CDSCO Medical Device Classification

CDSCO Medical Device Risk Classification Guide

This index provides a comprehensive classification of medical devices according to the Medical Devices Rules, 2017. Use the table below to navigate through the specific therapeutic categories and understand their respective risk assignments (Class A to D).

Name

Description

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Rehabilitation

Devices used to restore or improve physical functions and mobility.

View Rehabilitation Device Risk Classes

Dental

Instruments and equipment designed for oral healthcare and surgery.

View Dental Device Risk Classes

Operation Theater

Critical equipment used in surgical environments for patient safety.

View Operation Theatre Equipment Risk Classes

Urology

Equipment for treating disorders of the urinary tract and kidneys.

View Urology Device Risk Classes

Personal Protective Equipment

Medical grade gear designed to protect against infectious agents.

View Personal Protective Equipment Risk Classes

Dermatology

Devices used for skin care, aesthetics, and plastic surgery.

View Dermatology and Plastic Surgery Device Risk Classes

Physical Support

Products like braces and slings providing structural body stability.

View Physical Support Product Risk Classes

Gastroenterology

Tools for diagnosing and treating digestive system disorders.

View Gastroenterology Device Risk Classes

Oncology

High precision equipment for cancer diagnosis and radiation therapy.

View Oncology Equipment Risk Classes

Respiratory

Devices ranging from simple masks to advanced ICU ventilators.

View Respiratory Equipment Risk Classes

Neurology

Equipment and instruments used for diagnosing and treating disorders of the nervous system.

View Neurology Device Risk Classes

Radiotherapy

Specialized machines and accessories for delivering targeted radiation treatments.

View Radiotherapy Equipment Risk Classes

Software As Medical Device

Standalone software applications intended for medical diagnosis, treatment, or patient monitoring.

View Software as a Medical Device Classification

Class A (Self Notified)

Low risk medical devices requiring self certification rather than prior regulatory approval.

View Class A Self Notified Device Requirements

Ophthalmology

Instruments and devices designed for eye care, vision correction, and ocular surgery.

View Ophthalmology Device Risk Classes

ENT

Diagnostic and surgical tools specifically for ear, nose, and throat conditions.

View ENT Device Risk Classes

Cardiovascular

Critical equipment for diagnosing, monitoring, and treating heart and blood vessel conditions.

View Cardiovascular Device Risk Classes

Obstetrical And Gynecological

Devices and instruments used for female reproductive health, pregnancy, and childbirth.

View Obstetrical and Gynecological Device Risk Classes

Pain Management

Equipment such as stimulators and infusion pumps designed to alleviate acute and chronic pain.

View Pain Management Device Risk Classes

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Morulaa supports medical device and IVD manufacturers with global registration, technical documentation, quality management and post market compliance. Through our regulatory specialists and local partners, we provide coordinated support across key international markets.

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Global Regulatory Support, Built Around Your Device

Morulaa supports medical device and IVD manufacturers with global registration, technical documentation, quality management and post market compliance. Through our regulatory specialists and local partners, we provide coordinated support across key international markets.

© Morulaa HealthTech Pvt Ltd. All Rights Reserved.

Global Regulatory Support, Built Around Your Device

Morulaa supports medical device and IVD manufacturers with global registration, technical documentation, quality management and post market compliance. Through our regulatory specialists and local partners, we provide coordinated support across key international markets.

© Morulaa HealthTech Pvt Ltd. All Rights Reserved.

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