Introduction – Operation Theatre Equipment Classification in India
The importance of operating room equipment lies in the safe and effective execution of surgical procedures. The need for the safety and efficacy of these devices is ensured with the classification system that was established by the Central Drug Standard Control Organization under the Medical Device Rules 2017 and Notification No. 29/Misc/03/2020-DC(199).
India is Updating Existing Risk-Based Classifications for Medical Devices |
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On January 6th, 2025, India’s CDSCO published a draft annexure revisiting the existing classification lists and adding new entries. This blog specifically focuses on the updates made to the operation theatre equipment classification and highlights the changes introduced in this sector. The complete list published by the CDSCO for operation theatre equipment classification is provided in this document for easy reference. |
New devices, such as multiparameter monitors, sterile surgical probes and surgical robotic units, are now categorized into specific risk groups .streamlining the registration process and facilitating market access in compliance with medical device registration India standards. This classification table helps manufacturers and importers align with CDSCO medical device classification guidelines Indian regulatory requirements, streamlining the registration process and facilitating market access in compliance with medical device registration India standards.
In the below table highlighted with dark grey color indicates the new devices added into the classification. This classification table helps manufacturers and importers 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 enterosto 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 operation theatre equipment classification, highlights the importance of staying updated with the latest rules in India allowing manufacturers to stay compliant avoiding hindrance to their sales activities in India. These updates reflect the updated CDSCO medical device rules in India.
For support in navigating India’s regulatory landscape, Morulaa HealthTech offers expert consulting services with the aim to enhance medical device compliance in India. Our turnkey solutions for medical device registration under the Medical Device Rules 2017, CDSCO approvals, and compliance streamline your journey toward sales in India. Contact us today to stay updated on the latest rules and ensure your operation theatre equipment meets all regulatory requirements.