India Risk Classification for Pain Management as Medical Device
CDSCO Pain Management Device Classification Guide India
Introduction Pain Management as Medical Device India
The current article centers on the regulatory issues concerning pain management medical devices and classifying pain management devices as medical devices according to the Medical Device Rules 2017 in India. According to the Central Drugs Standard Control Organization (CDSCO), certain guidelines have been laid down for medical device classification in India, which include classification of the devices as Class A, B, C, and D in accordance with their risk levels. The medical devices vary from self notifying low risk items such as heat therapy gels and ice collars to high risk items that include implantable pain management devices.
India is Updating Existing Risk Based Classifications for Pain Management Medical Devices
According to the most recent notification MED-16014(12)/1/2024-eOffice, dated January 6, 2025, 8 devices have been downgraded from Class A to Class A (Self Notified), while 1 device has been downgraded from Class A to Class B. This change eases the burden of compliance for low risk medical devices and also follows the CDSCO registration for pain devices in India. The complete list of reclassified devices is provided below, including their new classifications, with modifications marked in dark grey.
Table : CDSCO Pain Management Device Classes and Risk Classification
S. No. | Device Name as per Medical Device Rules in India | Intended Use | Risk Class |
1 | Acupuncture electrical stimulation system | An assembly of devices used to apply electrical stimuli to acupuncture sites. | B |
2 | Acupuncture kit | A collection of instruments and supplies used to perform acupuncture procedures. | B |
3 | Acupuncture point detector | An electronic probe used to precisely locate an acupuncture point on a patient’s body. | B |
4 | Analgesic spinal cord electrical stimulation system | An assembly of devices that applies an electrical stimulus to all or part of the spinal cord to relieve pain (analgesia). | C |
5 | Cryogenic analgesia unit | A device designed to provide analgesia by applying extremely low temperatures to body tissues. It is used for postoperative and chronic intractable pain relief. | C |
6 | Electric pad localized-body heating system | An assembly of devices designed for the transcutaneous application of heat to a localized body site to relieve musculoskeletal pain. | B |
7 | Endothermic cold therapy pack | A device intended to be applied with pressure to the body surface to provide cold therapy to help reduce fever, pain, and inflammation associated with joint/muscle/tissue injury and/or minor burns. | B |
8 | Foot bath | A device designed to be filled with water to provide therapeutic heat treatment specifically to the feet. This device is intended to relieve foot pain as well as headaches, coughs, and other cold symptoms. | A |
9 | Heat therapy gel | A non-sterile gelatinous compound in a container that is dispensed for application to the body surface to provide a warming effect for underlying tissues. It is intended to reduce/relieve pain, muscle tension, and to increase local circulation.(Not in direct contact with tissue) | A |
10 | Ice collar | Intended to alleviate pain and/or promote healing in minor injuries of the neck, throat, and/or head and to alleviate a sore throat. | A |
11 | Implantable intrathecal infusion pump | A device designed to be implanted in a patient for the storing and subarachnoid (intrathecal) administration of narcotics/drugs to manage intractable pain and muscle spasms of malignant or non- malignant origin. | D |
12 | Implantable lumbar neuromuscular electrical stimulation system | The system is designed to deliver episodic electrical stimulation to nerves that innervate lumbar muscles to elicit contraction for the treatment of chronic low back pain (CLBP). | D |
13 | Inflatable hot/cold therapy pack/electric pump | A assembly of devices intended for localized thermal and compression therapy to facilitate the treatment of a variety of adverse conditions resulting from musculoskeletal injury. | B |
14 | Inhalational analgesia unit | A device primarily designed to administer analgesic gases to the patient, or produce analgesic vapours for inhalation. | B |
15 | Intervertebral disc prolapse therapy pack | A device intended to be applied to the skin overlying an affected area of the spine (cervical or lumbar) to reduce pain associated with a prolapsed (herniated) intervertebral disc. | B |
16 | Neurophysiologic monitoring system | An assembly of devices designed to monitor and provide electrical stimuli to spinal nerves or other neural pathways during intraoperative surgery or intensive care, typically to reduce the incidence of accidental injury during instrumented spine surgery, or to diagnose acute dysfunction in corticospinal conduction. | C |
17 | Pain-relief phototherapy skin patch | A skin patch designed to reflect the naturally emitted infrared energy back into the body, with a reduced range of wavelength, intended to provide comfort and localized temporary relief of body aches and pains by phototherapeutic stimulation of strategic points on the skin. | B |
18 | Acupressure wristband | A device designed to be worn on the wrist(s) for the application of pressure to the Nei-kuan (P6) acupressure point, the area identified to help relieve the sensation of nausea. | B |
19 | Bite relief pad | A thin, plastic, horseshoe-like wafer that is placed between the upper and lower sets of teeth and bitten down on, or chewed, to help relieve pain or discomfort after orthodontic treatment. | Class A (Self-Notified) |
20 | Ear microsystem needle | An instrument used in auriculotherapy to apply continuous pressure to stimulate meridian points. | Class A (Self-Notified) |
21 | Ice bag | Intended to alleviate pain and/or promote healing in minor injuries to the body or for application around the neck or limbs. | Class A (Self-Notified) |
22 | Intubation Teeth protector | A device designed to fit over the upper and lower sets of teeth to protect them from damage during endotracheal (ET) tube intubation procedures. | Class A (Self-Notified) |
23 | Inversion table | A fixed framework with a tilting table platform designed to support the body of a patient and provide traction for the back muscles and spine by allowing the patient manually invert their entire body in a supine position (feet up and head down), thereby assist patients eliminate/alleviate back pain. | Class A (Self-Notified) |
24 | Massage table/couch | A table designed for various kinds of complementary therapy. | Class A (Self-Notified) |
25 | Sitz bath | A tub filled with water, that is heated by its heating elements and circulated by its agitators, intended for use in external hydrotherapy to relieve pain or pruritus and to accelerate the healing of inflamed or traumatized tissues of the perianal and perineal areas. | Class A (Self-Notified) |
26 | Sitz bath chair | A device designed to be sat upon by a patient in a powered sitz bath for external hydrotherapy to relieve pain or pruritus and to accelerate the healing of inflamed or traumatized tissues of the perianal and perineal areas. | Class A (Self-Notified) |
Conclusion
The classification of pain management medical devices based on the Medical Device Rules 2017 is a result of continuous updating of India medical device regulatory approvals by the Central Drugs Standard Control Organization (CDSCO) in India. Pain management medical devices, which are classified based on their regulatory risk as Class A (self-notified) products (e.g., heat therapy gels & ice collars), Class B products, Class C products, and Class D products (e.g., implantable infusion pump), have to follow CDSCO's guidelines to ensure safety and efficacy of their use.
Morulaa can help you with the regulatory process for your pain management medical device in India. Contact us at admin@morulaa.com.
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