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Latest Update on Medical Devices Regulation

By 25 October 2019May 19th, 2022No Comments

All Medical Devices to be Regulated from December 1, 2019: On October 18th, the Union Health Ministry released a gazette notification that proposed all medical devices to get certified by the Central Drugs Standard Control Organization (CDSCO). The ministry further notified that the manufacturers and other stakeholders have a span of one month to share their views.

According to the proposal, all the medical devices classified as “drugs” will be regulated under the Drugs and Cosmetics (D&C) Act. The list of devices includes diagnostic equipment, nebulizers, syringes, stents, implant instruments, and all equipment used on human beings or animals as “drugs”. The draft notification also plans to recategorize medical devices that are used for diagnosis, life support, treatment or alleviation of any disease or disability, and even devices that are used to disinfect other medical devices.

Readings from the Draft Notification:

medical Devices-regulation

Effect on Medical Device Companies:

  • The Central Drugs Standard Control Organization (CDSCO) will be in charge of certifying medical devices for manufacture, import and sale once the regulation is finalized.
  • All devices manufactured, sold and distributed in the country will be thoroughly inspected and monitored for quality, efficacy, and safety by the CDSCO.
  • In addition to this, companies will also have to carry out clinical trials before launching a new product and be accountable for adverse events and the effectiveness of the product.

Do you agree that the proposed regulation will enhance safety and quality in all medical devices?

Source: Times of India, Economic Times, Live Mint,

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