Regulation on Medical Devices Leave a comment

Medical devices refer to those machines or devices used for treatment or diagnosis of diseases in human beings or animals and include devices such as syringes, thermometers, or spatulas. They are an indispensable part of the healthcare industry. Previously there were few or no regulations for governing the manufacturing and import of medical devices.

Recently, the government has introduced regulations to maintain high standards of quality, control prices and also to prevent incidents where faulty medical devices have caused harm.

Regulation of medical devices

Currently all the companies involved in introduction, sale and import medical devices need to strictly abide by the regulations laid out in the Medical Device Rules (MDR), 2017. The regulation of medical devices is done by the Central Drugs Standard Control Organization (CDSCO). It is also compulsory to get licenses for the manufacturing and importing of medical devices. All the application processes are done on an online portal named SUGAM which maintains the records of all medical devices.

By licensing with CDSCO, it makes the medical devices safe to use and assures quality. To obtain license, the companies are required to submit details about their products. The details include the date of manufacturing and expiry date. Any adverse side effects caused by medical devices also have to be reported.

Classification of medical devices

The medical devices have been divided into four categories taking into consideration the risk associated with them which are:

  • Class A (low risk),
  • Class B (moderate risk),
  • Class C (moderate-high risk),
  • Class D (high risk).

  • Safe to use Medical Devices

    Currently, there are 23 medical devices under the Drugs and Cosmetics Act which are regulated and labelled safe to use.The MDR will be governing 27 devices with effect from April 2020 and in three phases all medical devices are proposed to be regulated as drugs under the Drugs and Cosmetics Act.

    In February 2019, the government has notified more vital medical devices like MRI machines, all implantable medical devices, x-ray machines, and CT scan machines and from April 1, 2020, they will also come under the new regulations. Recently, other devices like nebulizers and glucometers had also been notified under the Drugs and Cosmetics Act and their inclusion will be implemented from 2020 in January.

    How regulation will impact medical devices?

    The implementation of these steps will put a stop to practices such as the import and sale of medical devices that have been refurbished. It will make the companies making medical devices more responsible for the safety of patients. The prices of the newly notified medical devices can also be brought under control just like the regulated drugs and it will consequently bring down the rates of healthcare. Thus it will help the government to attain the goal of providing quality and affordable healthcare services for health and family welfare goi. It will also make India one of the top medical device producing nations pof the world.

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