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Date: 2026-04-10 Category: Extra Ordinary State: Union Government Country: India

Draft Proposal to amend certain provisions under Medical Devices Rules 2017 EU

Issued by Ministry of Health and Family Welfare · Not Applicable

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Executive Summary & Key Takeaways

**Executive Summary** The Ministry of Health and Family Welfare has issued a draft notification dated April 10, 2026, to amend the Medical Devices Rules, 2017. The proposal introduces "Quality Management System" requirements and expands the list of recognized international jurisdictions. Stakeholders must submit any objections or suggestions within thirty days from the date the draft rules are made available to the public. **Key Points / Main Content** * **Amendments to Quality and Standard Requirements** * Rule 19H and Rule 19J are amended to include the phrase "and Quality Management System" following the word "standards" in their respective sub-rules. * The marginal heading for Rule 19 is substituted with the title "Government Medical Device Testing laboratories." * **Recognition of International Jurisdictions** * Rule 63, sub-rule (1), is amended to include "European Union countries" alongside existing recognized jurisdictions (such as Japan) within the specified proviso. * **Administrative and Regulatory Procedures** * The rules are titled the Medical Devices (.........Amendment) Rules, 2026. * These rules will officially come into force on the date of their final publication in the Official Gazette. * The Central Government will consider feedback received within the 30-day notice period before finalizing the rules. **Impact Analysis** **Medical Device Testing Laboratories** **Impact:** These entities are affected by the updated marginal heading of Rule 19 and the specific inclusion of "Quality Management System" (QMS) requirements in the regulatory framework. **Action Required:** Laboratories must ensure their operations and documentation align with the integrated "standards and Quality Management System" criteria. **Manufacturers and Importers** **Impact:** The inclusion of "European Union countries" under Rule 63 expands the scope of recognized international regulatory regimes for medical devices. **Action Required:** Stakeholders involved with devices from EU countries should review the amended rule to determine how it simplifies or alters their compliance and registration processes. **General Public and Affected Persons** **Impact:** Individuals or organizations likely to be affected by these changes have a legal right to influence the final regulations. **Action Required:** Interested parties must submit objections or suggestions to the Under Secretary (Drugs) via post or email (drugsdiv-mohfw@gov.in) within the 30-day deadline.

Key Entities Referenced

Medical Devices Rules, 2017: The primary regulatory framework being amended to incorporate 'Quality Management Systems' and recognize additional international standards. Drugs and Cosmetics Act, 1940: The parent legislation under which the Central Government exercises power to amend rules governing medical devices. Drugs Technical Advisory Board: The statutory advisory body consulted for technical guidance before the notification of these draft rules. Ministry of Health and Family Welfare: The central ministry responsible for the regulation of medical devices and the issuance of these amendment rules.
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रजिस्ट्री स.ं डी.एल.- 33004/99 REGD. No. D. L.-33004/99 सी.जी.-डी.एल.-अ.-10042026-271703 xxxGIDHxxx CG-DLxx-ExG-I1D0E0x4x2x0 26-271703 असाधारण EXTRAORDINARY भाग II—खण् ड 3—उप-खण्ड (i) PART II—Section 3—Sub-section (i) प्राजधकार स ेप्रकाजित PUBLISHED BY AUTHORITY स.ं 249] नई दिल्ली, िुक्रवार, अप्रलै 10, 2026/चत्रै 20, 1948 No. 249] NEW DELHI, FRIDAY, APRIL 10, 2026/CHAITRA 20, 1948 स्ट्वास्ट््य और पररवार कल्याण मत्रं ालय (स्ट्वास्ट््य और पररवार कल्याण जवभाग) अजधसचू ना नई दिल्ली, 10 अप्रलै , 2026 सा.का.जन. 269(अ).— जचदकत्सा उपकरण जनयम, 2017 म ें और संिोधन करन े के जलए कुछ जनयमों का जनम्नजलजखत प्रारूप, जिसे केंद्र सरकार औषजध 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 बनाना प्रस्ट्ताजवत करती ह,ै औषजध तकनीकी सलाहकार बोड ड के परामि ड के पश्चात ् एतद्द्वारा उन सभी व्यजियों की िानकारी के जलए प्रकाजित दकया िाता ह ै जिनके इसस े प्रभाजवत होने की संभावना ह ै और एतद्द्वारा नोरिस दिया िाता ह ै दक उि प्रारूप जनयमों पर उस तारीख स े तीस दिन की अवजध समाप्त होने पर या उसके पश्चात ् जवचार दकया िाएगा जिस तारीख को इन प्रारूप जनयमों वाले भारत के रािपत्र की प्रजतया ं िनता के जलए उपलब्ध कराई िाती ह;ैं आपजत्तयां और सुझाव िो ऊपर जनर्िडष्ट अवजध के भीतर दकसी भी व्यजि स े प्राप्त हो सकत े ह,ैं उन पर केंद्र सरकार द्वारा जवचार दकया िाएगा; 2597 GI/2026 (1)2 THE GAZETTE OF INDIA : EXTRAORDINARY [PART II—SEC. 3(i)] आपजत्तयां और सुझाव, यदि कोई हों, अवर सजचव (औषजध), स्ट्वास्ट््य और पररवार कल्याण मत्रं ालय, भारत सरकार, सी ववंग, कतडव्य भवन, नई दिल्ली - 110011 को संबोजधत दकए िा सकत े ह ैं या drugsdiv-mohfw@gov.in पर ईमले दकए िा सकते ह।ैं प्रारूप जनयम 1. (i) इन जनयमों को जचदकत्सा उपकरण (.........संिोधन) जनयम, 2026 कहा िा सकता ह।ै (ii) ये जनयम, िब तक अन्यथा जनर्िडष्ट न हो, रािपत्र म ेंउनके अंजतम प्रकािन की तारीख स े प्रवृत्त होंगे। 2. जचदकत्सा उपकरण जनयम, 2017 (जिन्ह ेंइसम ेंइसके बाि उि जनयम कहा िाएगा) म,ें जनयम 19एच म,ें उप-जनयम (2) म,ें खडं (v) में, िब्ि “मानकों” के पश्चात्, िब्ि “और गणु वत्ता प्रबंधन प्रणाली के रूप म”ें अंतःस्ट्थाजपत दकया िाएगा। 3. उि जनयमों म,ें जनयम 19ि ेम,ें उप-जनयम (2) में, खडं (v) म,ें िब्ि “मानकों” के पश्चात,् िब्ि “और गुणवत्ता प्रबंधन प्रणाली के रूप म”ें अतं ःस्ट्थाजपत दकया िाएगा। 4. उि जनयमों म,ें जनयम 19 म,ें उपांजतक िीषडक के स्ट्थान पर, जनम्नजलजखत उपांजतक िीषडक प्रजतस्ट्थाजपत दकया िाएगा, अथाडत:् – “सरकारी जचदकत्सा उपकरण परीक्षण प्रयोगिालाए”ं 5. उि जनयमों म,ें जनयम 63 म,ें उप-जनयम (1) म,ें परंतुक (iv) म,ें िब्ि “या िापान” के पश्चात,् िब्ि, “या यूरोपीय संघ के ििे ,” अंतःस्ट्थाजपत दकए िाएंगे। [फा. स.ं X.11035/112/2024-डीआर] हष ड मंगला, संयुक् त सजचव रिप्पणी: जचदकत्सा उपकरण जनयम, 2017 रािपत्र म ेंअजधसूचना संख्या 78 (ई), दिनांक 31 िनवरी, 2017 द्वारा प्रकाजित दकए गए थ ेऔर अंजतम बार अजधसूचना संख्या सा.का.जन. ………… (अ), दिनांक ………… द्वारा संिोजधत दकए गए थे।[भाग II—खण् ड 3(i)] भारत का रािपत्र : असाधारण 3 MINISTRY OF HEALTH AND FAMILY WELFARE (Department of Health and Family Welfare) NOTIFICATION New Delhi, the 10th April, 2026 G.S.R. 269(E).— The following draft of certain rules further to amend Medical Devices 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), is hereby published after consultation with the Drugs technical Advisory Board 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 thirty days from the date on which copies of the Gazette of India containing these draft rules are made available to public; 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, C Wing, Kartavya Bhavan, New Delhi - 110001 or emailed at drugsdiv- mohfw@gov.in. DRAFT RULES 1. (i) These rules may be called the Medical Devices (.........Amendment) Rules, 2026. (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 referred to as said rules), in rule 19H, in sub-rule (2), in clause (v), after the word “standards”, the word “and Quality Management System” shall be inserted. 3. In the said rules, in rule 19J, in sub-rule (2), in clause (v), after the word “standards”, the word “and Quality Management System” shall be inserted. 4. In the said rules, in rule 19, for the marginal heading, the following marginal heading shall be substituted, namely: – “Government Medical Device Testing laboratories” 5. In the said rules, in rule 63, in sub-rule (1), in Proviso (iv), after the words “or Japan”, the words, “or European Union countries,” shall be inserted. [F. No. X.11035/112/2024-DR] HARSH MANGLA, Jt. Secy. Note: The Medical Devices Rules, 2017 was published in the Official Gazette vide notification number 78 (E), dated the 31st January, 2017 and last amended vide notification number G.S.R. ………… (E), dated ………… 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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