Now, new rules to make medical devices

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(Representative image)
(Representative image)

PATNA: Those planning to set up a plant for manufacturing medical devices in the state would now have to apply for licence under the new Medical Device Rules, 2017 implemented in January this year. Earlier, the licence was issued under the Drugs and Cosmetics Act, 1940.

“The licences already issued under the Drugs and Cosmetics Act for manufacturing medical devices will stay the same,” the newly appointed medical device officer for the state, Amal Kumar, said.

He said the licences under the new rule would not need periodical renewal for manufacturing and import and would remain valid until they are either suspended, cancelled or surrendered. The licensee would have to pay a retention fee every five years for the licence to remain valid. An online portal — Sugam — by Central Drugs Standard Control Organization (CDSCO) has been launched to provide online services for granting licences for manufacturing, import, clinical investigation, sale and distribution of medical as well as in vitro diagnostics (IVD) devices.

“Now, a total of 598 items are in the list of medical devices,” said Kumar, adding the 2017 rules also include surgical sutures, bandages, dressings and staples, disinfectants, ligature and mechanical contraceptives. Setting new standards for the requirement to manufacture medical devices, they have been classified depending on the risk involved into four classes — low (Class A), low moderate (Class B), moderate high (Class C) and high (Class D).

“The application for manufacture of Class A or Class B medical devices will be assessed by the state licensing authority whereas the application for manufacture of Class C or Class D medical devices will be assessed by Drug Controller General of India (DCGI),” Kumar said.

He further said there were three plants in the state — two in Patna and one in Hajipur — for manufacturing devices under Class A and B. “The manufacturing sites will have to be inspected not less than once a year to check they are conforming to all the terms and conditions for the licences. Manufacturers are expected to follow stringently the quality management system while manufacturing medical devices,” he added.

Kumar said a one-day training programme on February 9 would be geld for all the medical device officers of the country in Delhi on how to implement the new rules properly.

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