Union Health Ministry Assigns Testing Labs for Surgical, Medical Examination Gloves, Amends MDR
New Delhi: The Union Health Ministry has amended the Medical Devices Rules, 2017, to expand testing and regulatory provisions for several critical medical devices, including surgical gloves, medical examination gloves, cotton bandages, anticoagulant solutions used in blood bags, and disposable syringes.
The notification, published in The Gazette of India on December 10, 2024, marks a significant step toward ensuring stringent regulatory oversight and quality assurance in medical devices.
The amendments specifically expand the scope of serial numbers in an earlier notification from June 1, 2018, to include surgical gloves, medical examination gloves, cotton bandages, anticoagulant solutions used in blood bags, and disposable syringes under the ambit of medical device testing.
The recent amendments to the Medical Devices Rules explicitly include surgical gloves and medical examination gloves under the testing categories. Additionally, the scope of regulated devices has been expanded to cover other essential medical accessories such as cotton bandages, anticoagulant solutions used in blood bags, and disposable syringes. The Gazette notification read;
“In the said notification, in the table,
(i) in serial number (2), in column (3), after the word, “Condoms”, the following shall be inserted, namely:- “, Surgical Gloves and Medical examination Gloves”;
(ii) in serial number (3), in column (3) after the word, “Disinfectant”, the following word shall be inserted, namely:- “, Surgical Gloves and Medical examination Gloves”;
(iii) in serial number (5), in column (3) after the word, “and Falope Rings”, the following shall be inserted, namely:- “, Surgical Gloves, Medical examination Gloves, Cotton Bandages, Anticoagulant Solutions used in blood bags and Disposable syringes”.
Under the notification, government analysts at designated labs have been authorized to test medical devices in compliance with rigorous quality standards. The amendments provide a structured framework for regulating a broader range of medical devices, focusing on their sterility, safety, and compliance with regulatory standards.
The Table given below as Medical Device Testing Officers in respect of the Medical Devices as specified against their names in column (4) of the said table, namely :-
TABLE
| Serial No. | Name of Government Analyst | Name of Laboratory | Medical Device (s) |
| (1) | (2) | (3) | (4) |
| 1. | Dr Saroj Kumar Ghosh | The Central Drugs Laboratory, Kolkata | Sterile and Single use Medical Devices, Non-sterile Medical Devices, Surgical dressings, Gloves for Medical purposes, Disinfectant. |
| 2. | Dr Rakesh Kumar Rishi | ||
| 3. | Dr Anjan Pal | ||
| 4. | Dr Dilip Kumar Panda | ||
| 5. | Smt Suparna Maitra | ||
| 6. | Smt C. Vijayalakshmi | The Central Drugs Testing Laboratory, Chennai | Mechanical Contraceptives, Gloves for Medical purposes. |
| 7. | Smt G. Sasikala | ||
| 8. | Shri Kishor Gembali | ||
| 9. | Shri C. Hariharan | The Central Drugs Testing Laboratory, Mumbai | Mechanical Contraceptives, Gloves for Medical purposes. |
| 10. | Smt Sayali U. Warde | ||
| 11. | Smt Akshata S. Paranjpe | ||
| 12. | Smt Sujata S. Kaisare | ||
| 13. | Dr Vijayakumar Munipalli | ||
| 14. | Smt Sukhada A. Navaratne | ||
| 15. | Shri Amar Jyoti Chamuah | The Regional Drugs Testing Laboratory, Guwahati, Assam | Sterile and Single Use Medical Devices, Non-sterile Medical Devices, Gloves for Medical purposes. |
| 16. | Shri Dilip Kr. Sarkar | ||
| 17. | Smt Rinku Kalita | ||
| 18. | Shri Hitesh Kumar Khare | The Regional Drugs Testing Laboratory, Chandigarh | Sterile and Single Use Medical Devices, Non-sterile Medical Devices, Surgical dressings, Gloves for Medical purposes. |
| 19. | Dr Debasis Maiti | ||
| 20. | Dr Rajesh Kumar Sharma | The National Institute of Biologicals, Noida
| In-vitro Diagnostic Medical Devices.
|
| 21. | Ms Kanchan Ahuja | ||
| 22. | Ms Ajanta Sircar | ||
| 23. | Dr Richa Baranwal
| ||
| 24. | Dr Pankaj Kumar Sharma |
Serial No. | Name of Government Analyst | Name of Laboratory | Medical Device (s) |
(1) | (2) | (3) | (4) |
25. | Dr Varun Singh | ||
26. | Dr Gauri Misra | ||
27. | Dr Ashwani Kumar Dubey |
