Classification of Medical Devices by CDSCO
The classification of Medical Devices by the CDSCO is one of the major regulatory functions that classify Medical Devices based on their intended use, risk of use, and potential to affect the safety of patients with respect to their use.
The classification also establishes the process for obtaining regulatory approval (and the necessary documentation) prior to the introduction of a Medical Device into the marketplace. This allows manufacturers, importers, and distributors to identify their regulatory obligations for licensing and approval by the Ministry of Health and Family Welfare.
Based on the risk associated with their use, these medical devices are classified into four categories in India: Class A, Class B, Class C, and Class D. These range from low-risk devices to high-risk devices, which are life-supporting or life-sustaining devices, with Class A being the lowest risk devices and Class D being the highest.
Medical devices are a wide range of products designed for use within a healthcare environment. They include devices, equipment, implants, reagents, and software used in the prevention, diagnosis, monitoring, treatment, or management of a medical condition. Medical equipment varies from simple items such as thermometers and surgical gloves to complex devices such as diagnostic imaging equipment and life-supporting implants.
Within India's regulatory framework, the Central Drugs Standard Control Organisation (CDSCO) classifies these devices according to their intended use and risk level. This categorization is employed to establish the extent of compliance required for the legal marketing of medical devices in the country.
In India, Medical Devices are classified into notified devices and non-notified devices depending on their status in the regulatory environment:
Medical devices are classified into 4 classes depending on their risk level:
| Category | Amount of Risk | Licensing Authority |
|---|---|---|
| A | Low risk | SLA |
| B | Low moderate risk | SLA |
| C | Moderate high risk | CLA |
| D | High risk | CLA |
There are 37 kinds of Medical Fields involving 200 Medical Devices in each category.
The need for the classification of medical devices by CDSCO cannot be emphasized enough, as this is a very important factor in deciding the regulatory process and level of scrutiny that the product will have to undergo before it can be launched in the Indian market. A wrong classification of a product can lead to non-compliance with regulatory requirements.
Since the process is quite technical, taking professional help can go a long way in ensuring that your product is placed in the correct risk category from the beginning. Professional Utilities provides expert assistance to businesses to ensure that their products are classified correctly and in accordance with the rules and regulations.
Speak Directly to our Expert Today
Reliable
Affordable
Assured
Industries Served by
Professional Utilities
Apparels
Footwear
Furniture
Gems and Jewellery
Tourism & Hospitality
Consumer Electronics
Chemicals
Telecom
Oils & Gas
Hotel
Railways
Liquor
Health & Medical
Food Processing
Dangerous/ Haz. Goods
Tea & Coffee
Capital Goods
Recycling
Rubber
NGOs
Silk
Handloom
IT & BPM
Steel
Automobile
Tobacco
Constructions
Testimonials
"Explore how Professional Utilities have helped businesses reach new heights as their trusted partner."
It was a great experience working with Professional Utilities. They have provided the smoothly. It shows the amount of confidence they are having in their field of work.
Atish Singh
It was professional and friendly experience quick response and remarkable assistance. I loved PU service for section 8 company registration for our Vidyadhare Foundation.
Ravi Kumar
I needed a material safety data sheet for my product and they got it delivered in just 3 days. I am very happy with their professional and timely service. Trust me you can count on them.
Ananya Sharma
Great & helpful support by everyone. I got response & support whenever I called to your system. Heartly thanx for Great & Super Service. Have a Great & Bright future of team & your company.
Prashant Agawekar
Thank you so much Professional Utilities team for their wonderful help. I really appreciate your efforts in getting start business. Pvt Ltd company registration was smooth yet quick.
Abhishek Kumar
I applied for Drug licence and company registration and their follow-up for work and regular updates helped me a lot. They are happily available for any kind of business consultancy.
Vidushi Saini
Great experience went to get my ITR done, process was quite convenient and fast. Had a few queries, am happy about the fact those people explained me all things I wanted to know.
Taniya Garyali
Great services provided by Professional Utilities. They are best in this industry and the best part is their prices are so affordable. Kudos to you. Now you guys are my full-time consultant.
Aftab Alam
Trusted By
.svg)
.svg)
