CDSCO Registration for Urology Medical Device – A Complete Analysis

Before 2006, the Medical Device Industry was utterly unregulated in India. Customers were exposed to various health and life threats caused by unregulated, cheap-quality medical devices. With the increase in the medical device industry, the risks increased. Due to customers’ exposure to unregulated medical devices, CDSCO mandated the registration of medical devices before being manufactured, imported or Sold in India. With this rule, it became mandatory to get registration certificates for notified medical devices. On 3^rd September 2020, CDSCO issued a notification that listed 24 Medical devices for registration. CDSCO Registration for Urology Medical Devices has also been included in the list.

CDSCO regulation on Medical Devices in India

The Central Drug Standard Control Organization has broadly classified two categories of Medical Devices based on their registration-

• Non-Notified Medical Devices
• Notified Medical Devices

Until the recent notification issued by CDSCO, only 37 notified medical devices were registered in India. Notification 648 (E), published by the Directorate General of Health and Services, listed the following medical devices to be considered drugs from 1^st April 2020.  

All the devices that are used as appliances, Instruments, materials, apparatus, implants or any other tool, which is used either separately or along with any another device, accessory or software for use in human beings or animals, and do not achieve the primary intended action in or on animal or human body by any pharmacological, Immunological or metabolic way, but it may help in its intended function or for one or more specific purpose of-

1. Diagnosis, monitoring, preventing and alleviating any injury or disability.
2. Diagnosis, monitoring, controlling, alleviating or treating any kind of disorder or disease
3. Life support and sustaining
4. Replacing, investigating, supporting or modifying a physiological process or the anatomy
5. Conception control
6. Medical Device disinfection

Classification of Notified Medical Devices

CDSCO issued a notice on 3^rd September 2020, which notified 24 medical devices to be listed in the category of mandatory CDSCO registration. The list included CDSCO Registration for Urology Medical Devices and 23 other medical devices. The list issued in a notification is mentioned as follows-

Sr. No.	Medical device Name
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

CSDCO Regulation on Urology Medical Devices

The Drug Controller General of India notified on 23^rd August 2021, notifying about the Classification of Medical Devices pertaining to Urology under the Medical Device Rules, 2017. The Classification listed 88 medical devices for CDSCO Registration for Urology Medical Device, based on the risk classification and Intended use. The list of medical devices is mentioned below-

Sr.No.	Device Name	Risk Class
1	Bare-metal urethral stent, short-term	C
2	Biliary/urinary stone retrieval basket	B
3	Bladder neck spreader	A
4	Bladder-emptying vibratory stimulator	B
5	Closed-ended wearable urine collection bag, nonsterile	A
6	Closed-ended wearable urine collection bag, sterile	A
7	Cystometer	B
8	Cystometer probe, ultrasonic	B
9	Cystoscopic electrode	B
10	Diaphragm wearable urinal	A
11	Draping incontinence liner	A
12	Drip wearable urinal	A
13	Electrohydraulic lithotripsy system	B
14	Electrohydraulic/pneumatic lithotripsy system probe, urinary, single-use	B
15	Electromechanical lithotripsy system, extracorporeal	B
16	Electromechanical lithotripsy system, intracorporeal	B
17	Female wearable urinal, reusable	A
18	Fibreoptic ureteral catheter, reusable	B
19	Filiform urethral bougie	B
20	Flexible endoscopic stoneretrieval forceps, reusable	B
21	Flexible fibreoptic cystonephroscope	B
22	Flexible fibreoptic cystoscope	B
23	Flexible fibreoptic cystourethroscope	B
24	Flexible fibreoptic nephroscope	B
25	Flexible fibreoptic ureterorenoscope	B
26	Flexible fibreoptic ureteroscope	B
27	Flexible fibreoptic urethroscope	B
28	Flexible ureteral sheath/fibreoptic telescope	B
29	Flexible video cystonephroscope	B
30	Flexible video cystoscope, reusable	B
31	Flexible video cystourethroscope	B
32	Flexible video nephroscope	B
33	Flexible video ureterorenoscope, reusable	B
34	Flexible video ureteroscope, reusable	B
35	Flexible video urethroscope	B
36	General-purpose ureteral catheter	B
37	Hand pneumatic lithotripsy system, urinary	B
38	Hand-held urinal, female	A
39	Hand-held urinal, male, reusable	A
40	Hepatic function analysis system	B
41	Home faecal specimen collection kit	A
42	Hydraulic male urinary incontinence treatment system	C
43	Hydraulic male urinary incontinence treatment system port	C
44	Hydraulic male urinary incontinence treatment system tubing	C
45	Hydraulic male urinary incontinence treatment system tubing plug	C
46	Incontinence device suspender	A
47	Incontinence penis clamp, reusable	A
48	Incontinence sensor/alarm	B
49	Inflatable penile prosthesis	C
50	Intermittent urethral catheterization kit, nonsterile	B
51	Intermittent urethral catheterization kit, sterile	B
52	Intermittent urethral drainage catheter, antimicrobial	B
53	Intermittent urethral drainage catheter, nonsterile	B
54	Intermittent urethral drainage catheter, sterile	B
55	Intracorporeal lithotripsy suction system	B
56	Intraurethral valve/pump	B
57	Laser lithotripsy fibre/suction guide	C
58	Laser lithotripsy system	C
59	Lithotrite	B
60	Male urinary outflow analysis system	B
61	Male urinary outflow analysis system cuff	B
62	Manometric catheter sheath	B
63	Microwave hyperthermia system catheter, prostaticablation, reusable	C
64	Penile extracorporeal shock wave therapy system	B
65	Penile extracorporeal shock wave therapy system applicator	B
66	Penis wearable urinal	B
67	Penis/scrotum wearable urinal	B
68	Perineal orifice incontinence-control electrical stimulation system, remote control	C
69	Piezoelectric lithotripsy system	C
70	Pyeloscope	B
71	Rigid cystoscope	B
72	Rigid cystourethroscope	B
73	Rigid nephroscope	B
74	Rigid ureterorenoscope	B
75	Rigid ureteroscope	B
76	Rigid urethroscope	B
77	Rigid video ureterorenoscope	B
78	Spark-gap lithotripsy system	B
79	Suprapubic needle, surgical, reusable	B
80	Temperature-monitoring indwelling urethral drainage catheter	B
81	Transobturator needle, reusable	B
82	Transvaginal needle, surgical	B
83	Ultrasonic lithotripsy system	B
84	Ureteral patency kit	B
85	Urethral drainage catheter punch	B
86	Urethral/suprapubic catheter valve-connector	A
87	Urinary-incontinence vaginal insert, reusable	A
88	Urodynamic measurement system	B

 

Documents required for CDSCO Registration for Urology Medical Device

1. Application Form
2. ISO 13485 Certificate
3. Declaration of conformity
4. Free sale certificate
5. Undertaking that only authentic details are provided
6. TR6 Challan
7. Device master file
8. Power of attorney
9. Full quality assurance certificate
10. Plant master file
11. Schedule D(I)
12. C.E. Design certificate

Procedure for CDSCO Registration for Urology Medical Device

To obtain CDSCO Registration for Urology Medical Devices in India, the following steps are followed-

1. To get CDSCO registration, it must be checked whether the medical device belongs to the notified or non-notified medical device category, along with their risk classification. In the case of a non-notified medical device, the manufacturer must obtain voluntary registration before the given deadline based on its risk class. The CDSCO Registration for Urology Medical Device falls under the ambit of notified medical devices, as notified by CDSCO.
2. A foreign manufacturer cannot perform any of the official duties in India. Therefore an Indian Authorized Agent (IAA) is appointed on his behalf to carry out all the official duties on behalf of the manufacturer as his representative.
3. The IAA or Manufacturer must complete all the necessary forms and submit all the required documents to the relevant Licencing authorities to obtain CDSCO Registration for Urology Medical Devices.
4. After verifying all the documents, the CDSCO License is granted to the applicant after the licensing authority is satisfied.

Conclusion

Getting CDSCO Registration for Urology^[1] Medical Devices before they are manufactured, sold or Imported in India is essential to ensure that the customers on whom these medical devices are being used are safe and free from health and life risks. The process of obtaining CDSCO registration for the medical device might be complicated in terms of procedure and rules. Therefore, professional and expert help must be taken to obtain CDSCO Registration for Urology Medical Devices to avoid losses.

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