CDSCO Paediatrics & Neonatology Medical Devices License

India has a growing demand for paediatric and neonatology medical devices, which has made regulatory compliance a top priority for manufacturers and importers. The CDSCO paediatrics and neonatology medical devices license is a requirement that must be met to manufacture, import, or market these products in the country. If you plan to introduce advanced neonatal ventilators or innovative paediatric monitoring systems, understanding how the CDSCO framework works is significant.

In this article, we’ll explain the process to procure the CDSCO paediatrics and neonatology license in India. We’ll go over the application process, classification of devices, and the stages for obtaining both manufacturing and import licenses for paediatrics and neonatology medical devices.

Table of Contents

CDSCO’s Role in Paediatrics & Neonatology Medical Devices

The Central Drugs Standard Control Organization (CDSCO) is India’s national regulatory authority. It oversees the quality, safety, and performance of medical devices. For paediatric and neonatology equipment, such as infant apnoea monitor, incubators and oxygen monitor, this issuing authority makes sure that they abide by the strict safety and performance benchmarks.

The CDSCO paediatrics medical devices license and CDSCO neonatology medical devices license are evidence of your devices being safe and do not cause irritation, infections, or even complications to the vulnerable patient group consisting of infants and children.

Classification of Paediatrics & Neonatology Medical Devices

The CDSCO follows a risk-based classification system, which has a great effect on the licensing process. The official CDSCO classification of paediatrics and neonatology Medical Devices determines the right documentation, technical assessments, and the approval timeline.

S. No	Name of Product	Risk 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, bioabsorbable	D
16	Craniofacial bone screw, non- bioabsorbable, 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, single- use	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	Microlaryngeal 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 intensive- care 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	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	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 analyser	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	Teething device, fluid- filled	B
134	Teething device, non- fluid-filled	A
135	Transport infant incubator	C
136	Visual-reinforcement- audiometry reward system	B

CDSCO Classification of Paediatrics and Neonatology Medical Devices

Class	Risk Level	Examples of Devices
Class A	Low Risk	Infant Care Table
Class B	Low-Moderate Risk	Wearable neonatal heart rate meter, Rocking Infant bed electric, Teething device, fluid filled
Class C	Moderate-High Risk	Neonatal CPAP Unit, Neonatal intensive-care ventilator
Class D	High Risk	Craniofacial bone screw, bioabsorbable

When Is A CDSCO Paediatrics & Neonatology License Required?

If you fall into one of the following categories, you must register and gain approval for the license by CDSCO.

Manufacturer of paediatric or neonatology devices in India
Import paediatric or neonatology medical devices from overseas
Distributor of medical devices
An entity conducting R&D activities
Foreign enterprise holding an Indian subsidiary

Import License for Paediatrics & Neonatology Medical Devices

The import license Form MD-15 is essential for foreign manufacturers to ensure that their devices follow India’s safety, quality, and performance standards before they enter the Indian market. For this, you need to appoint an Indian Authorized Agent, or IAA, who will then obtain a Medical Device Registration Certificate (Form MD-42).

The import license process follows the steps given below:

Appoint an IAA who has a valid manufacturing or wholesale license (Form 20B, 21B) or Medical Device Registration Certificate (Form MD-42), as it authorizes them to import your paediatric or neonatology medical devices.
Submit the Form MD-14 online at the Medical Device Sugam Portal. Fill the form with the needed documents, like the manufacturer’s details, device classification, international certifications, Free Sale Certificate from the country of origin, Plant master file and Device master file.
Once Form MD-15 or the import license for paediatric or neonatology medical device is issued, importers can proceed with customs clearance for their products.

Documentation for CDSCO Paediatrics & Neonatology Medical Devices License for Manufacturers and Importers

Manufacturers and importers must abide by a list of comprehensive documentation. It applies to both the CDSCO Paediatrics Medical Devices license and the CDSCO Neonatology Medical Devices license, and covers the following:

Device Master File (DMF)
Plant Master File (PMF)
ISO 13485 certification
CE/FDA approvals (if applicable)
Test License in Form MD-13 (for domestic manufacturers)
Clinical evaluation reports (where required)
Test reports from accredited labs
Power of Attorney (for imports)
Free Sale Certificate (for imports)

Steps to Obtain License for CDSCO Paediatrics & Neonatology Medical Devices in India

To gain the regulatory approval, you need to follow these steps. It starts with device classification, application submission, audit by the issuing authority officials, and finally the issuance of license.

Step	Description
Step 1	Device Classification for Paediatrics & Neonatology – The first step is to classify the paediatric or neonatology medical device according to CDSCO regulatory guidelines. Accurate classification determines the applicable regulatory pathway for devices like neonatal ventilators, paediatric thermometers, and other life-support equipment.
Step 2	Documentation Preparation – Prepare all necessary supporting documents for paediatric and neonatology devices, including technical details, safety data, clinical evaluation reports, and quality certifications relevant to the device.
Step 3	Application Form Completion – Fill out the applicable CDSCO registration form for Paediatrics Medical Devices license or Neonatology Medical Devices license with all required information, ensuring accuracy and completeness.
Step 4	Online Submission – Submit the completed application online through the CDSCO portal along with the necessary fees and documents, ensuring it is categorized under the correct device class.
Step 5	Review and Inspection – CDSCO officials will verify the submitted documents and review the application. For paediatric and neonatology devices, a facility inspection may be conducted, in case of domestic manufacturers to check whether it meets the compliance standards of manufacturing as per MDR-2017.
Step 6	Approval and Licensing – Upon successful evaluation, CDSCO will approve the paediatric or neonatology medical device and issue the required license. This authorises the legal sale and distribution of paediatric or neonatology devices in India.

License and Application Fee for Medical Devices

Depending on the classification of your medical device, the application process, fees, and processing time can be distinct. Below is a detailed overview of the CDSCO licensing requirements for each class of paediatrics and neonatology devices, as well as fees associated with your licence:

Device Class	Government Fees	Licensing Authority	Required Licenses
Manufacturing License for Paediatrics & Neonatology Devices
Class A	Rs. 5,000 for one site and Rs. 500 for each medical device.	State Licensing Authority (SLA)	Form MD 5/ Form MD 6
Class B	Rs. 5,000 for one site and Rs. 500 for each medical device.	State Licensing Authority (SLA)	Form MD 5/ Form MD 6
Class C	Rs. 50,000 for one site and Rs. 1,000 for each medical device.	CDSCO (Central Licensing Authority)	Form MD 9/ Form MD 10
Class D	Rs. 50,000 for one site and Rs. 1,000 for each medical device.	CDSCO (Central Licensing Authority)	Form MD 9/ Form MD 10
Import License for Paediatrics & Neonatology Devices
Class A	USD 1,000 for one Foreign manufacturing site and USD 50 for each medical device.	CDSCO (Central Licensing Authority)	Form MD 15
Class B	USD 2,000 for one Foreign manufacturing site and USD 1,000 for each medical device.	CDSCO (Central Licensing Authority)
Class C	USD 3,000 for one Foreign manufacturing site and USD 1,500 for each medical device.	CDSCO (Central Licensing Authority)
Class D	USD 3,000 for one Foreign manufacturing site and USD 1,500 for each medical device.	CDSCO (Central Licensing Authority)

*Note that this license is valid for 5 years and is renewable with a retention fee before expiry.

How Dueran Consultant Helps You?

As a leader in CDSCO regulatory service provider, matching the industry requirements, Dueran Consultant helps you identify the applicable guidelines, the class of your device, and the documentation. We also notify you of any changes to the process and respond promptly to CDSCO queries. You can trust us to handle the complexities of this process.

We’ll make sure that everything runs smoothly while you provide the necessary information as needed. Reach us through phone, call, or email, and we’ll quickly schedule a no-obligation consultation.

Conclusion:

The licensing process for CDSCO paediatrics & neonatology medical devices is rigorous, but imperative for patient safety and product quality. No matter the license you apply for, it can be a CDSCO Paediatrics Medical Devices license or a CDSCO Neonatology Medical Devices license, you must be aware of your device’s classification, key documentation, and approval steps, as mentioned above.

CDSCO Paediatrics & Neonatology Medical Devices Licensing in India