NEW DELHI: The Medical Technology Association of India has welcomed a gazette notification by the Centre proposing to regulate all medical devices in the country.
In a draft notification issued on Friday, the Union Ministry of Health and Family Welfare said, it plans to define all medical devices, which were earlier not under the purview of the apex drug controller, as drugs under the Drugs and Cosmetics Act from December 1.
“The Health Ministry’s proposal to regulate all medical devices will allow patients access to quality medical devices and put a check on garage manufacturing,” said Pavan Choudary, director-general and the chairman of MTaI.
He added that Central Drugs Standard Control Organization (CDSCO) has the expertise to regulate this intricate medical device sector. “Bringing all medical devices under regulation has been a long-pending demand from the industry.
It is encouraging to see the government taking cognizance of industry concerns,” Choudhary added The MTaI director-general added that the domestic industry would also benefit from this regulatory pathway, as compliance with global standards will open up access to global markets for more domestic manufacturers-and not just the big ones.