Medical device safety, quality, and performance standards are governed by the Drugs and Cosmetics Act of 1940 and the rules promulgated thereunder. The Drugs Controller General of India under the Directorate General of Health Services notified on 6th August 2021, under the Medical Device Rules of 2017, regarding the CDSCO Registration for Respiratory Medical Devices. Fifty-one medical devices with respiratory applications are classified as having been notified based on the intended use and risk-based classes.
Overview of Medical Device Rules, 2017
Central Drug Standard Control Organization is the national regulatory body of India. It is in charge of regulating various drugs and medical equipment in India. The Ministry of Health and Family Welfare oversees the CDSCO. The CDSCO is led by the Drug Controller General of India or DCGI[1]. Before 2006, no official body in India regulated the sale of medical devices. As a result, consumers were exposed to various risks brought on by subpar devices and unchecked imports. CDSCO Registration for Respiratory Medical Devices is also regulated under it.
The duties carried out by CDSCO are:
Registration of medical devices
Establishing guidelines for drugs, IVDs, medical devices, etc.
Establishing legislation, rules, amendments, and regulations for drugs, medications, medical equipment, IVDs, etc.
Regulating the approval of drugs and medical devices for sale.
Handling drug trials and clinical research in India.
Approval of a license to produce specific drugs and other equipment related to medicine
Regulates the quality of drugs imported into India.
Drug testing at Central Drugs laboratories.
Risk-based classification of medical devices-
Medical devices and IVDs have been categorized into four classes by CDSCO based on the risk associated with them. Under the Medical device rules, 2017, a medical device is categorized based on risk as follows:
|
Classification of medical devices |
Risk association level |
|
Class-A |
Low risk |
|
Class-B |
Low-moderate risk |
|
Class-C |
Moderate- high risk |
|
Class-D |
High risk |
Classification of Non-Notified Medical devices in India
Notified medical devices and Non-Notified medical devices are the categories into which medical devices fall. Only notified medical devices were previously regulated in India, but on CDSCO’s orders, non-notified medical devices were invited to voluntarily register by a specific deadline. Even non-notified devices will be included in the category of required registration by CDSCO once the deadline has passed. Class A and B medical devices must be voluntarily registered by 1st October 2022, and Class C and D medical devices are to be registered by 1st October 2023.
CDSCO in India previously regulated only 37 medical devices, but as the country’s medical device market grew, more unregulated medical devices were exposed to Indian consumers, posing severe health risks. The Ministry of Health and Family Welfare recently invited voluntary registration of all unnotified medical devices in a notification published on 11th February 2020.
On 3rd September 2020, CDSCO published a new notice that included a list of 24 medical devices that had not yet been registered with CDSCO. The list also included CDSCO Registration for Respiratory Medical Devices. The list also included a variety of other medical devices, including medical devices for anaesthesia, pain management, cardiovascular health, etc. The list of those 24 newly listed devices is as follows:
|
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 Respiratory Medical Devices
The list includes CDSCO Registration for Respiratory Medical Devices and other devices. In total, 51 medical devices are categorized in the CDSCO Registration for Respiratory Medical Device list according to the intended use, which is as follows, per a notice released by CDSCO on 6th August 2021.
|
Sr. No. |
Medical Device Name |
Risk Class |
|
1 |
Activated-oxygen generator |
B |
|
2 |
Argon gas analyzer |
B |
|
3 |
Artificial airway tube cuff pressure monitor |
B |
|
4 |
Bulk oxygen concentration system |
A |
|
5 |
Cardiopulmonary resuscitation mask |
A |
|
6 |
Cerebral oximeter |
B |
|
7 |
Chest-oscillation airway secretion-clearing system |
B |
|
8 |
Chest-percussion airway secretion-clearing system |
B |
|
9 |
Cold-air diagnostic inhalation system |
B |
|
10 |
Cough long-term ambulatory recording system |
A |
|
11 |
Cricothyrotomy |
B |
|
12 |
Dry powder inhaler |
A |
|
13 |
The dry salt therapy device |
A |
|
14 |
Electroacoustic airway secretion-clearing system |
B |
|
15 |
Endotracheal tube introducer |
A |
|
16 |
Exhaled-gas oesophageal intubation detector |
A |
|
17 |
Foetal pulse oximeter |
B |
|
18 |
Gas pipeline/supply system air compressor |
B |
|
19 |
Heated respiratory humidifier |
B |
|
20 |
Home-use sleep apnoea recording system |
B |
|
21 |
Hyperbaric chamber |
C |
|
22 |
Hypopnea sensor/alarm |
B |
|
23 |
Impedance pneumography recording/analysis system |
B |
|
24 |
Implantable sleep apnoea treatment system |
C |
|
25 |
Infant apnoea monitor |
B |
|
26 |
Manual chest percussor |
B |
|
27 |
Nitrogen monoxide analyzer |
B |
|
28 |
Nitrous oxide analyzer |
B |
|
29 |
Pulse oximetry telemetric monitoring system |
B |
|
30 |
Respiratory apnoea monitoring system |
B |
|
31 |
Steam inhaler |
A |
|
32 |
Stress test treadmill |
A |
|
33 |
Therapeutic air ionizer |
A |
|
34 |
Therapeutic positive pressure breathing ventilator |
C |
|
35 |
The thoracic conductance measurement system |
B |
|
36 |
Thoracic electrical impedance segmentography system |
B |
|
37 |
The thoracic electrical impedance tomography system |
C |
|
38 |
Thoracic suction pump |
B |
|
39 |
Tongue-adjustment sleep apnoea treatment system |
B |
|
40 |
Tracheostoma protective filter |
A |
|
41 |
Tracheostoma protector |
A |
|
42 |
Tracheostomy tube lubricant |
A |
|
43 |
Transcutaneous blood gas monitoring system |
B |
|
44 |
Valsalva manoeuvre mouthpiece |
A |
|
45 |
Video intubation laryngoscope handle/monitor |
A |
|
46 |
Whole-body plethysmograph |
B |
|
47 |
Diagnostic Spirometer |
B |
|
48 |
Monitoring Spirometer |
B |
|
49 |
Oxygen Concentrator |
B |
|
50 |
Pulmonary function analysis system |
B |
|
51 |
Public respirator (2-ply, 3-ply face mask) |
A |
Documents needed for CDSCO Registration for Respiratory Medical Device
The prerequisites for CDSCO Registration for Respiratory Medical Devices are as follows:
Application form
TR6 Challan
ISO 13485
Power of Attorney
An undertaking confirming the accuracy of the information provided
Assurance of quality certificate
Accreditation from C.E. Design
Statement of compliance
D Schedule (I)
Device master file
Plant master file
Free sale receipt
Procedure for CDSCO Registration for Respiratory Medical Device
Following is a list of the steps involved in CDSCO Registration for Respiratory Medical Devices in India.
The applicants must first check the Medical Devices and IVDs list to see if a medical device has been notified or not. All non-notified medical devices must complete voluntary registration before the deadline to be marketed in India.
In cases where the manufacturer of the medical device is not an Indian, an Indian Authorized Agent is chosen on his behalf. He is in charge of performing the manufacturer’s responsibilities. The IAA conducts all of its official business in India and represents the manufacturer in court.
To obtain a registration license, all necessary paperwork and documentation must be submitted to the relevant authorities.
The manufacturer receives the license once the licensing authorities are satisfied with all the paperwork and other requirements.
Conclusion
To comply with the most recent medical device regulations in India, the Ministry of Health and Family Welfare has released a new risk-based Classification for CDSCO Registration for Respiratory Medical Devices. The notice was issued on 3rd September 2020, and it listed 24 medical devices as respiratory medical devices that CDSCO will classify as non-notified medical devices. Medical device registration can be a technical process; even a small error could result in significant time and financial losses. To avoid wasting time and money on a potential failure, getting in touch with an experienced professional for CDSCO Registration for Respiratory Medical Devices is always advisable.
