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Date: 02-Jun-2023 Category: Extra Ordinary State: Union Government Country: India

AMENDMENT IN MEDICAL DEVICE RULE 18 AND RULE 19

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

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Executive Summary & Key Takeaways

What it means

  • The gazette notification introduces the Medical Devices (Amendment) Rules, 2023, which amends the Medical Devices Rules, 2017. These amendments pertain to the establishment and designation of State Medical Devices Testing Laboratories.

Key Changes

  • The rules are called the Medical Devices (Amendment) Rules, 2023 and come into force on the date of their publication in the Official Gazette which is June 2, 2023.
  • A new sub-rule (zua) is inserted in rule 3 of the Medical Devices Rules, 2017, defining 'State Medical Devices Testing Laboratory' as a medical devices laboratory established or designated by the State Government under sub-rule (3) of rule 19.
  • Rule 18(1) of the Medical Devices Rules, 2017 is amended to include 'or, as the case may be, the State Government' after the words 'Central Government'.
  • Rule 19 of the Medical Devices Rules, 2017 is amended to change the heading to 'Medical Device Testing Laboratories'.
  • Sub-rules (3) and (4) are inserted in Rule 19, allowing State Governments to establish State Medical Devices Testing Laboratories for testing and evaluation of medical devices or to carry out any other specifically assigned function.
  • State Governments can also designate existing laboratories with testing and evaluation facilities for medical devices as State Medical Devices Testing Laboratories, provided they are accredited by the National Accreditation Body for Testing and Calibration Laboratories.

Impact Analysis

State Governments

  • Should notify the establishment or designation of State Medical Devices Testing Laboratories.

Medical Device Manufacturers

  • Should be aware of the designated State Medical Devices Testing Laboratories in their state.

Testing and Calibration Laboratories

  • Laboratories should align their processes with the requirements of the amended rules.

Central Government

  • Monitor and ensure the state laboratories adhere to standards and guidelines.

Key Entities Referenced

Medical Devices Rules, 2017: The principal rules being amended by this notification. Medical Devices (Amendment) Rules, 2023: The amending rules introduced by this notification. Drugs and Cosmetics Act, 1940: The enabling legislation under which the rules are framed. Specifically, sections 12 and 33 are referenced. State Medical Devices Testing Laboratory: A medical devices laboratory established or designated by the State Government under the amended rules. National Accreditation Body for Testing and Calibration Laboratories (NABL): The accreditation body that must accredit medical device testing laboratories for designation as State Medical Devices Testing Laboratories. Drugs Technical Advisory Board: Body consulted by the Central Government before making these rules.
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रजिस्ट्री स.ं डी.एल.- 33004/99 REGD. No. D. L.-33004/99 xxxGIDHxxx ससीी..जजीी..--डडीी..एएलल..--अअ..--0022006622002233--224466224422 xxxGIDExxx CCGG--DDLL--EE--0022006622002233--224466224422 असाधारण EXTRAORDINARY भाग II—खण् ड 3—उप-खण्ड (i) PART II—Section 3—Sub-section (i) प्राजधकार स ेप्रकाजित PUBLISHED BY AUTHORITY स.ं 335] नई दिल्ली, िुक्रवार, िनू 2, 2023/ज्य ष्े ठ 12, 1945 No. 335] NEW DELHI, FRIDAY, JUNE 2, 2023/JYAISHTHA 12, 1945 स्ट्वास्ट््य और पररवार कल्याण मत्रं ालय (स्ट्वास्ट््य और पररवार कल्याण जवभाग) अजधसचू ना नई दिल्ली, 2 िून, 2023 सा.का.जन. 409(अ).—िबदक जचदकत्सा उपकरण जनयमावली, 2017 म ें और संिोधन करन े के जलए कुछ जनयमों का मसौिा, िो औषजध और प्रसाधन सामग्री अजधजनयम, 1940 (1940 का 23) की धारा 12 और 33 के तहत आवश्यक ह,ै दिनांक 1 माच,च 2023 को भारत के रािपत्र, असाधारण, भाग II, खंड 3, उप- खंड (i) म,ें स्ट्वास्ट््य और पररवार कल्याण मंत्रालय (स्ट्वास्ट््य और पररवार कल्याण जवभाग) म ें भारत सरकार की अजधसूचना सा.का.जन. संख्या 157(अ) के माध्यम से प्रकाजित दकया गया था, जिसम ें इससे प्रभाजवत होने वाल े व्यजियों से उि अजधसूचना वाले सरकारी रािपत्र की प्रजतयां िनता के जलए उपलब्ध कराए िान े के सात दिनों की अवजध की समाजि से पहले आपजियां और सुझाव आमंजत्रत दकए गए थ;ें और िबदक, 1 माच,च 2023 को उि सरकारी रािपत्र की प्रजतयां िनता के जलए उपलब्ध कराई गई थीं; और िबदक, उि मसौिा जनयमों पर िनता से प्राि आपजियों और सुझावों पर केंद्रीय सरकार द्वारा जवचार दकया गया ह;ै 3485 GI/2023 (1)2 THE GAZETTE OF INDIA : EXTRAORDINARY [PART II—SEC. 3(i)] इसजलए, अब औषजध और प्रसाधन सामग्री अजधजनयम, 1940 (1940 का 23) की धारा 12 और 33 द्वारा प्रिि िजियों का प्रयोग करते हुए, केन्द्द्रीय सरकार, औषध तकनीकी सलाहकार बोडच के साथ परामिच करने के बाि, जचदकत्सा उपकरण जनयमावली, 2017 म ेंसंिोधन करन े के जलए जनम्नजलजखत जनयम बनाती ह,ै अथाचत ्:- 1. (1) इन जनयमों का नाम जचदकत्सा उपकरण (संिोधन) जनयमावली, 2023 ह।ै (2) ये जनयमावली सरकारी रािपत्र में इनके प्रकािन की तारीख से प्रवृि होंगे। 2. जचदकत्सा उपकरण जनयमावली, 2017 (यहां इसके बाि उि जनयमावली के रूप म ें संिर्भचत) म,ें जनयम 3 म,ें उप-जनयम (य.प) के बाि, जनम्नजलजखत उप-जनयम िोड़े िाएंग,े अथाचत,् (य.प.क) "राज्य जचदकत्सा उपकरण परीक्षण प्रयोगिाला" का अथच ह ै जनयम 19 के उपजनयम (3) के तहत राज्य सरकार द्वारा स्ट्थाजपत या नाजमत जचदकत्सा उपकरण प्रयोगिाला । 3. उि जनयमावली म,ें जनयम 18 म,ें उप-जनयम (1) म,ें "केंद्रीय सरकार" िब्िों के बाि, "या, िैसा भी मामला हो, राज्य सरकार" िब्ि अंतःस्ट्थाजपत दकए िाएंगे। 4. उि जनयमावली म,ें जनयम 19 म,ें (क) हाजिए के िीषचक के स्ट्थान पर जनम्नजलजखत हाजिए का िीषचक रखा िाएगा अथाचत:- "जचदकत्सा उपकरण परीक्षण प्रयोगिाला"। (ख) उप जनयम (2) के बाि, जनम्नजलजखत अंतःस्ट्थाजपत दकया िाएगा, अथाचत:- "(3) (1) राज्य सरकार, अजधसूचना द्वारा, जनम्नजलजखत के प्रयोिनाथच राज्य जचदकत्सा उपकरण परीक्षण प्रयोगिाला की स्ट्थापना कर सकती ह,ै - (क) जचदकत्सा उपकरणों का परीक्षण और मूल्यांकन; या (ख) कोई अन्द्य कायच करना िो उसे जविेष रूप से सौंपा िाए। (4) उप-जनयम (3) को प्रजतकूल रूप स े प्रभाजवत दकए जबना, राज्य सरकार उप-जनयम (3) में जवजनर्िष्टच प्रयोिनों के जलए जचदकत्सा उपकरणों के परीक्षण और मूल्यांकन की सुजवधा रखने वाली दकसी प्रयोगिाला को भी राज्य जचदकत्सा उपकरण परीक्षण प्रयोगिाला के रूप में नाजमत कर सकती ह:ै बिते दक कोई भी जचदकत्सा उपकरण परीक्षण प्रयोगिाला, तब तक नाजमत नहीं की िाएगी िब तक दक इस े परीक्षण और अंिांकन प्रयोगिालाओं के जलए राष्ट्रीय प्रत्यायन जनकाय द्वारा जवजधवत मान्द्यता प्राि न हो। [फा. सं. एक्स.11014/7/2022-डीआर] आराधना पटनायक, संयक्ु त सजचव नोट: जचदकत्सा उपकरण जनयमावली 2017, 31 िनवरी, 2017 की अजधसूचना संख्यांक सा.का.जन. 78(अ) द्वारा सरकारी रािपत्र में प्रकाजित दकए गए थे और अंजतम बार 14 अक्टूबर, 2022 की अजधसूचना संख्यांक सा.का.जन. 777(अ) द्वारा संिोजधत दकए गए थे। MINISTRY OF HEALTH AND FAMILY WELFARE (Department of Health and Family Welfare) NOTIFICATION New Delhi, the 2nd June, 2023 G.S.R. 409(E).—Whereas a draft of certain rules further to amend the Medical Devices Rules, 2017 was published, as required under sections 12 and 33 of the Drugs and Cosmetics Act, 1940 (23 of 1940) vide notification[भाग II—खण् ड 3(i)] भारत का रािपत्र : असाधारण 3 of the Government of India in the Ministry of Health and Family Welfare (Department of Health and Family Welfare) number G.S.R. 157 (E), dated the 1st March, 2023, in the Gazette of India, Extraordinary, Part II, section 3, sub-section (i), inviting objections and suggestions from persons likely to be affected thereby, before the expiry of a period of seven days from the date on which the copies of the Official Gazette containing the said notification were made available to the public; And whereas, copies of the said Official Gazette were made available to the public on the 1st March, 2023; And whereas, objections and suggestions received from the public on the said draft rules have been considered by the Central Government; Now, therefore, in exercise of the powers conferred by sections 12 and 33 of the Drugs and Cosmetics Act, 1940 (23 of 1940), the Central Government, after consultation with Drugs Technical Advisory Board, hereby makes the following rules further to amend the Medical Devices Rules, 2017, namely:― 1. (1) These rules may be called the Medical Devices (Amendment) Rules, 2023. (2) They shall come into force on the date of their publication in the Official Gazette. 2. In the Medical Devices Rules, 2017 (hereinafter referred as the said rules), in rule 3, after sub-rule (zu), the following sub-rule shall be inserted namely:– ‘(zua) “State Medical Devices Testing Laboratory” means a medical devices laboratory established or designated by the State Government under sub-rule (3) of rule 19’. 3. In the said rules, in rule 18, in sub-rule (1), after the words “Central Government”, the words “or, as the case may be, the State Government” shall be inserted. 4. In the said rules, in rule 19,– (a) for the marginal heading, the following marginal heading shall be substituted, namely:– “Medical Device Testing Laboratories”; (b) after sub-rule (2), the following shall be inserted, namely: — “(3) (1) The State Government may, by notification, establish State Medical Devices Testing Laboratory for the purpose of, – (a) testing and evaluation of medical devices; or (b) to carry out any other function as may be specifically assigned to it. (4) Without prejudice to provisions of sub-rule (3), the State Government may also designate any laboratory having facility for carrying out test and evaluation of medical devices as State Medical Devices Testing Laboratory for the purposes specified in sub-rule (3): Provided that no medical devices testing laboratory shall be so designated unless it has been duly accredited by the National Accreditation Body for Testing and Calibration Laboratories.”. [F. No. X.11014/7/2022-DR] ARADHANA PATNAIK, Jt. Secy. Note : The Medical Device Rules, 2017 were published in the Official Gazette vide notification number G.S.R. 78(E), dated the 31st January, 2017 and last amended vide notification number G.S.R. 777(E), dated the 14th October, 2022. 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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