Read or download the official PDF of this gazette notification issued by the Ministry of Health and Family Welfare on 19th August 2026. Classified under Extra Ordinary.
Executive Summary
The Ministry of Health and Family Welfare has notified the Medical Devices (Third Amendment) Rules, 2026, to further amend the Medical Devices Rules, 2017. These rules were finalized following a 30-day public consultation period on the draft version published in April 2026. The amendments come into force on August 19, 2026, the date of their final publication in the Official Gazette.
Key Points / Main Content
Title and Effectiveness
The rules are officially titled the Medical Devices (Third Amendment) Rules, 2026.
The provisions are effective immediately upon their publication in the Official Gazette (August 19, 2026).
Quality Management System Integration
Rule 19H and 19J Updates: In sub-rules 19H(2)(v) and 19J(2)(v), the phrase "and Quality Management System" is inserted after the word "standards." This integrates QMS requirements into the specified regulatory clauses.
Nomenclature Revisions
Laboratory Headings: The marginal heading for Rule 19 is substituted with the specific title: “Government Medical Device Testing laboratories.”
Recognition of Foreign Jurisdictions
Expansion of Provisos: Under Rule 63, sub-rule (1), proviso (iv), “European Union countries” has been added to the list of recognized jurisdictions following the mention of “Japan.”
Impact Analysis
Medical Device Manufacturers and ImportersImpact
They are now subject to explicitly stated "Quality Management System" requirements under Rules 19H and 19J. Additionally, those relying on international certifications gain recognition for "European Union countries" under the amended Rule 63.
Action Required
Entities must ensure their compliance documentation and processes align with the newly integrated Quality Management System standards and update applications to reflect recognized EU country certifications where relevant.
Government Medical Device Testing LaboratoriesImpact
The official terminology and marginal heading governing these entities have been formally updated.
Action Required
Laboratories should update official letterheads, portals, and documentation to reflect the new heading: “Government Medical Device Testing laboratories.”
Regulatory and Licensing AuthoritiesImpact
Authorities now have a clarified legal basis to enforce Quality Management System standards and recognize regulatory approvals from European Union countries.
Action Required
Regulatory officers must incorporate these amendments into their inspection, verification, and licensing workflows for medical devices.
Key Entities Referenced
Medical Devices (Third Amendment) Rules, 2026: The specific amendment rules being notified to update regulations concerning medical device standards and testing.
Medical Devices Rules, 2017: The principal set of rules governing the regulation of medical devices in India that this notification seeks to amend.
Drugs and Cosmetics Act, 1940: The primary legislation under which the Central Government exercises power to make and amend rules for medical devices.
Ministry of Health and Family Welfare: The nodal ministry responsible for the notification and administration of medical device regulations.
Drugs Technical Advisory Board: The statutory body consulted by the Central Government to provide technical expertise during the amendment of these rules.
रजिस्ट्री स.ं डी.एल.- 33004/99 REGD. No. D. L.-33004/99
सी.जी.-डी.एल.-अ.-21082026-275639
xxxGIDHxxx
CG-DLxx-ExG-I2D1E0x8x2x0 26-275639
असाधारण
EXTRAORDINARY
भाग II—खण् ड 3—उप-खण्ड (i)
PART II—Section 3—Sub-section (i)
प्राजधकार स ेप्रकाजित
PUBLISHED BY AUTHORITY
स.ं 678] नई दिल्ली, बुधवार, अगस्ट्त 19, 2026/श्रावण 28, 1948
No. 678] NEW DELHI, WEDNESDAY, AUGUST 19, 2026/SHRAVAN 28, 1948
स्ट्वास्ट््य और पररवार कल्याण मत्रं ालय
(स्ट्वास्ट््य और पररवार कल्याण जवभाग)
अजधसचू ना
नई दिल्ली, 14 अगस्ट् त, 2026
lk.का.fu. 744(अ) .— ओषजध और प्रसाधन सामग्री अजधजनयम, 1940 (1940 का 23) की धारा 12 की
उपधारा (1) तथा धारा 33 की उपधारा (1) द्वारा यथा अपेजित जचदकत्सा युजि जनयम, 2017 का और संिोधन करने के
जलए कजतपय प्रारूप जनयम, भारत के रािपत्र, असाधारण, भाग 2, खंड 3, उप-खंड (i) द्वारा संखयांक सा.का.जन.
269(अ), तारीख 10 अप्रलै , 2026 द्वारा प्रकाजित दकया गया थ,े जिसम े उि अजधसूचना को अंतर्विष्ट करने वाली रािपत्र
की प्रजतयां िनता को उपलब्ध कराए िान े की तारीख स े तीस दिन की अवजध के अवसान स े पूवि उससे प्रभाजवत होन े वाल े
सभी संभाव्य व्यजियों स े आपिे और सुझाव आमंजत्रत दकए गए थ;े
और उि आजधकाररक रािपत्र की प्रजतयां 10 अप्रलै , 2026 को िनता को उपलब्ध करा िी गईं थी;
और उि प्रारूप जनयमों के सबं ंध म ें िनता स े प्राप्त आपिे ों और सुझावों पर केंद्रीय सरकार द्वारा जवचार दकया
गया ह।ै
अतः, अब केंद्रीय सरकार ओषजध और प्रसाधन सामग्री अजधजनयम, 1940 (1940 का 23) की धारा 12 तथा
धारा 33 द्वारा प्रित्त िजियों का प्रयोग करत े हुए, ओषजध तकनीकी सलाहकार बोडि के साथ परामि ि के पश्चात, जचदकत्सा
युजि जनयम, 2017 का और सिं ोधन करने के जलए जनम्नजलजखत जनयम बनाती ह,ै अथाित्:-
6410 GI/2026 (1)2 THE GAZETTE OF INDIA : EXTRAORDINARY [PART II—SEC. 3(i)]
1. (क) संजिप्त नाम और प्रारंभ .-(1) इन जनयमों का संजिप् त नाम जचदकत्सा युजत (तीसरा संिोधन) जनयम,
2026 ह।ै
(ख) य ेजनयम, िब तक अन्यथा जवजनर्ििष्ट न हो, रािपत्र म ें इनके अंजतम प्रकािन की तारीख को प्रवृत्त होंगे।
2. जचदकत्सा युजि जनयम, 2017 (जिसे इसम ें इसके पश्चात ् उि जनयम कहा गया ह)ै के जनयम 19(ि) म,ें उपजनयम
(2) के खंड(v) म ें"मानकों" िब्ि के पश्चात "और गुणवत्ता प्रबधं न प्रणाली" िब्ि अंतःस्ट्थाजपत दकए िाएंगे।
3. जचदकत्सा युजि जनयम, 2017 के जनयम 19(ञ) म ें उपजनयम (2) के खंड(v) म ें "मानकों" िब्ि के पश्चात "और
गुणवत्ता प्रबंधन प्रणाली" िब्ि अंतःस्ट्थाजपत दकए िाएगं े।।
4. उि जनयमों के जनयम 19 म,ें पार्श् ि िीषि के स्ट्थान पर जनम्नजलजखत पार्श् ििीषि रखा िाएगा, अथाित्: –
“सरकारी जचदकत्सा युजि परीिण प्रयोगिाला”
5. उि जनयमों के जनयम 63 म ें उपजनयम (1) के परंतुक (iv) म,ें िब्ि “या िापान” के पश्चात ् “या यूरोपीय
संघ के ििे ” िब्ि अतं ःस्ट्थाजपत दकए िाएंगे।
[फा. सं. एस.11035/112/2024-डीआर]
हष ि मंगला, संयुि सजचव
रिप्पण: जचदकत्सा युजि जनयम, 2017 रािपत्र म ें अजधसूचना संखया 78 (अ), दिनांक 31 िनवरी, 2017 द्वारा प्रकाजित
दकए गए थ े तथा अंजतम बार अजधसूचना संखयांक सा.का.जन. 165(अ), दिनांक 02 माचि, 2026 द्वारा संिोजधत दकए गए
थे।
MINISTRY OF HEALTH AND FAMILY WELFARE
(Department of Health and Family Welfare)
NOTIFICATION
New Delhi, the 14th August, 2026
G.S.R. 744(E).— Whereas a draft of certain rules further to amend Medical Device Rules, 2017, were
published in the Gazette of India, Extraordinary, Part II, Section 3, Sub-section (i) vide number G.S.R. 269(E), dated
the 10th April, 2026 as required by Sub-section (1) of section 12 and Sub-section (1) of section 33 of the Drugs and
Cosmetics Act, 1940 (23 of 1940), inviting objections and suggestions from all person likely to be affected thereby
before the expiry of a period of thirty days from the date which on the copies of the Official Gazette containing the
said notification was published were made available to public;
And whereas, copies of the said Official Gazette were made available to the public on 10th April, 2026;
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 section 12 and section 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. (i) These rules may be called the Medical Devices (Third Amendment) Rules, 2026.
(ii) These rules unless specified otherwise, come into force on the date of their final publication in the
Official Gazette.[भाग II—खण् ड 3(i)] भारत का रािपत्र : असाधारण 3
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. 165(E), dated 2nd March, 2026.
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