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Date: 01-Mar-2023 Category: Extra Ordinary State: Union Government Country: India

Medical Device Rule 18 and 19 Amendment (Central Government and State Government)

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 proposes amendments to the Medical Devices Rules, 2017. These amendments primarily focus on empowering state governments in the establishment and designation of medical device testing laboratories.
  • The notification is issued by the Ministry of Health and Family Welfare.

Key Changes

  • Definition of 'State Medical Devices Testing Laboratory': A new sub-rule (zua) is inserted in Rule 3 of the Medical Devices Rules, 2017, defining 'State Medical Devices Testing Laboratory' as a laboratory established or designated by the State Government under rule 19(3).
  • Empowerment of State Governments in Rule 18: In Rule 18(1), after the words 'Central Government', the words 'or, as the case may be, the State Government' are inserted, indicating that State Governments also have a role.
  • Substitution in Rule 19: The words 'Central Medical Device Testing Laboratory' are replaced with 'Medical Device Testing Laboratory' in Rule 19.
  • Insertion of Sub-rule (3) in Rule 19: A new sub-rule (3) is 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 facilities as State Medical Devices Testing Laboratories.
  • Accreditation Requirement: Any laboratory designated as a State Medical Devices Testing Laboratory must be duly accredited by the National Accreditation Body for Testing and Calibration Laboratories (NABL).

Impact Analysis

Impact on Medical Device Manufacturers

  • Action Item: Manufacturers should monitor the establishment and designation of State Medical Devices Testing Laboratories in their relevant states and understand the scope of testing services offered. They should also ensure that their devices meet the required testing standards and obtain necessary certifications from accredited laboratories.

Impact on State Governments

  • Action Item: State Governments should develop a strategic plan for establishing or designating State Medical Devices Testing Laboratories, including resource allocation, infrastructure development, and accreditation processes. They should also establish mechanisms for monitoring and enforcing compliance with medical device regulations.

Impact on Testing Laboratories

  • Action Item: Testing laboratories should assess their capabilities and resources and pursue NABL accreditation to become eligible for designation as State Medical Devices Testing Laboratories. They should also explore opportunities to expand their scope of services and collaborate with State Governments.

Impact on Consumers

  • Action Item: Consumers should be aware of the importance of using medical devices that have been tested and certified by accredited laboratories. They should also report any adverse events or quality concerns related to medical devices to the appropriate regulatory authorities.

Key Entities Referenced

Drugs and Cosmetics Act, 1940: The principal legislation governing the regulation of drugs and cosmetics in India. The notification is issued in exercise of the powers conferred by sub-section (1) of section 12 and sub-section (1) of section 33 of this act. Medical Devices Rules, 2017: The rules framed under the Drugs and Cosmetics Act, 1940, specifically for regulating medical devices in India. This notification proposes amendments to these rules. Drugs Technical Advisory Board: A statutory body constituted by the Central Government to advise on technical matters related to drugs and cosmetics. The amendments are proposed in consultation with this board. National Accreditation Board for Testing and Calibration Laboratories (NABL): The accreditation body for testing and calibration laboratories in India. Accreditation by NABL is a prerequisite for designation as a State Medical Devices Testing Laboratory. Ministry of Health and Family Welfare: The central government ministry responsible for health and family welfare matters in India. The notification is issued by this ministry. State Government: The government of an individual state within India. The amendments empower state governments to establish and designate medical device testing laboratories.
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रजिस्ट्री स.ं डी.एल.- 33004/99 REGD. No. D. L.-33004/99 सी.जी.-डी.एल.-अ.-02032023-244036 xxxGIDHxxx CG-DL-E-02032023-244036 xxxGIDExxx असाधारण EXTRAORDINARY भाग II—खण् ड 3—उप-खण्ड (i) PART II—Section 3—Sub-section (i) प्राजधकार स ेप्रकाजित PUBLISHED BY AUTHORITY स.ं 121] नई दिल्ली, बुधवार, माच च1, 2023/फाल्ग नु 10, 1944 No. 121] NEW DELHI, WEDNESDAY, MARCH 1, 2023/PHALGUNA 10, 1944 स्ट्व ास्ट्् य और पररवार कल्य ाण मत्रं ालय (स्ट्वास्ट््य और पररवार कल्याण जवभाग) अजधसचू ना नई दिल्ली, 1 माच च 2023 सा.का.जन. 157(अ).—औषध और प्रसाधन सामग्री अजधजनयम, 1940 (1940 का 23) की धारा 12 की उप-धारा (1) और धारा 33 की उप-धारा (1) द्वारा प्रित्त िजियों का प्रयोग करत े हुए केंद्र सरकार औषध तकनीकी सलाहकार बोड च के परामि च स े जचदकत्सा उपकरण जनयम, 2017 म ें और संिोधन करन े के जलए जिन कजतपय जनयमों को बनान े का प्रस्ट्ताव करती ह ैउनका जनम्नजलजखत मसौिा इससे प्रभाजवत होने वाले संभाजवत सभी व्यजियों के सूचनार्च एतद्द्वारा प्रकाजित दकया िाता ह ै और एतद्द्वारा सूचना िी िाती ह ै दक उि जनयमों का मसौिा इन मसौिा जनयमों से युि भारत के रािपत्र की प्रजतयां आम िनता के जलए उपलब्ध कराए िाने की तारीख से सात दिनों की अवजध समाप्त होने पर या उसके बाि जवचारार्च जलया िाएगा; ऊपर जनर्िचष्ट अवजध के भीतर दकसी भी व्यजि से प्राप्त आपजत्तयों और सुझावों पर सरकार द्वारा जवचार दकया िाएगा; आपजत्तयां और सुझाव, यदि कोई ह,ैं अवर सजचव (औषध), स्ट्वास्ट््य और पररवार कल्याण मंत्रालय, भारत सरकार, कमरा सं. 434, सी-ववंग, जनमाचण भवन, नई दिल्ली-110011 को भेिे िा सकत े ह ैं या drugsdiv-mohfw@gov.in. पर ई-मेल दकए िा सकत े ह।ैं 1364 GI/2023 (1)2 THE GAZETTE OF INDIA : EXTRAORDINARY [PART II—SEC. 3(i)] मसौिा जनयम 1. (i) इन जनयमों का नाम जचदकत्सा उपकरण (............. संिोधन) जनयम, 2023 ह।ै (ii) ये जनयम, िब तक अन्यर्ा जनर्िचष्ट न दकया गया हो, सरकारी रािपत्र में इनके अंजतम रूप से प्रकािन की तारीख से प्रवृत्त होंगे। 2. जचदकत्सा उपकरण जनयम, 2017 (जिन्ह ें यहा ं इसके बाि उि जनयम कहा गया ह)ै म ें जनयम 3 में, उप-जनयम (य प क) के बाि, जनम्नजलजखत उप-जनयम िोडा िाएगा नामत: “(य प क)”राज्य जचदकत्सा उपकरण परीक्षण प्रयोगिाला” का अर् च ह ैजनयम 19(3) के तहत राज्य सरकार द्वारा स्ट्र्ाजपत या नाजमत जचदकत्सा उपकरण प्रयोगिाला।” 3. उि जनयमों में, जनयम 18 में, उप-जनयम (1) म,ें "केंद्रीय सरकार"िब्िों के बाि,"या, िैसा भी मामला हो, राज्य सरकार" िब्ि अंत:स्ट्र्ाजपत दकए िाएंगे। 4. (1) उि जनयमों म,ें जनयम 19 में, "केंद्रीय जचदकत्सा उपकरण परीक्षण प्रयोगिाला” िब्िों के स्ट्र्ान पर "जचदकत्सा उपकरण परीक्षण प्रयोगिाला" िब्ि रखे िाएंगे। (2) उि जनयमों म,ें जनयम 19 म,ें उप-जनयम (3) अंतःस्ट्र्ाजपत दकया िाएगा, अर्ाचत:् - "(3) (1) राज्य सरकार, अजधसूचना द्वारा, जनम्नजलजखत प्रयोिन के जलए राज्य जचदकत्सा उपकरण परीक्षण प्रयोगिाला की स्ट्र्ापना कर सकती ह-ै (क) जचदकत्सा उपकरणों का परीक्षण और मूल्यांकन; या (ख) कोई अन्य कायच, िो उसे जविेष रूप से सौंपा िाए, करने के जलए। (2) उप-जनयम (3) (1) को प्रजतकूल रूप से प्रभाजवत दकए जबना, राज्य सरकार उप-जनयम (3) (1) में जनर्िचष्ट प्रयोिनों के जलए दकसी प्रयोगिाला, जिसमें जचदकत्सा उपकरणों के परीक्षण और मूल्यांकन की सुजवधा हो, को भी राज्य जचदकत्सा उपकरण परीक्षण प्रयोगिाला के रूप में नाजमत कर सकती ह।ै बिते दक कोई भी जचदकत्सा उपकरण परीक्षण प्रयोगिाला, इस प्रकार तब तक नाजमत नहीं की िाएगी िब तक दक उस े राष्ट्रीय परीक्षण और अंिांकन प्रयोगिाला प्रत्यायन जनकाय द्वारा जवजधवत मान्यता न िी गयी हो। [फा.सं.एक्स.11014/7/2022-डीआर] रािीव वधावन, सलाहकार (लागत) नोट: मूल जनयम दिनांक 31 िनवरी, 2017 की अजधसूचना संख्या सा.का.जन. 78(अ) द्वारा सरकारी रािपत्र म ें प्रकाजित दकए गए र् े और दिनांक 14 अक्टूबर, 2022 की अजधसूचना संख्या सा.का.जन. 777(अ) द्वारा अंजतम बार संिोजधत दकए गए र्े। MINISTRY OF HEALTH AND FAMILY WELFARE (Department of Health and Family Welfare) NOTIFICATION New Delhi, the 1st March,2023 G.S.R. 157(E).—The following draft of certain rules further to amend the Medical Device Rules, 2017, which the Central Government proposes to make, in exercise of the powers conferred by sub-section (1) of section 12 and sub-section (1) of section 33 of the Drugs and Cosmetics Act, 1940 (23 of 1940) in consultation with the Drugs Technical Advisory Board, is hereby published for information of all persons likely to be affected thereby and notice is hereby given that the said draft rules shall be taken into consideration on or after the expiry of a period of seven days from the date on which copies of the Gazette of India containing these draft rules are made available to public;[भाग II—खण् ड 3(i)] भारत का रािपत्र : असाधारण 3 Objections and suggestions which may be received from any person within the period specified above will be considered by the Central Government; Objections and suggestions, if any, may be addressed to the Under Secretary (Drugs), Ministry of Health and Family Welfare, Government of India, Room No. 434, C Wing, Nirman Bhawan, New Delhi - 110011 or emailed at drugsdiv-mohfw@gov.in. DRAFT RULES 1. (i) These rules may be called the Medical Devices (.........Amendment) Rules, 2023. (ii) These rules unless specified otherwise, come into force on the date of their final publication in the Official Gazette. 2. In the Medical Devices Rules, 2017(hereinafter to be referred as the said rules), in rule 3, after sub-rule (zu), 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 rule 19(3).” 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. (1) In the said rules, in rule 19, the words “Central Medical Device Testing Laboratory” shall be substituted with “Medical Device Testing Laboratory”. (2) In the said rules, in rule 19, sub-rule (3) 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. (2) Without prejudice to sub-rule (3) (1), 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) (1): 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] RAJIV WADHAWAN, Advisor (Cost) Note: The principal rules 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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