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.
|Risk class A||Risk class B|
|Aerosol delivery tubing||Aerosol face mask|
|Airway device cleaning utensil||Aerosol inhalation monitor|
|Airway pressure alarm||Airway pressure/oxygen monitor|
|Airway protection face mask||Airway temperature monitoring system|
|Airway tube forceps||Anaesthesia breathing circuit|
|Anaesthesia catheter Luer connector||Anaesthesia depth monitor|
|Anaesthesia depth simulator||Anaesthesia workstation gas scavenger|
|Anaesthesia instrument table||Anaesthetic gas absorption/desorption device|
|Anaesthesia mask stabilizer||Artificial airway washing/disinfection jar|
|Anaesthesia system leakage tester||Brachial plexus anaesthesia kit|
|Anaesthesia warmer||Breathing circuit gas-sampling/monitoring set|
|Anaesthetic gas scavenging terminal unit||Breathing circuit washer/disinfector|
|Anaesthesia Face mask||CPAP/BPAP nasal mask|
|Artificial airway stylet||CPAP/BPAP oral mask|
|Atomizer||Electronic oesophageal stethoscope|
|Breathing circuit bag||Helium/oxygen breathing gas mixer|
|Breathing circuit condenser||Inhalation analgesia unit|
|Breathing circuit dryer||Intracardiac oximeter|
|Breathing mouthpiece||Intravascular blood gas/pH monitoring system|
|Capnography oxygen mask||Invasive arterial pressure cardiac output/oximetry monitor|
|Capnography sampling adapter||Laryngectomy tube|
|Endobronchial airway sizing kit||Laryngotracheal anaesthesia applicator|
|In-line arterial blood sampling set||Microbial medical gas filter|
|In-line backflow valve||Neonatal chest precursor|
|Intubation laryngoscope||Nitric oxide delivery unit|
|Intubation teeth protector||Non-heated respiratory humidifier|
|Laryngeal airway introducer||Oxygen/air breathing gas mixer|
|Mechanical positive pressure airway secretion-clearing device||Pleural manometer|
|Medical gas flowmeter||Pneumatic chest precursor|
|Medical gas flowmeter, Thorpe tube||Pressure algometer/aesthesiometer|
|Medical gas pipeline system||Pulse Co-oximeter|
|Medical gas pipeline system automatic outlet analyser||Respiration monitor|
|Medical gas pipeline system pressure monitor||Respiration oxygen monitor|
|Medical gas terminal unit||Respiration oxygen therapy monitor/regulator|
|Nerve-block injection manometer||Saddle block anaesthesia kit|
|Non-rebreathing oxygen face mask||Ultrasonic respiratory humidifier|
|Nose clip||Vacuum-assisted airway secretion-clearing system|
|Oxygen administration hood||Venturi oxygen face mask|
|Oxygen saturation/pulse rate simulator||Venturi oxygen face mask|
|Rebreathing oxygen face mask||Bulk oxygen concentration system|
|Rigid non-bladed video intubation laryngoscope||Endotracheal secretion monitoring system|
|Spirometer/pulmonary function analyser syringe||Nasopharyngeal airway|
|Tracheal surgery dilator||Peak flow meter|
|Tracheotome||Pulmonary function analysis system|
|Ultrasonic cough simulation system||Retrograde endotracheal intubation kit|
|Medicine chamber spacer|
|Risk class C||Risk Class D|
|Anaesthesia machine||Electronic epidural space locator control unit|
|Anaesthesia vaporizer||Spinal needle bioimpedance navigation unit|
|Carbon dioxide monitor|
|Intravascular membrane oxygenator|
|Manual jet ventilation|
|Patient physiologic monitoring system|
|Epidural anesthesia kit|
|Oxygen/air/nitrous oxide breathing gas mixer|
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:
- Intended use.
- Risk factors.
- 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.
- The Drugs Controller General (India) has listed a new classification of medical devices pertaining to Anesthesiology from July 12, 2021.
- The classification is based on the device’s intended use, risk, and other parameters listed in the First Schedule.
- This classification may be revised from time to time.
- Classification of medical devices pertaining to Anesthesiology under the provisions of Medical Devices Rules, 2017-Reg. Accessed on Aug 8, 2021.