DCGI Enlists New Regulation For The Classification Of Medical Devices Pertaining To Anesthesiology

The Drugs and Cosmetics Act, 1940, and Rules regulate the safety, quality, and performance of all medical devices. The Central Government has notified Medical Devices Rules, 2017 vide G.S.R. 78E dated January 31, 2017, to regulate the import, manufacture, clinical investigation, sale, and distribution of medical devices.

DCGI enlists new classification for Medical Devices pertaining to Anesthesia

The Drugs Controller General (India) (DCGI), Directorate General of Health Services, has classified medical devices pertaining to anaesthesiology. DCGI implemented this classification on July 12, 2021.

Classification of medical device

Under the provisions of Medical Devices Rules, 2017, the medical devices are classified into four risk classes, i.e., Risk Class A, B, C, and D. Tables 1 and 2 give the list of all medical devices and their classification pertaining to Anaesthesiology.

Factors associated with the classification of medical devices

As per the sub-rule (3) of rule 4 of Medical Devices Rules, 2017, the DCGI has classified the Medical Devices based on the following factors:

1. Intended use.
2. Risk factors.
3. Other parameters as per the First Schedule of Drugs and Cosmetics Ace, 1940.

The classification is subjected to changes.

As per the provisions of Medical Devices Rules, 2017, this classification of medical devices pertaining to Anesthesiology can revise from time to time.

Summary:

1. The Drugs Controller General (India) has listed a new classification of medical devices pertaining to Anesthesiology from July 12, 2021.
2. The classification is based on the device’s intended use, risk, and other parameters listed in the First Schedule.
3. This classification may be revised from time to time.

References

1. Classification of medical devices pertaining to Anesthesiology under the provisions of Medical Devices Rules, 2017-Reg. Accessed on Aug 8, 2021.