The Department of Health and Family Welfare under the Union health ministry has amended the list of government analysts designated as the Medical Device Testing Officers (MDTO) for test and evaluation of surgical gloves and medical examination gloves along with diagnostic kits, which was earlier notified through amendment of Medical Devices Rules (MDR), 2017, in December, 2024.
While the number of government analysts and laboratories to test the medical devices including gloves for medical purposes remain the same, some of the analysts have been replaced with some other officials, through the amendment, in the National Institute of Biologicals (NIB), Noida.
Besides, while NIB was designated to test in-vitro diagnostic (IVD) medical devices by all the eight analysts assigned under the list earlier, now three analysts from the institution has been assigned to test IVD, one for biochemical kits, two for molecular diagnostic kits, and another two for blood grouping reagents.
The Central Drugs Testing Laboratory, Mumbai, from where six analysts were earlier assigned to test mechanical contraceptives and gloves for medical purposes, the amendment now has assigned these six analysts to test sterile and single use medical devices, non-sterile medical devices, surgical dressings, mechanical contraceptives, gloves for medical purposes, absorbent gauge, and disinfectant.
In December, 2024, the Department has assigned 27 medical device testing officers from six laboratories - The Central Drugs Laboratory (CDL), Kolkata; the Central Drugs Testing Laboratory (CDTL), Chennai; CDTL, Mumbai; Regional Drugs Testing Laboratory (RDTL), Guwahati, Assam; RDTL, Chandigarh; and the NIB, Noida, to test various medical devices including gloves for medical purposes.
In another amendment, notified on December 10, 2024, the Department has included "surgical gloves and medical examination gloves" as categories of medical devices specifically assigned to be tested in the CDTL, Chennai; CDTL, Kolkata; and CDTL, Mumbai. Five laboratories were specifically assigned by the central government, through a notification issued on June 1, 2018, to test specified categories of medical devices.
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. |