New Delhi: The Union health ministry has amended the Medical Devices Rules (MDR), 2017 to assign testing of surgical gloves and medical examination gloves to three medical devices testing laboratories in the country.
It has also amended the relevant rules under the MDR to designate 27 government analysts in six laboratories as medical device testing officers for various medical devices including gloves for medical purposes.
According to the amendment notified on December 10, the ministry has included “surgical gloves and medical examination gloves” as categories of medical devices specifically assigned to be tested in the Central Drugs Testing Laboratory (CDTL), Chennai; CDTL, Kolkata; and CDTL, Mumbai. Further, the CDTL Mumbai also has been assigned to test cotton bandages, anticoagulant solutions used in blood bags and disposable syringes, through this notification.
Five laboratories were specifically assigned by the Central government, through a notification issued on June 1, 2018, to test specified categories of medical devices.
The CDTL, Chennai was assigned to test Condoms, while the CDTL, Kolkata was assigned to test surgical dressings, surgical cotton, surgical bandages, and disinfectants. The CDTL in Mumbai was assigned to test IntraUterine Devices (IUD) and Falope Rings.
Besides, the National Institute of Biologicals, Noida was assigned to test in-vitro diagnostics for human immunodeficiency virus, Hepatitis B Surface Antigen and Hepatitis C Virus, blood grouping sera, glucose test strip, and fully automated analyser based glucose reagent.
The Regional Drugs Testing Laboratory (RDTL), Guwahat has been assigned to test disposable hypodermic syringes, disposable hypodermic needle, disposable perfusion sets, and IV cannulae. These laboratories are duly accredited by the National Accreditation Body for Certification Laboratories (NABL), said the department during the time.
In another notification on December 10, 2024, the Department has assigned five government analysts from CDTL Kolkata and two government analysts from the Regional Drugs Testing Laboratory, Chandigarh to test sterile and single use medical devices, non-sterile medical devices, surgical dressings, gloves for medical purposes and disinfectant; three government analysts from CDTL, Chennai and six government analysts from CDTL Mumbai to test mechanical contraceptives and gloves for medical purposes.
Three government analysts from the Regional Drugs Testing Laboratory, Assam are assigned to test sterile and single use medical devices, non-sterile medical devices, and gloves for medical purposes. Eight government analysts from the National Institute of Biologicals, Noida, have been assigned to test in vitro diagnostic medical devices, through the notification.
It may be noted that the government has been taking various measures to beef up the manpower in both the regulatory office and the devices testing laboratories to regulate, monitor and test the medical devices distributed and sold in the country, after it has announced the devices as drugs in the recent past. The Ministry has also been taking measures to set up more medical devices testing laboratories, mostly with the support of private laboratories, in various parts of the country to enable medical devices companies to test their products for regulatory approval and distribution across the country without delay.
