Introduction – Pain Management as Medical Device India
This article deals with the latest rules of Pain Management 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 Pain Management as Medical Device in India. All Pain Management 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.
|
Sr. No |
Medical Device Name |
Intended Use |
Risk Class |
| 1 | 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. | A |
| 2 | Acupuncture electrical stimulation system | An assembly of devices used to apply electrical stimuli to acupuncture sites. | B |
| 3 | Acupuncture kit | A collection of instruments and supplies used to perform acupuncture procedures. | B |
| 4 | Acupuncture pointdetector | An electronic probe used to precisely locate an acupuncture point on a patient’s body. | B |
| 5 | 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 |
| 6 | 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. | A |
| 7 | 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 |
| 8 | Ear microsystem needle | An instrument used in auriculotherapy to apply continuous pressure to stimulate meridian points. | A |
| 9 | 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 |
| 10 | 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 |
| 11 | 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 |
| 12 | 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 |
| 13 | Ice bag | Intended to alleviate pain and/or promote healing in minor injuries to the body or for application around the neck or limbs. | A |
| 14 | 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 |
| 15 | 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 |
| 16 | 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 |
| 17 | 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 |
| 18 | Inhalational analgesia unit | A device primarily designed to administer analgesic gases to the patient, or produce analgesic vapours for inhalation. | B |
| 19 | 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 |
| 20 | 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. | A |
| 21 | 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. | A |
| 22 | Massage table/couch | A table designed for various kinds of complementary therapy. | A |
| 23 | 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 |
| 24 | 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 |
| 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. | A |
| 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. | 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 Pain Management 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 30th September of Pain Management 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.