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CDSCO Registration for Radiotherapy Medical Devices – An Overview

calendar21 Oct, 2022
timeReading Time: 6 Minutes
CDSCO Registration for Radiotherapy Medical Devices - An Overview

Before 2006, there was no such law governing the Medical Device Industry in India. The devices had no regulation or licenses, which exposed the consumers to health and life risks. Later, the Central Drug Standard Control Organization made it mandatory for all medical devices to be regulated before they were sold or marketed in India. CDSCO issued a notification on 3rd September 2020, which notified 24 Medical devices for mandatory CDSCO registration. The list also includes CDSCO Registration for Radiotherapy Medical Devices.

CDSCO regulation on Medical Devices in India

CDSCO has classified Medical Devices into two broad categories based on Registration-

  • Notified Medical Devices
  • Non-Notified Medical Devices

Until now, only Notified Medical Devices were supposed to get registered in India. There were 37 listed medical devices which required Registration in India. A Notification 648 (E) was issued by the Directorate General of Health and Services, which notified that the following medical devices are to be considered as drugs from 1st April 2020-

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

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

Classification of Notified Medical Devices

CDSCO issued another notification on 3rd September 2020 that notified 24 new medical devices in the category of a notified medical device for mandatory Registration. The Notification also mandated CDSCO Registration for Radiotherapy Medical Devices and 23 other medical devices. The devices notified in the list are mentioned 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                   

CDSCO regulation on Radiotherapy Medical Devices

The Drugs Controller General of India notified on 6th August 2021 about the Classification of Radiotherapy under the Medical Device Rules, 2017[1] . The Notification included 101 new devices in the list of CDSCO Registration for Radiotherapy Medical Devices. The following table mentions all the items listed in the Notification based on their class risks.

Sr.No. MEDICAL DEVICE NAME RISK CLASS
1 Medical charged particle radiation therapy system C
2 Absorbable perirectal spacer C
3 Absorbable tissue spacer for radiotherapy D
4 Applicator for bile duct manual brachytherapy C
5 Applicator for bladder manual brachytherapy C
6 Applicator for bladder remote after loading brachytherapy C
7 Applicator for brachytherapy bile duct remote after loading C
8 Applicator for brachytherapy Cervical/endometrial remote after loading C
9 Applicator for brachytherapy noncentral circulatory general-purpose manual C
10 Applicator for brachytherapy noncentral circulatory general-purpose remote after loading C
11 Applicator for bronchial manual brachytherapy applicator C
12 Applicator for bronchial remote after loading brachytherapy C
13 Applicator for esophagus manual brachytherapy C
14 Applicator for esophagus remote after loading brachytherapy C
15 Applicator for eye manual brachytherapy C
16 Applicator for manual cervical/endometrial brachytherapy C
17 Applicator for manual rectal/anal brachytherapy C
18 Applicator for nasopharynx manual brachytherapy C
19 Applicator for nasopharynx remote after loading brachytherapy C
20 Applicator for neck manual brachytherapy C
21 Applicator for neck remote after loading brachytherapy C
22 Applicator for pancreas manual brachytherapy C
23 Applicator for pancreas remote after loading brachytherapy C
24 Applicator for prostate manual brachytherapy C
25 Applicator for prostate remote after loading brachytherapy C
26 Applicator for rectal/anal remote after loading brachytherapy C
27 Applicator for tongue manual brachytherapy C
28 Applicator for tongue remote after loading brachytherapy C
29 Applicator for vaginal manual brachytherapy C
30 Applicator for vaginal remote after loading brachytherapy C
31 Bile duct brachytherapy system applicator, remote-after loading C
32 Bladder brachytherapy system applicator, manual C
33 Blood vessel manual brachytherapy applicator D
34 Blood vessel remote after loading brachytherapy applicator D
35 Brachytherapy needle B
36 Brachytherapy radionuclide phantom, anthropomorphic B
37 Brachytherapy system chair B
38 Brachytherapy system remote after loading source safe C
39 Brachytherapy system remote after loading source transfer tube C
40 Brain brachytherapy system applicator, remote-after loading C
41 Brain manual brachytherapy applicator D
42 Brain remote after loading brachytherapy applicator D
43 Breast ductography cannula C
44 Central circulatory general-purpose manual brachytherapy applicator D
45 Central circulatory general-purpose remote after loading brachytherapy applicator D
46 Central circulatory manual brachytherapy therapeutic radionuclide system D
47 Central circulatory permanent implant manual brachytherapy therapeutic radionuclide source D
48 Central circulatory remote after loading brachytherapy therapeutic radionuclide source D
49 Central circulatory remote after loading brachytherapy therapeutic radionuclide system D
50 Central circulatory temporary placement manual brachytherapy therapeutic radionuclide source D
51 Compact thermoluminescent dosimetry electrometer A
52 Conformal Brachytherapy Source C
53 High-frequency hyperthermia system C
54 Intra-vaginal organ positioning device for diagnostic imaging and radiotherapy B
55 Laser irradiation therapy kit B
56 Light beam patient position indicator A
57 Living tissue radiotherapy system C
58 Manual radionuclide applicator system A
59 Medical neutron radiation therapy system C
60 MOSFET radiation therapy dosimetry system B
61 Noncentral circulatory manual brachytherapy therapeutic radionuclide system C
62 Noncentral circulatory permanent implant manual brachytherapy therapeutic radionuclide source C
63 Noncentral circulatory remote after loading brachytherapy therapeutic radionuclide source C
64 Noncentral circulatory remote after loading brachytherapy therapeutic radionuclide system C
65 Noncentral circulatory temporary placement manual brachytherapy therapeuticradionuclide source C
66 Non-powered accelerator system table A
67 Non-powered neutron therapy table A
68 Radionuclide brachytherapy table B
69 Non-powered remote irradiation therapy table A
70 Non-powered X-rays radiation therapy table A
71 Operator radiation protection spectacles B
72 Patient positioning device for breast diagnostic imaging and radiotherapy B
73 Patient positioning device for extremity diagnostic imaging and radiotherapy B
74 Patient positioning device for pelvis diagnostic imaging and radiotherapy B
75 Patient positioning device for whole body diagnostic imaging and radiotherapy B
76 Post Breast Biopsy Hemostatic Breast Compression Device C
77 Powered neutron therapy table B
78 Powered patient table for accelerator B
79 Powered radiation therapy patient support assembly C
80 Powered radionuclide brachytherapy table B
81 Powered remote irradiation therapy table B
82 Powered X-rays radiation therapy table B
83 Radiation therapy beam-shaping block C
84 Radiation therapy simulation system C
85 Radiographic Protective Glove B
86 Radionuclide brachytherapy source C
87 Radionuclide dynamic function testing equipment B
88 Radionuclide radiation therapy system. C
89 Radionuclide source for remote irradiation therapy C
90 Radionuclide system contour detector for remote irradiation therapy C
91 Real-time position management respiratory gating system, optical C
92 Rectal balloon for prostate immobilization C
93 Remote controlled radionuclide applicator system C
94 Stationary radiation protection barrier B
95 Stereotactic radiotherapy accelerator system C
96 X-ray CT system for radiotherapy planning C
97 X-ray radiation therapy system C
98 X-ray/C.T. combined linear accelerator system C
99 X-ray/C.T. combined particle radiotherapy equipment C
100 Patient Positioning System, Ultrasound C
101 X-ray/M.R. combined linear accelerator system. C

Documents required for CDSCO Registration for Radiotherapy Medical Devices

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

Procedure for CDSCO Registration for Radiotherapy Medical Devices

The steps to be followed for CDSCO Registration for Radiotherapy Medical Devices in India-

  1. Identifying if Medical Devices require Registration or not: To obtain CDSCO registration, the applicant must first verify if the Medical Device is notified or not. All the notified devices in India must be registered before being marketed. All the Non-notified medical devices must obtain a voluntary registration before the given deadline based on their class risks. The CDSCO Registration for Radiotherapy Medical Devices falls under the ambit of notified medical devices, as notified by CDSCO.
  2. Appointing Indian Authorized Agent (IAA): If the manufacturer who intends to apply for CDSCO Registration for Radiotherapy Medical Devices is not an Indian, then an Indian Authorized Agent is appointed to carry out official duties on his behalf as his representative.
  3. Documentation process: The manufacturer or IAA must submit all the necessary documents and forms to the licensing authorities to obtain  CDSCO Registration for Radiotherapy Medical Devices
  4. Grant of Registration License: After completing the documentation, all the records are verified by the licensing authority, and after fulfilling all the requirements, the registration certificate is granted to the applicant.

Conclusion

Medical Device Industry is increasing at a rapid scale, therefore it gets necessary to get CDSCO registration for medical devices to ensure product quality and safety to the customers on whom these medical devices are being used. However, the medical device registration process might get technical in terms of rules and procedures. Therefore, it is always advisable to get help from professionals to obtain CDSCO registration certificate for medical devices to save from losses in terms of time and extra expenses.

Read Our Article:A Step by Step guide for Registration Process for Medical Devices in India

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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