Download the classification of medical devices dated 09-09-2022, link is given below: The Central Drugs Standard Control Organisation (CDSCO) has issued a notice classifying the non-sterile, non-powered, hand-held, or hand-manipulated surgical instruments for general use intended to be used in various general surgical procedures based on the risk associated with them.
This is part of the drug regulator’s efforts to classify medical devices under the Medical Devices Rules, 2017, based on the intended use, the risk associated with the device, and other parameters specified in the first schedule of the Rules.
“Non-Sterile and Invasive Surgical Instruments’ are commonly intended for surgical use in cutting, drilling, sawing, scratching, scraping, clamping, retracting, clipping, or similar procedures without a connection to an active device and are intended by the manufacturer to be used after appropriate procedures such as cleaning, disinfection, and sterilization have been carried out,” defines the notice.
The notice lists four types of medical devices and their intended use, classifying all of them based on the risks associated with Class A.
Cutting and dissecting surgical instruments, which are transient use invasive surgical instruments, usually have short edges or tips to cut through skin, tissue, and suture material and are intended to cut and dissect tissue to explore irregular growths and to remove dangerous or damaged tissue, are one type of medical device classified under Class A.
These instruments are also used for cutting sutures.
Devices for transient use mean a device intended for continuous use for less than sixty minutes.
An invasive device, according to the notice, means a device that, in whole or part, penetrates inside the body, either through a body orifice or through the surface of the body.
The second type is clamping and occluding surgical instruments, which are transient-use invasive surgical instruments, intended for use in many surgical procedures for compressing blood vessels or hollow organs in order to prevent their contents from leaking or control bleeding or occlude.
These devices, which are classified as Class A, are designed straight, curved or angled, or ratcheted and have a variety of inner jaw patterns.
The third type that falls into Class A is the retracting and exposing surgical instruments, which are transient-use invasive surgical instruments, intended to hold back or retract access to the operative area during a surgical procedure.
They spread open the skin, ribs, and other tissues; and are also used to separate the edges of a surgical incision.
The fourth type is grasping and holding surgical instruments, which are transient-use invasive surgical instruments intended to grasp and hold tissues or blood vessels that may be in the way during a surgical procedure, designed to be serrated or non-serrated at the tip.
These are also classified as Class A medical devices, through the notice.
The risk associated with Class A is perceived to be low, while B has low to moderate risk, C has moderate to high risk, and D has a high risk, according to the widely accepted classification criteria.
The safety, quality, and performance of medical devices are regulated under the provisions of the Drugs and Cosmetics Act, 1940, and rules for the regulation of medical devices for imports, manufacture, clinical investigation, sale, and distribution. The Central Government has notified the Medical Devices Rules, 2017, which commenced on January 1, 2018.
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