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Date: 10-Dec-2024 Category: Extra Ordinary State: Union Government Country: India

MDTL and MDTO Notification

Issued by Ministry of Health and Family Welfare · Department of Health and Family Welfare

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Executive Summary & Key Takeaways

Gazette Notification 5330(E)

  • This notification amends the existing notification S.O. 2237(E), dated 1st June, 2018, which pertains to the regulation of medical devices.
  • The amendment expands the list of medical devices under specific categories by including surgical gloves and medical examination gloves.
  • This notification is issued by the Ministry of Health and Family Welfare.

Gazette Notification 5331(E)

  • This notification designates certain Government Analysts as Medical Device Testing Officers.
  • It supersedes the previous notification S.O. 3739(E), dated 2nd August, 2022, except for actions already completed.
  • The notification lists the names of the analysts, their respective laboratories and the medical devices they are authorized to test.
  • This notification is issued by the Ministry of Health and Family Welfare.

Key Changes in 5330(E)

  • In serial number (2) of the original notification, after 'Condoms', 'Surgical Gloves and Medical examination Gloves' are added.
  • In serial number (3), after 'Disinfectant', 'Surgical Gloves and Medical examination Gloves' are added.
  • In serial number (5), after 'and Falope Rings', 'Surgical Gloves, Medical examination Gloves, Cotton Bandages, Anticoagulant Solutions used in blood bags and Disposable syringes' are added.

Key Changes in 5331(E)

  • A total of 27 government analysts are designated as medical device testing officers.
  • These analysts are distributed across different laboratories, including The Central Drugs Laboratory in Kolkata, Chennai and Mumbai, The Regional Drugs Testing Laboratory in Guwahati and Chandigarh and The National Institute of Biologicals in Noida.
  • Each analyst is assigned specific medical devices for testing, such as sterile and single-use medical devices, non-sterile medical devices, surgical dressings, gloves for medical purposes, mechanical contraceptives, and in-vitro diagnostic medical devices.

Impact Analysis

Medical Device Manufacturers and Suppliers

  • Action Item: Review product portfolios and ensure compliance with the updated regulations. Update quality control processes and documentation.

Healthcare Providers

  • Action Item: Update procurement guidelines to include only compliant products. Train staff on the new regulations.

Government Agencies

  • Action Item: Develop and implement a monitoring and enforcement plan for the updated regulations. Provide training to testing officers.

Consumers

  • Action Item: No direct action required, but increased awareness of compliant products is beneficial.

Medical Device Testing Laboratories

  • Action Item: Ensure adequate resources and training for testing of newly included medical devices.

Key Entities Referenced

Ministry of Health and Family Welfare: The government ministry responsible for issuing and enforcing health-related regulations, including those related to medical devices. Medical Devices Rules, 2017: The regulatory framework governing the manufacture, import, sale, and distribution of medical devices in India. Drugs and Cosmetics Act, 1940: The primary legislation governing drugs and cosmetics in India, which also covers certain aspects of medical devices. Notification S.O. 2237(E), dated 1st June, 2018: The original notification being amended by S.O. 5330(E), which lists medical devices under regulation. Notification S.O. 3739(E), dated 2nd August, 2022: The previous notification being superseded by S.O. 5331(E), which designated government analysts as medical device testing officers. The Central Drugs Laboratory, Kolkata: One of the testing laboratories mentioned in the notification S.O. 5331(E). The Central Drugs Testing Laboratory, Chennai: One of the testing laboratories mentioned in the notification S.O. 5331(E). The Central Drugs Testing Laboratory, Mumbai: One of the testing laboratories mentioned in the notification S.O. 5331(E). The Regional Drugs Testing Laboratory, Guwahati, Assam: One of the testing laboratories mentioned in the notification S.O. 5331(E). The Regional Drugs Testing Laboratory, Chandigarh: One of the testing laboratories mentioned in the notification S.O. 5331(E). The National Institute of Biologicals, Noida: One of the testing laboratories mentioned in the notification S.O. 5331(E).
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रजिस्ट्री स.ं डी.एल.- 33004/99 REGD. No. D. L.-33004/99 सी.जी.-डी.एल.-अ.-11122024-259336 CG-DLxx-ExG-1ID11H2x2x0x 24-259336 xxxGIDExxx असाधारण EXTRAORDINARY भाग II—खण् ड 3—उप-खण्ड (ii) PART II—Section 3—Sub-section (ii) प्राजधकार स ेप्रकाजित PUBLISHED BY AUTHORITY स.ं 4934] नई दिल्ली, मगं लवार, दिसम्ब र 10, 2024/अग्रहायण 19, 1946 No. 4934] NEW DELHI, TUESDAY, DECEMBER 10, 2024/AGRAHAYANA 19, 1946 स्ट्वास्ट््य और पररवार कल्याण मत्रं ालय (स्ट्वास्ट््य और पररवार कल्याण जवभाग) अजधसचू ना नई दिल् ली, 10 दिसम् बर, 2024 का.आ. 5330(अ).— केंद्रीय सरकार, जचदकत्सा युजि जनयम, 2017 के जनयम 19 के उपजनयम (2) द्वारा प्रित्त िजियों का प्रयोग करत े हुए, भारत के रािपत्र, असाधारण, भाग II, खंड 3, उपखंड (ii) म ें प्रकाजित भारत सरकार के स्ट्वास्ट््य और पररवार कल्याण मंत्रालय (स्ट्वास्ट््य और पररवार कल्याण जवभाग) की अजधसूचना संखयांक का. आ. 2237 (अ), तारीख 1 िून, 2018 म ेंसंिोधन करने के जलए और जनम्नजलजखत सिं ोधन करती ह:ै- उि अजधसूचना की, सारणी म,ें (i) क्रम सखं यांक (2) म,ें स्ट्तंभ (3) म ें“कंडोम’’िब्ि के पश्चात,् जनम्नजलजखत अतं : स्ट्थाजपत दकया िाएगा, अथाात:- “सर्िाकल िस्ट्तान ेऔर जचदकत्सा परीक्षण िस्ट्तान”े ; (ii) क्रम संखयांक(3) म,ें स्ट्तंभ(3) म ें “रोगाणुनािी” िब्ि के पश्चात,् जनम्नजलजखत िब्ि अंत: स्ट्थाजपत दकए िाएंग,े अथाात:् - “सर्िाकल िस्ट्तान ेऔर जचदकत्सा परीक्षण िस्ट्तान”े ; (iii) क्रम संखयांक(5) म,ें स्ट्तंभ(3) म ें “और फलोप ररंग्स” िब्ि के पश्चात,् जनम्नजलजखत अंत: स्ट्थाजपत दकया िाएगा, अथाात:् - 7994 GI/2024 (1)2 THE GAZETTE OF INDIA : EXTRAORDINARY [PART II—SEC. 3(ii)] “सर्िाकल िस्ट्ताने, जचदकत्सा परीक्षण िस्ट्ताने, रुई की पट्टी, रुजधर थैजलयों और जडस्ट्पोिेबल जसररंिों में प्रयुि एंटीकोगुलेटं सोल्यूिंस’’। [फा. स.ं एक्स. 11035/29/2024-डीआरएस] रािीव वधावन, सलाहकार (लागत) रटप्पण: मलू अजधसूचना भारत के रािपत्र, असाधारण, भाग II, खडं 3, उपखंड (ii) म ें का. आ.संखयांक 2237 (अ), तारीख 1 िून, 2018 द्वारा प्रकाजित की गई थी और अजधसूचना संखयांक का. आ. 1928 (अ), तारीख 25 अप्रलै , 2023 द्वारा अंजतम बार संिोजधत की गई थी। 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. अजधसचू ना नई दिल् ली, 10 दिसम् बर, 2024 का.आ. 5331(अ).—केन्द्द्रीय सरकार, जचदकत्सा युजि जनयम 2017 के जनयम 18 के उपजनयम (1) के साथ परित ओषजध और प्रसाधन सामग्री अजधजनयम, 1940 (1940 का 23) की धारा 20 की उपधारा (2) द्वारा प्रित्त िजियों का प्रयोग करत े हुए, और भारत के रािपत्र, असाधारण, भाग II, खंड 3, उप-खंड (ii), तारीख 8 अगस्ट्त, 2022 म ें प्रकाजित भारत सरकार के स्ट्वास्ट््य और पररवार कल्याण मंत्रालय (स्ट्वास्ट््य और पररवार कल्याण जवभाग) की अजधसूचना संखयांक का.आ 3739 (अ), तारीख 2 अगस्ट्त, 2022 को उन बातों के जसवाय अजधक्रांत करते हुए जिन्द्ह ें ऐस े अजधक्रमण स े पूवा दकया गया ह ै या करने का लोप दकया गया ह,ै नीच े िी गई सारणी के स्ट्तंभ (2) म ें जवजनर्िाष्ट जनम्नजलजखत सरकारी जवश्लेषकों को उि सारणी के स्ट्तंभ (4) म ें उनके नामों के समक्ष यथा जवजनर्िाष्ट जचदकत्सा युजियों के संबंध म ें जचदकत्सा युजि परीक्षण अजधकारी के रूप म ेंपिाजभजहत करती ह,ै अथाता :-[भाग II—खण् ड 3(ii)] भारत का रािपत्र : असाधारण 3 सारणी प्रयोगिाला का क्रम स.ं सरकारी जवश्लषे क का नाम जचदकत्सा यजु ि (यजु ियों) नाम (1) (2) (3) (4) 1. डॉ सरोि कुमार घोष 2. डॉ राकेि कुमार ऋजष केंद्रीय ओषजध रोगाणु मिु और एकल उपयोग जचदकत्सा युजि, 3. डॉ अंिन पाल प्रयोगिाला, गैर- रोगाण ु मिु जचदकत्सा युजि , सर्िाकल ड्रेससंग, कोलकाता जचदकत्सीय प्रयोिनों के जलए िस्ट्ताने, रोगाणुनािी। 4. डॉ दिलीप कुमार पांडा 5. श्रीमती सुपणा ा मैत्रा 6. श्रीमती सी. जवियालक्ष्मी केंद्रीय ओषजध यांजत्रक गभाजनरोधक, जचदकत्सीय प्रयोिनों के जलए 7. श्रीमती िी. िजिकला परीक्षण िस्ट्ताने। प्रयोगिाला, चेन्नई 8. श्री दकिोर गेम्बाली 9. श्री सी. हररहरन 10. श्रीमती सयाली य.ू वाड े 11. श्रीमती अक्षता एस परांिप े केंद्रीय ओषजध यांजत्रक गभाजनरोधक, जचदकत्सीय प्रयोिनों के जलए परीक्षण िस्ट्ताने। श्रीमती सुिाता एस. कैसरे 12. प्रयोगिाला, मुंबई 13. डॉ जवियकुमार मुजनपल्ली 14. श्रीमती सुखिा ए नवरत्न े 15. श्री अमर ज्योजत चमआु क्षेत्रीय ओषजध रोगाणुमिु और एकल उपयोग जचदकत्सा युजि, गरै - परीक्षण 16. श्री दिलीप कुमार सरकार रोगाणुमिु जचदकत्सा युजि, जचदकत्सीय प्रयोिनों के प्रयोगिाला, 17. श्रीमती ररंकू कजलता गुवाहाटी, असम जलए िस्ट्ताने। श्री जहतेि कुमार खरे क्षेत्रीय ओषजध 18. रोगाणुमिु और एकल उपयोग जचदकत्सा युजि, गरै - परीक्षण रोगाणुमिु जचदकत्सा युजि, सर्िाकल ड्रेससंग, प्रयोगिाला, डॉ िेबाजसस मैती जचदकत्सीय प्रयोिनों के जलए िस्ट्ताने। 19. चंडीगढ़ 20. डॉ रािेि कुमार िमाा 21. सुश्री कंचन आहूिा 22. सुश्री अिंता सरकार 23. डॉ ऋचा बरनवाल राष्ट्रीय िैजवक इन-जवरो नैिाजनक जचदकत्सा युजि । संस्ट्थान, नोएडा 24. डॉ. पंकि कुमार िमाा 25. डॉ वरुण ससहं 26. डॉ गौरी जमश्रा 27. डॉ अश्वनी कुमार िबू े [फा. स.ं एक्स. 11035/29/2024-डीआरएस] रािीव वधावन, सलाहकार (लागत)4 THE GAZETTE OF INDIA : EXTRAORDINARY [PART II—SEC. 3(ii)] 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 Sterile and Single use Medical Devices, 2. Dr. Rakesh Kumar Rishi Non-sterile Medical Devices, The Central Drugs 3. Dr. Anjan Pal Surgical dressings, Laboratory, Kolkata Gloves for Medical purposes, 4. Dr. Dilip Kumar Panda Disinfectant. 5. Smt. Suparna Maitra 6. Smt. C. Vijayalakshmi The Central Drugs Mechanical Contraceptives, 7. Smt. G. Sasikala Testing Laboratory, Gloves for Medical purposes. Chennai 8. Shri Kishor Gembali 9. Shri. C. Hariharan 10. Smt. Sayali U. Warde 11. Smt. Akshata S. Paranjpe The Central Drugs Mechanical Contraceptives, 12. Smt. Sujata S. Kaisare Testing Laboratory, Gloves for Medical purposes. Mumbai Dr. Vijayakumar 13. Munipalli Smt. Sukhada A. 14. Navaratne Shri. Amar Jyoti 15. Chamuah The Regional Drugs Sterile and Single Use Medical Devices, Testing Laboratory, Non-sterile Medical Devices, 16. Shri. Dilip Kr. Sarkar Guwahati, Assam Gloves for Medical purposes. 17. Smt. Rinku Kalita Sterile and Single Use Medical Devices, 18. Shri. Hitesh Kumar Khare The Regional Drugs Non-sterile Medical Devices, Testing Laboratory, Surgical dressings, Chandigarh 19. Dr. Debasis Maiti Gloves for Medical purposes. 20. Dr. Rajesh Kumar Sharma 21. Ms. Kanchan Ahuja The National 22. Ms. Ajanta Sircar Institute of In-vitro Diagnostic Medical Devices. Biologicals, Noida Dr. Richa Baranwal 23. Dr. Pankaj Kumar 24. Sharma[भाग II—खण् ड 3(ii)] भारत का रािपत्र : असाधारण 5 Serial Name of Government Name of Laboratory Medical Device (s) No. Analyst (1) (2) (3) (4) Dr. Varun Singh 25. Dr. Gauri Misra 26. Dr. Ashwani Kumar Dubey 27. [F.No. X. 11035/29/2024-DRS] RAJIV WADHAWAN, Advisor (Cost). Uploaded by Dte. of Printing at Government of India Press, Ring Road, Mayapuri, New Delhi-110064 and Published by the Controller of Publications, Delhi-110054.

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