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CDSCO extends License Validity of 8 regulated Medical Devices by 6 Months

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New Regulatory Regime for 8 Medical Items

Central Drugs Standard Control Organisation (CDSCO) has extended the License Validity of 8 Medical Devices (listed under Drugs & Cosmetics Act, 1940) by additional 6 Months for manufacturers/importers who have already submitted their applications to Central/State Licencing authorities.

  • This has been done to ensure continued access to 8 Medical devices during the transition to new regulatory order under the Medical Device Rules (MDR), 2017.

i.The Ministry of Health & Family Welfare (MoHFW)  had notified 8 Medical devices to be regulated under the Drugs & Cosmetics Act (which came into effect from 1st April 2021). The devices are

  • All Implantable Medical Device, CT scan equipment, MRI equipment, Defibrillators, PET Equipment, Dialysis Machine, X-Ray Machine & Bone marrow cell separator
  • The importers/manufacturers of these devices need to take a license from Central Licencing Authority or State Licencing Authority for manufacture/import of these with effect from 1st April 2021.

Medical Devices Rules, 2017

It is a regulatory framework for regulating the manufacture/import of Medical Devices in India. Prior to this, the regulation of medical devices was done under the Drug and Cosmetics Act, 1940.

  • In February 2020, MoHFW amended the Medical Devices Rules 2017, which were to be called Medical Devices (Amendment) Rules 2020.
  • Under the amended rule, the medical devices shall be voluntarily registered for a period of 18 months from 1 April 2020.

Recent Related News:

i.On October 29, 2020, the Department of Pharmaceuticals, Ministry of Chemicals and Fertilizers has revised guidelines of the Production Linked Incentive (PLI) schemes for the promotion of domestic manufacturing of bulk drugs and medical devices.

About Central Drugs Standard Control Organisation (CDSCO)

It is India’s National Regulatory Authority (NRA) India for Pharmaceuticals & Medical Devices. It comes under the Directorate General of Health Services, MoHFW.

Drugs Controller General of India – Dr V. G. Somani
Headquarters – New Delhi