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CDSCO Registration for Oncology Medical Devices – An Overview

calendar02 Nov, 2022
timeReading Time: 4 Minutes
CDSCO Registration for Oncology Medical Devices

The CDSCO is the national regulatory body for pharmaceutical, medical, and cosmetic goods. The Indian Government plans to bring all medical devices under the purview of the CDSCO to regulate and ensure the quality, safety and performance of medical devices. Scroll down to check more information regarding CDSCO Registration for Oncology Medical Devices.

What are Oncology Medical Devices?

Before we dig into the CDSCO Registration for Oncology Medical Devices, lets understand the meaning of Oncology Medical Devices. Oncology refers to the branch of medicine concerned with the diagnostics and treatment of cancerous diseases. The term ‘medical device’ can refer to any device/apparatus/instrument as such that is used in medical practices on humans or animals, with specific intended purposes related to analysis, treatment, prevention, etc., of physiological afflictions. Several medical devices exist to aid, primarily, in diagnosing cancer patients and to map the severity of the affliction; these are referred to as Oncology Medical Devices. Imaging technologies such as MRIs, PET Scans, ultrasounds, etc., are regularly used by oncologists to diagnose cancerous diseases and growths such as tumours.

Currently, only certain medical devices notified under the Drugs & Cosmetics Act 1940[1] are regulated. In 2020, The CDSCO provided a list of Oncology Medical Devices, which consisted of 31 devices and classified them based on their intended use and risk class. As of October 2022, all Medical Devices labelled under Risk Class A or B will require CDSCO licensing. Importers of Oncology Medical Devices would require a licence from the CDSCO to sell their products in India. The comprehensive list is available online on the CDSCO webpage.

Applicants must start their application through the registration link made available on the CDSCO online portal. While Class A and B devices have now begun to fall under the licencing regime as of October 2022, Class C and D devices will follow the same pattern and fall under the licencing regime from October 2023.

For devices already in the market before the CDSCO notification, the manufacturer and/or importer must comply with the CDSCO rules and register the oncology medical device within the specified period after the device is notified under the CDSCO list.

Risk Classification System in India

All medical devices have been classified under four categories, based on their use and the risk involved, under the New Medical Rules 2017. The following table depicts these four categories, known as Risk Classes.

Risk Class Risk Level Examples
A Low risk Wheelchairs or tongue depressors
B Low to moderate risk Hypodermic needles or suction equipment
C Moderate to high risk Ventilators or bone fixation plates
D High risk Heart valves or implantable defibrillators

A variety of factors affect the classification level of Oncology Medical Devices, such as-.

  • The duration of contact the medical device has with the body.
  • The degree of invasiveness.
  • Whether the medical device delivers energy or any medicinal products to the patient.
  • If the device is intended to have a biological effect on the patient.
  • Local versus systemic effects (e.g. conventional versus absorbable sutures).

In the case of a collection of medical devices that comply with all regulatory requirements individually, the risk classification for the collective depends on the owner’s purpose for packaging and marketing.

Any accessories aimed specifically at helping a particular Oncology Medical Device function will be subject to the same regulatory practices as the main device itself. 

Any software that is not embedded into the Medical Device itself is considered standalone software and can be deemed to fall under the scope of a Medical Device. Hence, such standalone software is then subject to classification as follows-

  • If the software drives or influences the use of a separate medical device, its classification depends on the intended purpose of the combination.
  • If the software is independent of any other medical device, it is classified as its own device accordingly to the classification rules.
  • Standalone software is deemed to be an active medical device.

Documents Required for CDSCO Registration for Oncology Medical Devices 

Following are some vital documents required for CDSCO Registration for Oncology Medical Devices:

Pre-screening checklist-CDSCO Registration for Oncology Medical Devices

  • Covering Letter
  • Self-attested copy of authorization letter to the person issued by the Director/Company Secretary/Partner of the Indian Agent firm
  • Detail Product description along with the material of construction, intended use, Product specification, product literature, package inserts along with a sample
  • The regulatory status of the said product in the country of origin
  • Regulatory certificates in respect of said product

To register on the online portal-

  • Id Proof Details
  • Undertaking
  • Corporate Address Proof Details (Certificate of Incorporation)
  • Copy of the Manufacturing Licence and the Wholesale Licences

For Registration of devices by the manufacturer-

  • Name & address of the company/firm/any other entity manufacturing the medical device, along with the name & address of the manufacturing site of the medical device.
  • Details of the medical device.
  • Certificate of compliance concerning ISO 13485 accredited by National Accreditation Board for Certification Bodies/International Accreditation Forum in respect of such medical device.
  • Undertaking duly-signed by the manufacturer stating that the information provided by the applicant is true and authentic.

For Registration of devices by the importers-

  • Name of the company/firm/any other entity importing the medical device.
  • Details of the medical device.
  • Specification and standards of that medical device.
  • Certificate of compliance concerning ISO 13485 accredited by National Accreditation Board for Certification Bodies/International Accreditation Forum in respect of such medical device.
  • Free sale certificate from country of origin.
  • Undertaking duly-signed by the importer stating that the information provided by the applicant is authentic.

CDSCO Registration for Oncology Medical Devices – Procedure

Following is the procedure for CDSCO Registration for Oncology Medical Devices:

  1. Identify Whether a Medical Device needs to be registered: The CDSCO has provided a list of notified medical devices that require Registration under the Drugs & Cosmetics Act, 1940 and as per MDR, 2017. However, there may be any medical devices that haven’t been notified by the CDSCO, or in the case of a new medical device, the manufacturer or importer shall be required to get a NOC in such cases.
  2. Appoint an IAA: In the case of a Foreign Manufacturer, an Indian Authorised Agent is appointed. The Indian Authorised Agent or IAA represents the manufacturer in court & carries out all of their official business in India.
  3. Documentation: To Obtain a CDSCO Registration License, all required documents must be submitted to the concerned authorities.
  4. Issuance of License: The manufacturer gets the Registration License after submitting the application & all the required documents to the appropriate authorities.

Conclusion 

At present, all Medical Devices labelled under Risk Class A or B will require CDSCO licensing, but come October 2023, Class C and D devices will follow the same pattern and fall under the licence regime.

Read our Article:CDSCO Registration for General Hospital Medical Devices – An Overview

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