MDTL and MDTO Notification

REGD. No. D. L.-33004/99 The Gazette of India CG-DL-E-11122024-259336 EXTRAORDINARY PART II-Section 3—Sub-section (ii) PUBLISHED BY AUTHORITY No. 4934] NEW DELHI, TUESDAY, DECEMBER 10, 2024/AGRAHAYANA 19, 1946 7994 GI/2024 (1) MINISTRY OF HEALTH AND FAMILY WELFARE (Department of Health and Family Welfare) NOTIFICATION New Delhi, the 10th December, 2024 S.O. 5330(E).— In exercise of the powers conferred by sub-rule (2) of rule 19 of the Medical Devices Rules, 2017, the Central Government hereby makes the following amendment further to amend the notification of the Government of India in the Ministry of Health and Family Welfare (Department of Health and Family Welfare) number S.O. 2237(E), dated the 1st June, 2018, published in the Gazette of India, Extraordinary, Part II, Section 3, Sub-section (ii), namely:- 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”. [F.No. X. 11035/29/2024-DRS] RAJIV WADHAWAN, Advisor (Cost). Note: The principal notification was published in the Gazette of India, Extraordinary, Part II, Section 3, Sub-section (ii), vide number S.O. 2237(E), dated the 1st June, 2018 and last amended vide notification number S.O. 1928(E), dated the 25th April, 2023. NOTIFICATION New Delhi, the 10th December, 2024 S.O. 5331(E). In exercise of the powers conferred by sub-section (2) of section 20 of the Drugs and Cosmetics Act, 1940 (23 of 1940) read with sub-rule (1) of rule 18 of the Medical Devices Rules 2017, and in supersession of the notification of the Government of India in the Ministry of Health and Family Welfare (Department of Health and Family Welfare) number S.O. 3739(E), dated, the 2nd August, 2022 published in the Gazette of India, Extraordinary, Part II, Section 3, Sub-section (ii), dated the 8th August, 2022 except as respects things done or omitted to be done before such supersession, the Central Government hereby designates the following Government Analysts specified in column (2) of 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 | Name of Government | Name of Laboratory | Medical Device (s) | | No. | Analyst | | | +==========+============================+===================================+=========================================================+ | (1) | (2) | (3) | (4) | +----------+----------------------------+-----------------------------------+---------------------------------------------------------+ | 1. | Dr. Saroj Kumar Ghosh | The Central Drugs | Sterile and Single use Medical Devices, | | 2. | Dr. Rakesh Kumar Rishi | Laboratory, Kolkata | Non-sterile Medical Devices, | | 3. | Dr. Anjan Pal | | Surgical dressings, | | 4. | Dr. Dilip Kumar Panda | | Gloves for Medical purposes, | | 5. | Smt. Suparna Maitra | | Disinfectant. | +----------+----------------------------+-----------------------------------+---------------------------------------------------------+ | 6. | Smt. C. Vijayalakshmi | The Central Drugs | Mechanical Contraceptives, | | 7. | Smt. G. Sasikala | Testing Laboratory, | Gloves for Medical purposes. | | 8. | Shri Kishor Gembali | Chennai | | | 9. | Shri. C. Hariharan | | | +----------+----------------------------+-----------------------------------+---------------------------------------------------------+ | 10. | Smt. Sayali U. Warde | The Central Drugs | Mechanical Contraceptives, | | 11. | Smt. Akshata S. Paranjpe | Testing Laboratory, | Gloves for Medical purposes. | | 12. | Smt. Sujata S. Kaisare | Mumbai | | | 13. | Dr. Vijayakumar | | | | | Munipalli | | | +----------+----------------------------+-----------------------------------+---------------------------------------------------------+ | 14. | Smt. Sukhada A. | The Regional Drugs | Sterile and Single Use Medical Devices, | | | Navaratne | Testing Laboratory, | Non-sterile Medical Devices, | | 15. | Shri. Amar Jyoti | Guwahati, Assam | Gloves for Medical purposes. | | | Chamuah | | | | 16. | Shri. Dilip Kr. Sarkar | | | | 17. | Smt. Rinku Kalita | | | +----------+----------------------------+-----------------------------------+---------------------------------------------------------+ | 18. | Shri. Hitesh Kumar Khare | The Regional Drugs | Sterile and Single Use Medical Devices, | | 19. | Dr. Debasis Maiti | Testing Laboratory, | Non-sterile Medical Devices, | | | | Chandigarh | Surgical dressings, | | | | | Gloves for Medical purposes. | +----------+----------------------------+-----------------------------------+---------------------------------------------------------+ | 20. | Dr. Rajesh Kumar Sharma | The National | In-vitro Diagnostic Medical Devices. | | 21. | Ms. Kanchan Ahuja | Institute of | | | 22. | Ms. Ajanta Sircar | Biologicals, Noida | | | 23. | Dr. Richa Baranwal | | | +----------+----------------------------+-----------------------------------+---------------------------------------------------------+ | 24. | Dr. Pankaj Kumar | | | | | Sharma | | | +----------+----------------------------+-----------------------------------+---------------------------------------------------------+ [F.No. X. 11035/29/2024-DRS] RAJIV WADHAWAN, Advisor (Cost).