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Kandarp Vanita
| Updated: 14 Mar, 2021 | Category: Medical device

Regulation for all Medical Devices under CDSCO Directive

Medical Devices under CDSCO Directive

The national regulatory body for pharmaceuticals and medical devices in India is Central Drugs Standard Control Organisation (CDSCO). According to the Indian regulatory body it is imperative to have a CDSCO license for all the medical devices seller and medical devices manufacturers. Every nation’s ministry of health has its very own dedicated supervision body to take care of each part of pharmaceuticals and medical devices. In India, the authority responsible for regulating the registration and sale of notified medical devices is CDSCO. The Indian government has pulled all the medical devices under CDSCO regulation. Now all the medical devices will have assured quality and safety.

Indian Government’s Notification for Medical Devices under CDSCO Regulation

The Ministry of Health and Family Welfare[1], Government of Indian has by way of three notifications dated December 27, 2019 and October 21, 2020, extended the effective date of earlier notifications which consecutively brought 13 new categories of medical devices under CDSCO regulation  also known as “New Device Notifications”.

Expansion of Devices

India’s pharmaceutical regulator and medical device, the Central Drugs Standard Control Organization (CDSCO), has now further issued an extension for various types of medical devices to register for market authorization.

The CDSCO has expanded and included more device types formerly expected to register under India’s Medical Device Rules, 2017 by January 1, 2020, but now have extended the registration deadline to January 2021 by first notification.

  • Nebulizers
  • Digital thermometers
  • Glucometers
  • Blood pressure monitoring equipment

CDSCO has extended the compliance deadlines for several types of other imaging devices in addition to the above devices to April 1, 2021 by 2nd notification and these include:

  • Implantable devices
  • MRI equipment
  • X-Ray machines
  • CT scan equipment
  • Bone marrow cell separation device
  • Defibrillators
  • Dialysis systems
  • PET equipment

Read our article:Know the Checklist for Documents Required For Medical Device Registration in India

Ultrasound Equipment under CDSCO Regulation

The New Device third Notifications has amended the date of notification dated October 16, 2019 and has brought ultrasound equipment under CDSCO regulation from November 01, 2020 extending to November 01, 2021

Emergo by UL consultants in New Delhi will observe the CDSCO’s progress and shall implement the new regulatory scope for development. India is regarded as one of the top international medical devices markets with its noteworthy offer towards imports of device.

The country’s agency for regulation of device, Central Drugs Standard Control Organization, CDSCO  has made classification of the medical devices which is headed by Drug Controller General of India (DCGI) and it has classified medical devices into four classes (A, B, C, and D) as per the regulation.

Risk-Based Classifications for Medical Devices under CDSCO

Medical Devices under CDSCO are in general based on the risks and on the basis of the medical devices intended use and purpose, the real risk-based classification is done. The medical devices under CDSCO classification have a larger group of devices such as stent and cannulas in more specific subgroups.

  • Low Risk – Class A – (Surgical dressing, Absorbent cotton wools, alcohol swabs, etc)
  • Low Moderate Risk – Class B – (BP monitoring device, Thermometer, disinfectants etc)
  • Moderate High-Risk ­– Class C – (Haemodialysis catheter, Implants etc)
  • High risk – Class D – (heart valve, Angiographic guide wire)

Medical Devices under CDSCO are Provided Relaxations on Regulatory Compliance

India’s apex drug regulator, CDSCO has issued the public notice relaxing compliance requirements under the D&C Act in light of the outbreak of Covid-19 pandemic.

Medical Devices under CDSCO are Provided Relaxations

Import Relaxation

Under the Medical Device Rules, 2017, medical devices importers are mandated to submit an application to the CDSCO for obtaining an import license before importing medical devices into India. Besides submitting the application for the import license, notarization of certain documents together is also a necessary condition that an applicant has to comply.

The Import Relaxation is given to the applicant on the provisional basis if the applicant submits these documents after self-attestation along with an undertaking that within four months  or when the situation becomes normal whichever is earlier the applicant will provide the notarize documents.

 GMP Relaxation

The GMP Relaxation extends this period by six more months from the date of expiry for CoPPs. The CoPP is the Certificate of Pharmaceutical Product issued by CDSCO under the WHO-GMP certification scheme for the reason of registration of Indian pharmaceutical products in foreign countries with the purpose that Indian companies can export their drugs to keep up and continue of essential activities in the pharmaceutical industry.

RC Notification

The RC Notification aims to avoid the undesirable impact due to COVID-19 pandemic on the supply of drugs. The RC Notification was issued in response to foreign pharmaceutical companies whose registration certificates (a precondition for foreign pharmaceutical companies looking for exporting drugs to India) were about to expire soon and the same shall be extended.

Drug Import Notification

The Drug Import Notification was issued in reply to pharmaceutical companies whose import licenses were about to expire soon, those import license holders have to apply for an import license prior to the expiry of the existing one.

These relaxations provided to the medical devices under CDSCO and the pharmaceutical companies were like a greeting measure to make sure the continuity of medical business in these tough times.

Conclusion

The covid- 19 pandemic had a little impact on the medical device industry because of the regulations of CDSCO. The medical industry is looking at two key developments in the prospect of 2021 that whether any improvement will be made to propose for a separate legislation to regulate medical devices under CDSCO and whether the required licenses for import of medical devices will be given in a timely manner by the CDSCO.

The risk classifications of the medical devices under CDSCO will permit the Indian medical device markets registrants and delegates to improve costs, clinical information requisites, quality and safety of medical devices and import permit authority.

The new guideline will regulate the operation of medical devices rule under CDSCO with the International Standards and shall ensure the quality and ease of manufacturing and import of medical devices.

Read our article:A Step by Step guide for Registration Process for Medical Devices in India

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Kandarp Vanita

Kandarp Vanita has done masters in Corporate and Commercial Law from WB National University of Juridical Sciences. She has 3 yrs of experience in drafting legal documents & dissertations. Being a curious reader, she is also passionately into providing legal backups and comprehensive understandings in every aspect of Law to the firms.

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