This article deals with the latest rules of Physical Support as a Medical Device in 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 Physical Support and Medical Device in India. All Physical Support 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 38.
Table: Physical Support As Medical Device India
| S.No | Name of the MedicalDevice | Intended use | Classification |
| 1 | Ankle continuous passivemotion exerciser | Electrical device intended tocontinuously move the ankle joint (e.g.,flexion, inversion/eversion) withoutpatient assistance during continuouspassive motion (CPM) exercisetherapy usually following surgery ortrauma to the joint. | B |
| 2 | Ankle/foot orthosis | Intended to encompass the ankle joint,or the ankle and foot, to support, align,prevent, or correct orthopaedicdeformities/injuries or to improvefunction of the ankle and/or foot; it mayalso be intended to offload andredistribute foot pressures that affectpedal circulation to improve blood flowand help heal diabetic foot ulcers orpostsurgical wounds. | A |
| 3 | Balance board | Intended to train patient with difficultiesin balance (e.g., a paraplegic or astroke victim) walks for balancetraining. | A |
| 4 | Bed traction frame | Intended to treat patients with fracturesand other orthopaedic disorders (e.g.,of the lower or cervical spine, hip). | A |
| 5 | Body arch traction table | Intended to support the body of apatient and provide traction for theback muscles and spine by flexing thepatient into a reverse supine bodyarch. | A |
| 6 | Canalith repositioningprocedure chair, manual | Intended to treat balance disorders[e.g., benign paroxysmal positionalvertigo (BPPV), canalithiasis] causedby displaced canaliths (otoconia) in theinner ear of the patient | A |
| 7 | Cervical spine collar | Intended to support or immobilize thecervical spine to treat deformities,fractures, sprains, or strains (often totreat whiplash resulting from anautomobile accident). | A |
| 8 | Cervical spineimmobilization head ring | Intended to be fixed to the skull of apatient at brow level using pointed,steel, threaded bolts (typically four)that are adjusted to penetrate the outerbone of the skull. | D |
| 9 | Cervicothoracic spineorthosis | Intended to support or immobilizedeformities, fractures, sprains, orstrains of the cervicothoracic spine. | A |
| 10 | Cervicothoracolumbosacralspine orthosis | Intended to encompass thecervicothoracolumbosacral spineregion of the neck and trunk. | A |
| 11 | Chest-oscillation airwaysecretion clearing system | Intended to rapidly inflate and deflateagainst the chest wall of the patient forpromoting airway clearance bycreating high frequency chest walloscillation (HFCWO), resulting in themobilization of bronchial secretions. | B |
| 12 | Collar and cuff arm slingmaterial | Fabric and form composite materialintended to immobilize forearm, elbow,humerus or shoulder injuries. | A |
| 13 | Cranial orthosis | Intended to be worn on the head of aninfant with an abnormal head shape(e.g., due to plagiocephaly,brachycephaly, scaphocephaly), orafter craniosynostosis repair surgery,to apply pressure to the cranium andimprove cranial symmetry/shapeduring growth over a period of months. | A |
| 14 | Elbow orthosis | Intended to encompass the elbow jointto support, align, prevent, or correctdeformities/injuries or to improvefunction of the elbow. | A |
| 15 | Finger orthosis | Intended to encompass the whole orpart of the finger to support, align,prevent, or correct deformities/injuriesor to improve function of the finger. | A |
| 16 | Flotation therapy bed,adult | Intended to minimize pressure pointson a patient’s body by providingcontact with as much of the bodysurface as possible, typically through amattress that contains a large volumeof constantly moving media, e.g.,water, air, or mud that lifts the patientto simulate a floating effect. | B |
| 17 | Flotation therapy bed,neonatal | Intended to minimize pressure pointson neonatal patient’s body byproviding contact with as much of thebody surface as possible, typicallythrough a mattress that contains alarge volume of constantly movingmedia, e.g., water, air, or mud that liftsthe patient to simulate a floating effect. | B |
| 18 | Foot orthosis | Intended to encompass the whole orpart of the foot, or designed as aplantar insert, and intended to providerigid or semi-rigid correction of the footfor persons with orthopaedicdeformities/injuries of the feet | A |
| 19 | Hand orthosis | Intended to encompass the whole orpart of the hand to support, align,prevent, or correct deformities/injuriesor to improve function of the hand. | A |
| 20 | Hand/finger splint | Intended to immobilize an injured handto protect injuries to, e.g., the digits,metacarpals, and wrist during thehealing process. | A |
| 21 | Hand/wrist continuouspassive motion exerciser | A mains electricity (AC-powered)deviceIntenedd to continuously movethe metacarpal/interphalangeal joints(e.g., flexion and extension) withoutpatient assistance during continuouspassive motion (CPM) exercisetherapy usually following surgery ortrauma to the joints. | B |
| 22 | Hip/knee continuouspassive motion exerciser | A mains electricity (AC-powered)device Intended to provide continuouspassive motion (CPM) exercisetherapy for the hip and/or knee,typically following joint surgery/traumato promote healing; some types mayalso operate with patient assistanceunder controlled active motion (CAM). | B |
| 23 | Horizontal non-poweredtraction system | Non powered device intended to beattached to a table for the applicationof constant horizontal traction forces tothe cervical or lumbar vertebrae bymeans of attached harnesses whilstthe patient typically lies in a supineposition on the table during treatment. | A |
| 24 | Incentive spirometer | Intended to be used in respiratorytherapy to encourage and motivatedeep-breathing manoeuvres, typicallyfor the postsurgical treatment andprevention of atelectasis (lungcollapse) and to help facilitate airwayopening and clearing. | A |
| 25 | Intermittent traction system | It is an AC powered electronic device.Intended to apply and relieve pre-settraction forces from a motor throughharnesses typically attached to thecervical or lumbar vertebrae. | B |
| 26 | Kinetic bed | Intend to enable continuous change ofthe patient’s lying position, e.g., it cantilt the entire bed mattress supportsystem (this includes the mattress, theframework that supports the mattress,and the bedding) lengthways,sideways or to a near vertical tilt. | A |
| 27 | Knee immobilizer | Intended to temporarily render theknee immovable, either preoperativelyor following injury or arthroscopy. | A |
| 28 | Neuro-controlledambulation exoskeleton | Intended to assist a patient with awalking disability (neurogenic,muscular, or osseous in origin) regainlost motor function by transmission ofthe patient’s residual nerve function,via cutaneous electrodes, to the devicemotor assembly. | C |
| 29 | Orthopaedic bed | Intended to provide support for skeletaltraction to stabilize fracture sites. | A |
| 30 | Paediatric dorsiflexionslant board | Intended to be used in the treatment ofvarious medical conditions (e.g.,congenital, neurological, post-traumatic) in paediatrics, where tendontightness and muscle contractureaffect the ability to dorsiflex the foot,possibly leading to an abnormal gait | A |
| 31 | Parapodium walking frame | Intended to encompasses and providesupport for the body of a patient who isunable to stand unassisted to helpthem move (walk) by changing theircentre of gravity (COG). | A |
| 32 | Physical therapy massager | Electrically powered device intended toprovide therapeutic massage to alarger area than hand-held massagingdevices. | B |
| 33 | Shoulder continuouspassive motion exerciser | It is a mains electricity (AC-powered)device Intended to continuously movethe shoulder joint (e.g., flexion,rotation, adduction/abduction) withoutpatient assistance during continuouspassive motion (CPM) exercisetherapy usually following surgery ortrauma to the joint. | B |
| 34 | Shoulder immobilizer | Intended to temporarily immobilize orlimit abduction of the shoulder joint tosupport healing of an injury or asurgical wound. | A |
| 35 | Swivel-walker | Intended to encompasses and providesupport for the body of a patient who isunable to stand unassisted, to helpthem move (walk) by rocking sideways(shifting their weight from side-to-sidewith a shoulder movement) whichmakes the footplate of the deviceswivel so that it “walks” forward. | A |
| 36 | Toe separator | Intended to space the toes of the footto relieve pain, pressure/frictionbetween toes, and/or to facilitaterealignment of the toes to a naturalposition. | A |
| 37 | Traction table, line-powered | Intended to support a patient and toprovide traction for the back musclesand spine (e.g., lumbar, cervical) by amotorized mechanical manipulation ofthe spine. | B |
| 38 | Wrist immobilizer | Intended to temporarily render thewrist immovable as therapy for non-displaced fractures, strains, sprains,and muscle injuries of the wrist. | 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 Physical Support 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 Physical Support 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.