Navigating India’s CDSCO Rules for Rheumatology Device Compliance
Introduction – Rheumatology Equipment Classification in India
This article discusses the latest rules for Rheumatology equipment classification in India as a Medical Device under the Medical Device Rules 2017 in India. Indian healthcare regulators at the Central Drugs Standard Control Organization (CDSCO) have issued a substantial risk-based classification for all Rheumatology Products. All Rheumatology Products need to be registered to comply with the Medical Device Rules 2017 as per the Updated CDSCO medical device rules in India.
India is Updating Existing Risk-Based Classifications for Medical Devices
On January 6th, 2025, the Central Drugs Standard Control Organization (CDSCO) published a draft annexure revisiting the existing classification lists under notification number MED-16014(12)/1/2022-eoffice. There are no changes in the Rheumatology equipment classification in India as outlined in the previous notifications.
Table: CDSCO Rheumatology Equipments Classification
Below is a table that helps manufacturers classify their products and apply with the Indian Health Ministry accordingly.
S.No | Device name as per Medical Device Rules 2017 in India | Intended Use | Risk Based Classification |
1 | Back Brace | Back Brace Provides with Strong Support to lower back and waist, Stabilize and Support your Shoulders, Chest and back with this posture correction brace. | I |
2 | Canes | Canes may help seniors and elderly people with types of arthritis like patellofemoral or other knee, hip and even hand arthritis. | I |
3 | Lateral Wedge insoles | Intended for treatment of pain in patients with medical knee Osteoarthritis | I |
4 | Grab bars in Showers and tubes | The horizontal bars on the walls are used to get in and out of the tub. The vertical bar on the wall containing the controls serves as a support for the user to turn the water on and | I |
5 | Shoe Insert | A medical Insole is a device intended for medical purposes that is placed inside a shoe to relieve the symptoms of athlete’s foot infection by absorbing moisture | I |
6 | Reachers | Reacher will allows arthritis Suffers to pick up or extend their reach to retrieve items otherwise not possible | I |
7 | Orthopaedic Pillow | Designed to correct body positioning in bed or while lying on any other surface | I |
8 | Orthopaedic Shoes | Orthopaedic Shoes protect the toes,feet,and ankles from injuries such as crushing of the toes,twisting of the ankles and torn muscles in the legs. | I |
9 | Stairway Chair Lift | Intended to take persons up the staircase with the ease of usability | I |
10 | Toilet Frames | Intended to help the patients with rheumatoid. Osteoarthritis ,Elderly arthritis, seniors with arthritis.Raised toilet seats can help to minimize the problem | I |
11 | Bottle and Jar Openers | Intended for people ,who has arthritic hands of fingers,opening jars and bottles is often difficult and painful | I |
Conclusion: Medical Device Compliance in India for Rheumatology Equipments
The CDSCO has classified the Rheumatology devices as per the medical device registration in India based on the intended use, risks associated, and other parameters specified with the device. The table above outlines the general intended use for each device. Manufacturers must specify any unique intended uses for their products. Adhering to the Medical Device Rules 2017 in India is important for fulfilling regulatory obligations for medical device classification in India. For similar technical frameworks, you can also find the related risk classification for Pain Management and Physical Support here.
To obtain MDR in India, contact Morulaa. We at Morulaa will help you understand the latest rules for Rheumatology as a Medical Device in India. We are a turnkey solution provider with an in-house Medical Device Consultancy team to conduct medical device registration in India. To comply with the regulations, contact us at [email protected]. Visit our website to learn more about the latest rules and Updated CDSCO medical device rules in India.
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