A Guidance for Neurological Devices Manufacturing and Regulatory Compliance

What are Neurological devices? 

Numerous neurological disorders and conditions, including Alzheimer’s disease, Parkinson’s disease, major depression, epilepsy, spinal cord injury, and traumatic brain damage, can be identified, prevented from occurring, and treated with the aid of Neurological devices. 

Examples of Neurological devices are: 

• Neurodiagnostics devices –these are the devices which are used to diagnose and monitor number of conditions affecting the brain, identify the cause of problem such as memory problems falls under this type of devices.  
• Neurointerventional devices- this area is emerging area in the study of neurology as the rise in prevalence of stroke and brain cases. The market for the devices like embolic coils, flow diverters is expected to grow in near future. 
• Neurostimulation devices – These devices are the devices which delivers electrical stimulation to electrodes implanted in specific areas of the brain to control the movement in order to block abnormal nerve signals that cause the symptoms. 

The neurological devices such as DBS (deep brain stimulation) or Spinal cord stimulation (SCS) are used to diagnose, prevent and treat the conditions such as Alzheimer’s, Parkinson’s disease, epilepsy and pain management.   

Neurological Medical Device Manufacturing and Regulatory challenges: 

Manufacturers of these medical devices must make sure that each component is precisely calibrated for the intended use.  for example, if we talk for medical wire the manufacturers do not have the in-house expertise to design and develop medical wire for neurological devices. The ultra-fine high-quality wires are used in DBS and SCS devices. As a medical device design and development consultant, will help you ensure continued compliance with the design control procedures for your devices, from design to commercialization. Most of these devices are imported from USA and Europe. The material used in manufacturing these devices depends on applications. 

Regulatory pathway: 

Regulatory compliance differs from country to country. When a device maker wants to establish a neurological device manufacturing firm in India, he /she need to register with CDSCO and obtain the CDSCO manufacturing license. As a CDSCO Manufactuing consultant, we take care of required documentation and submission to the respective bodies to make it easy for the manufacturers to obtain the CDSCO manufacturing license.  

If you want to place a device in USA one need to classify their product as per the risk associated with them. For example, DBS and the devices used in treatment of brain tumors are categorized as Class III devices, neurostimulators and blood clot retrievers are categorized in Class II devices. AS FDA 510(k) consultant we help manufacturers to classify their product to apply correct regulations for the certification. Classification of devices are based on risk associated with the devices. 

USFDA, EUMDR, India, Saudi-Arabia, UK market place differs in regulations. Our global network and extensive experience in regulatory compliance supports the manufacturers and service providers of medical companies. Feel free to contact us for your regulatory and QMS requirement.