The Union health ministry has revised the Medical Devices Regulations (MDR), 2017 to appoint three testing laboratories in the nation for the evaluation of surgical and medical examination gloves.
Additionally, alterations have been made to pertinent rules under the MDR, which now appoint 27 government analysts in six distinct laboratories as officers tasked with testing various medical devices, including gloves.
Per the notification dated December 10, the ministry has categorized “surgical gloves and medical examination gloves” as specific types of medical devices designated for assessment at the Central Drugs Testing Laboratory (CDTL) in Chennai, Kolkata, and Mumbai. Moreover, the CDTL in Mumbai will also carry out tests for cotton bandages, anticoagulant solutions in blood bags, and disposable syringes as per this announcement.
Previously, on June 1, 2018, the Central Government had designated five laboratories to test certain classes of medical devices through an official notification.
The CDTL, Chennai was tasked with testing condoms, while the Kolkata lab was appointed to examine surgical dressings, surgical cotton, surgical bandages, and disinfectants. The Mumbai lab specialized in testing IntraUterine Devices (IUD) and Falope Rings.
In addition, the National Institute of Biologicals in Noida was appointed to test in-vitro diagnostics for HIV, Hepatitis B Surface Antigen, Hepatitis C Virus, blood grouping sera, glucose test strips, and fully automated analyzer-based glucose reagents.
The Regional Drugs Testing Laboratory (RDTL) in Guwahati is responsible for evaluating disposable hypodermic syringes, disposable hypodermic needles, disposable perfusion sets, and IV cannulae. These facilities have been accredited by the National Accreditation Board for Testing and Calibration Laboratories (NABL), as confirmed by the department.
On December 10, 2024, another notification appointed five government analysts from CDTL Kolkata and two from the Regional Drugs Testing Laboratory, Chandigarh for testing sterile, single-use, non-sterile medical devices, surgical dressings, medical gloves, and disinfectants. Three analysts from CDTL, Chennai, and six from CDTL, Mumbai have been designated to analyze mechanical contraceptives and medical gloves.
Moreover, three analysts from the Regional Drugs Testing Laboratory in Assam are responsible for testing sterile, single-use, non-sterile medical devices, and gloves. Eight analysts from the National Institute of Biologicals, Noida, will assess in vitro diagnostic medical devices as indicated in the announcement.
It is noteworthy that the government is actively enhancing the workforce both in regulatory offices and in medical device testing laboratories to effectively regulate, monitor, and test medical devices distributed and marketed nationwide. Following the recent classification of these devices as drugs, the ministry is endeavoring to establish additional testing laboratories, primarily in partnership with private labs, throughout the country to facilitate the swift regulatory approval and distribution of medical devices.