CDSCO Registration for Interventional and Radiology Medical Devices – An Overview

In India, medical experts use interventional radiology techniques to diagnose & treat diseases. Medical experts can treat so many medical conditions through interventional radiology. In this medical technique, medical experts insert some same tools into the body, such as catheters or wire for different machines such as CT Scan, X-ray, and Ultrasound Machines. This interventional radiology can be an alternate option for surgery for different medical conditions and it also reduces the hospitalisation period for patients. In this writ, we will discuss CDSCO Registration for Interventional and Radiology Medical Devices.

Risk-Based Classification of Medical Devices

On 3^rd September 2020, CDSCO released a draft classification for Non-Notified Medical Devices. The Ministry of Health & Family Welfare is going to classify non-notified medical devices such as gowns, adhesive drapes, and cover all under Class A, and surgical drapes & Non-Notified In-vitro Diagnostics (IVD) as Class B Medical Devices. In Feb 2020, the Ministry of Health & Family Welfare made a great move by releasing the Medical Device definition & inclusion of Chapter III A under MDR, 2017. This led all Manufacturers & Importers to register the Non-Notified Medical Devices with the CDSCO, effective from 1^st April 2020.

According to the Medical Device Rules 2017 Chapter II Rule (3), the Central Licensing Authority (CLA) for Medical Devices, the Medical Devices classification should be based on risk such as:

• Low Risk – Class A
• Low Moderate Risk – Class B
• Moderate-High Risk – Class C
• High Risk – Class D

Categorisation of Medical Devices

The notification also mandated CDSCO Registration for Interventional and Radiology Medical Devices and other medical devices also. 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

Classification of Medical Devices Pertaining to Interventional and Radiology

Following is the classification of Medical Devices pertaining to Interventional and Radiology:

Name of the Medical Device	Risk Class
Scintillation (gamma) camera	A
Positron camera	A
Nuclear whole-body counter	A
Bone densitometer	C
Bone sonometer	B
Emission computed tomography system	C
Fluorescent scanner	C
Nuclear rectilinear scanner	A
Nuclear Tomography System	C
Nuclear uptake probe	A
Nuclear Whole Body Scanner	A
Nuclear Scanning Bed	A
Radionuclide Dose Calibrator	B
Radionuclide Rebreathing System	C
Nuclear Sealed  Calibration Source	A
Nuclear Electrocardiograph Synchronizer	A
Non-Fatal Ultrasonic Monitor	B
Ultrasonic Pulsed Doppler Imaging System	B
Ultrasonic Pulsed Echo Imaging System	B
Diagnostic Ultrasonic Transducer	B
Angiographic X-Ray System	C
Diagnostic X-Ray Beam-Limiting Device	C
Cine or Spot Fluorography X-Ray Camera	C
Electrostatic X-Ray Imagining System	C
Radiographic Film Marking System	A
Image-Intensified Fluoroscopic X-Ray System	C
Non-Image Intensified Fluoroscopic X-Ray System	C
Spot-Film Device	B
Diagnostic X-Ray High Voltage Generator	A
Mammographic X-Ray System	C
Photofluorography X-Ray System	C
Diagnostic X-Ray Tube Housing Assembly	A
Diagnostic X-Ray Tube Mount	A
Pneumoenceph Alographic Chair	B
Radiologic Patient Cradle	A
Radiographic Film	A
Radiographic Film Cassette	B
Radiographic Film or Cassette Changer	B
Wall-Mounted Radiographic Cassette Holder	A
Radiographic Fil Illuminator	A
Automatic Radiographic Film Processor	C
Radiographic Grid	A
Radiographic Head Holder	A
Radiologic Quality Assurance Instrument	A
Radiographic Intensifying Screen	A
Radiographic ECG or Respirator Synchroniser	A
Radiologic Table	A
Transilluminator for Breast Evaluation	D
Medical Image Storage Device	A
Radiological Computer-Assisted Diagnostic Software for Lesions Suspicious of Cancer	C
Medical Image Analyser	B
Radiological Computer-Aided Triage & Notification Software	C
Full-body MRI system, permanent magnet	C
Full-body MRI system, resistive magnet	C
Full-body MRI system, superconducting magnet	C
Foetal cardiac monitor	C
Foetal Doppler system	C
Flexible ultrasound colonoscope	B
Flexible ultrasound duodenoscope	B
Flexible ultrasound gastro duodenoscopy	B
Flexible ultrasound laparoscope	B
Flexible ultrasound bronchoscope	B
Bladder ultrasound imaging transducer	B
Blood flowmeter catheter, Doppler	C
General-purpose ultrasound imaging system	B

Documents Required for CDSCO Registration for Interventional and Radiology Medical Devices

Following is the list of all the crucial documents required for CDSCO Registration for Interventional and Radiology Medical Devices:

1. Duly-filled application form;
2. ISO 13485 Certificate;
3. Full Quality Assurance Certificate;
4. CE Design Certificate;
5. Undertaking that all details provided is authentic;
6. Either an FSC (Free Sale Certificate)/Certificate from the Foreign Government;
7. Plant Master Report;
8. Device Master File;
9. Declaration of Conformity.

Procedure for CDSCO Registration for Interventional and Radiology Medical Devices

Following is the step-by-step online procedure for CDSCO Registration for Interventional and Radiology Medical Devices:

Step 1: Identifying whether your Medical Devices are under Notified List/Not: The CDSCO has provided a list of notified medical devices that need to mandatorily get Registration under the Drugs & Cosmetics Act, 1940^[1] & as per the Medical Device Rules, 2017. However, there may be any medical devices/equipment that have not been notified by the CDSCO, or in the case of new Medical devices, the importer/Manufacturer shall be required to get a NOC in such instances.

Step 2: Appoint an Authorised Representative (In case of Foreign Entity): For a Foreign Entity, it shall be vital to appoint an Authorised business entity in India, who shall be the contact person or individual for the inspection authorities during the process, help in device approvals & Registration Process, & vigilance adverse event reporting.

Step 3: Filing the Application Form: In this Registration step, the Manufacturer or Importer of Medical Device shall be required to submit the Registration Form of a Regulatory dossier, along with all the requisited fee on the CDSCO portal, to the DGCI.

Step 4: Obtain Registration Certificate: Once the application is submitted to the CDSCO, the authority may send a query or raise a query through an inquiry letter to the Manufacturer/from the Authorised Representative of the Importer along with the prescribed timeline within which the query should be answered & sometimes, may also ask for a technical presentation. On satisfactory, the concerned authority may issue a License.

Note: The Certificate for CDSCO Registration for Interventional and Radiology Medical Devices is valid for 3 years from the issuance of Registration unless cancelled or suspended by the DCGI authority for proper causes.

Post-Compliance after Getting CDSCO Registration for Interventional and Radiology Medical Devices

1. In case of any alteration that has taken place concerning the constitution of the Firm and/or address of the registered office/factory premises, the Medical Devices Manufacturer/Authorised Representative of the Importer to intimate the Licensing Authority regarding the same in writing.
2. In case of any such alterations have taken place, the existing registration certificate shall be valid for 3 months from the date on which the change or alteration has taken place, and during this time, the Authorised Representative or Manufacturer shall be needed to obtain a new Registration Certificate.

Conclusion

In India, the Medical Device industry is increasing at a rapid scale; therefore it is vital to obtain a Certificate for CDSCO Registration for Interventional and Radiology Medical Devicesto ensure the quality & safety of the device to the consumers on whom these medical devices are being used. However, the Medical Device Registration process might get technical in terms of rules & procedures.

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