‘Single’ category applies to individual medical devices sold in separate packages according to grouping by CDSCO regulations. These devices are not eligible for other groupings such as Family, IVD Test Kit, System, or Group. Each product requires distinct licensing, fees and documentation to ensure regulatory compliance., 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, fees and documentation to ensure regulatory compliance.
To maintain Single Grouping regulatory requirements under the Medical Device Rules, 2017 in India, contact us at Morulaa to understand how we can assist manufacturers determine devices which are considered as Single and impact the costing of applying for the registration process.
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 it meets these criteria.
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.
Keeping track of regulatory updates and ensuring compliance with India’s medical device registration and Medical Device Rules, 2017, is essential for market access. Morulaa’s expertise in this area can help streamline the process, ensuring all necessary regulations are met.
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 fees and documentation when applying for the CDSCO license.
Under the regulatory requirements of Medical Device Rules, 2017, System Grouping is the most complex to define in India. Challenges when a system contain individual sellable components: ex. Spinal Implant System having rods, screws, plates etc – CDSCO in India asks for separate fees for each. Morulaa can guide manufacturers through this grouping process in the registration, ensuring all regulatory and documentation requirements are met.
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.
When using this category, it is important to understand how the individual items within the common packaging is regulated under the Medical Device Rules, 2017. Morulaa, being an India authorized importer, provides guidelines to ensure compliance with CDSCO regulations and facilitate market access.
Examples of CDSCO Medical Device Grouping Structure in India
Below is a table that provides examples of medical devices for each CDSCO grouping category under the India Classification medical device framework. This is only an indicative representation; for accurate grouping by CDSCO, please contact the Morulaa team to reconfirm updated data:
Understanding the nuances of each grouping category and ensuring compliance with regulatory updates, including those outlined in the Medical Device Rules, 2017, is crucial for successful market access in India. Morulaa offers comprehensive support to navigate the CDSCO’s classification and registration process effectively.
| Single | Family | System | Group |
|---|---|---|---|
| Condoms (various package sizes) | Condoms (different colors, sizes, textures) | Hip replacement system (femoral and acetabular components) | First aid kit (bandages, gauzes, drapes, thermometers) |
| Blood Pressure Monitors | IV administrative sets (varying features like safety wings, tubing lengths) | Glucose monitoring system (meter, test strips, control solutions) | Emergency medical kits (syringes, scalpels, dressings) |
| Thermometers (digital, mercury) | Steerable guidewires (various lengths, tip shapes) | Catheter placement kit (scalpels, syringes, needles, gloves) | Surgical kits (various surgical tools, supplies) |
| Bandages (sold separately from kits) | Cardiac catheters (different lumens, lengths, diameters) | Orthopedic implant systems (various compatible implants) | Wound care kits (dressings, ointments, cleaning solutions) |
| Surgical Gloves (powdered, powder-free) | Dental brackets (different materials) | Dialysis kits (dialyzers, tubing, needles) | IV start kits (catheters, antiseptic wipes, gloves) |
Understanding the CDSCO’s India medical device groupings, along with the India Classification medical device framework, is crucial for navigating the 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.
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, as an India authorized importer, supports manufacturers 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.