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CDSCO Medical Device Registration for Paediatrics and Neonatology

calendar13 Oct, 2022
timeReading Time: 7 Minutes
Paediatrics and Neonatology

The Central Drug Standard Control Organization, or CDSCO, is the national regulatory authority of India, headed by the DCGI. The Medical Device Rules, 2017, were introduced to regulate the laws and rules related to the Manufacture, Import, Clinical Investigation, Distribution and Sale of Medical devices in India. On 23rd August 2021, the DCGI notified CDSCO Medical Device Registration for Paediatrics and Neonatology, which listed 136 medical devices that would be classified as medical devices pertaining to Paediatrics and Neonatology under the Medical Device Rules, 2017.

Overview of Medical Device Rules, 2017

The government introduced the Medical device rules to differentiate medical devices and pharmaceuticals for CDSCO regulation[1]. The Medical device rules became effective on 1st January 2018.

Medical Devices are specific devices or substances meant for internal or external use, to treat, diagnose, mitigate or prevent any disorder or disease in humans or animals.

Medical devices can also be specific substances notified by the government, which are meant to affect any kind of function or structure of the human body. It also includes substances that are used for in vitro diagnosis. Devices used as surgical dressings, bandages, staples, sutures, ligatures, and Blood and blood componens, either with or without anticoagulant, may also be categorized as medical devices.

The Medical Device Rules 2017 has also introduced a risk-based classification system for regulating medical devices, which is listed as follows-

Medical device class Risk level
Class-A Low-level risk
Class-B Low-Moderate level risk
Class-C Moderate-High level risk
Class-D High-level risk

The classification, as mentioned above, is done based on the risk associated with each device. Risk types can be classified as low-level risk, low- moderate level risk, Moderate- High-level risk and High-level risk. All the medical devices falling into the respective categories are divided into classes A, B, C and D, respectively. The classification makes it much easier to identify the medical devices for their registration and intended use.

Classification of medical devices in India

In India, Medical devices are broadly identified into two types-

  • Notified medical devices
  • Non Notified medical devices

Earlier, there was regulation on only notified medical devices, but later, CDSCO issued a notice which invited the voluntary registration of non-notified medical devices by a given deadline. The deadline for voluntary registration of Class A and Class B medical devices is 1st October 2022, and the deadline for Voluntary registration of Class C and Class D medical devices is 1st October 2023. After the deadline is crossed, even the non-notified medical devices shall fall on the ambit of mandatory registration. Earlier, only 37 medical devices were notified in India. Still, as the medical device sector has increased in India, various unregulated medical devices are exposed to Indian customers, exposing multiple health and life threats.

The Ministry of Health and Family Welfare was notified on 11th February 2020, inviting voluntary registration of all non-notified medical devices in India. Regarding this, another notice was issued on 3rd September 2020, which listed 24 new non-notified medical devices for CDSCO medical device registration. The list also notified about CDSCO Medical Device Registration for Paediatrics and Neonatology along with another medical device, as listed below –

S.L. No. Categories of medical device
1 Anaesthesiology            
2 Pain Management            
3 Cardiovascular             
4 Dental                     
5 Ear, Nose, Throat (ENT)    
6 Gastroenterological        
7 Urological                 
8 General Hospital           
9 Operation Theater (O.T.)     
10 Respiratory                
11 Neurological               
12 Personnel use              
13 Obstetrical and Gynaecological (O.G.)
14 Ophthalmic                 
15 Rehabilitation             
16 Physical support           
17 Interventional and Radiology
18 Rheumatology               
19 Dermatology and Plastic Surgery
20 Paediatric and Neonatology Medical
21 Oncology                   
22 Radiotherapy               
23 Nephrology and Renal care  
24 Software                   

Classification of Paediatric and Neonatology Medical

The DCGI notified on 23rd August 2021, notifying the classification of medical devices pertaining to Paediatric and Neonatology Medical under the Medical device rules 2017.

According to the notification, a total of 136 medical devices fall under the CDSCO Medical Device Registration for Paediatrics and Neonatology category, listed according to the class risks and intended use.

Following is the list of classifications for the same-

Sr.no. Name of Product Class
1 Aerosol tent, paediatric B
2 Airway Pressure /Oxygen Monitor B
3 Anaesthesia Facemask, single-use (paediatric) B
4 Anaesthesia Facemask, reusable (paediatric) B
5 Antimicrobial endotracheal tube, paediatric C
6 Assistive ergonomic chair mobility base A
7 Breathing circuit gas flow sensor, reusable C
8 Breathing circuit gas flow sensor, single-use C
9 Cerebral oximeter C
10 Circulating-air whole-body heating/cooling system pad, reusable B
11 Circulating-air whole-body heating/cooling system pad, single-use, sterile B
12 Circulating-fluid whole-body heating/cooling system pad, reusable B
13 Circulating-fluid whole-body heating/cooling system pad, single-use B
14 Closed-ended adhesive infant/paediatric urine collection bag B
15 Craniofacial bone screw, bio absorbable D
16 Craniofacial bone screw, non bio absorbable, sterile C
17 Electric pad whole-body heating system B
18 Electric pad whole-body heating system pad B
19 Enteral feeding kit, adult/paediatric, sterile B
20 Exhaled-gas oesophageal intubation detector, paediatric A
21 External counterpulsation system, paediatric B
22 External defibrillator electrode, paediatric, reusable B
23 External defibrillator electrode, paediatric, single-use B
24 Flexible bone nail, non-sterile C
25 Flexible bone nail, sterile C
26 Funnel chest remodelling bar C
27 Growth-correction orthopaedic fixation plate kit C
28 Hepatic ultrasound elastography system applicator B
29 Infant apnoea monitor C
30 Infant bed crib top B
31 Infant bed restraint B
32 Infant care table A
33 Infant heat shield B
34 Infant incubator control unit C
35 Infant incubator warming hood A
36 Infant inguinal hernia truss A
37 Infant limb immobilizer, reusable A
38 Infant limb immobilizer, singleuse A
39 Infant resuscitation cabinet B
40 Infant resuscitation table B
41 Infant scale, electronic A
42 Infant sleep positioner A
43 Infant warmer C
44 Infant whole-body immobilizer, reusable A
45 Infant whole-body immobilizer, single-use A
46 Infant/regional-body warmer C
47 Infant-hammock bed mattress A
48 Infant-hammock bed mattress overlay A
49 Internal defibrillator electrode, paediatric C
50 Lacrimal intubation set C
51 Liquid crystal vein locator B
52 Micro laryngeal probe A
53 Multifunction cardiac electrode, paediatric C
54 Neonatal chest percussor B
55 Neonatal CPAP unit C
56 Neonatal electrocardiographic electrode B
57 Neonatal hypothermia cot B
58 Neonatal hypothermia cot heat conduction mattress B
59 Neonatal hypothermia cot heat-retention pad B
60 Neonatal intensivecare ventilator C
61 Neonatal kangaroo care garment A
62 Neonatal physiologic monitoring system C
63 Neonatal pulmonary surfactant catheter A
64 Neonatal/paediatric heart rate monitoring application software C
65 Neonatal/paediatric heart rate monitoring hardware C
66 Nitric oxide delivery unit, system-based C
67 Non-rechargeable public semi-automated external defibrillator electrode, paediatric B
68 Open-ended adhesive infant/paediatric urine collection bag A
69 Open-surgery manual linear cutting stapler, reprocessed C
70 Open-surgery manual linear cutting stapler, reusable C
71 Open-surgery manual linear cutting stapler, single-use C
72 Open-surgery manual linear stapler, reusable C
73 Open-surgery manual linear stapler, single-use C
74 Ophthalmic tonometer, battery operated B
75 Orthopaedic medialization instrument B
76 Oxygen administration hood, paediatric A
77 Oxygen administration tent, neonatal/paediatric A
78 Paediatric bed B
79 Paediatric blood donor set B
80 Paediatric cardiopulmonary bypass cannula C
81 Paediatric dental chair, electric B
82 Paediatric dental chair, mechanical B
83 Paediatric dorsiflexion slant board A
84 Paediatric strabismus screening scanner B
85 Paediatric urine collection/analysis kit A
86 Paediatric temperature nasogastric/orogastric tube B
87 Polyglyconate suture D
88 Blanket/pad infant phototherapy unit B
89 Flotation therapy bed, neonatal B
90 Mobile steam washer/disinfector C
91 Otoacoustic emission system, battery-powered B
92 Otoacoustic emission system, line-powered B
93 The overhead infant phototherapy unit B
94 Phototherapy eye protector, reusable A
95 Phototherapy eye protector, single-use A
96 Respiratory gas heating wire, infant C
97 The stationary pneumatic high-frequency ventilator respiration monitor C
98 Syringe pump C
99 Thoracic electrical impedance segmentography system B
100 Thoracic electrical impedance segmentography system electrode array B
101 Transcutaneous intracranial pressure sensor C
102 Wearable neonatal heart rate meter B
103 Antimicrobial infant garment B
104 Birthing bath A
105 Boiling water sterilizer B
106 Newborn-infant bed A
107 Resuscitator face mask, reusable B
108 Resuscitator face mask, single-use B
109 Warming infant bed, adjustable C
110 Warming infant bed, non-adjustable C
111 Bedrail pad A
112 Blanket/pad infant phototherapy unit tester B
113 Blood transfusion set, exchange B
114 Blue light radiometer B
115 Cardiac septostomy catheter, balloon C
116 Cardiac septostomy catheter, blade C
117 Conventional infant incubator C
118 Cranial orthosis B
119 Home BPAP unit B
120 Multi-purpose saline solution B
121 Nappy changing table, portable A
122 Nasal aspirator, electric A
123 Open infant incubator C
124 Oral medicine dropper A
125 Oxygen breath analyzer C
126 Oxygen terminal unit A
127 Pulmonary function analysis system, paediatric B
128 Reactive-gel heating pad B
129 Respiratory apnoea monitoring system C
130 Rocking infant bed, electric B
131 Skin transilluminator, battery-powered C
132 Skin transilluminator, line-powered C
133 The teething device, fluid-filled B
134 The teething device, nonfluid-filled A
135 Transport infant incubator C
136 Visual-reinforcement audiometry reward system B

Documents required for CDSCO Medical Device Registration for Paediatrics and Neonatology

The following is a checklist for CDSCO Medical Device Registration for Paediatrics and Neonatology:

  • Application form
  • Challan TR6
  • Power of Attorney
  • Certificate of quality assurance
  • C.E. Design accreditation
  • ISO 13485
  • Declaration of conformity
  • Schedule D(I)
  • Plant Master File
  • An Undertaking stating that the information is correct
  • Device master file
  • Free sale certificate

Procedure for CDSCO Medical Device Registration for Paediatrics and Neonatology

Following is the procedure to apply for CDSCO Medical Device Registration for Paediatrics and Neonatology-

  1. The applicants must first check the Medical Devices and IVDs list to see if a medical device has been notified or not. All non-notified medical devices must complete voluntary registration before the deadline to be marketed in India.
  2. In cases where the medical device manufacturer is not an Indian, an Indian Authorized Agent is chosen on his behalf. He is in charge of performing the manufacturer’s responsibilities. The IAA conducts all of its official business in India and represents the manufacturer in court.
  3. All necessary paperwork and documentation must be submitted to the relevant authorities to obtain a registration license.
  4. The manufacturer receives the license once the authorities are pleased with all the paperwork and other requirements.

Conclusion

The CDSCO Medical Device Registration for Paediatrics and Neonatology has been listed by the government for registration as medical devices. A notice was issued on 3rd September 2020, which listed 24 new devices which were to be included in the list of medical devices. The medical devices are required to be registered before being manufactured, imported, sold or marketed in India. However, the process of registration can be technical, and a slight mistake might lead to considerable challenges in terms of funds and time. It is always better to connect with an experienced professionals for CDSCO Medical Device Registration for Paediatrics and Neonatology to save time and money wasted on any failure.

Read our Article:Classification of Medical Devices in Operation Theatre

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