Regulation/Guidelines

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

  • 17th September, 2021
DCGI enlists new regulation for the classification of Medical Devices pertaining to Anaesthesiology

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 ARisk class B
Aerosol delivery tubingAerosol face mask
Airway device cleaning utensilAerosol inhalation monitor
Airway pressure alarmAirway pressure/oxygen monitor
Airway protection face maskAirway temperature monitoring system
Airway tube forcepsAnaesthesia breathing circuit
Anaesthesia catheter Luer connectorAnaesthesia depth monitor
Anaesthesia depth simulatorAnaesthesia workstation gas scavenger
Anaesthesia instrument tableAnaesthetic gas absorption/desorption device
Anaesthesia mask stabilizerArtificial airway washing/disinfection jar
Anaesthesia system leakage testerBrachial plexus anaesthesia kit
Anaesthesia warmerBreathing circuit gas-sampling/monitoring set
Anaesthetic gas scavenging terminal unitBreathing circuit washer/disinfector
Anaesthesia Face maskCPAP/BPAP nasal mask
Artificial airway styletCPAP/BPAP oral mask
AtomizerElectronic oesophageal stethoscope
Breathing circuit bagHelium/oxygen breathing gas mixer
Breathing circuit condenserInhalation analgesia unit
Breathing circuit dryerIntracardiac oximeter
Breathing mouthpieceIntravascular blood gas/pH monitoring system
BronchoscopeIntravascular oximeter
Capnography oxygen maskInvasive arterial pressure cardiac output/oximetry monitor
Capnography sampling adapterLaryngectomy tube
Endobronchial airway sizing kitLaryngotracheal anaesthesia applicator
In-line arterial blood sampling setMicrobial medical gas filter
In-line backflow valveNeonatal chest precursor
Intubation laryngoscopeNitric oxide delivery unit
Intubation teeth protectorNon-heated respiratory humidifier
Laryngeal airway introducerOxygen/air breathing gas mixer
Mechanical positive pressure airway secretion-clearing device Pleural manometer
Medical gas flowmeterPneumatic chest precursor
Medical gas flowmeter, Thorpe tubePressure algometer/aesthesiometer
Medical gas pipeline systemPulse Co-oximeter
Medical gas pipeline system automatic outlet analyserRespiration monitor
Medical gas pipeline system pressure monitorRespiration oxygen monitor
Medical gas terminal unitRespiration oxygen therapy monitor/regulator
Nerve-block injection manometerSaddle block anaesthesia kit
Non-rebreathing oxygen face maskUltrasonic respiratory humidifier
Nose clipVacuum-assisted airway secretion-clearing system
Oxygen administration hoodVenturi oxygen face mask
Oxygen saturation/pulse rate simulatorVenturi oxygen face mask
Rebreathing oxygen face maskBulk oxygen concentration system
Rigid non-bladed video intubation laryngoscopeEndotracheal secretion monitoring system
Spirometer/pulmonary function analyser syringeNasopharyngeal airway
Tracheal surgery dilatorPeak flow meter
TracheotomePulmonary function analysis system
Ultrasonic cough simulation systemRetrograde endotracheal intubation kit
Bronchial cannula
Laryngeal airway
Medicine chamber spacer
Oropharyngeal airway
Table 1: List of Medical Devices included in Risk Class A and B
Risk class CRisk Class D
Anaesthesia machineElectronic epidural space locator control unit
Anaesthesia vaporizerSpinal needle bioimpedance navigation unit
Carbon dioxide monitor
High-frequency ventilator
Intravascular membrane oxygenator
Manual jet ventilation
Negative-pressure ventilator
Patient physiologic monitoring system
Pulmonary resuscitator
Pulse oximeter
Bronchoscopy tube
Epidural anesthesia kit
Oxygen/air/nitrous oxide breathing gas mixer
Tracheostomy kit
Table 2: List of Medical Devices included in Risk Class C and D

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.