Introduction – Operation Theatre as Medical Device India
This article deals with the latest rules of Operation Theatre Products as a Medical Device India – Non Notified Medical Device Registration. Indian healthcare regulators at the Central Drugs Standard Control Organization (CDSCO) have issued substantial new risk based classification lists for Operation Theatre as Medical Device in India. All Operation Theatre Products now need to be registered in order to comply with the latest Medical Device Rules in India ( i.e 30th September, 2021). Below is a table which helps manufacturers classify their products and apply with the Indian Health Ministry Accordingly. The total number of Devices classified are 26.
Table: Operation Theatre as Medical Device India
| S. No. | Device name | Intended Use | Risk Class |
| 1 | Distractor/Retractor s | 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/Pneumaticc | 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-purposediagnosis/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 clipapplier | 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 Surgicalforceps | A surgical or dental device that is used to clamp and sever the cartilage, bone and other hard tissues. | A |
| 11b | Sterile Surgicalforceps | 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 Surgicalpunch | 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 surgicalstripper | 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 Surgicalprobe | 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 operationtable | 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 |
Conclusion:
The above article is taken from S.O 648(E) & G.S.R 102(E) which mentions that all Medical Devices will be regulated in a phase manner. The CDSCO has classified the MDR in India as Appendix A based on the Intended Use, Risks Associated and Other Parameters Specified with the device. The above table has the general intended use against each device, however if any specific intended use for a particular device, it has to be mentioned by the manufacturer. The list is dynamic and is subject to changes. To obtain MDR in India, contact Morulaa. We at Morulaa will help you understand the latest rules for Operation Theatre as a Medical Device India. We are a turnkey solution provider with an in-house Medical Device Consultancy team to conduct registrations of Medical Devices in India. In order to comply with the deadline 30th September of Operation Theatre Products as a Medical Device in India contact us at [email protected]. You can also subscribe to our website to learn about the Latest Rules and Medical Regulations.