**Executive Summary**
This document introduces the Medical Devices (Amendment) Rules, 2026, amending the Medical Device Rules, 2017. The amendments, published in the Gazette of India Extraordinary on March 10, 2026, define specific educational qualifications for Inspectors and Government Analysts involved in medical device regulation. These rules come into effect upon their publication.
**Key Points / Main Content**
* **Medical Devices (Amendment) Rules, 2026:** These rules amend the existing Medical Device Rules, 2017, and will be effective from their publication date.
* **Qualifications for Inspector:**
* A Bachelor's degree in engineering (Biomedical, Chemical, Mechanical, Electrical, Electronics, Instrumentation, Biotechnology, Polymer, Computer Science, or Medical Electronics) or equivalent from a recognized university.
* Alternatively, a Bachelor's degree in Pharmacy, Pharmaceutical Science, Microbiology, Bio-Chemistry, Chemistry, or Life Sciences from a recognized university.
* **Qualifications for Government Analyst:**
* A Bachelor's degree in engineering (Biomedical, Chemical, Mechanical, Electrical, Electronics, Instrumentation, Biotechnology, Polymer, Computer Science, or Medical Electronics) or equivalent from a recognized university, along with at least five years of postgraduate experience in testing medical or in-vitro diagnostic devices under the supervision of a Government Analyst or an approved laboratory head. This includes an option for two years of specific training.
* Alternatively, a Bachelor's degree in Pharmacy, Pharmaceutical Science, Microbiology, Bio-Chemistry, Chemistry, or Life Sciences from a recognized university, with at least five years of postgraduate experience in testing medical or in-vitro diagnostic devices under similar supervision, also including an option for two years of specific training.
**Impact Analysis**
**Individuals applying for or currently serving as Inspectors for Medical Device Rules, 2017:**
* **Impact:** They must meet the newly defined educational and experiential requirements to be appointed or continue in their roles.
* **Action Required:** Ensure their qualifications align with the stipulated criteria. Those who do not meet the requirements may need to seek further education or training.
**Individuals applying for or currently serving as Government Analysts for Medical Device Rules, 2017:**
* **Impact:** They must possess the specific degrees and postgraduate experience outlined for the role, including supervised testing experience or equivalent training.
* **Action Required:** Verify their educational background and professional experience against the defined qualifications. Individuals lacking the necessary experience or training may need to complete it.
**Regulatory Bodies and Enforcement Agencies:**
* **Impact:** These bodies will be responsible for implementing and enforcing the new qualification standards for Inspectors and Government Analysts.
* **Action Required:** Update their recruitment and appointment processes to reflect the new qualification criteria.
Key Entities Referenced
Medical Devices Rules, 2017: The principal rules being amended by this notification.
Drugs and Cosmetics Act, 1940: The primary legislation under which these rules are made and enforced.
Medical Devices (Amendment) Rules, 2026: The specific rules introduced by this notification.
Oṣadhi Takniki Salahakar Board: The advisory board consulted for these rule amendments.
Ministry of Health and Family Welfare: The administrative ministry issuing this notification.
रजिस्ट्री स.ं डी.एल.- 33004/99 REGD. No. D. L.-33004/99
सी.जी.-डी.एल.-अ.-10032026-270811
CG-DxLx-xEG-I1D0H0x3x2x0 26-270811
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असाधारण
EXTRAORDINARY
भाग II—खण् ड 3—उप-खण्ड (i)
PART II—Section 3—Sub-section (i)
प्राजधकार स ेप्रकाजित
PUBLISHED BY AUTHORITY
स.ं 159] नई दिल्ली, मगं लवार, माच च10, 2026/फाल्ग नु 19, 1947
No. 159] NEW DELHI, TUESDAY, MARCH 10, 2026/PHALGUNA 19, 1947
स्ट्वास्ट््य और पररवार कल्याण मत्रं ालय
(स्ट्वास्ट््य और पररवार कल्याण जवभाग)
अजधसचू ना
नई दिल् ली, 2 माच,च 2026
सा.का.जन. 165(अ) .— जचदकत्सा युजि जनयम, 2017 का और संिोधन करने के जलए कजतपय जनयमों का प्रारूप,
ओषजध एव ं सौंिय च प्रसाधन अजधजनयम, 1940 (1940 का 23) की धारा 12 और धारा 33 की उपधारा (1), द्वारा यथा
अपेजित, भारत के रािपत्र, असाधारण, भाग 2, खंड 3, उप-खंड (i) म ें संख्या सा. का. जन. 748(अ), तारीख 10 अक्टूबर,
2025 द्वारा प्रकाजित दकया गया था, जिसके द्वारा उन व्यजियों स,े जिनके उससे प्रभाजवत होने की संभावना ह,ै उस तारीख
स,े जिसको उि अजधसूचना वाले रािपत्र की प्रजतया ंिनता को उपलब्ध करायी गई थी, तीस दिन की अवजध, स ेपूवच, आपेि
और सुझाव आमंजत्रत दकए गए थ;े
और उि आजधकाररक रािपत्र की प्रजतयां 10 अक्टूबर, 2025 को िनता को उपलब्ध करा िी गईं थी;
और जनयमों के उि प्रारूप पर िनता स े प्राप्त आपेिों और सुझावों पर केंद्रीय सरकार द्वारा जवचार दकया गया ह;ै
अतः, केंद्रीय सरकार ओषजध और प्रसाधन अजधजनयम, 1940 (1940 का 23) की धारा 12 और धारा 33 द्वारा प्रित्त िजियों
का प्रयोग करते हुए, ओषजध तकनीकी सलाहकार बोडच स े परामिच करने के पश्चात, जचदकत्सा युजि जनयम, 2017 का और
संिोधन करने हते ु जनम्नजलजखत जनयम बनाती ह,ै अथाचत:् —
1. (1) इन जनयमों का संजिप् त नाम जचदकत्सा युजक्त (संिोधन) जनयम, 2026 ह।ै
1705 GI/2026 (1)2 THE GAZETTE OF INDIA : EXTRAORDINARY [PART II—SEC. 3(i)]
(2) य ेजनयम, िब तक अन्यथा जवजनर्िचष्ट न दकया िाए, रािपत्र म ेंइनके अंजतम प्रकािन की तारीख को प्रवृत्त होंगे।
2. जचदकत्सा युजक्त जनयम, 2017 म,ें जनयम 18 के पश्चात ् जनम्नजलजखत जनयम अंतःस्ट्थाजपत दकया िाएगा, अथाचत:् -
“18क. जनरीिक की अहताचए ं - जचदकत्सा युजि जनयम, 2017 के कायाचन्वयन के प्रयोिनों के जलए अजधजनयम के
अधीन जनरीिक के रूप म ें जनयिु व्यजि वह व्यजि होगा, िो जनम्नजलजखत अहताचए ं रखता हों —
(i) दकसी मान्यता प्राप्त जवश्वजवद्यालय या संस्ट्थान स े िैव जचदकत्सा या रसायन या यंजत्रकीय या इलेजक्रकल या
इलेक्रॉजनक्स या इंस्ट्ूमेंटेिन या िैव प्रोधोयोजगकी या पॉलीमर या कंप्यूटर जवज्ञान या जचदकत्सा इलेक्रॉजनक्स
इंिीजनयररंग म ेंइंिीजनयररंग प्रोधोयोजगकी म ें स्नातक की जडग्री या समकि जडग्री; या
(ii) दकसी मान्यता प्राप्त जवश्वजवद्यालय या संस्ट्थान स े भेषिी या ओषध भषे िीय जवज्ञान या सूक्ष्म िैजवकी या िैव
रसायन या रसायन या िीवन जवज्ञान म ें स्नातक की जडग्री।
18ख. सरकारी जवश्लेषक की अहताचएं - अजधजनयम के अधीन सरकारी जवश्लेषक के रूप म ेंजनयुि दकया िाने वाला व्यजि एसा
होगा िो जनम्नजलजखत म ेंस े कोई जडग्री रखता हो-
1. दकसी मान्यता प्राप्त जवश्वजवद्यालय या संस्ट्थान से िैव प्रोधोयोजगकी या रसायन या यंजत्रकीय या इलेजक्रकल या
इलेक्रॉजनक्स या इंस्ट्ूमेंटेिन या िैव प्रोधोयोजगकी या पॉजलमर या कंप्यूटर जवज्ञान या जचदकत्सा इलेक्रॉजनक्स
इंिीजनयररंग म ेंइंिीजनयररंग स्नातक या समकि जडग्री; और जिसके पास उि अजधजनयम के अधीन जनयिु सरकारी
जवश्लेषक के जनयंत्रण वाली प्रयोगिाला म ें जचदकत्सा उपकरणों या इन-जवरो डायग्नोजस्ट्टक उपकरणों के परीिण म ें
कम स े कम पांच वष च का स्नातकोत्तर अनुभव हो, िो जनम्नजलजखत के जनयंत्रण म ेंप्रयोगिाला म ेंदकया गया हो:
(i) उि अजधजनयम के अधीन जनयुि सरकारी जवश्लेषक, या
(ii) जनयुजि प्राजधकारी द्वारा इस उद्देश्य के जलए अनुमोदित दकसी संस्ट्थान या परीिण प्रयोगिाला का प्रमुख (या
जचदकत्सा उपकरणों या इन-जवरो डायग्नोजस्ट्टक उपकरणों के परीिण पर िो वष च का प्रजििण पूरा दकया हो)।
या,
2. दकसी मान्यता प्राप्त जवश्वजवद्यालय या संस्ट्थान स े भेषिी या भेषिीय जवज्ञान या सूक्ष्म िैजवकी या िैव रसायन
या रसायन या िीवन जवज्ञान म ें स्नातक की जडग्री और जचदकत्सा उपकरणों या इन-जवरो डायग्नोजस्ट्टक उपकरणों के
परीिण म ें कम स े कम पांच वषच का स्नातकोत्तर अनुभव, िो जनम्नजलजखत के जनयंत्रण म ें प्रयोगिाला म ें दकया गया
हो:
(i) उि अजधजनयम के अधीन जनयुि सरकारी जवश्लेषक, या
(ii) जनयुजि प्राजधकारी द्वारा इस उद्देश्य के जलए अनुमोदित दकसी संस्ट्थान या परीिण प्रयोगिाला का प्रमुख (या
जचदकत्सा उपकरणों या इन-जवरो डायग्नोजस्ट्टक उपकरणों के परीिण पर िो वष च का प्रजििण पूरा दकया हो)।
[फा. सं. एक्स.11012/04/2025–डीआर]
हष च मंगला, संयुि सजचव
रटप्पण: मलू जनयम अजधसूचना संख्या सा.का.जन.78 (अ), दिनाकं 31 िनवरी, 2017 द्वारा रािपत्र म ें प्रकाजित दकए गए
थ ेऔर अजधसूचना सख्ं या सा.का.जन. 409 (अ) दिनांक 2 िून, 2023 द्वारा अंजतम संिोधन दकया गया था ।
MINISTRY OF HEALTH AND FAMILY WELFARE
(Department of Health and Family Welfare)
NOTIFICATION
New Delhi, the 2nd March, 2026
G.S.R. 165(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. 748(E), dated
the 10th October, 2025 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[भाग II—खण् ड 3(ii)] भारत का रािपत्र : असाधारण 3
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 the 10th October, 2025;
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. (1) These rules may be called the Medical Devices (Amendment) Rules, 2026.
(2) They shall come into force on the date of their publication in the Official Gazette.
2. In the Medical Devices Rules 2017, after Rule 18, the following rule shall be inserted, namely: ⸻
“18A. Qualifications of Inspector ⸻ A person who is appointed as an Inspector under the Act for the purposes of
the implementation of the Medical Devices Rules, 2017 shall be a person who has a ⸻
(i). Bachelor’s degree in engineering or equivalent in Bio medical or Chemical or Mechanical or Electrical or
Electronics or Instrumentation or Bio-technology or Polymer or Computer Science or Medical Electronics
Engineering from a recognised university or institute; or
(ii). Bachelor's degree in Pharmacy or Pharmaceutical Science or Microbiology or Bio- Chemistry or Chemistry
or Life Sciences from a recognised university or institute.
18B. Qualifications of Government Analyst. ⸻ A person who is appointed as a Government analyst under the Act
shall be a person who has a ⸻
(a) Bachelor’s of engineering or equivalent in Bio medical or Chemical or Mechanical or Electrical or
Electronics or Instrumentation or Bio-technology or Polymer or Computer Science or Medical Electronics
Engineering from a recognised university or institute; and who possesses not less than five years' post-
graduate experience in the testing of medical devices or in-vitro diagnostics devices in a laboratory under
the control of ⸻
(i) a Government Analyst appointed under the said Act, or
(ii) the head of an Institution or testing laboratory approved for the purpose by the appointing authority
(or has completed two years' training on testing of medical devices or in-vitro diagnostics devices);
Or,
(b) Bachelor’s degree in Pharmacy or Pharmaceutical Science or Microbiology or Bio- Chemistry or
Chemistry or Life Sciences from a recognised university or institute and possesses not less than five years'
post-graduate experience in the testing of medical devices or in-vitro diagnostics devices in a laboratory
under the control of ⸻
(i) a Government Analyst appointed under the said Act, or
(ii) the head of an institution or testing laboratory approved for the purpose by the appointing authority (or
has completed two years' training on testing of medical devices or in-vitro diagnostics devices)
[F. No. X.11012/04/2025-DR]
HARSH MANGLA, Jt. Secy.
Note: The principal rules were published in the Official Gazette vide notification number
G.S.R. 78 (E), dated 31st January,2017 and last amended vide notification number
GSR 409 (E) dated 2nd June, 2023.
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.