India’s Union Health Ministry has announced that medical devices intended for human and animal use will go through the scrutiny of the Central Drugs and Standard Control Organisation (CDSCO).
This move aims to improve the safety and quality of the medical devices in the wake of Johnson & Johnson’s faulty hip implants case that left several people disabled.
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The draft notification issued by the Ministry of Health and Family Welfare stated that it plans to define all medical devices as drugs under the Drugs and Cosmetics Act from 1 December.
The ministry has sought comments from all stakeholders within 30 days before its implementation on 1 December.
Presently, 23 medical devices come under the purview of the Drugs and Cosmetics Act 1940.
Following the finalisation of the notification, the import, manufacture and sale of all medical devices will have to be certified by the CDSCO.
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By GlobalDataFurthermore, medical device makers will also have to get licenses from the Drug Controller General of India.
Along with implants and contraceptives, the draft notification will also re-categorise devices used for diagnosis, life support or treatment.
Various stakeholders have been seeking for regulating all non-notified medical devices due to concerns regarding their safety, quality and performance.
In February, the government had categorised devices such as implantable medical devices, MRI equipment, defibrillators, CT scan equipment, PET equipment, dialysis machines, X-Ray machines and bone marrow cell separators under the Drugs and Cosmetics Act.
