Classification of Medical Device pertaining to Operation Theatre under the provisions of Medical Devices Rules 2017

Appendix-A File No. 29/Misc./03/2020-DC (199) Drugs Controller General (India) Directorate General of Health Services Central Drugs Standard Control Organisation FDA Bhawan, Kotla Road, New Delhi Notice Classification of Medical Devices Pertaining to Operation Theatre S. No. Device name Intended Use Risk Class Distractor/Retractor A surgical device used to separate connected surfaces, and to retain 1 A s their positions to allow a surgical operation to be performed. Suction system portable, A device that generates negative pressure used for such treatment as 2 A Electrical/Pneumati the aspiration of liquid or granular substances. c Suction system A device used for such treatment as the aspiration of liquid or granular 3 operated by substances by using negative pressure supplied by the hospital's A vacuum medical gas supply system at bed side for using on patient. A complete surgical table system intended change the patient's Operation table 4 position and enable attaching various table accessories that aid in A system surgery. General-purpose A table for general diagnosis and procedures in examination room to 5 diagnosis/treatment A aid in patient examination. table Surgical light An illuminator device intended to providing optimial light and colour 6 A system renderingn to aid in performing surgery. Non-sterile A surgical device designed to apply a hemostatic clip for ligation of a 7a Hemostatic clip A blood vessel. applier Sterile Hemostatic A surgical device designed to apply a hemostatic clip for ligation of a 7b B clip applier blood vessel. The blade intended to transmits heat directly to body tissues to achieve 8 Hemostatic knife B hemostasis. 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 scalpel. B Non-sterile Surgical A surgical or dental device that is used to clamp and sever the 11a A forceps cartilage, bone and other hard tissues. Sterile Surgical A surgical or dental device that is used to clamp and sever the 11b B forceps cartilage, bone and other hard tissues. General-purpose A unit used to resect/ablate the tissue or to coagulate the 12 C electrosurgical unit incision/wound site with high-frequency waves. Long-term use A hollow device to be placed surgically in the stomach, duodenum or 13 enterostomy C jejunum to provide enteral nutrition. It is for long-term use. feeding tube A device to be used for heating and rapidly infusing blood or other Warming high-flow 14 fluids during surgical procedures involving major bleeding, or for burns C infusion pump or injuries. High-flow blood A device to be used for rapidly infusing blood or other fluids during 15 C transfusion pump surgical procedures involving major bleeding, or for burns or injuries. 1 of 2A metal or plastic surgical instrument used to remove staples from a Non-sterile Staple 16a surgical wound or incision that no longer requires stapling to stay A remover closed. A metal or plastic surgical instrument used to remove staples from a Sterile Staple 16b surgical wound or incision that no longer requires stapling to stay B remover closed. Non-sterile Surgical A surgical instrument used to create a hole for suturing or anastomosis 17a A punch of a tissue, blood vessel, etc. Sterile Surgical A surgical instrument used to create a hole for suturing or anastomosis 17b B punch of a tissue, blood vessel, etc. A manually operated, hand-held surgical instrument with a series of Non-sterile Surgical 18a bumps or teeth on its surface that is used to smooth out, grind off, or A file sever tissues. A manually operated, hand-held surgical instrument with a series of 18b Sterile Surgical file bumps or teeth on its surface that is used to smooth out, grind off, or B sever tissues. Non-sterile Blood 19a vessel surgical A surgical instrument used for complete or partial vascular resection. A stripper Sterile Blood vessel 19b A surgical instrument used for complete or partial vascular resection. B surgical stripper Non-sterile Surgical The device is used to explore sinuses, fistulae, and other cavities and 20a A probe wounds. Sterile Surgical The device is used to explore sinuses, fistulae, and other cavities and 20b B probe wounds. A unit that collects monitoring parameters (include an electrocardiogram (ECG), blood pressure, body temperature, cardiac Multiparameter output, and respiratory gases; in addition, other critical parameters 21 monitor with critical (supporting detection of arrhythmia or apnea; and in the case of C parameters 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. An operation support device used in open surgery or endoscopic 22 Surgical robot unit surgery that performs treatment of tissues including suturing, detaching B and severing, and installing a prosthesis. A device equipped with an electric mechanical or software controlled Motorized motor that retains, retrieves, and projects light for direct observation of 23 diagnostic imaging medical images taken using a variety of methods such as X‐ray, A view box magnetic resonance (MR), CT, and ultrasound, and recorded in radiographic film. General-purpose A completely mobile surgical table (general-purpose) that has been 24 manually-operated improved to make it usable for almost all parts of the body that require A operation table surgery. Manual or hydraulic operation. Powered general- A completely mobile surgical table (general-purpose) that has been 25 purpose operation improved to make it useable for almost all parts of the body that require A table surgery. Electrically line or battery operated. A system that consists of several components that form a complete surgical table system. It is used to replace tabletops, change the Operation table 26 patient's position, and transfer the patient to and from the operating A system room. Usually, it consists of columns, a removable tabletop, remote controller for the trolley, and a trolley. 2 of 2