CDSCO Neurological Medical Devices Registration in India

Medical devices that help diagnose and treat neurological conditions (issues related to the brain and nervous system) are advancing rapidly in India. But before they are used to save the lives of patients, CDSCO ensures that they meet rigorous safety standards. If you manufacture or import neurological medical devices in India, you must note the updated requirements. It will facilitate you in getting the manufacturing (MD-5, MD-6, MD-9 and MD-10) or import (MD-15) license quickly. Keep reading as we explain all that you should do to produce and sell neurological medical devices in India.

Table of Contents

What CDSCO Says About Neurological Medical Devices?

The CDSCO, or Central Drugs Standard Control Organisation, is India’s primary medical device regulator under the Ministry of Health and Family Welfare. It operates through the Drug Controller General of India (DCGI), who leads all regulatory operations.

Few years back, CDSCO published its foundational neurological device classification list. CDSCO medical device classification for Neurology ensures that all devices meet regulatory standards. Based on the risk class of every device, it needs to undergo a specific licensing process.

CDSCO Medical Device Classification for Neurology

CDSCO license for neurological medical devices operates on a risk-based classification framework, dividing devices into 4 risk categories. These are:

Low-risk Class A devices
Low to moderate risk Class B devices
Moderate high-risk Class C devices
High-risk Class D devices

The class-wise list of medical devices is published by the CDSCO which shows the regulatory requirements and allows manufacturers to plan the product development, testing, and approval processes of their neurological devices. You can also refer to the table below to check which class your device belongs to. From deep-brain stimulation systems, neurostimulators, to Electroencephalographic monitoring systems, and more, everything is classified here.

S No.	Device Name	Risk Class
1	Analgesic PENS system	B
2	Analgesic TENS system	B
3	Analytical non- scalp cutaneous electrode	A
4	Analytical non- scalp cutaneous lead	A
5	Analytical scalp electrode	B
6	Analytical scalp lead	B
7	Aneurysm clip	D
8	Antiseizure/psychiatric-therapy vagus nerve electrical stimulation system	D
9	Atrial cerebrospinal fluid catheter	D
10	Autonomic neuropathy heart rate meter	C
11	Bare-metal intracranial vascular stent	D
12	Behavioural therapy electrical stimulation system	C
13	Bladder/bowel- evacuation implantable electrical stimulation system	D
14	Brain injury adjunctive interpretive electroencephalograph assessment aid.	C
15	Brain-responsive electrical stimulation system	D
16	Cardiac-therapy vagus nerve electrical stimulation system	D
17	Cerebral perfusion catheter	D
18	Cerebrospinal fluid manometer,	C
19	Cerebrospinal fluid shunt valve programmer	C
20	Coma-arousal vagus nerve electrical stimulation system	D
21	Cortical electrode	D
22	Cranial bur	A
23	Cranial electrotherapy stimulator	D
24	Cranial perforator	B
25	Cranial trephine	A
26	Craniotomy power tool system handpiece	C
27	Cryogenic surgical device.	D
28	Cutaneous electrode.	B
29	Deep-brain electrical stimulation system	D
30	Deep-brain electrical stimulation system lead	C
31	Depth electrode	C
32	Diagnostic peripheral nerve electrical stimulation system	C
33	Diagnostic somatosensory tactile stimulation system	B
34	Diskectomy system, percutaneous, automatic	D
35	Dura mater sealant	C
36	Echoencephalograph	C
37	Ejaculation electrical stimulation system	C
38	Electroconvulsive therapy system	C
39	Electroencephalogram (EEG) signal spectrum analyser	B
40	Electroencephalograph electrode/lead tester	B
41	Electroencephalograph test signal generator	B
42	Electroencephalograph tester	A
43	Electroencephalograph	C
44	Electroencephalographic electrode cap	B
45	Electroencephalographic long-term ambulatory recorder	B
46	Electroencephalographic monitoring system	C
47	Electromyograph	B
48	Electronystagmograph	B
49	Epicranial brain electrical stimulation system	C
50	Esthesiometer	A
51	Extramuscular diaphragm/phrenic nerve electrical stimulation system	D
52	Facial nerve locating system	B
53	Gait- enhancement electrical stimulation system, external	B
54	Gait-enhancement electrical stimulation system, implantable	D
55	Home seizure monitoring system	C
56	Human dura mater	D
57	Implantable pulse generator mesh bag, bioabsorbable	D
58	Implantable spinal cord electrical stimulation system programmer	C
59	Implanted cerebellar stimulator	D
60	Implanted diaphragmatic/phrenic nerve stimulator	D
61	Implanted intracerebral/subcortical stimulator for pain relief	D
62	Implanted neuromuscular stimulator	D
63	Implanted spinal cord stimulator for bladder evacuation	D
64	Intracranial pressure monitor device	D
65	Intramuscular diaphragm/phrenic nerve electrical stimulation system	D
66	Intramuscular diaphragm/phrenic nerve electrical stimulation system programmer	C
67	Intranasal cooling system	C
68	Invasive- detection physiological monitor	C
69	Leukotome	B
70	Magnetoencephalography system	B
71	Manual surgical saw, flexible	B
72	Meningeal prosthesis	D
73	Nasopharyngeal electrode	C
74	Needle electrode	C
75	Nerve conduction velocity measurement device	C
76	Nerve guide, bioabsorbable, animal-derived	D
77	Nerve guide, bioabsorbable, synthetic	D
78	Nerve guide, non- bioabsorbable	D
79	Neurological endoscope	C
80	Neurological stereotactic surgery system	C
81	Neuromuscular transmission electrical skin sensor	C
82	Neuromuscular transmission motion sensor	B
83	Neuropsychiatric interpretive electroencephalograph assessment aid	C
84	Neurosurgical chair	A
85	Neurosurgical head holder (skull clamp)	B
86	Neurosurgical headrests	A
87	Neurosurgical microscope	B
88	Neurosurgical ultrasound navigation system	B
89	Non- electroencephalogram (EEG) physiological signal-based seizure monitoring system	C
90	Nonpowered neurosurgical instrument	A
91	Olfactometry system	C
92	Percussion hammer, manual	A
93	Percussor	A
94	Photodiode subretinal prosthesis system	C
95	Physical therapy ultrasound/neuromuscular stimulation system	B
96	Pinwheel	A
97	Rheoencephalograph	D
98	Scalp clip	C
99	Scoliosis- treatment electrical stimulation system	D
100	Skull plate anvil	A
101	Skull punch	A
102	Skullplate screwdriver	A
103	Stereotactic neuronavigation/ planning system	B
104	Stereotactic radiosurgical system	D
105	Tibial nerve percutaneous incontinence- control electrical stimulation system	D
106	Transcranial electrical stimulation system, continuous- current and pulsed-current	B
107	Transvenous phrenic nerve electrical stimulation control unit	D
108	Tuning fork	A
109	Ultrasonic scanner calibration test block	A
110	Vagus nerve electrical stimulation system programmer	C

Which License Do You Need to Manufacture Your Neurological Device in India?

Once you know the risk-based classification of your neurological device, you can apply for one or both of the following licenses.

Class A and B devices with low to moderate risk require the MD-5/ MD-6 manufacturing license which will be issued by the State Licensing Authority (SLA).
Class C and D devices with moderate to high risk require the MD-9/ MD-10 manufacturing license, which will be issued by the Central Licensing Authority (CDSCO).

Which License Do You Need to Import Your Neurological Device in India?

The MD-15 is the import license for neurological devices. To apply for it, importers must fill out the MD-14 application form. The entire process is overseen by CDSCO and, if done properly, gets approval in a stipulated time.

Checklist for the Manufacturing License of Neurological Devices

Your application to manufacture Neurological Medical devices needs the following documents:

Device master file with extensive Device Details
Plant/Site Master File (PMF/SMF) describing the manufacturing facility, layout, processes, and controls
Quality management procedures
ISO 13485 certification or equivalent quality management documentation
Product test reports from approved laboratories
Post-market surveillance and adverse event reporting plan
Proof of facility ownership or lease
Building layout with room dimensions
Technical staff qualifications
Government Fees as per the Medical Devices Rules 2017

Safety/clinical safety summary, where applicable

How to Get the Form MD-15 License to Import Neurological Devices in India?

CDSCO issues Form MD-15 license for all imported medical Neurological devices. Regardless of your product’s risk class, you must follow the regulatory process for MD-15 in order to gain approval. If the following documents are accurate and are submitted on time, you receive the license in stipulated time.

Application in Form MD-14
Regulatory approvals from the country of origin
Free Sale Certificate proving the device is freely sold in the country of origin
Free Sale Certificate from any of the following countries like United States of America (USA), the United Kingdom (UK), the European Union, Canada, Australia or Japan.
Device master file with complete technical specifications
Plant Master File as per the Medical Devices Rules 2017
Quality management system certification (ISO 13485 or equivalent)
Risk management documentation
Post-market surveillance Data
Audit Report

Concluding Words:

That’s all you need to know to manufacture or import neurological devices in India. Do not consider the CDSCO medical device classification for Neurology merely a regulatory obligation. It is your commitment to Indian neurological patients. At the same time, growing neurological disease burden and healthcare investment have created genuine opportunities for quality neurological devices. Professional regulatory guidance accelerates your market entry and establishes a foundation for sustained business growth.

If you are trying to get a license for the first time or simply don’t have enough time to understand the changing regulatory needs, feel free to seek our support. Dueran Consultant experienced team stands ready to guide you toward successful CDSCO approval and sustained market leadership. We have been helping importers and manufacturers simplify medical device licensing complexities so they can bring their products to market faster while being compliant. You can seek our customised assistance anytime and be assured of 100% approval from the Indian regulatory authorities.

Frequently Asked Questions (FAQ’s)

1. Can a Foreign Manufacturer Apply for MD-15 Directly?

Answer: No. A foreign manufacturer cannot apply for an MD-15 import license directly in India. Under the Medical Device Rules 2017, the MD-15 license is always issued to an Indian entity, an authorised Indian agent, distributor, or importer who holds a valid wholesale/distribution license (Form 20B/21B or MD‑42 for medical devices). They must be a registered legal entity in India with an active CIN and an Indian resident signatory.

Import License for your Neurological Device:

Here are the steps to appoint an Indian authorised agent to get an import license for your neurological device.

Identify the agent. Shortlist importers, distributors, or regulatory firms that already hold 20B/21B or MD‑42 license.
Issue a Power of Attorney (POA) that authorises the Indian agent to act on the manufacturer’s behalf for all CDSCO matters for obtaining the MD‑15 license.

In a separate agreement, clearly assign obligations to the agent for post‑market surveillance and SAE reporting, labelling, vigilance communication, and license renewals and change notifications.