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CDSCO License

Snehita Shukla
| Updated: 26 Sep, 2022 | Category: CDSCO

Classification of Medical Devices in Operation Theatre

Medical Devices in Operation Theatre
Reading Time: 6 minutes

The Central Drugs Standard Control Organization or CDSCO, is the Indian medical device industry regulatory body. Each country has a specific regulatory body under the ministry of health to handle all facets of drugs and both notified and non-notified medical devices. The Central Drugs Standard Control Organisation lists 26 medical devices for Classification of Medical Devices in Operation Theatre on 13th September 2021, such as Distractor/Retractors, the Suction system operated by vacuum, Non-sterile Surgical forceps, and Warming high-flow infusion pump etc., under the Medical Device Rules 2017. Scroll down to check the Classification of Medical Devices in Operation Theatre

CDSCO Regulation on Medical Device Rules, 2017

The medical devices are categorized into risk classes of A, B, C and D based on the intended use, the risk associated with the device, and other parameters specified under the medical device rules 2017.

Any person who intends to apply for a grant of license of medical devices for import/manufacture for sale or distribution/ sale, stock, exhibit or offer for sale may group all or any medical device under the guidelines to be issued from time to time by the Ministry of Health & Family Welfare in the Central Government, by taking into consideration the technological changes/development in the field of medical devices and in vitro diagnostic medical devices.

“A Medical Device can be any instrument, tool, apparatus, implement, machine, appliance, implant & reagent for the purpose of in vitro use, software, material or any other related article, intended by the manufacturer to be used, alone/in combination for a medical purpose.”

A medical device is classified into two types-

  • Notified medical device
  • Non-Notified Medical Device

Earlier, there was no regulation on the selling of Medical Devices by the manufacturers. They used to market medical devices without any rule/law governing them. Later, as a policy of the FDA, Indian Medical Device Regulations (IMDR) were made by CDSCO, which made it compulsory for the Import/Export of Medical Devices in India to be regulated. Only the notified medical devices in India need to be controlled by CDSCO.

Non-Notified Medical Device Classification

Earlier, CDSCO only regulated 37 medical devices; the current notification provides a classification of non-notified medical devices that fall under the definition of a medical device. According to a new notice issued by CDSCO on 3rd September 2020, 24 non-notified devices are categorized under the Medical Device Rules, 2017[1]. Classification of Medical Devices in Operation Theatre is also a part of the same. The Classification of Non-notified medical devices is as follows-

SL No. Categories of medical device
1 Anaesthesiology            
2 Pain Management            
3 Cardiovascular             
4 Dental                     
5 Ear, Nose, Throat (ENT)    
6 Gastroenterological        
7 Urological                 
8 General Hospital           
9 Operation Theater (OT)     
10 Respiratory                
11 Neurological               
12 Personnel use              
13 Obstetrical and Gynaecological (OG)
14 Ophthalmic                 
15 Rehabilitation             
16 Physical support           
17 Interventional and Radiology
18 Rheumatology               
19 Dermatology and Plastic Surgery
20 Paediatric and Neonatology Medical
21 Oncology                   
22 Radiotherapy               
23 Nephrology and Renal care  
24 Software                   

Classification of Medical Devices in Operation Theatre under CDSCO

Under Chapter III Rule 4, subclause (3) of Medical Device Rules, CDSCO has notified Classification of Medical Devices in Operation Theatre based on their Intended Use and the level of risk involved in them, along with other parameters specified in the First schedule. The Classification of medical devices in Operation Theatre is defined as follows:

Classification of Medical Devices in Operation Theatre

Sr. no.

Name of Product

Intended Use

IMDR

1

 

Distractor/Retractors

A surgical device is used for separating connected surfaces and for retaining their positions so that a surgical operation can be performed.

A

2

Suction system portable, Electrical/Pneumatic

A suction system portable, Electrical/Pneumatic device generates negative pressure, which is used for treatments like aspiration of liquid or granular substances.

A

 

3

Suction system operated by vacum

Suction system operated by vacum is a device which is used for treatment like the aspiration of liquid/granular substances by using negative pressure, supplied by the hospital’s medical gas supply system at bed-side of the patient.

A

4

Operation table system

Operation table system is a complete surgical table system to change the patient’s position and to attach various table accessories that are helpful in surgery.

A

 

5

General-purpose diagnosis/treatment table

General-purpose diagnosis/treatment table is used for general diagnosis and procedures in examination room for examination of the patient.

A

6

Surgical light system

A surgical light system is an illuminator device used to provide optimal light and colour rendering to aid in performing surgery.

A

7a

Non-Sterile Hemostatic clip applier

Non-Sterile Hemostatic clip applier is a surgical device designed to apply a hemostatic clip for ligation of a blood vessel

A

7b

Sterile Hemostatic clip applier

Sterile Hemostatic clip applier is a surgical device designed to apply a hemostatic clip for ligation of a blood vessel.

B

8

Hemostatic knife

A hemostatic knife is a blade used to transmit heat directly to body tissues to achieve hemostasis.

B

9a

Non-sterile Scalpel

Non-sterile Scalpel is an instrument used to sever and separate body tissues during surgery

A

9b

Sterile Scalpel

Sterile Scalpel is an instrument used to sever and separate body tissues during surgery

B

10

Scalpel blade

Scalpel blade  is a blade attached to the handle of scalpel

B

11 a

Non-sterile Surgical forceps

A surgical or dental device used to clamp and sever the cartilage, bone and other hard tissues.

A

11b

Sterile Surgical

forceps

A surgical or dental device which is used to clamp and sever the cartilage, bone and other hard tissues.

B

12

General-purpose

electrosurgical unit

General-purpose electrosurgical unit is used to resect/ablate the tissue or to coagulate the incision/wound site with high-frequency waves.

C

13

Long-term use enter ostomy feeding tube

Long-term use enter ostomy feeding tube is a hollow device to be placed surgically in the stomach, duodenum/jejunum to provide enteral nutrition. It’s for long-term use.

C

14

Warming high-flow

infusion pump

A device used for the purpose of heating & rapidly infusing blood/other fluids during surgical procedures involving major bleeding/for burns or injuries.

C

15

High-flow blood

transfusion pump

A device used for the purpose of rapidly infusing blood/other fluids during surgical procedures involving major bleeding, or for burns/injuries.

C

16a

Non-sterile Staple remover

Non-sterile Staple remover is a metal or plastic surgical instrument used to remove staples from a surgical wound/incision that no longer requires stapling to stay closed.

A

16b

Sterile Staple remover

Sterile Staple remover is a metal or plastic surgical instrument used to remove staples from a surgical wound/incision that no longer requires stapling to stay closed.

B

17a

Non-sterile Surgical punch

Non-sterile Surgical punch is a surgical instrument used to create a hole for suturing or anastomosis of tissue, blood vessel, etc.

A

17b

Sterile Surgical punch

A surgical instrument is to create a hole for suturing or anastomosis of tissue, blood vessel, etc.

B

18 a

Non-sterile Surgical file

Sterile Surgical file is a manually operated, hand-held surgical instrument with a series of bumps/teeth on its surface used to smooth out, grind off/sever tissues.

A

18b

Sterile Surgical file

Sterile Surgical file is a manually operated, hand-held surgical instrument with a series of bumps/teeth on its surface used to smooth out, grind off/sever tissues.

B

19a

Non-sterile Blood vessel surgical

stripper

Non-sterile Blood vessel surgical Stripper is a surgical instrument used for complete or partial vascular resection

A

19b

Sterile Blood vessel surgical

stripper

Sterile Blood vessel surgical stripper is a surgical instrument used for complete or partial vascular resection

B

20a

Non-Sterile Surgical probe

Non-Sterile Surgical probe explores sinuses, fistulae, and other cavities and wounds

A

20b

Sterile Surgical probe

Sterile Surgical probe examines sinuses, fistulae, and other cavities and wounds.

B

21

Multipara meter

monitor with critical

parameters

Multipara meter monitor with critical

parameter is a unit that collects monitoring parameters (including an electrocardiogram (ECG), blood pressure, body temperature, cardiac output, and respiratory gases; moreover, other critical parameters (supporting detection of arrhythmia or apnea; and in the case of anesthesia, using an embedded  module, function kit, or other devices to display data, by the bed or by the patient.

C

22

Surgical robot unit

A surgical robot unit is an operation support device used in open or endoscopic surgery that performs treatment of tissues, comprising suturing, detaching and severing, and installing a prosthesis.

B

23

Motorized diagnostic

imaging view box

Motorized diagnostic imaging view box is a device equipped with an electric mechanical or software-controlled motor that retains, retrieves, and projects light for direct observation of medical images taken using various methods such as X-ray, magnetic resonance (MR), CT, and ultrasound recorded in radiographic film.

A

24

General-purpose

manually-operated

operation table

General-purpose manually-operated operation table is a completely mobile surgical table (general-purpose) that has been improved to make it usable for almost all body parts that require surgery. Manual or hydraulic operation

A

25

Powered general purpose operation

table

A completely mobile surgical table (general-purpose) has been improved to make it useable for almost all body parts that require surgery. Electrically line or battery operated.

A

26

Operation table

system

A system consisting of several components forms a complete surgical table system. It is used to replace table tops, change position of the patient and transfer to the operating room. Usually, has columns, a removable tabletop, a remote controller for the trolley, and a trolley.

A

Conclusion

The Indian healthcare regulators at Central Drug Standard Control Organization CDSCO have issued a new risk-based Classification of Medical Devices in Operation Theatre in India to comply with the latest medical device rules in India. The operation Theatre products are classified as Non-Notified Medical Devices by CDSCO. The category includes 26 medical devices, including parts of Sterile and Non-Sterile Medical devices as per the rules.

Read our Article:Who can apply for CDSCO License?

Snehita Shukla

Snehita has her qualifications in B.Com LLB and LLM, and holds a specialization in Corporate & Financial Laws and Policy. She is hardworking, dedicated and sincere. She has a great command in english and has great problem solving, critical thinking and writing skills which makes her stand out of the crowd. She has a keen interest in legal research work and content writing, she also has a hold in legal research methodology. She loves to take challenges and to explore new topics to research on. She aims to improve her knowledge and skills through her experience.

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