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CDSCO Registration for General Hospital Medical Devices – An Overview

calendar19 Oct, 2022
timeReading Time: 6 Minutes
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 1st 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 1st October 2022
  • For Class C and D Medical Devices, the deadline is 1st 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 16th 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 3rd 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.

Read Our Article:CDSCO Registration for Rheumatology Medical Devices

Snehita Shukla

Snehita has her qualifications in B.Com LLB and LLM, and holds a specialization in Corporate & Financial Laws and Policy. She is hardworking, dedicated and sincere. She has a great command in english and has great problem solving, critical thinking and writing skills which makes her stand out of the crowd. She has a keen interest in legal research work and content writing, she also has a hold in legal research methodology. She loves to take challenges and to explore new topics to research on. She aims to improve her knowledge and skills through her experience.

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