CDSCO Registration for Rheumatology Medical Devices

The Central Drug Standard Control Organisation issued a notice on 3^rd September 2020, which notified about the classification of Non-notified Medical Devices and their registration under CDSCO. The notification listed the category 24 non-notified medical devices as per the classification in the first schedule of Medical device rules, 2017. The list also includes a classification for Rheumatology Medical Devices. Scroll down to check CDSCO Registration for Rheumatology Medical Devices.

Role of CDSCO

Central Drug Standard Control Organization or CDSCO, is the National Regulatory Authority of India. It is responsible for regulating different kinds of drugs and medical devices in India. The CDSCO works under the Ministry of Health and Family Welfare. The Drug Controller General of India or the DCGI is the head of CDSCO. Before the year 2006, medical devices were sold in India without any official body regulating them. Due to this, the consumers were exposed to various risks caused by poor quality devices and unregulated imports.

The functions performed by CDSCO are–

• Medical Device Product Registration
• Setting up standards for Medical devices, Drugs, IVDs etc.
• Setting up laws, regulations, amendments and rules for Drugs, Medicines, Medical Devices, IVDs, etc.
• Regulating the market authorization of Drugs and Medical Devices.
• Regulating the Clinical Research and Drug trials in India.
• Approval of license to manufacture certain Drugs and other medicine-related devices
• Regulating the standard of imported drugs in India.
• Testing of Drugs through Central Drugs labs.

Risk-Based Classification of Medical Devices

CDSCO has classified medical devices and IVDs into four classes according to the risk associated with them. The risk-based classification of medical devices according to the medical device rules, 2017 are as follows-

Medical devices classification	Risk level Association
Class-A	Low-level risk involved
Class-B	The low-Moderate level risk involved
Class-C	The moderate-High level risk involved
Class-D	High-level risk involved

Classification of Non-Notified Medical devices in India

The Medical Devices are classified into two categories- Notified medical devices and Non- Notified Medical Devices. Earlier, only notified medical devices were regulated in India, but later, as per the directions of CDSCO, non-notified medical devices were invited to be registered on a voluntary basis by a given deadline. After the deadline is crossed, even the non- notified devices would be considered in the category of mandatory registration by CDSCO.

Earlier, CDSCO used to regulate only 37 medical devices in India, but with the increase in the medical device market in India, various unregulated medical devices were exposed to Indian consumers, involving numerous health risks. A recent notification which was issued by the Ministry of Health and Family Welfare on 11^th February ,2020, invited voluntary registration of all the non- notified medical devices.

Another notice was issued by CDSCO on 3^rd September 2020, where a list of 24 non-notified medical devices was included for the purpose of CDSCO registration. The list included various medical devices such as devices related to Anaesthesiology, Pain Management, Cardiovascular, Rheumatology^[1], etc. following is the list of those 24 newly listed devices-

S.L. No.	Categories of Medical Device
1	Anaesthesiology
2	Pain Management
3	Cardiovascular
4	Dental
5	Ear, Nose, Throat (ENT)
6	Gastroenterological
7	Urological
8	General Hospital
9	Operation Theater (O.T.)
10	Respiratory
11	Neurological
12	Personnel use
13	Obstetrical and Gynaecological (O.G.)
14	Ophthalmic
15	Rehabilitation
16	Physical support
17	Interventional and Radiology
18	Rheumatology
19	Dermatology and Plastic Surgery
20	Paediatric and Neonatology Medical
21	Oncology
22	Radiotherapy
23	Nephrology and Renal care
24	Software

Classification for Rheumatology Medical Devices

According to the list, CDSCO Registration for Rheumatology Medical Devices has also been listed along with other devices. According to a notice issued by CDSCO on 3^rd September 2020, there is a total of 11 medical devices which are classified in the list of CDSCO Registration for Rheumatology Medical Devices according to the intended use, which are as follows-

Sr. No.	Medical Device Name
1	Back Brace
2	Canes
3	Lateral wedge insoles
4	Grab bars in showers and tubs
5	Shoe Insert
6	Reachers
7	Orthopaedic pillow
8	Orthopaedic shoes
9	Stairway chair lift
10	Toilet frames
11	Bottle and jar openers

Documents required for CDSCO Registration for Rheumatology Medical Devices

The following is a list of the requirements for CDSCO Registration for Rheumatology Medical Devices:

• Application form
• Challan TR6
• ISO 13485
• Power of Attorney
• An Undertaking stating that the information provided is accurate
• Certificate of quality assurance
• C.E. Design accreditation
• Declaration of conformity
• Schedule D(I)
• Master Plant File
• Device Master File
• Free Sale Certificate

Procedure for CDSCO Registration for Rheumatology Medical Devices

The process for CDSCO Registration for Rheumatology Medical Devices in India is listed below. –

• Identify whether the medical devices need to be registered: The applicants must first determine whether a medical device has been notified or not; they must first check the Medical Devices and IVDs list. Before being marketed in India, all non- notified medical devices notified must first obtain voluntary registration before the given deadline.
• Indian Authorized Agent Appointment: If the medical device manufacturer is not Indian, an IAA or Indian Authorized Agent is appointed on their behalf. He is responsible for carrying out the duties of manufacturers. The IAA represents the manufacturer in court and carries out all their official business in India.
• Documentation procedure: To obtain a registration license, all required documentation and paperwork must be submitted to the appropriate authorities.
• Obtaining Registration and License: The registration license is provided to the manufacturer after the licensing authorities are satisfied with all the submitted paperwork and other requirements.

Conclusion

The Ministry of health and family welfare has issued a new risk-based Classification for CDSCO Registration for Rheumatology Medical Devices in India to comply with the latest medical device rules in India. The notice was issued on 3^rd September 2020, which listed that Rheumatology Medical Devices are to be classified as Non-Notified Medical Devices by CDSCO, with in total of 24 medical devices listed in it. The registration process for medical devices can be technical and small mistakes might lead to huge losses in terms of money and time; therefore, it is always advisable to connect with an experienced professional for CDSCO Registration for Rheumatology Medical Devices to save time and money wasted on any kind of failure.

Read our Article:CDSCO Registration for Dermatology and Plastic Surgery Medical Devices