Last Updated on January 9, 2024 by The Health Master
The Drug Controller General India (DCGI) has issued a notice classifying 133 medical devices from general hospital and orthopaedic instruments under the provisions of Medical Devices Rules, 2017, vide DCGI notice dt 23-02-2022 regarding Classification of Medical Devices Pertaining to General Hospital.
The decision comes as the latest in the drug regulator’s efforts to classify the medical devices sold in the country based on the perceived risk of the product type and its use in patients.
The measure is to help the authority to bring in all the medical devices under the regulatory control, according to experts.
According to the regulator, around 86 devices, among others, are classified as Class A medical devices, including:
- Bed exit monitor (fall prevention),
- Stand-on patient scale,
- Clinical color change thermometer,
- Apgar timer,
- Hydraulic and manual adjustable hospital bed,
- Non powered flotation therapy mattress,
- Therapeutic medical binder,
- Burn sheet,
- Neonatal eye pad,
- Nipple shield,
- Lamb feeding nipple,
- Suction snake bite kit,
- Therapeutic scrotal support,
- Cardiopulmonary resuscitation board,
- Medical insole,
- Medical examination light,
- Skin pressure protectors,
- Body waste receptacle,
- Washers for body waste receptacles,
- Hand-carried and manual wheeled stretchers,
- Liquid crystal vein locator,
- Blood bank centrifuge.
Another around 38 medical devices, among others, are classified as Class B medical devices, including:
- Liquid crystal forehead temperature strip,
- Spinal fluid manometer,
- Electrically powered spinal fluid pressure monitor,
- Sterilisation process indicator,
- Paediatric medicare crib,
- Medical bassinet,
- Pressure infusion for an I.V bag,
- Intravascular administration set,
- Automated air removal system,
- Patient care reverse isolation chamber,
- Jet lovage,
- Electrically powered patient lift,
- Ultrasonic cleaner for medical instruments,
- Remote medication management system,
- Ultraviolet radiation environmental disinfection device,
- Vacuum-powered body fluid suction apparatus,
- Sterilisation wrap,
- Motorised wheeled stretcher.
Further, 8 medical devices are classified as Class C medical devices, including:
- Electronic monitor for gravity flow infusion systems,
- Ingestible event marker,
- Ultraviolet radiation chamber disinfection device,
- Ethylene oxide gas steriliser,
- Dry-heat steriliser,
- Steam steriliser,
- Liquid chemical sterilants or high level disinfectants
- Hydrogen peroxide gas plasma sterilisation system.
The only medical device in the list under Class D is the chemical cold pack snakebite kit.
The risk associated with the Class A is perceived to be low, while B has low to moderate risk, C has moderate to high risk and D has the 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 and 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 from January 1, 2018.
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