Nagpur: Medical device manufacturers have been urged to re-register themselves under the rules of medical devices, 2017, in September this year or face action.
Medical devices were told first registered earlier under the rules of the drug and cosmetics, 1945.
Following instructions from the Standard Control Organization Center (CDSCO), Food and Narcotics Administration (FDA) has issued a notification to the manufacturer to switch to the new licensing regime.
Medical devices include those used for preventive, diagnostic and therapeutic treatments that are classified as low risk (group A), low moderate risk (group B), moderate high risk (Group C) and high risk (Group D).
Group A and B is intended to be controlled by the State Authority, while the rest will be under the center of the center.
The source said four manufacturing, including three of Wardha and one from Nagpur, has re-registered themselves in accordance with CDSCO guidelines.
Five manufacturing, which includes four of the Nagpur and one in Wardha, has purchased a license after new norms forced.
Of the nine registered manufacturing, six make changing materials, two syringes and one laboratory reagent.
Syringes and laboratory reagents are considered as low-risk products, while changing materials are considered low risk.
“Notification has gone to all pharmaceutical companies and device manufacturers.
Anyone found operating without being registered under the rules of medical devices, 2017, post-September, will face action,” said an FDA official.
Manufacturing medical devices told to re-register
