Critical medical devices such as pacemakers, CT scanners and X-ray machines will soon have an assurance of quality, with the government set to regulate their manufacture, import and sale in the country.
The Drugs Technical Advisory Board approved a proposal on May 16 to include implantable medical devices and high-end medical equipment under the purview of the Drugs and Cosmetics Act, 1940, according to the minutes of its latest meeting. This will allow the country’s apex drug regulatory body to set quality standards for implantable medical devices and equipment, including defibrillators, dialysis and X-ray machines as well as PET, CT scan and MRI equipment.
The government wanted to regulate implantable medical devices because they are high-risk and inserted into the human body using surgical means, remaining there for over 30 days, according to another person aware of the development. It wanted to set standards for high-end equipment like CT scanners, MRI machines and defibrillators because of their potentially life-saving roles, according to the person.
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