Clarity On Classification Of Medical Devices

Rehabilitation medical devices:

CDSCO has issued a risk-based classification list of rehabilitation and medical devices in India. As per notification the rehabilitation products need to be registered to comply with the latest medical device rule in India. For the safety, quality and performance of medical devices they are regulated under Drugs and & cosmetics 1940.   

The total number of devices which are classified is 60. The below table helps manufacturers to classify their product. Here we are briefing the table. The whole list or table given on the CDSCO.GOV.in website. We have listed a few devices and the complete list of devices is given on the CDSCO website. The Class A devices are having low risk, Class B having low-moderate risk The Class C has Moderate –high risk, whereas Clas D has high risk according to classification criteria. As a medical device regulatory consultant, our aim is to make you aware of updated rules and regulations, and the latest notification from CDSCO and other regulatory authorities so we have launched a monthly Newsletter. kindly subscribe/download for more regulatory updates. We are a turnkey solution provider with a team of expert consultants who can guide you in the registration process for medical devices.  

 Referances- Rehabilitation updated list with public notice DC

Clarity on Classification of  Medical Devices : Neurology

Neurological devices are used to diagnose, prevent and treat a variety of neurological disorders like Alzheimer’s disease, Parkinson’s disease, major depression, epilepsy, spinal cord injury etc. DCGI is working to enhance the regulatory process for developers and medical device manufacturers. 

So, DCGI issued clarity on classification of Neurological medical devices. List of classification of medical devices pertaining to neurological is given on CDSCO website. 

 Reference link – https://cdsco.gov.in/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=NzcyNQ== 

Clarity on Classification of  Medical Devices: Radiotherapy 

CDSCO has issued risk-based classification list for radiotherapy medical devices in India. These Medical devices like medical Linear accelerator used for treatment of Cancer. The radiotherapy products need to be registered to comply with the latest MDR2017. The table given on CDSCO’s website is helpful for manufacturers to classify their product. You can refer to the link given below.  

References:  

https://cdsco.gov.in/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=NzU2Ng== 

Clarity on Classification of  Medical Devices: Cardiovascular

Medical devices are classified into 4 risk classes namely Class A, Class B, Class C & Class D. The DCGI has enlisted classification of medical devices pertaining to cardiovascular. Classification of medical devices pertaining to cardiovascular devices is given on CDSCo’s website. You can refer to the link below for details. 

References: 

https://cdsco.gov.in/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=NzQ5Mg== 

Clarity on Classification of  Medical Devices :Physical support

CDSCO the regulatory body for pharmaceuticals and medical devices in India regulating these devices. CDSCO is constantly introducing several changes which deal with the intended use of the products. CDSCO classified these devices on the basis of risk associated with them and with reference to few specific parameters. CDSCO has published a table on Classification of Physical Support Medical Devices. Link of the website is given here. 

https://cdsco.gov.in/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=NzQ1NQ== 

Clarity on Classification of  Medical Devices : Radiology

Safety, quality and performance of medical devices are regulated under the provisions of the Drugs and Cosmetics Act, 1940 and rules made thereunder. For the regulation of medical devices with respect to the import, manufacture, clinical investigation, sale and distribution, the Central Government, after consultation with the Drugs Technical Advisory Board, has notified Medical Devices Rules, 2017 vide G.S.R. 78 (E) dated 31.01.2017 which are to be commence from 01.01.2018 

In this connection, in exercise of the powers conferred under sub-rule (3) of rule 4 of Medical Devices Rules, 2017, the undersigned hereby classifies the medical devices, based on the intended use of the device, risk associated with the device and other parameters specified in the First Schedule. 

The list is available on the link below; 

https://cdsco.gov.in/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=NzQ1NA== 

Clarity on Classification of ENT Medical Devices 

Hearing aids are wearable instruments designed for the purpose of or compensating for impaired hearing. FDA has established regulatory requirement for hearing aid which include quality system regulations, technical standards, labeling requirements ets. Clarity on classification for the ENT medical devices is given on CDSCO website. we are here providing a link for the reference 

https://cdsco.gov.in/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=NzU2Nw== 

Clarity on Classification of Dermatological Medical Devices 

The instruments used in surgical procedures, treatment or diagnosis for skin disorder are dermatological medical devices. CDSCO issued clarity on a new risk-based classification list for these devices. The table given in reference link will help manufacturers to classify their product. 

Reference link –https://cdsco.gov.in/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=NzU2NQ== 

Clarity on Classification of Respiratory Medical Devices 

List of medical devices placed at Appendix A subjected to the following: 

1. General intended use given against each of the devices is for guidance to the applicants intending to furnish application of import or manufacture of medical devices under the provisions of Medical Devices Rules, 2017. However, a device may have specific intended use as specified by its manufacturer.
2. This list is dynamic and is subject to revision from time to time under the provisions of the Medical Devices Rules, 2017.

Reference link –https://cdsco.gov.in/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=NzU2NQ== 

Clarity on Classification of Urology Medical Devices 

The medical devices used to diagnose and treat urinary tract systems are urological medical devices. These devices are helpful in the treatment of chronic kidney problems such as prostate cancer and kidney stone. The clarity for the classification of these devices is issued by CDSCO on their website. Below link will help manufacturers to classify their product. 

Reference link –https://cdsco.gov.in/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=NzU5Mg== 

Clarity on Classification of Medical Devices for Pain Management 

Pain management is hospital treatment which does not require insertion or surgical procedure all time. The market size for pain management devices is expected to grow from 2022-2030. The Clarity on Classification of Medical Devices for Pain Management is available in the form of table on CDSCO s website. 

   Reference link – https://cdsco.gov.in/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=NzcyOA== 

Clarity on Classification of General Hospital Medical Devices 

Medical devices are categorized into 4 classes as per the risk associated with them. While manufacturing these devices manufacturers should identify the classes for their product to get regulatory compliance. CDSCO has issued clarity on classification of general hospital medical devices. The reference link is given below 

Reference link –  

https://cdsco.gov.in/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=ODI1Nw== 

Clarity on Classification of Gastroenterology Medical Devices 

Safety, quality and performance of medical devices are regulated under the provisions of the Drugs and Cosmetics Act, 1940 and rules made thereunder. For the regulation of medical devices with respect to the import, manufacture, clinical investigation, sale and distribution, the Central Government, after consultation with the Drugs Technical Advisory Board, has notified Medical Devices Rules, 2017 vide G.S.R. 78 (E) dated 31.01.2017 which are to be commence from 01.01.2018 
Clarity on Classification of Gastroenterology Medical Devices is given in table format on CDSCO website. 

Reference link – https://cdsco.gov.in/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=NzcyNw== 

Clarity on Classification of Ophthalmology 

Ophthalmology is a branch of medicine which deals with diseases and anatomy of eye. The manufacturers, distributors, suppliers are making efforts to introduce new medical devices. CDSCO issued clarity on classification of ophthalmology. To check this the reference link is given below: 

Reference link – https://cdsco.gov.in/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=NzU3MA== 

Clarity on Classification of Obstetrical and Gynecological 

CDSCO issued a new classification list for medical devices pertaining to Obstetrical and Gynecological. One thing to remember here is Class A and Class B devices will be under the licensing regime 1 October 2022. The list of classifications is available on CDSCO website. Reference link is given below  

 Reference: 

https://cdsco.gov.in/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=ODU0OA== 

Clarity on Classification of Nephrology and Renal Care 

CDSCO issued a risk-based classification list to help manufacturers classify their product. The list is given on CDSCO’s website. The Operon Strategist team will help you to understand and classify your products as per issued lists. 

Reference link – https://cdsco.gov.in/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=NzY2Mw== 

Clarity on Classification of Personal Protective Equipment 

Personal protective equipment plays a crucial role in keeping the workplace safe.it protects employees from viral infections. The CDSCO issued Clarity on Classification of Personal Protective Equipment. the link for the reference is given here 

Reference link –  https://cdsco.gov.in/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=NzY2MA== 

Clarity on CDSCO Classification for Anesthesiology Products 

The commonly used devices provide flow of air containing a regulated supply of gas. Anesthesia machines are used to deliver general anesthesia to patients as they undergo medical procedures. 

CDSCO issued Clarity on CDSCO Classification for Anesthesiology Products, to check the details please clock on the link given below. 

References: https://cdsco.gov.in/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=NzQyNg== 

Clarity on Classification of Medical Devices in Operation Theatre

Reference link – https://cdsco.gov.in/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=NzY2Mg==

Safety, quality and performance of medical devices are regulated under the provisions of the Drugs and Cosmetics Act, 1940 and rules made thereunder. For the regulation of medical devices with respect to the import, manufacture, clinical investigation, sale and distribution, the Central Government, after consultation with the Drugs Technical Advisory Board, has notified Medical Devices Rules, 2017 vide G.S.R. 78 (E) dated 31.01.2017 which are to be commence from 01.01.2018
In this connection, in exercise of the powers conferred under sub-rule (3) of rule 4 of Medical Devices Rules, 2017, the undersigned hereby classifies the medical devices, based on the intended use of the device, risk associated with the device and other parameters specified in the First Schedule.