CDSCO Medical Device Registration for 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 23^rd 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 1^st 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 1^st October 2022, and the deadline for Voluntary registration of Class C and Class D medical devices is 1^st 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 11^th February 2020, inviting voluntary registration of all non-notified medical devices in India. Regarding this, another notice was issued on 3^rd 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 23^rd 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 3^rd 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.

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