India Risk Classification for Operation Theatre as Medical Device
CDSCO Operation Theatre Equipment Classification Guide
Introduction Operation Theatre Equipment Classification in India
The significance of the equipment used in the operating room arises from the safety and effectiveness of performing the operation procedure. The demand for the safety and effectiveness of such devices is ensured through the system of classification which was created by the Central Drug Standard Control Organization through the Medical Device Rules 2017 and Notification No. 29/Misc/03/2020-DC(199).
India is Updating Existing Risk Based Classifications for Medical Devices
The CDSCO came up with a draft annexure on January 6th, 2025, in which it has reviewed the current lists of classifications and introduced new lists. In this blog post, we are talking about the additions to the list of classification in the operation theatre equipment sector. The list of classification for the operation theatre equipment has been given by the CDSCO is attached.
There are some new devices which have been included in this new list of classification in different risk groups. Multiparameter monitors, sterile surgical probes and surgical robots are a few of these new devices included in the list of classification and make the registration process smooth in accordance with medical device registration India standards. This classification table helps manufacturers and importers to comply with CDSCO medical device classification guidelines.
The dark grey colour in the following table represents the newly included devices. This classification table helps manufacturers and importers to comply with CDSCO medical device classification guidelines
Table: CDSCO Operation Theatre Equipment Classification
S. No. | Device name as per medical Device Rules 2017 | Intended Use | Risk Class |
|---|---|---|---|
1 | Distractor/Retractors | A surgical device used to separate connected surfaces, and to retain their positions to allow a surgical operation to be performed. | A |
2 | Suction System portable,Electrical/Pneumatic | A device that generates negative pressure used for such treatment as the aspiration of liquid or granular substances. | A |
3 | Suction system operated by vacuum | A device used for such treatment as the aspiration of liquid or granular substances by using negative pressure supplied by the hospital’s medical gas supply system at bedside for use on patients. | A |
4 | Operation Table system | A complete surgical table system intended to change the patient’s position and enable attaching various table accessories that aid in surgery. | A |
5 | General purpose diagnosis/treatment table | A table for general diagnosis and procedures in the examination room to aid in patient examination. | A |
6 | Surgical light system | An illuminator device intended to provide optimal light and colour rendering to aid in performing surgery. | A |
7a | Non sterile Hemostatic clip applier | A surgical device designed to apply a hemostatic clip for ligation of a blood vessel. | A |
7b | Sterile Hemostatic clip applier | A surgical device designed to apply a hemostatic clip for ligation of a blood vessel. | B |
8 | Hemostatic knife | The blade intended to transmit heat directly to body tissues to achieve hemostasis. | B |
9a | Non sterile Scalpel | An instrument used to sever and separate body tissues during surgery. | A |
9b | Sterile Scalpel | An instrument used to sever and separate body tissues during surgery. | B |
10 | Scalpel blade | A blade intended to be attached to the handle of the scalpel. | B |
11a | Non sterile Surgical forceps | A surgical or dental device that is used to clamp and sever the cartilage, bone and other hard tissues. | A |
11b | Sterile Surgical forceps | A surgical or dental device that is used to clamp and sever the cartilage, bone and other hard tissues. | B |
12 | General purpose electrosurgical unit | A unit used to resect/ablate the tissue or to coagulate the incision/wound site with high frequency waves. | C |
13 | Long term use enterostomy feeding tube | A hollow device to be placed surgically in the stomach, duodenum or jejunum to provide enteral nutrition. It is for long term use. | C |
14 | Warming high flow infusion pump | A device to be used for heating and rapidly infusing blood or other fluids during surgical procedures involving major bleeding, or for burns or injuries. | C |
15 | High flow blood transfusion pump | A device to be used for rapidly infusing blood or other fluids during surgical procedures involving major bleeding, or for burns or injuries. | C |
16a | Non sterile Staple remover | A metal or plastic surgical instrument used to remove staples from a surgical wound or incision that no longer requires stapling to stay closed. | A |
16b | Sterile Staple remover | A metal or plastic surgical instrument used to remove staples from a surgical wound or incision that no longer requires stapling to stayclosed. | B |
17a | Non sterile Surgical punch | A surgical instrument used to create a hole for suturing or anastomosis of a tissue, blood vessel, etc. | A |
17b | Sterile Surgical punch | A surgical instrument used to create a hole for suturing or anastomosis of a tissue, blood vessel, etc. | B |
18a | Non sterile Surgical file | A manually operated, hand held surgical instrument with a series of bumps or teeth on its surface that is used to smooth out, grind off, or sever tissues. | A |
18b | Sterile Surgical file | A manually operated, hand held surgical instrument with a series of bumps or teeth on its surface that is used to smooth out, grind off, or sever tissues. | B |
19a | Non sterile Blood vessel surgical stripper | A surgical instrument used for complete or partial vascular resection. | A |
19b | Sterile Blood vessel surgical stripper | A surgical instrument used for complete or partial vascular resection. | B |
20a | Non sterile Surgical probe | The device is used to explore sinuses, fistulae, and other cavities and wounds. | A |
23 | Motorized diagnostic imaging view box | 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 a variety of methods such as X‐ray, magnetic resonance (MR), CT, and ultrasound, and recorded in radiographic film. | A |
24 | General purpose manually operated operation table | A completely mobile surgical table (general purpose) that has been improved to make it usable for almost all parts of the body that require surgery. Manual or hydraulic operation. | A |
25 | Powered general purpose operation table | A completely mobile surgical table (general purpose) that has been improved to make it usable for almost all parts of the body that require surgery. Electrically line or battery operated. | A |
26 | Operation table system | A system that consists of several components that form a complete surgical table system. It is used to replace tabletops, change the patient’s position, and transfer the patient to and from the operating room. Usually, it consists of columns, a removable tabletop, remote controller for the trolley, and a trolley. | A |
27 | Multiparameter monitor with critical parameters | A unit that collects monitoring parameters (include an electrocardiogram (ECG), blood pressure, body temperature, cardiac output, and respiratory gases; in addition, other critical parameters (supporting detection of arrhythmia or apnea; and in the case of anesthesia, determination of dose levels of a relaxant or local anaesthesia) using an embedded function kit, module, or other devices to display data, by bed or by patient. | C |
28 | Sterile Surgical probe | The device is used to explore sinuses, fistulae, and other cavities and wounds. | B |
29 | Surgical Robot Unit | An operation support device used in open surgery or endoscopic surgery that performs treatment of tissues including suturing, detaching and severing, and installing a prosthesis. | B |
Conclusion
The classification of operation theatre equipment, emphasizes the need to be aware of the new rules being implemented in India, which will help manufacturers to stay in compliance and avoid any impediments to the sale of their product in India. The above information is based on the new medical device rules as per CDSCO in India.
Morulaa HealthTech provides professional consulting services for navigating through the Indian regulatory scenario with the intent of improving compliance of medical devices in India. Our end to end solutions for the registration of medical devices as per the Medical Device Rules 2017, CDSCO approvals and compliance will ease your path to sales in India.
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