Medical Device Grouping: Simplifying Regulation for Enhanced Efficiency

In the intricate realm of medical devices, robust regulations stand as sentinels of patient safety and product efficacy. Recognizing the imperative to streamline the licensing process, the Indian Government introduced the concept of “medical device grouping” under the Medical Device Rule, 2017 (MDR 2017). This innovation aims to expedite the licensing procedure, rendering it more cost-effective. This blog elucidates the essence of medical device grouping and delves into the categories outlined by the Ministry of Health and Family Welfare (MoHFW) in their guidelines of March 16, 2018, supplemented by illuminating Frequently Asked Questions (FAQs).

What is Medical Device Grouping?

Medical device grouping entails classifying devices based on shared purposes or technology. This empowers applicants to seek a single license for devices with akin uses or common technology, thus streamlining the licensing process while optimizing costs. The primary motive is to enhance efficiency without compromising safety.

Types of Medical Device Grouping:

MoHFW’s guidelines lay out a systematic approach to categorize devices for licensing. Here are the categories and their implications:

1. Single

This pertains to distinct packaged devices that don’t fit other grouping categories. Each such device necessitates a separate fee and documentation. For instance, a sole blood pressure monitoring machine qualifies as a single grouping.

2. Family

Devices under the same license holder, sharing risk classification, intended use, and design, can be grouped, considering permissible variations. A unified fee covers the entire group. For example, contact lenses with additional UV protection can form a family grouping.

3. System

This involves devices from the same license holder designed to work together for a common purpose. Components shared across systems require inclusion in each relevant application. The fee structure varies based on distribution. For instance, a hip replacement system could comprise femoral and acetabular components, constituting a system grouping.

4. Group Grouping

Here, devices are sold together in a single package by the same license holder for a common purpose. Devices may differ in names, intended use, and manufacturers. A single fee applies (determined by the highest risk class), with documentation required for each device. A first aid kit with diverse medical devices exemplifies a group grouping.

Conclusion:

Medical device grouping marks a stride by MoHFW to enhance the licensing process. Beyond its procedural ease, the concept drives cost-effectiveness for applicants. Regulatory Solutions India provides expertise on medical device grouping and the broader regulatory landscape.

FAQs:

1. What is medical device grouping?

Medical device grouping categorizes devices based on shared purposes or technology, enabling a single license application for similar devices, streamlining and cost-effectiveness.

2. How are medical devices grouped?

Devices can be grouped as “Single,” “Family,” “System,” or “Group,” each with specific criteria.

3. What is the difference between a Family and a Group?

A family grouping unites devices under the same license holder with shared risk classification and design. A group grouping entails diverse devices united for a common purpose.

4. How can medical device grouping benefit manufacturers?

Medical device grouping simplifies licensing, reducing costs and preparation time for importers and manufacturers.