Health Ministry to Alter Schedule M-III for medical devices
The Union health ministry is aiming to revise the Schedule M-III for medical devices under the Drugs and Cosmetics Rules, 1945 replacing the present limited Schedule M-III to target the problems of medical device industry so that it becomes amicable to the international standards. The medical device industry has been insistent that the requirement of GMP compliance for medical devices should be as per IS: 15579: (ISO 13485) standards.
Till date the government has notified 14 categories of medical devices. They are disposable hypodermic syringes; disposable hypodermic needles; disposable perfusion sets; in vitro diagnostic devices for HIV, HBsAg and HCV; cardiac stents; drug eluting stents; catheters; intra ocular lenses; I.V. cannulae; bone cements; heart valves; scalp vein set; orthopedic implants; and internal prosthetic replacements.
It is not obligatory that all the provisions of Schedule M are required to be complied by the manufacturers of medical devices. Provisions could be modified and approved on case to case basis.