Classification of Medical Devices in Operation Theatre

26 Sep, 2022

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

Page Contents

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?

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