CDSCO Registration for General Hospital Medical Devices – An Overview

The Drugs Controller General of India, or DCGI, issued a notification on 16th March 2022, which notified about the classification of medical devices pertaining to CDSCO Registration for General Hospital Medical Devices under the provisions of Medical Device Rules, 2017. The notification includes 146 Medical Devices based on their Intended Use and Risk Classification.

Overview of CDCSO Medical Device Rules, 2017

The Central Drug Standard Control Organization (CDCSO) Introduced the Medical Device Rules, 2017, which became effective on 1^st January 2018. The Rules were introduced to differentiate between Medical Devices and pharmaceuticals for registration.

According to section 2(zb) of Medical Device Rules 2017, the meaning of Medical Devices can be interpreted as specific substances or devices meant for external or internal use to diagnose, treat, prevent or mitigate any kind of disorder or disease in humans or animals.

Medical devices can also be defined as specific substances which are notified by the government and are meant to affect any kind of structure or function of the human body. It also includes substances used for in vitro diagnosis. Devices used as surgical dressings, staples, bandages, sutures, ligatures, and Blood and blood components, whether with or without anticoagulants, can also be called medical devices.

CDSCO has done a classification of Medical Devices based on the risk involved with the devices. The category has been made as follows-

Medical device	Risk level
Class-A Medical devices	Low risk
Class-B Medical devices	Low-Medium risk
Class-C Medical devices	Medium-High risk
Class-D Medical devices	High risk

Medical Device Classification in India

Based on registration, the Medical Devices have been classified into two types-

• Notified Medical Devices
• Non-Notified Medical Devices

Earlier, only 37 Medical devices were regulated in India. Gradually, with the increased awareness of health and related issues, the demand for medical devices increased among Indian Customers, and health-related matters were also exposed. Slowly, more devices were put into the ambit of Notified Medical devices to ensure the safety of the Customers.

Ministry of Health and Family Welfare issued a notification on 11th Feb 2020, which invited the Voluntary registration of Non-Notified medical devices before the given deadline. The deadline has been classified according to the risk classification of medical devices, which are as follows-

• For Class A and B Medical Devices, the deadline is till 1^st October 2022
• For Class C and D Medical Devices, the deadline is 1^st October 2023

After the deadline, all non-notified medical devices will be included in the category of mandatory registration along with the notified medical devices.

CDSCO also notified 24 new medical devices for registration, in a notificati0on dated 3rd September 2020. The list also included CDSCO Registration for General Hospital Medical Devices. The details of the devices are listed in the table below –

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

Classification of General Hospital Medical Devices 

On 16^th March 2022, The DCGI issued a notification related to CDSCO Registration for General Hospital Medical Devices, titled- “Classification of Medical Devices Pertaining to General Hospital/Orthopaedic Instruments”, governed by the Medical Device Rules, 2017^[1].

The notification listed 146 Medical devices for registration based on Intended Use and Risk Classification. The list of devices is as follows-

Sr.No.	Device Name	Risk Class
1	Liquid crystal forehead temperature strip	B
2	Bed exit monitor, Fall prevention	A
3	Electronic monitor for gravity flow infusion systems	C
4	Electrically powered spinal fluid pressure monitor	B
5	Spinal fluid manometer	B
6	Stand-on patient scale	A
7	Patient scale	A
8	Sterilization process indicator(Biological)	B
9	Sterilization process indicator (Physical/chemical)	B
10	Clinical colour change thermometer	A
11	Apgar timer.	A
12	Hydraulic adjustable hospital bed.	A
13	Manual adjustable hospital bed.	A
14	Pediatric medical crib.	B
15	Medical bassinet.	B
16	Nonpowered flotation therapy mattress.	A
17	Therapeutic medical binder.	A
18	Burn sheet.	A
19	Neonatal eye pad.	A
20	Pressure infusor for an I.V. bag.	B
21	Intravascular administration set, automated air removal system.	B
22	Patient care reverse isolation chamber.	B
23	Jet lavage.	B
24	Patient lift, Electrcially powered	B
25	Nipple shield.	A
26	Lamb feeding nipple.	A
27	Suction snakebite kit.	A
28	Chemical cold pack snakebite kit	D
29	Therapeutic scrotal support.	A
30	Cardiopulmonary resuscitation board.	A
31	Ultrasonic cleaner for medical instruments.	B
32	Medical insole.	A
33	Ingestible event marker	C
34	Remote Medication Management System	B
35	Medical examination light, A.C. powered or Battery	A
36	Skin pressure protectors	A
37	Ultraviolet (U.V.) radiation environmental disinfection device	B
38	Ultraviolet (U.V.) radiation chamber disinfection device.	C
39	Body waste receptacle	A
40	Vacuum-powered body fluid suction apparatus.	B
41	Washers for body waste receptacles.	A
42	Sterilization wrap	B
43	Ethylene oxide gas sterilizer.	C
44	Dry-heat sterilizer.	C
45	Steam sterilizer	C
46	Liquid chemical sterilants/high-level disinfectants.	C
47	Hand-carried stretcher.	A
48	Manual Wheeled stretcher.	A
49	Motorised Wheeled stretcher	B
50	Liquid crystal vein locator.	A
51	Medical washer	B
52	Medical washer-disinfector	B
53	Hydrogen Peroxide Gas Plasma Sterilization System	C
54	Blood bank centrifuge	A
55	Environmental chamber for storage of platelet concentrate	B
56	Blood storage refrigerator	B
57	Heat-sealing device	A
58	Templates	A
59	X- ray marker for strut	A
60	Clamp	A
61	Container for orthopaedic cement dispensor	A
62	Box Wrench for Nut/Bolt	A
63	The instrument set for an external fixation system	A
64	Spinal cage system instruments	A
65	Cervical plate system instruments	A
66	Mesh system instruments	A
67	Cervical disc spacer instruments for the Spine	A
68	Spinal Instrument	A
69	Instrument set for Bone Screws & Plates	A
70	Electronic Drive Instruments & Accessories	A
71	Instrument system for bipolar hip system	A
72	Plaster Instruments/Saw	A
73	Wire tensioner	A
74	Thick /Thin Guide Pin	A
75	Depth Gauge	A
77	Bone Tap	A
78	Reamer & its attachment	A
79	Torque Wrench	A
80	Pedical Screw Instruments	A
81	Surgical Probe	A
82	Rod Cutter/Reducer	A
83	Alignment Guide	A
84	Retractor Holder	A
85	Extractor	A
86	Retractor	A
87	Bone Curette	A
88	Bone Cutter	A
89	Surgical Punch/Bone Punch	A
90	Surgical	A
91	Hook	A
92	Dissector	A
93	Surgical Spatula	A
94	Osteotome	A
95	Surgical Elevator	A
96	Needle Holder	A
97	Scissor	A
98	Approximator	A
99	Pliers	A
100	Tamp, Surgical	A
101	Orthopaedic Countersink	A
102	Wrench	A
103	Periostic elevator	A
104	Pneumatic Tourniquet & its attachment	A
105	Electronically operated Tourniquet Single & Double Cuff Consol	B
106	Forceps	A
107	Plaster Knife	A
109	Surgical Drill & its attachment	B
110	Surgical Trays	A
111	Implant Trials	B
112	Computer-Assisted Surgery System	B
113	Knee System Instruments	B
114	Hip System Instrument	B
115	Insertion and removal instruments	A
116	Bone cement accessories	B
117	Sleeves and their attachment	A
118	Arthroscopes	B
119	Arthroscopic Instruments	B
120	Shaver System	B
121	A visualization system for the arthroscopic and endoscopic procedure	A
122	Fluid Management System	B
123	Bone Chisel	A
124	Pusher	A
125	Bender	A
126	Dilator & accessories	A
127	Surgical Screw Driver	A
128	Orthopaedic implant impactor	A
129	Rail Fixation System	B
130	The external Ring fixation system	B
131	Six-axis correction apparatus with software	B
132	Unilateral External Fixation System	B
133	Intramedullary Locking Nail Instrument Sets	B
134	Adhesive Plaster B.P.’ 88 (Zinc Oxide Adhesive Plaster)	A
135	Adhesive Tape USP	A
136	Elasticated Cohesive Bandage	A
137	Cotton and Rubber Elastic Bandage	A
138	Cotton Crepe Bandage	A
139	Elastic Adhesive Bandage	A
140	Extension Plaster –width-wise stretchable	A
141	Microporous surgical tape	A
142	Orthopaedic cast padding	A
143	Plaster of Paris Bandage	A
145	Skin traction kit	A
146	Tearable Adhesive Tape	A

Documents required for CDSCO Registration for General Hospital Medical Devices

The following is a checklist for CDSCO Registration for General Hospital Medical Devices:

• Application form
• Power of Attorney
• Certificate of quality assurance
• C.E. Design accreditation
• Challan TR6
• Plant-Master File
• ISO 13485 certificate
• Declaration of conformity
• Schedule D(I)
• An Undertaking declaring that the information stated is correct
• Device-master file
• Free sale certificate

Procedure for CDSCO Registration for General Hospital Medical Devices

CDSCO Registration for General Hospital Medical Devices can be applied by following procedure-

1. The applicant must first Identify the Medical device category and its risk based classification
2. If the manufacturer is not an Indian, then an Indian Authorized Agent is appointed on his behalf to carry out his official functions and duties in India.The IAA is also liable to represent the manufacturer in  court.
3. All the required documents and forms must be submitted to the relevant licensing authority to obtain the registration certificate.
4. After verifying the submitted documents and reports, if the licensing authority is satisfied, then the CDSCO Registration for General Hospital Medical Devices is granted to the manufacturer.

Conclusion

The government has listed the CDSCO Registration for General Hospital Medical Devices for registration as medical devices. A notice was issued on 3^rd September 2020, which listed 24 new machines to be included in the list of medical devices. The medical devices must be registered before being manufactured, imported, sold or marketed in India. However, the registration process can be technical, and a slight mistake might lead to considerable challenges in terms of funds and time. It is always better to connect with experienced professionals for CDSCO Registration for General Hospital Medical Devices to save time and money wasted on any failure.

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