Neurological devices, instrumental in diagnosing and treating conditions related to the nervous system, are under stringent regulatory oversight in India. These devices have to be strictly regulated to ensure they are safe and effective. The Central Drugs Standard Control Organization (CDSCO) is at the helm of medical device regulation in India. Thus, CDSCO aims to protect public health and safeguard the Indian healthcare system. Hence, securing the CDSCO license for neurological medical devices is mandatory for manufacturing or importing neurological medical devices. In this guide, we offer a comprehensive look into the CDSCO registration for neurological medical devices. We have provided an overview of the CDSCO neurological medical devices classification system. Additionally, we have summarised the CDSCO license application process. Furthermore, we have provided tips on how to overcome common challenges of the CDSCO neurological medical devices license application process.

Understanding CDSCO Neurological Medical Device Classification System

Medical devices have been categorised based on the potential risks associated with their use. The CDSCO medical device classification system has been formulated to simplify the CDSCO license application process.

Neurological devices are crucial in ensuring accurate diagnosis and effective treatment of neurological conditions. Given their importance in the healthcare sector, CDSCO registration and licensing is mandatory for neurological devices. Hence, to apply for the CDSCO registration for neurological medical devices, you need to have an understanding of the CDSCO medical device classification.

CDSCO neurological medical device classes

We have listed few examples of medical devices belonging to each CDSCO class. To check which class your medical device belongs to, use our free tool.

Class A:

• Analytical non-scalp cutaneous electrode
• Analytical non-scalp cutaneous lead
• Back/leg/chest dynamometer
• Skull plate anvil
• Skull punch
• SkulI plate screwdriver
• Tuning fork
• Ultrasonic scanner calibration test block

Class B:

• Analgesic PENS system
• Analgesic TENS system
• Analytical scalp electrode
• Analytical scalp lead
• Arthritis TENS system
• Electroencephalographic simulator
• Electromyograph
• Electronystagmograph

CDSCO class C:

• Autonomic neuropathy heart rate meter
• Behavioural therapy electrical stimulation system
• Brain injury adjunctive interpretive electroencephalograph assessment aid.
• Cerebrospinal fluid manometer
• Cerebrospinal fluid shunt valve programmer
• Deep brain electrical stimulation system lead
• Depth electrode
• Diagnostic peripheral nerve electrical stimulation system

Class D:

• Analgesic spinal cord electrical stimulation system
• Aneurysm clip
• Antiseizure/psychiatric-therapy vagus nerve electrical stimulation system
• Atrial cerebrospinal fluid catheter
• Bare-metal intracranial vascular stent
• Bladder/bowel-evacuation implantable electrical stimulation system
• Brain-responsive electrical stimulation system
• Cardiac-therapy vagus nerve electrical stimulation system
• Cerebral perfusion catheter
• Coma-arousal vagus nerve electrical stimulation system
• Implantable lumbar neuromuscular electrical stimulation system pulse generator
• Implantable pulse generator mesh bag, bioabsorbable
• Implantable sleep apnoea treatment system

CDSCO Registration for Neurological Medical Devices in India

CDSCO Registration for Neurological Medical Devices: Forms and License Types

• Manufacturing class A and B neurologic medical devices: MD 5 License is required. Moreover, a fee of Rs. 5,000 for the manufacturing license and Rs. 500 for each distinct device is required. The license has to be obtained from the state licensing authority.
• Manufacturing class C and D neurologic medical devices: MD 9 License is required.Moreover,a fee of Rs. 50,000 for the manufacturing license and Rs. 1,000 for each distinct device is required. The license has to be obtained from the central licensing authority.
• Importing neurologic medical devices into India: MD 15 Import License has to be secured from the CDSCO to import neurologic medical devices into India.

Documents Required for Securing CDSCO Registration for Neurological Medical Devices

We have provided an overview of the documents required for securing the CDSCO neurological medical device license.

1. Organization identity proof
2. Sale Deed/Rent Deed of the Premises
3. Plant Master File
4. Building Layout with Dimension
5. Device Master File
6. Documents for the team of qualified and experienced staff who can manufacture and test your medical devices.
7. Test License, if required for testing the neurological medical device
8. Environmental regulation compliance documents
9. Certificate of analysis of 3 consecutive batches
10. ISO 13485 Certificate

A Step-by-step Guide for Securing CDSCO Registration for Neurological Medical Devices

The CDSCO registration journey for neurological devices involves the following primary steps:

• Documentation: Collate all necessary documents, including clinical trial data and product specifications.
• Application Submission: File the application on the CDSCO’s official online portal, SUGAM.
• Query Resolution: Promptly address any queries raised by CDSCO. Provide supporting documentation if required.
• Inspection: Be prepared for the CDSCO inspection and audit phase.
• License Approval: Once all criteria are satisfied, the CDSCO will grant the CDSCO neurological medical device license.

Common CDSCO License Application Challenges and How to Overcome Them

Manufacturers and importers applying for the CDSCO manufacturing or import license might grapple with the following challenges:

• Documentation Gaps: Ensuring all documents are current and resonate with CDSCO’s standards.
• Delays in Query Resolution: Establishing a dedicated team to address CDSCO queries swiftly.
• Inspection Hurdles: Conducting regular internal audits of facilities to ensure they resonate with CDSCO guidelines.

Validity of the CDSCO Neurological Medical Device License

CDSCO neurological medical device registration and license are valid indefinitely. However, to maintain the validity, the license retention fee has to be paid every 5 years.

New Guidelines for CDSCO Registration for Neurological Medical Devices

CDSCO, in its commitment to safeguarding patient health and ensuring top-notch product quality, has updated its guidelines. For Class C and Class D neurological devices, the focus is on meticulous testing, quality assurance, and alignment with global standards.

The Deadline: Key Dates to Remember

CDSCO has transitioned Class C and Class D neurological devices from the mandatory registration framework to a licensing structure. This has been detailed in GSR 102(E) dated 11.02.2020. This pivotal change will be in effect from October 1, 2023.

Manufacturers and importers are advised to update themselves with the latest guidelines mentioned in Medical Devices Rules (MDR) 2017. They are required to submit their applications through CDSCO’s online portal along with the required documents and fees. For a more in-depth understanding, the official CDSCO circular serves as an invaluable guide.

How Can Pharmadocx Consultants Assist in Securing the CDSCO Registration for Neurological Medical Devices?

Regulatory compliance is a testament of the manufacturer’s dedication to patient safety and product excellence. Furthermore, ensuring compliance not only builds trust but also fortifies the brand’s reputation. Moreover, CDSCO regulatory compliance will translate to consistent product quality and efficacy. However, navigating the CDSCO regulatory guidelines is a tough task. Additionally, applying for the CDSCO license is not easy. Fret not! With our support, the CDSCO neurological medical device license application process is going to be a cake walk. Pharmadocx Consultants offers a suite of services tailored for neurological device manufacturers:

• Expert Guidance: Assistance throughout the CDSCO medical device registration process.
• Mock Audits: Conducting pre-inspection audits to ensure readiness.
• Query Resolution: Our team will help you promptly address CDSCO queries.
• End-to-End Support: Comprehensive support from the initial application to license approval. We will provide support till you successfully secure the CDSCO medical device license.
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CDSCO registration for neurological medical devices ensures healthcare professionals are equipped with the most advanced tools for patient care. With seasoned regulatory partners like Pharmadocx Consultants, the registration pathway will be seamless. Need expert guidance with the CDSCO registration process for neurological devices? Partner with Pharmadocx Consultants today!