**Executive Summary**
This document is a draft notification regarding amendments to the Medical Device Rules, 2017. It proposes changes to the qualifications required for Medical Device Inspectors and Government Analysts. The draft rules will be considered after a 30-day period from the date of gazette publication for public feedback.
**Key Points / Main Content**
* **Short Title and Commencement:**
* The amended rules are called the Medical Devices (Amendment) Rules, 2024.
* The rules will come into force on the date of their final publication in the Official Gazette, unless otherwise specified.
* **Insertion of New Rules in the Medical Devices Rules, 2017:**
* **Rule 18A: Qualifications of Inspector (Medical Device)**
* Requires that an appointed inspector must possess a degree in:
* Engineering technology in Bio Medical, Chemical, Mechanical, Electrical, Electronics, Instrumentation, Bio-Technology, Polymer, Computer Science or Medical Electronics Engineering from a recognized university or institute; OR
* Pharmacy, Pharmaceutical Science, Microbiology, Bio-Chemistry, Chemistry, or Life Sciences from a recognized university or institute.
* **Rule 18B: Qualifications of Government Analyst**
* Requires that an appointed government analyst must possess a degree in:
* Engineering technology in Bio Medical, Chemical, Mechanical, Electrical, Electronics, Instrumentation, Bio-Technology, Polymer, Computer Science or Medical Electronics Engineering from a recognized university or institute; OR
* Pharmacy, Pharmaceutical Science, Microbiology, Bio-Chemistry, Chemistry, or Life Sciences from a recognized university or institute.
**Impact Analysis**
**Ministry of Health and Family Welfare**
* **Impact**: Responsible for implementing the amended rules.
* **Action Required**: Consider public feedback received within 30 days of the gazette publication and finalize the amendment.
**Individuals aspiring to be Medical Device Inspectors or Government Analysts**
* **Impact**: Need to meet the new qualification criteria to be eligible for the roles.
* **Action Required**: Ensure they have the required degrees specified in the amended rules.
**Medical Device Industry**
* **Impact**: Ensures that regulatory oversight is conducted by individuals with the specified qualifications.
* **Action Required**: Remain informed about the new rules and ensure compliance.
**Public**
* **Impact**: Benefit from enhanced quality control and regulatory oversight of medical devices.
* **Action Required**: If affected by the draft rules, provide feedback within 30 days.
Key Entities Referenced
Medical Devices Rules, 2017: The principal rules being amended by this notification.
Medical Devices (Amendment) Rules, 2024: The short title given to the amended rules in this notification.
Drugs and Cosmetics Act, 1940: The Act under which the Medical Devices Rules are framed, specifying the powers exercised.
Ministry of Health and Family Welfare: The ministry responsible for the notification regarding the amendment of the Medical Devices Rules.
New Delhi: Location where the notification is issued.
रजिस्ट्री स.ं डी.एल.- 33004/99 REGD. No. D. L.-33004/99
सी.जी.-डी.एल.-अ.-10102025-266848
CG-DxLx-xEG-I1D0H1x0x2x0 25-266848
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.ं 664] नई दिल्ली, िुक्रवार, अक्त बू र 10, 2025/आजव न 18, 1947
No. 664] NEW DELHI, FRIDAY, OCTOBER 10, 2025/ASVINA 18, 1947
स्ट्वास्ट््य और पररवार कल्याण मत्रं ालय
(स्ट्वास्ट््य और पररवार कल्याण जवभाग)
अजधसचू ना
नई दिल्ली, 10 अक् तूबर, 2025
सा.का.जन. 748(अ).— चिकित्सा युचित चियम, 2017 म ें संशोधि िरि े िे चिए िचिपय चियमों िा चिम्नचिचिि
मसौदा, चिस े िेन्द्रीय सरिार ओषचध और प्रसाधि सामग्री अचधचियम, 1940 (1940 िा 23) िी धारा 12 िी उपधारा
(1) और धारा 33 िी उपधारा (1) द्वारा प्रदत्त शचियों िा प्रयोग िरिे हुए संशोधि िरि े िा प्रस्िाव िरिी ह,ै िो इसस े
प्रभाचवि होिे वाि े सभी संभाचवि व्तयचित यों िी सूििा िे चिए, एिद्द्वारा सूचिि किया िािा ह ै कि इस अचधसूििा वाि े
रािपत्र िी प्रचियां प्रिाचशि होिे और उसे िििा िो उपिब्तध िरािे िी िारीि स े या िीस कदि िी अवचध िी समाचि िे
पश्तिाि ् उित मसौदा चियमों पर चविार किया िाएगा।
उपरोि चवचिर्दिष्ट अवचध िे अिं गिि उित प्रारूप चियमों िे सबं ंध म ें किसी भी व्तयचित स े प्राप्ित होिे वािी
आपचत्तयों या सुझावों पर िेंर सरिार द्वारा चविार किया िाएगा;
6807 GI/2025 (1)2 THE GAZETTE OF INDIA : EXTRAORDINARY [PART II—SEC. 3(i)]
इि प्रारूप चियमों िे संबंध म ेंआपचत्तयां एव ं सुझावों, यकद िोई हों, िो अवर सचिव (औषचध), स्वास््य और
पररवार िल्याण मंत्रािय, भारि सरिार, िमरा संख्या 545, ए ववंग, चिमािण भवि, िई कदल्िी - 110011 या ईमिे
drugsdiv-mohfw@gov.in िे माध्तयम स े भेिा िा सििा ह।ै
मसौदा चियम
1. (i) इि चियमों िा संचिप्ति िाम चिकित्सा युचित (संशोधि) चियम, 2024 ह।ै
(ii) ये चियम, िब िि अन्द्यथा चवचिर्दिष्ट ि किया िाए, रािपत्र म ें इििे अंचिम प्रिाशि िी िारीि स े प्रवृत्त
होंगे।
2. चिकित्सा युचित चियम, 2017 म,ें चियम 18 िे पश्चाि ् चिम्नचिचिि चियम अंिःस्थाचपि किया िाएगा, अथािि:् -
18ि. चिरीिि (चिकित्सा युचित ) िी अहिािए ं- अचधचियम िे अधीि चिरीिि िे रूप म ें चियिु व्यचि वह होगा चिसिे
पास चिम्नचिचिि म ें स ेिोई चिग्री हो -
(i) किसी मान्द्यिा प्राि चवश्वचवद्यािय या सस्ं थाि स े बायो मेचििि या िेचमिि या मैिेचििि या इिेचििि
या इिेिॉचिस या इंस्ूमेंटेशि या बायो-टेक्नोिॉिी या पॉिीमर या िंप्यूटर साइंस या मेचििि
इिेिॉचिस इंिीचियररंग म ेंइंिीचियररंग टेक्नोिॉिी म ेंस्नािि िी चिग्री; या
(ii) किसी मान्द्यिा प्राि चवश्वचवद्यािय या सस्ं थाि स े फामेसी या फामािस्युरटिि साइंस या माइक्रोबायोिॉिी
या बायो-िेचमस्िी या िेचमस्िी या िाइफ साइंसेि म ें स्नािि िी चिग्री।
18ि. सरिारी चवश्लेषि िी अहिािए ं - अचधचियम िे अधीि सरिारी चवश्लेषि िे रूप म ें चियिु किया िािे वािा व्यचि
वह होगा चिसिे पास चिम्नचिचिि म ें स े िोई चिग्री हो-
(i) किसी मान्द्यिा प्राि चवश्वचवद्यािय या सस्ं थाि स े बायो मेचििि या िेचमिि या मैिेचििि या इिेचििि
या इिेिॉचिस या इंस्ूमेंटेशि या बायो-टेक्नोिॉिी या पॉिीमर या िंप्यूटर साइंस या मेचििि
इिेिॉचिस इंिीचियररंग म ेंइंिीचियररंग टेक्नोिॉिी म ेंस्नािि िी चिग्री; या
(ii) किसी मान्द्यिा प्राि चवश्वचवद्यािय या सस्ं थाि स े फामेसी या फामािस्युरटिि साइंस या माइक्रोबायोिॉिी
या बायो-िेचमस्िी या िेचमस्िी या िाइफ साइंसेि म ें स्नािि िी चिग्री।
[फा. स.ं एस.11012/04/2025–िीआरएस]
चिचिि गिराि, संयुक् त सजचव
िोट: मिू चियम अचधसूििा सख्ं या सा.िा.चि.78 (अ), कदिांि 31 ििवरी, 2017 द्वारा रािपत्र म ें प्रिाचशि किए गए थ े
और अंचिम बार अचधसूििा सख्ं या सा.िा.चि. 409 (अ) कदिांि 2 िूि, 2023 द्वारा संशोचधि किए 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 October, 2025
G.S.R. 748(E).— The following draft of certain rules to amend 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), 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, Room No. 545, A Wing, Nirman Bhavan, New Delhi - 110011 or emailed at
drugsdiv-mohfw@gov.in.
DRAFT RULES
1. (i) These rules may be called the Medical Devices (Amendment) Rules, 2024.
(ii) These rules shall, unless specified otherwise, come into force on the date of their final 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 (Medical Device). - A person who is appointed as an Inspector under the Act shall be
a person who has a degree in-
i. Bachelors of engineering technology 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. Bachelors 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 degree in-
i. Bachelors of engineering technology 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. Bachelors degree in Pharmacy or Pharmaceutical Science or Microbiology or Bio- Chemistry or Chemistry or Life
Sciences from a recognised university or institute.
[F. No. X.11012/04/2025 -DR]
NIKHIL GAJRAJ, Jt. Secy.
Note: The principal rules were published in the Official Gazette vide notification number G.S.R.78(E),
dated 31stJanuary,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.