admin / 17th September, 2021

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

Regulation/Guidelines

Medical Device,

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Summary:

The Drugs Controller General (India) has listed a new classification of medical devices pertaining to anaesthesiology based on the device’s intended use and risk and other parameters.

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 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
Bronchoscope	Intravascular oximeter
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
Bronchial cannula
Laryngeal airway
Medicine chamber spacer
Oropharyngeal airway

Table 1: List of Medical Devices included in Risk Class A and B

Risk class C	Risk Class D
Anaesthesia machine	Electronic epidural space locator control unit
Anaesthesia vaporizer	Spinal 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:

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.

Summary:

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.