DCGI classifies over 100 medical devices linked to Radiology, Plastic Surgery, Details

S.No.

Medical Device

Name

Intended Use

Risk

Class

1

Scintillation (gamma) camera

A scintillation (gamma) camera is a device intended to image the distribution of radionuclides in the body by means of a photon radiation detector.

A

2

Positron camera

A positron camera is a device intended to image the distribution of positron-emitting radionuclides in the body.

A

3

Nuclear whole body counter

A nuclear whole body counter is a device intended to measure the amount of radionuclides in the entire body.

A

4

Bone densitometer

A bone densitometer is a device intended for medical purposes to measure bone density and mineral content by x-ray or gamma ray transmission measurements through the bone and adjacent tissues.

C

5

Bone sonometer

A bone sonometer is a device that transmits ultrasound energy into the

human body to measure acoustic properties of bone that indicate overall bone health and fracture risk.

B

6

Emission computed tomography system.

An emission computed tomography system is a device intended to detect the location and distribution of gamma ray- and positron-emitting radionuclides in the body and produce cross-sectional images through computer reconstruction of the data

C

7

Fluorescent scanner

A fluorescent scanner is a device intended to measure the induced fluorescent radiation in the body by exposing the body to certain x-rays or low-energy gamma rays.

C

8

Nuclear rectilinear scanner

A nuclear rectilinear scanner is a device intended to image the distribution of radionuclides in the body by means of a detector (or detectors) whose position moves in two directions with respect to the patient.

A

9

Nuclear tomography system

A nuclear tomography system is a device intended to detect nuclear radiation in the body and produce images of a specific cross-sectional plane of the body by blurring or eliminating detail from other planes.

C

10

Nuclear uptake probe

A nuclear uptake probe is a device intended to measure the amount of radionuclide taken up by a particular organ or body region

A

11

Nuclear whole body scanner

A nuclear whole body scanner is a device intended to measure and image the distribution of radionuclides in the body by means of a wide- aperture detector whose position moves in one direction with respect to the patient.

A

12

Nuclear scanning bed

A nuclear scanning bed is an adjustable bed intended to support a patient during a nuclear medicine procedure.

A

13

Radionuclide dose calibrator

A radionuclide dose calibrator is a radiation detection device intended to assay radionuclides before their administration to patients

B

14

Radionuclide rebreathing system

A radionuclide rebreathing system is a device intended to be used to contain a gaseous or volatile radionuclide or a radionuclide-labeled aerosol and permit it to be respired by the patient during nuclear medicine ventilatory tests (testing process of exchange between the lungs and the atmosphere).

C

15

Nuclear sealed calibration source

A nuclear sealed calibration source is a device that consists of an encapsulated reference radionuclide intended for calibration of medical nuclear radiation detectors.

A

16

Nuclear electrocardiogra ph synchronizer

A nuclear electrocardiograph synchronizer is a device intended for use in nuclear radiology to relate the time of image formation to the cardiac cycle during the production of dynamic cardiac images

A

17

Nonfetal ultrasonic monitor

A nonfetal ultrasonic monitor is a device that projects a continuous high frequency sound wave into body tissue other than a fetus to determine frequency changes (doppler shift) in the reflected wave and is intended for use in the investigation of nonfetal blood flow and other nonfetal body tissues in motion

B

18

Ultrasonic pulsed doppler imaging system

An ultrasonic pulsed doppler imaging system is a device that combines the features of continuous wave doppler-effect technology with pulsed-echo effect technology and is intended to determine stationary body tissue characteristics, such as depth or location of tissue interfaces or dynamic tissue characteristics such as velocity of blood or tissue motion.

B

19

Ultrasonic pulsed echo imaging system

An ultrasonic pulsed echo imaging system is a device intended to project a pulsed sound beam into body tissue to determine the depth or location of the tissue interfaces and to measure the duration of an acoustic pulse from the transmitter to the tissue interface and back to the receiver.

B

20

Diagnostic ultrasonic transducer

A diagnostic ultrasonic transducer is a device made of a piezoelectric material that converts electrical signals into acoustic signals and acoustic signals into electrical signals and intended for use in diagnostic ultrasonic medical devices.

B

21

Angiographic x- ray system

An angiographic x-ray system is a device intended for radiologic visualization of the heart, blood vessels, or lymphatic system during or after injection of a contrast medium.

C

22

Diagnostic x-ray beam-limiting device

A diagnostic x-ray beam-limiting device is a device such as a collimator, a cone, or an aperture intended to restrict the dimensions of a diagnostic x-ray field by limiting the size of the primary x-ray beam

C

23

Cine or spot fluorographic x- ray camera

A cine or spot fluorographic x-ray camera is a device intended to photograph diagnostic images produced by x-rays with an image intensifier

C

24

Electrostatic x- ray imaging system

An electrostatic x-ray imaging system is a device intended for medical purposes that uses an electrostatic field across a semiconductive plate, a gas-filled chamber, or other similar device to convert a pattern of x- radiation into an electrostatic image and, subsequently, into a visible image.

C

25

Radiographic film marking system

A radiographic film marking system is a device intended for medical purposes to add identification and other information onto radiographic film by means of exposure to visible light.

A

26

Image- intensified fluoroscopic x- ray system

An image-intensified fluoroscopic x-ray system is a device intended to visualize anatomical structures by converting a pattern of x-radiation into a visible image through electronic amplification.

C

27

Non-image- intensified fluoroscopic x- ray system

A non-image-intensified fluoroscopic x-ray system is a device intended to be used to visualize anatomical structures by using a fluorescent screen to convert a pattern of x-radiation into a visible image.

C

28

Spot-film device

A spot-film device is an electromechanical component of a fluoroscopic x-ray system that is intended to be used for medical purposes to position a radiographic film cassette to obtain radiographs during fluoroscopy

B

29

Diagnostic x-ray high voltage generator

A diagnostic x-ray high voltage generator is a device that is intended to supply and control the electrical energy applied to a diagnostic x-ray tube for medical purposes.

A

30

Mammographic x-ray system

A mammographic x-ray system is a device intended to be used to produce radiographs of the breast

C

31

Photofluorographic x-ray system

A photofluorographic x-ray system is a device that includes a fluoroscopic x-ray unit and a camera intended to be used to produce, then photograph, a fluoroscopic image of the body

C

32

Diagnostic x-ray tube housing assembly.

A diagnostic x-ray tube housing assembly is an x-ray generating tube encased in a radiation-shielded housing that is intended for diagnostic purposes.

A

33

Diagnostic x-ray tube mount

A diagnostic x-ray tube mount is a device intended to support and to position the diagnostic x-ray tube housing assembly for a medical radiographic procedure.

A

34

Pneumoencephalographic chair

A pneumoencephalographic chair is a chair intended to support and position a patient during pneumoencephalography (x-ray imaging of the brain).

B

35

Radiologic patient cradle

A radiologic patient cradle is a support device intended to be used for rotational positioning about the longitudinal axis of a patient during radiologic procedures.

A

36

Radiographic film

Radiographic film is a device that consists of a thin sheet of radiotransparent material coated on one or both sides with a photographic emulsion intended to record images during diagnostic radiologic procedures.

A

37

Radiographic film cassette

A radiographic film cassette is a device intended for use during diagnostic x-ray procedures to hold a radiographic film in close contact with an x-ray intensifying screen and to provide a light-proof enclosure for direct exposure of radiographic film

B

38

Radiographic film/cassette changer

A radiographic film/cassette changer is a device intended to be used during a radiologic procedure to move a radiographic film or cassette between x-ray exposures and to position it during the exposure.

B

39

Radiographic film/cassette changer

programmer

A radiographic film/cassette changer programmer is a device intended to be used to control the operations of a film or cassette changer during serial medical radiography.

B

40

Wall-mounted radiographic cassette holder

A wall-mounted radiographic cassette holder is a device that is a support intended to hold and position radiographic cassettes for a radiographic exposure for medical use

A

41

Radiographic film illuminator

A radiographic film illuminator is a device containing a visible light source covered with a translucent front that is intended to be used to view medical radiographs

A

42

Automatic radiographic film processor

An automatic radiographic film processor is a device intended to be used to develop, fix, wash, and dry automatically and continuously film exposed for medical purposes.

C

43

Radiographic grid

A radiographic grid is a device that consists of alternating radiolucent and radiopaque strips intended to be placed between the patient and the image receptor to reduce the amount of scattered radiation reaching the image receptor

A

44

Radiographic head holder

A radiographic head holder is a device intended to position the patient's head during a radiographic procedure.

A

45

Radiologic quality assurance instrument

A radiologic quality assurance instrument is a device intended for medical purposes to measure a physical characteristic associated with another radiologic device.

A

46

Radiographic intensifying screen

A radiographic intensifying screen is a device that is a thin radiolucent sheet coated with a luminescent material that transforms incident x-ray photons into visible light and intended for medical purposes to expose radiographic film.

A

47

Radiographic ECG/respirator synchronizer

A radiographic ECG/respirator synchronizer is a device intended to be used to coordinate an x-ray film exposure with the signal from an electrocardiograph (ECG) or respirator at a predetermined phase of the cardiac or respiratory cycle.

A

48

Radiologic table

A radiologic table is a device intended for medical purposes to support a patient during radiologic procedures. The table may be fixed or tilting and may be electrically powered.

A

49

Transilluminator for breast evaluation

A transilluminator, also known as a diaphanoscope or lightscanner, is an electrically powered device that uses low intensity emissions of visible light and near-infrared radiation (approximately 700-1050 nanometers (nm)), transmitted through the breast, to visualize translucent tissue for the diagnosis of cancer, other conditions, diseases, or abnormalities.

D

50

Medical image storage device

A medical image storage device is a device that provides electronic storage and retrieval functions for medical images. Examples include devices employing magnetic and optical discs, magnetic tape, and digital memory.

A

51

Radiological computer- assisted diagnostic software for lesions suspicious of cancer

A radiological computer-assisted diagnostic software for lesions suspicious of cancer is an image processing prescription device intended to aid in the characterization of lesions as suspicious for cancer identified on acquired medical images such as magnetic resonance, mammography, radiography, or computed tomography. The device characterizes lesions based on features or information extracted from the images and provides information about the lesion(s) to the user.

C

52

Medical image analyzer

Medical image analyzers, including computer-assisted/aided detection (CADe) devices for mammography breast cancer, ultrasound breast lesions, radiograph lung nodules, and radiograph dental caries detection, is a prescription device that is intended to identify, mark, highlight, or in any other manner direct the clinicians' attention to portions of a radiology image that may reveal abnormalities during interpretation of patient radiology images by the clinicians. This device incorporates pattern recognition and data analysis capabilities and operates on previously acquired medical images. This device is not intended to replace the review by a qualified radiologist, and is not intended to be used for triage, or to recommend diagnosis.

B

53

Radiological computer aided triage and notification software

Radiological computer aided triage and notification software is an image processing prescription device intended to aid in prioritization and triage of radiological medical images. The device notifies a designated list of clinicians of the availability of time sensitive radiological medical images for review based on computer aided image analysis of those images performed by the device.

C

54

Full-body MRI system, permanent magnet

A general-purpose magnetic resonance imaging (MRI) system designed to scan any targeted area of the body. It includes a permanent magnet assembly.

C

55

Full-body MRI system, resistive magnet

A diagnostic general-purpose magnetic resonance imaging (MRI) system designed to scan any targeted area of the body (full-body imaging). It includes a resistive magnet assembly.

C

56

Full-body MRI system, superconducting magnet

A diagnostic general-purpose magnetic resonance imaging (MRI) system designed to scan any targeted area of the body (full-body imaging). This system includes a superconducting magnet assembly.

C

57

Foetal cardiac monitor

A mains electricity (AC-powered) device designed to detect, measure, and display foetal heart activity during the perinatal period.

C

58

Foetal Doppler system

A portable, hand-held, battery-powered device assembly consisting of a measuring and display unit and an attached probe or interchangeable probes designed to noninvasively detect foetal heart beats using ultrasound/Doppler technology. The heart beats are typically conveyed audibly via the measuring/display unit and attached probe which is applied to the surface of the pregnant woman's abdomen. The device aids in determining foetal viability.

C

59

Flexible ultrasound colonoscope

An endoscope with a flexible inserted portion intended for the visual examination and treatment of the entire colon [lower gastrointestinal (GI) tract]. It is inserted through the anus during colonoscopy.

B

60

Flexible ultrasound duodenoscope

An endoscope with a flexible inserted portion, combined with an ultrasound probe, intended for the visual examination and treatment of the duodenum (the first part of the small intestine). It is inserted into the body through the mouth during duodenoscopy.

B

61

Flexible ultrasound gastroduodenos cope

An endoscope with a flexible inserted portion, combined with an ultrasound probe, intended for the visual examination and treatment of the upper gastrointestinal (GI) tract [oesophagus, stomach, and duodenum (the first part of the small intestine), including the pancreas and the bile duct]. It is inserted into the body through the mouth during gastroduodenoscopy.

B

62

Flexible ultrasound laparoscope

An endoscope with a flexible inserted portion, combined with an ultrasound probe, intended for the visual examination, treatment, and ultrasonic imaging of the abdominal/retroperitoneal cavity and its organs. It is inserted through an incision made in the abdominal wall (routinely just below the umbilicus) during laparoscopy.

B

63

Flexible ultrasound

bronchoscope

An endoscope with a flexible inserted portion intended for the visual examination and treatment of the trachea, bronchi, and lungs. It is inserted through the mouth or nose during bronchoscopy.

B

64

Bladder ultrasound imaging transducer

An ultrasound imaging transducer assembly specifically designed to be positioned within the bladder either manually or under endoscopic guidance that steers, focuses, and detects the ultrasound beam and resulting echoes either mechanically or electronically.

B

65

Blood flowmeter catheter, Doppler

A flexible tube intended to be inserted into the lumen of a blood vessel to determine blood-flow velocity by measuring the ultrasonic frequency shift between transmitted and reflected signals (Doppler principle).

C

66

General- purpose ultrasound imaging system

A stationary or mobile (e.g., on wheels) assembly of devices designed to collect, display, and analyse ultrasound images during a variety of extracorporeal and/or intracorporeal (endosonography or endoscopic) ultrasound imaging procedures (e.g., cardiac, OB/GYN, endoscopy, breast, prostate, vascular, and intra-surgical imaging).

B

S.No

Name of the Medical Device

Intended use

Classification India as per First Schedule part- 1 MDR 2017

1

Acupressure calf band

Intended to wear around the calf to apply pressure to an acupressure point to relieve low back pain, including sciatica and piriformis syndrome. A Non powered belt like device.

A

2

Arthritis TENS system

Intended to be used as adjunctive therapy in reducing the level of pain and stiffness associated with rheumatoid arthritis or osteoarthritis by electrically stimulating peripheral nerves across the skin (transcutaneous).

B

3

Back pulldown exerciser

Intended to strengthen the muscles of the back (especially the latissimus dorsi) through a repetitive pulldown motion performed with the arms against the force

of a weight.

A

4

Back row exerciser

intended to strengthen the muscles of the back through a repetitive rowing motion (as in rowing a boat with oars) performed with the arms against the force of a weight.

A

5

Back/leg/chest dynamometer, electronic

Powered device intended to assess neuromuscular function by measuring the force or power exerted by the back, chest,

and/or leg muscles during flexion.

B

6

Back/leg/chest dynamometer, mechanical

Non powered device intended to assess neuromuscular function by measuring the force or power exerted by the back, chest, and/or leg muscles during flexion.

A

7

Balance ball exerciser

Intended to be used as an unstable surface on which to perform exercise to

improve balance and posture.

A

8

Balance-training tongue electrical stimulation system

Intended to provide biofeedback for training of balance by sensing body movements and subsequently producing signals which are translated into electrical stimuli applied to the tongue, enabling a patient to correlate electrotactile stimulation with their head and body position during exercise sessions.

B

9

Bed/chair electric massager

Intended to provide therapeutic massage to the occupant of a bed or chair for the treatment of body aches and pains.

B

10

Bicycle ergometer

Intended to be used to provide a quantitative measurement of the rate at which work (energy) is performed by a muscle or group of muscles under controlled conditions.

A

11

Bladder-emptying vibratory stimulator

Intended to initiate urination and facilitate complete bladder emptying through application of small mechanical vibrations to the lower abdomen to promote urethral sphincter relaxation.

B

12

Blue/red/infrared phototherapy lamp

Intended to emit blue light, red light, and infrared radiation (heating effect) for phototherapy treatment of mild skin disorders (e.g., mild acne), superficial skin wounds, and musculoskeletal symptoms (e.g., pain, spasm, stiffness).

A

13

Body elastic exerciser

Intended to primarily strengthen several or all of the major muscle groups of the body (i.e., in the arms, legs, chest, back, and/or abdomen) through repetitive body motion against elastic resistance.

A

14

Body flywheel exerciser

Intended to strengthen several of the major muscle groups of the body (i.e., in the arms, legs, chest, back) through repetitive body motion against a flywheel.

A

15

Circulating-fluid thermal therapy system

Intended to be used to pump heated and/or cooled fluid (e.g., water) through externally applied packs for localized hot and/or cold therapy to help treat a variety of adverse conditions resulting from musculoskeletal injury (e.g., pain, swelling, inflammation).

B

16

Cold compression therapy cervical spine collar

Intended to facilitate, through cooling and compression, the treatment of a variety of conditions resulting from injury/surgery to the neck region (e.g., inflammation, stiffness, whiplash).

A

17

Cold/cool therapy gel

intended for localized topical skin application to provide a cooling effect for underlying muscles/joints to reduce pain

and swelling.

A

18

Cold-air therapy unit

Intended to reduce localized pain/inflammation, and/or to reduce thermal skin damage by applying cold stream of air during dermatological laser treatments.

B

19

Core-body mechanical weight exerciser

Intended to enable a patient with a lumbar spine injury to perform controlled extension, contraction, and/or twisting movements of the lumbar/thoracic spine back region and the abdomen, for testing

and rehabilitation.

A

20

Deep-tissue electromagnetic stimulation system

Intended to apply an electromagnetic (EM) field to body tissues to: 1) treat musculoskeletal disorders (e.g., osteoarthritis, osteoporosis); 2) treat body pain (musculoskeletal, postsurgical); and/or 3) help facilitate soft and hard tissue wound/injury healing, with no production of a therapeutic deep heat.

B

21

Electric massager

Intended for respiratory therapy or physiotherapy (e.g., help reduce muscular tension, arthritic pain or joint mobility) in the home and/or healthcare facility.

B

22

Electromechanical orthopaedic extracorporeal shock wave therapy system

Intended to provide electromechanical orthopaedic extracorporeal shock wave therapy (OEST) to treat musculoskeletal disorders.

C

23

Electronic goniometer/kinesiology sensor

Intended to evaluate a patient's range of motion/movement of individual joints/limbs/spine; it is used in a clinical setting typically before/after a medical/surgical intervention, or to assess degree of physical fitness.

B

24

Exothermic heat therapy pack

Intended to be applied to the body surface, sometimes with pressure, to provide heat therapy to reduce muscle spasms and cramps and/or for joint and muscle stiffness and pain.

A

25

Finger/hand exerciser

intended primarily to strengthen the muscles of the fingers and hands through repetitive finger/hand motion against resistance from elasticity or density.

A

26

Foot sensorimotor therapy mechanical neurostimulator

Intended to provide non-invasive peripheral neurostimulation to the feet for improving somatosensory integration, typically for reducing motor impairments and balance disturbances in patients with neurological or neurodegenerative

disorders (e.g., Parkinson's disease).

C

27

Gait analysis system

Intended to be used to study walking or running patterns.

A

28

Hand dynamometer/pinch meter, electronic

Electronic device intended to assess neuromuscular function by measuring the force or power exerted by the muscles of the hand/forearm to squeeze/pinch an object.

B

29

Hand dynamometer/pinch meter, mechanical

Mechanical device intended to assess neuromuscular function by measuring the force or power exerted by the muscles of

the hand/forearm to squeeze/pinch an object.

A

30

Hydrotherapy treadmill

Powered device intended for use in partially immersed in water, e.g., in a hydrotherapy tank, to provide additional resistance to the treadmill walking exercise without increasing the impact and/or stress

on the patient's joints.

A

31

Interferential electrical stimulation system

Intended to stimulate peripheral nerves through the transcutaneous application of two currents of slightly different frequencies that cross-over/interfere, producing a beating frequency at the

treatment point.

C

32

Manual goniometer

Non powered device intended to be used in a clinical setting to measure the range of motion of the limb of a patient by measuring the angle of movement achieved at the joint.

A

33

Medium-wave diathermy treatment system

Intended to produce a therapeutic deep heat within specific volumes of the body through the transcutaneous transmission of electromagnetic (EM) energy in the radio- frequency (RF) bands of 0.5 MHz to 1 MHz

B

34

Microwave diathermy treatment system

Intended to produce a therapeutic heat 1 to 2 cm below the skin within specific volumes of the body through the transcutaneous transmission of high frequency electromagnetic (EM) energy, typically 2,450 megahertz (MHz) [microwave], to promote tissue healing and pain relief.

B

35

Musculoskeletal infrared phototherapy unit,

Intended to provide a source of infrared (IR) heat for localized treatment of musculoskeletal pain/injury (e.g., muscle pain, sports injury, rheumatism) and to improve blood circulation in the treated

areas to facilitate healing.

B

36

Musculoskeletal intense therapeutic ultrasound system

Intended to produce and deliver intense therapeutic ultrasound (ITU) waves through the skin to create ablative lesions in subcutaneous soft tissues (e.g., muscles, tendons).

C

37

Musculoskeletal/ physical therapy laser

Intended to provide noninvasive laser therapy [e.g., infrared phototherapy, low- level laser therapy (LLLT)] for localized treatment of musculoskeletal conditions (e.g., muscle pain, sports injury, disorders of the joints and soft/connective tissues), improving blood circulation in the treated

areas to facilitate healing, or for non- needle acupuncture.

C

38

Parallel bar exerciser,

Intended to assist users in maintaining good walking posture, particularly a person with a disability, a paraplegic, or a patient who has suffered a stroke and is learning

to walk.

A

39

Physical therapy massager

Electrically powered device intended to provide therapeutic massage to a larger

area than hand-held massaging devices.

B

40

Physical therapy paraffin wax bath

Intended to be filled with liquid paraffin wax for physical therapy.

B

41

Physical therapy steam bath

Intended to apply hot steam as a physical therapy to a patient.

B

42

Pulsed signal therapy system

Intended to regenerate damaged cartilage, particularly by stimulating the production of collagen types that are present in healthy cartilage.

C

43

Short-wave diathermy treatment system

Intended to provide a therapeutic deep heat within specific volumes of the body through the transcutaneous transmission of electromagnetic (EM) energy in the radio- frequency (RF) bands of 13 MHz to 27.12 MHz

C

44

Standard treadmill, mechanical

Intended to facilitate in-place walking, jogging, or running to promote muscle redevelopment, to restore motion to joints, and to promote weight loss and cardiovascular fitness.

A

45

Standard treadmill, powered

Electrically powered unit intended to facilitate in-place walking, jogging, or running to promote muscle redevelopment, to restore motion to joints, and to promote weight loss and cardiovascular fitness.

A

46

Telemetric diagnostic spirometer

It is a Battery powered portable device Intended to measure several or all respiratory-gas volume and flow parameters needed to evaluate basic pulmonary function [e.g., vital capacity (VC), peak expiratory flow (PEF), forced expiratory volume (FEV), and forced expiratory flow (FEF)], and to transmit the pulmonary function data via a communication device to a healthcare professional(s) at a remote server.

B

47

Therapeutic nuclear magnetic resonance system

Intended to influence cellular metabolism using nuclear magnetic resonance (NMR) for the treatment of degenerate and pathological changes to the movement/support profiles of a patient's body, in particular diseased skeletal joints, bones, and surrounding muscle tissue (e.g., cervical and lumbar spine, shoulders, elbows, hands, hips, knees, feet).

C

48

Wall bars

A device that is permanently fixed to the wall intended for training and rehabilitation to regain and/or improve body movement and balance and/or for strengthening the limbs and the trunk of the body.

A

Sr.No.

Medical Device Name

Intended Use

Risk Class

1

Organ bag.

An organ bag is a device that is a flexible plastic bag intended to be used as a temporary receptacle for an organ during surgical procedures to prevent moisture loss.

B

2

Surgical camera and accessories.

A surgical camera and accessories is a device intended to be used to record operative procedures.

A

3

Implantable ligating clip

An implantable clip is a clip-like device intended to connect internal tissues to aid healing. It is not absorbable.

C

4

Laser surgical instrument for use in general and plastic surgery and in dermatology.

A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.

C

5

Low energy ultrasound wound cleaner

A low energy ultrasound wound cleaner is a device that uses ultrasound energy to vaporize a solution and generate a mist that is used for the cleaning and maintenance debridement of wounds.

B

6

Non-powdered surgeon's glove.

A non-powdered surgeon's glove is a device intended to be worn on the hands of operating room personnel to protect a surgical wound from contamination

A

7

Surgical drape and drape accessories

A surgical drape and drape accessories is a device made of natural or synthetic materials intended to be used as a protective patient covering to isolate a site of surgical incision from microbial and other contamination.

B

8

Suture retention device

A suture retention device is a device, such as a retention bridge, a surgical button, or a suture bolster, intended to aid wound healing by distributing suture tension over a larger area in the patient

B

9

Ultraviolet lamp for dermatologic disorders.

An ultraviolet lamp for dermatologic disorders is a device (including a fixture) intended to provide ultraviolet radiation of the body to photo activate a drug in the treatment of a dermatologic disorder if the labeling of the drug intended for use with the device bears adequate directions for the device's use with that drug.

B

10

Wound auto fluorescence imaging device

A wound auto fluorescence imaging device is a tool to view auto fluorescence images from skin wounds that are exposed to an excitation light. The device is not intended to provide quantitative or diagnostic information.

B

11

Battery-powered trephine system

A rotary surgical device consisting of a motor (an engine) and a cylindrical or trephine insertion portion. It usually has an extremely sharp-edged saw blade or a cutting blade with a thin saw blade. The blade is beveled on one side. It is used for removal of the intervertebral disc, other hard tissues, or soft tissues. It may have a speed control device. This is a battery- driven device

B

12

Carbon dioxide laser

A gas laser that is used in surgical procedures. It utilizes carbon dioxide as the substrate. It is widely used in several clinical fields (e.g., gynecology, neuroscience, dermatology).

C

13

Colonoscope, General & Plastic Surgery

Colonoscopes are used for the removal of foreign bodies, excision of tumors or colorectal polyps (polypectomy), and control of hemorrhage. Routine colonoscopy is important in diagnosing intestinal cancer

B

14

Copper vapour laser

A gas laser used in surgical procedures, etc. It utilizes copper vapor as the substrate. It is used in dermatology, etc. for treatment of cutaneous vascular lesions (e.g., port-wine stains, telangiectasia).

C

15

Cryosurgical unit and accessories

A cryosurgical unit with a liquid nitrogen cooled cryoprobe and accessories is a device intended to destroy tissue during surgical procedures by applying extreme cold.

B

16

Dermal dilator

A device to be temporarily implanted subcutaneously to dilate the surrounding skin. Usually, a balloon is implanted subcutaneously where solutions including saline solution are infused.

B

17

Dermatome

A surgical knife used to harvest the skin for grafting. Either manual or electric-powered.

A

18

Dermatome skin approximation tape

A tape that comes in various sizes with adhesive on both sides. It is attached onto a skin graft knife to collect a skin graft tissue. This device is for single-

use.

A

19

Drape adhesive.

A drape adhesive is a device intended to be placed on the skin to attach a surgical drape.

A

20

Electrically- powered trephine system

A rotary surgical device consisting of a motor (an engine) and a cylindrical or trephine insertion portion. The blade is beveled on one side. It is used for removal of the intervertebral disc, other hard soft tissues, or soft tissues.

B

21

Electrosurgical cutting and coagulation device and

Electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.

C

22

Electrosurgical device for over- the- counter aesthetic use

An electrosurgical device for over-the-counter aesthetic use is a device using radiofrequency energy to produce localized heating within tissues for non- invasive aesthetic use.

B

23

Esophagoscope, General & Plastic Surgery

An endoscope used for visual examination, diagnosis, and treatment of the esophagus. The insertion section changes its shape corresponding to the shape of the body cavity. The device is inserted through the oral cavity.

B

24

Eye pad.

An eye pad is a device that consists of a pad made of various materials, such as gauze and cotton, intended for use as a bandage over the eye for protection or absorption of secretions.

A

25

Gas-powered dermatome

A gas pressure-operated surgical device used to cut a thin piece of skin for grafting, or to resect a small skin lesion. A dedicated blade is required for this purpose.

B

26

Gas-powered surgical saw

A saw has a handpiece with an attachment that generates vibration or reciprocal movements. It adopts either a micro or macro design. Rechargeable batteries are used. Usually, compressed air or compressed nitrogen is used.

B

27

Gas-powered trephine system

A rotary surgical device consisting of a motor (an engine) and a cylindrical or trephine insertion portion. It usually has an extremely sharp-edged saw blade or a cutting blade with a thin saw blade. The blade is beveled on one side. It is used for removal of the intervertebral disc, other hard tissues, or soft tissues. It may have a speed control device. This is a gas- driven device.

B

28

Gastroscope, General & Plastic Surgery

A gastroscope is a flexible tube that has a small light and a video camera attached to the end of it. The tube can be used to take tissue samples by inserting instruments such as small pincers.

B

29

General electrosurgical unit

A device accompanied by accessories that cuts/coagulates tissues with a high-frequency current or with the electricity/heat of the heating element. The device is used by a physician to confirm that an incision or coagulation is made as intended, macroscopically or microscopically.

C

30

Hemostatic knife

A surgical severing instrument that is similar to a scalpel, excluding the fact that its blade is designed to be heated with an electric current. The blade transmits heat directly to body tissues to achieve hemostasis.

The instrument uses thermal energy for the purpose and requires no grounding pad.

B

31

Hydrophilic wound dressing.

A hydrophilic wound dressing is a sterile or non- sterile device intended to cover a wound and to absorb exudate. It consists of nonresorbable materials with hydrophilic properties that are capable of absorbing exudate (e.g., cotton, cotton derivatives, alginates, dextran, and rayon).

A

32

Implantable staple

An implantable staple is a staple-like device intended to connect internal tissues to aid healing.

C

33

Internal tissue marker.

An internal tissue marker is a prescription use device that is intended for use prior to or during general surgical procedures to demarcate selected sites on internal tissues.

A

34

Irrigating wound retractor device.

An irrigating wound retractor device is a prescription device intended to be used by a surgeon to retract the surgical incision, to provide access to the surgical wound, to protect and irrigate the surgical wound, and to serve as a conduit for removal of fluid from the surgical wound

B

35

Laparoscope, General & Plastic Surgery

"These electrodes are intended for use in minimally invasive surgical procedures where monopolar electrosurgical cutting and coagulation are desired

B

36

Laparoscopy Tray

Laparoscopy Tray is intended for single-use to enable a suitable trained health care professional to perform an laparoscopic procedure.

A

37

Liposuction catheter

A rigid tube inserted into the subcutaneous layer transdermally for removal of fatty deposits.

Aspiration is performed with an appropriate unit.

This device is for single-use.

B

38

Manual operating table and accessories and manual operating chair and accessories

A manual operating table and accessories and a manual operating chair and accessories are non- powered devices, usually with movable components, intended to be used to support a patient during diagnostic examinations or surgical procedures.

A

39

Manually-operated dermatome

A hand-held surgical device used to sever a thin piece of skin for grafting, or to resect a small skin lesion. A dedicated blade is required for this purpose.

A

40

Occlusive wound dressing.

An occlusive wound dressing is a nonresorbable, sterile or non-sterile device intended to cover a wound, to provide or support a moist wound environment, and to allow the exchange of gases such as oxygen and water vapor through the device.

A

41

Plastic surgery osteotome

A surgical, chisel-like, instrument designed to cut and/or shape small bones and/or cartilage during plastic surgery. It is hand-held by the surgeon who will typically use a surgical mallet or hammer to manually impart an impacting force to the proximal end of the instrument.

A

42

Powered corneal trephine

An electric cylindrical device for ophthalmic surgery equipped with a blade for resection/removal of a ring- shaped piece of corneal tissue (corneal button). For example, when a healthy corneal graft is obtained from a cadaver, the recipient's morbid cornea is resected and removed to allow transplantation of the graft.

B

43

Powered dermatome

An electric surgical device used for removal of the fragment of damaged skin or for thinly slicing the skin of a donor for skin graft. A dedicated blade should be used for these purposes.

B

44

Powered suction pump.

A powered suction pump is a portable, AC-powered or compressed air-powered device intended to be used to remove infectious materials from wounds or fluids from a patient's airway or respiratory support system. The device may be used during surgery in the operating room or at the patient's bedside. The device may include a microbial filter

B

45

Removable skin clip

A removable skin clip is a clip-like device intended to connect skin tissues temporarily to aid healing. It is not absorbable

B

46

Removable skin staple

A removable skin staple is a staple-like device intended to connect external tissues temporarily to aid healing. It is not absorbable.

B

47

Reusable dermatome blade

A blade that comes in various sizes, attached to the skin graft knife, and is used to harvest the skin graft. This device is reusable after sterilization. Usually, the blade point should be sharpened periodically.

A

48

Single-use dermatome blade

A blade, available in various sizes, attached to a dermatome for collection of skin grafts. The device is intended for single-use.

B

49

Skin marker

A skin marker is a pen-like device intended to be used to write on the patient's skin, e.g., to outline surgical incision sites or mark anatomical sites for

accurate blood pressure measurement.

A

50

Skin Stapler

Skin Stapler is intended to be applied to close lacerations on the outer layer of the dermis.

B

51

Soft tissue trephine

A cylindrical or coronary saw used to resect discs of tissues other than bones. It comes in various sizes and configurations according to the size and hardness of the tissue to be resected.

B

52

Surgical apparel.

Surgical apparel are devices that are intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and the operating room personnel from transfer of microorganisms, body fluids, and particulate

A

53

Surgical guillotine

A cutter that consists of a metal frame. The cutter slides through the frame. It comes in various configurations and sizes according to the type of tissue to be severed. Various cranks or shaft driver mechanisms generate the power.

A

54

Surgical lamp

Identification. A surgical lamp (including a fixture) is a device intended to be used to provide visible illumination of the surgical field or the patient.

A

55

Surgical microscope and accessories.

A surgical microscope and accessories is an AC- powered device intended for use during surgery to provide a magnified view of the surgical field.

A

S.No

Name of the Medical Device

Intended use

Classification India as per First Schedule part- 1 MDR 2017

1

Ankle continuous passive motion exerciser

Electrical device intended to continuously move the ankle joint (e.g., flexion, inversion/eversion) without patient assistance during continuous passive motion (CPM) exercise therapy usually following surgery or trauma to the joint.

B

2

Ankle/foot orthosis

Intended to encompass the ankle joint, or the ankle and foot, to support, align, prevent, or correct orthopaedic deformities/injuries or to improve function of the ankle and/or foot; it may also be intended to offload and redistribute foot pressures that affect pedal circulation to improve blood flow and help heal diabetic foot ulcers or postsurgical wounds.

A

3

Balance board

Intended to train patient with difficulties in balance (e.g., a paraplegic or a stroke victim) walks for balance training.

A

4

Bed traction frame

Intended to treat patients with fractures and other orthopaedic disorders (e.g., of the lower or cervical spine, hip).

A

5

Body arch traction table

Intended to support the body of a patient and provide traction for the back muscles and spine by flexing the patient into a reverse supine body arch.

A

6

Canalith repositioning procedure chair, manual

Intended to treat balance disorders [e.g., benign paroxysmal positional vertigo (BPPV), canalithiasis] caused by displaced canaliths (otoconia) in the inner ear of the patient

A

7

Cervical spine collar

Intended to support or immobilize the cervical spine to treat deformities, fractures, sprains, or strains (often to treat whiplash resulting from an automobile accident).

A

8

Cervical spine immobilization head ring

Intended to be fixed to the skull of a patient at brow level using pointed, steel, threaded bolts (typically four) that are adjusted to penetrate the outer bone of the skull.

D

9

Cervicothoracic spine orthosis

Intended to support or immobilize deformities, fractures, sprains, or strains of the cervicothoracic spine.

A

10

Cervicothoracolumbosacral spine orthosis

Intended to encompass the cervicothoracolumbosacral spine region of the neck and trunk.

A

11

Chest-oscillation airway secretion clearing system

Intended to rapidly inflate and deflate against the chest wall of the patient for promoting airway clearance by creating high frequency chest wall oscillation (HFCWO), resulting in the mobilization of bronchial secretions.

B

12

Collar and cuff arm sling material

Fabric and form composite material intended to immobilize forearm, elbow, humerus or shoulder injuries.

A

13

Cranial orthosis

Intended to be worn on the head of an infant with an abnormal head shape (e.g., due to plagiocephaly, brachycephaly, scaphocephaly), or after craniosynostosis repair surgery, to apply pressure to the cranium and improve cranial symmetry/shape during growth over a period of months.

A

14

Elbow orthosis

Intended to encompass the elbow joint to support, align, prevent, or correct deformities/injuries or to improve function of the elbow.

A

15

Finger orthosis

Intended to encompass the whole or part of the finger to support, align, prevent, or correct deformities/injuries or to improve function of the finger.

A

16

Flotation therapy bed, adult

Intended to minimize pressure points on a patient's body by providing contact with as much of the body surface as possible, typically through a mattress that contains a large volume of constantly moving media, e.g., water, air, or mud that lifts the patient to simulate a floating effect.

B

17

Flotation therapy bed, neonatal

Intended to minimize pressure points on neonatal patient's body by providing contact with as much of the body surface as possible, typically through a mattress that contains a large volume of constantly moving media, e.g., water, air, or mud that lifts

the patient to simulate a floating effect.

B

18

Foot orthosis

Intended to encompass the whole or part of the foot, or designed as a plantar insert, and intended to provide rigid or semi-rigid correction of the foot for persons with orthopaedic deformities/injuries of the feet

A

19

Hand orthosis

Intended to encompass the whole or part of the hand to support, align, prevent, or correct deformities/injuries

or to improve function of the hand.

A

20

Hand/finger splint

Intended to immobilize an injured hand to protect injuries to, e.g., the digits, metacarpals, and wrist during the

healing process.

A

21

Hand/wrist continuous passive motion exerciser

A mains electricity (AC-powered) deviceIntenedd to continuously move the metacarpal/interphalangeal joints (e.g., flexion and extension) without patient assistance during continuous passive motion (CPM) exercise therapy usually following surgery or trauma to the joints.

B

22

Hip/knee continuous passive motion exerciser

A mains electricity (AC-powered) device Intended to provide continuous passive motion (CPM) exercise therapy for the hip and/or knee, typically following joint surgery/trauma to promote healing; some types may

also operate with patient assistance under controlled active motion (CAM).

B

23

Horizontal non-powered traction system

Non powered device intended to be attached to a table for the application of constant horizontal traction forces to the cervical or lumbar vertebrae by means of attached harnesses whilst the patient typically lies in a supine

position on the table during treatment.

A

24

Incentive spirometer

Intended to be used in respiratory therapy to encourage and motivate deep-breathing manoeuvres, typically for the postsurgical treatment and prevention of atelectasis (lung collapse) and to help facilitate airway opening and clearing.

A

25

Intermittent traction system

It is an AC powered electronic device. Intended to apply and relieve pre-set traction forces from a motor through harnesses typically attached to the cervical or lumbar vertebrae.

B

26

Kinetic bed

Intend to enable continuous change of the patient's lying position, e.g., it can tilt the entire bed mattress support system (this includes the mattress, the framework that supports the mattress, and the bedding) lengthways, sideways or to a near vertical tilt.

A

27

Knee immobilizer

Intended to temporarily render the knee immovable, either preoperatively or following injury or arthroscopy.

A

28

Neuro-controlled ambulation exoskeleton

Intended to assist a patient with a walking disability (neurogenic, muscular, or osseous in origin) regain lost motor function by transmission of the patient's residual nerve function,

via cutaneous electrodes, to the device motor assembly.

C

29

Orthopaedic bed

Intended to provide support for skeletal traction to stabilize fracture sites.

A

30

Paediatric dorsiflexion slant board

Intended to be used in the treatment of various medical conditions (e.g., congenital, neurological, post- traumatic) in paediatrics, where tendon tightness and muscle contracture affect the ability to dorsiflex the foot, possibly leading to an abnormal gait

A

31

Parapodium walking frame

Intended to encompasses and provide support for the body of a patient who is unable to stand unassisted to help them move (walk) by changing their centre of gravity (COG).

A

32

Physical therapy massager

Electrically powered device intended to provide therapeutic massage to a larger area than hand-held massaging devices.

B

33

Shoulder continuous passive motion exerciser

It is a mains electricity (AC-powered) device Intended to continuously move the shoulder joint (e.g., flexion, rotation, adduction/abduction) without patient assistance during continuous passive motion (CPM) exercise therapy usually following surgery or trauma to the joint.

B

34

Shoulder immobilizer

Intended to temporarily immobilize or limit abduction of the shoulder joint to support healing of an injury or a surgical wound.

A

35

Swivel-walker

Intended to encompasses and provide support for the body of a patient who is unable to stand unassisted, to help them move (walk) by rocking sideways (shifting their weight from side-to-side with a shoulder movement) which makes the footplate of the device

swivel so that it "walks" forward.

A

36

Toe separator

Intended to space the toes of the foot to relieve pain, pressure/friction between toes, and/or to facilitate realignment of the toes to a natural

position.

A

37

Traction table, line- powered

Intended to support a patient and to provide traction for the back muscles and spine (e.g., lumbar, cervical) by a motorized mechanical manipulation of the spine.

B

38

Wrist immobilizer

Intended to temporarily render the wrist immovable as therapy for non- displaced fractures, strains, sprains, and muscle injuries of the wrist.

A