The Central Drugs Standard Control Organisation (CDSCO) stands as the pivotal regulatory authority for the medical device industry in India. On 13 September 2021, CDSCO specified 26 specific medical devices for classification in Operation Theatres. This list includes devices such as Distractors/Retractors, vacuum-operated Suction systems, Non-sterile Surgical forceps, and the Warming high-flow infusion pump, all of which fall under the purview of the Medical Device Rules 2017. Now, let’s look at how these devices are grouped.
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CDSCO Classification and Regulation of Medical Devices
Medical devices are put into four classes: A, B, C, and D. These groups are based on how the device is used, the risk it might have, and other rules from the Medical Device Rules 2017. If someone wants to get a license to manufacture medical devices, or a license to import medical devices, they need to follow guidelines from the Ministry of Health & Family Welfare. These guidelines can change because of new technology or other updates in medical devices.
A medical device can be many things. It can be a tool, machine, implant, or even software. The main thing is that it’s used for medical purposes.
Types of Medical Devices
In India, medical devices are of two main types: Notified and Non-Notified. In the past, there were no strict rules for selling medical devices. Manufacturers could sell them without following any specific rules. But later, CDSCO made the Indian Medical Device Regulations (IMDR). With these rules, selling medical devices in India became more controlled. Now, only the notified medical devices need to follow CDSCO’s rules.
- Notified Medical Devices: These devices require approval and oversight from CDSCO before they can be sold or used in India.
- Non-Notified Medical Devices: These devices do not need CDSCO’s approval and can be sold without specific regulatory checks.
After 30 September 2022, all Class A & B Medical Devices become notified medical devices & after 30 September 2023, all Class C & D Medical devices will become notified medical devices. (Only applicable for devices that had been earlier classified as non-notified)
Notified Medical Devices Categories by CDSCO
There are 23 categories of Medical Devices notified by CDSCO. These are –
|S.No.||Medical Device Category|
|4||Dermatological and Plastic surgery|
|7||General Hospital/ Orthopaedic instruments|
|9||Nephrology and Renal Care|
|11||Obstetrical and Gynecological|
|16||Personal Protective Equipment|
|23||Non-sterile, Non-Powdered, Hand-Held, or Hand manipulated surgical instruments for general use in various surgical procedures|
Classification of Medical Devices for Operation Theatre by CDSCO
CDSCO has classified devices in the Operation Theatre category based on their intended use and risk class. There are a total of 26 devices classified by CDSCO for Operation Theatre. These are –
|S. No.||Name of Product||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 bed side for using on patient.||A|
|A complete surgical table system intended 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 examination room to aid in patient examination.||A|
|6||Surgical light system||An illuminator device intended to providing optimial light and colour renderingn 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 transmits 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 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.
|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 stay closed.||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|
|20b||Sterile Surgical probe||The device is used to explore sinuses, fistulae, and other cavities and wounds.||B|
|21||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|
|22||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|
|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 useable 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|
Pharmadocx Consultants provides services for the grant of CDSCO manufacturing and import licenses for Operation Theatre Medical Devices. Contact us today to get started in the world of medical devices!
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