## Policy Analysis Report: Medical Devices Third Amendment Rules, 2022
**1. Executive Summary:**
This report analyzes the Medical Devices Third Amendment Rules, 2022, published on May 18, 2022. This amendment modifies the Medical Devices Rules, 2017 by introducing a new rule, 43A, concerning the suspension and cancellation of licenses for medical device manufacturers or licensees who fail to comply with the rules or the Drugs and Cosmetics Act, 1940. The key finding is that this amendment provides a clear mechanism for the Central Licensing Authority to enforce compliance, offering a process for suspension, cancellation, and appeal.
**2. Introduction:**
The purpose of this report is to provide an informative analysis of the Medical Devices Third Amendment Rules, 2022, based solely on the information provided in the official gazette notification. This analysis will outline the changes introduced by the amendment, its rationale, and potential impact.
**3. Policy Overview:**
* This document is an amendment to the Medical Devices Rules, 2017.
* The core objective, as inferred from the text, is to strengthen the enforcement of existing regulations pertaining to medical devices by providing a clear mechanism for suspending or canceling licenses in cases of non-compliance.
**4. Background and Rationale:**
The amendment likely aims to address potential weaknesses in the enforcement of the Medical Devices Rules, 2017. The introduction of Rule 43A suggests that there was a perceived need for a more explicit and readily enforceable mechanism to address instances where manufacturers or licensees fail to comply with the existing rules and regulations. By explicitly outlining the procedures for suspension and cancellation of licenses, the amendment seeks to ensure stricter adherence to the established standards and requirements for medical devices.
**5. Key Provisions / Changes:**
This amendment introduces a new rule, Rule 43A, into the Medical Devices Rules, 2017.
* **Specific Part of Original Policy Changed:** A new rule is *added* after Rule 43 in the Medical Devices Rules, 2017.
* **New Rule/Provision:** Rule 43A establishes the process for "Suspension and cancellation of license." It states that if a manufacturer or licensee fails to comply with the conditions of an import license or the Drugs and Cosmetics Act, 1940, the Central Licensing Authority can, after providing an opportunity to show cause, cancel or suspend the license. The Authority can also direct the licensee to stop import, sale, or distribution and order the destruction of the medical device.
* **Difference/Effect of Change:** This change creates a more defined and enforceable process for dealing with non-compliance. Previously, the process for license suspension or cancellation might have been less explicit or required relying on more general provisions. Now, Rule 43A provides a specific and detailed framework, outlining the steps the Central Licensing Authority can take and the rights of the manufacturer or licensee, including the right to appeal to the Central Government.
**6. Target Audience and Stakeholders:**
Based on the text, the directly affected parties are:
* Manufacturers and licensees involved in the import, sale, or distribution of medical devices.
* The Central Licensing Authority responsible for overseeing compliance with the Medical Devices Rules, 2017, and the Drugs and Cosmetics Act, 1940.
* The Central Government, in its role as the appellate body for decisions made by the Central Licensing Authority.
**7. Implementation Aspects (Inferred):**
* **Responsible Agency/Bodies:** The Central Licensing Authority is responsible for implementing the provisions of Rule 43A. The Central Government acts as the appellate authority.
* **Timelines/Procedures:** The amendment specifies that the Central Licensing Authority must provide the manufacturer or licensee with an opportunity to show cause before suspending or canceling the license. An aggrieved party has thirty days to file an appeal to the Central Government. The Central Licensing Authority is also responsible for authorising an officer for the destruction of medical devices, if required.
**8. Expected Outcomes / Impact of Changes:**
The intended outcome of this amendment is likely to:
* Increase compliance with the Medical Devices Rules, 2017, and the Drugs and Cosmetics Act, 1940.
* Provide a clearer and more efficient mechanism for the Central Licensing Authority to address instances of non-compliance.
* Deterrent for medical device manufacturers and licensees against violating regulations, due to the risk of losing their license.
* Potentially increase safety and quality of medical devices available in the market.
**9. Conclusion:**
The Medical Devices Third Amendment Rules, 2022, introduces a significant change by establishing a clear framework for the suspension and cancellation of licenses for medical device manufacturers and licensees who fail to comply with regulations. This amendment strengthens the enforcement capabilities of the Central Licensing Authority, promoting greater adherence to the Medical Devices Rules, 2017, and contributing to a safer and more reliable market for medical devices. The introduction of a specific appeal process also adds a layer of fairness and transparency.
Key Entities Referenced
New Delhi: Location of the notification issuance.
Drugs and Cosmetics Act, 1940: Indian legislation governing drugs and cosmetics.
Medical Devices Rules, 2017: Indian regulations pertaining to medical devices.
Ministry of Health and Family Welfare: The Government of India ministry responsible for health policy.
Department of Health and Family Welfare: Department within the Ministry of Health and Family Welfare.
Central Government: The Union Government of India.
Drugs Technical Advisory Board: Advisory board consulted by the Central Government.
Medical Devices Third Amendment Rules, 2022: The title of the amendment rules being introduced.
Central Licensing Authority: Licensing authority for manufacturers or licensees.
Dr. Mandeep K. Bhandari: Joint Secretary mentioned in the notification.
Mayapuri, New Delhi: Location of the Government of India Press.
Delhi: Location of the Controller of Publications.
रजिस्ट्री स.ं डी.एल.- 33004/99 REGD. No. D. L.-33004/99
xxxGIDHxxx
सी.जी.-डी.एलxx.x-GअID.-E1x8x0x 52022-235837
CG-DL-E-18052022-235837
असाधारण
EXTRAORDINARY
भाग II—खण्ड 3—उप-खण्ड (i)
PART II—Section 3—Sub-section (i)
प्राजधकार स ेप्रकाजित
PUBLISHED BY AUTHORITY
स.ं 340] नई दद्ली, बधु वार, मई 18, 2022/विै ाख 28, 1944
No. 340] NEW DELHI, WEDNESDAY, MAY 18, 2022/VAISAKHA 28, 1944
स्ट्व ास्ट्् य रर पिरवार क्य ाण मरं ालय
(स्ट्व ास्ट्् य रर पिरवार क्य ाण जवभाग)
अजधसचू ना
नई दद् ली, 18 मई, 2022
सा.का.जन. 356(अ).—जचदकत्सा युजि जनयम, 2017 का रर संिोधन करने के जलए कजतपय जनयमों का प्रारूप,
रषजध रर प्रसाधन सामग्री अजधजनयम, 1940 (1940 का 23) की धारा 12 की उप-धारा (1) रर धारा 33 की उप-
धारा (1) के अधीन यथा अपेजित, भारत सरकार के स्ट् वास्ट् ् य रर पिरवार क् याण मंरालय (स्ट् वास्ट् ् य रर पिरवार क् याण
जवभाग) की अजधसूचना सं. सा.का.जन. 23(अ), तारीख 18 िनवरी, 2022 द्वारा भारत के रािपर, असाधारण, भाग II,
खंड 3, उपखंड (i) में प्रकाजित दकया गया था, जिसमें उन सभी व् यजियों स,े जिनके उससे प्रभाजवत होने की संभावना ह ै
उस तारीख स,े जिसको उक्त अजधसूचना वाली रािपर की प्रजतयां िनता को उपलब् ध करा दी गई थी, पैंतालीस ददनों की
अवजध की समाजि से पहले आिेप रर सुझाव आंमजरत दकए गए थे;
रर, उि रािपर की प्रजतयां 19 िनवरी, 2022 को िनता को उपलब् ध करा दी गई थी;
रर केन्द रीय सरकार द्वारा उक्त जनयमों पर िनता से प्राि आिपे रर सझु ावों पर जवचार कर जलया गया ह;ै
अत:, अब, केन्द रीय सरकार, रषजध रर प्रसाधन सामग्री अजधजनयम, 1940 (1940 का 23) की धारा 12 रर
धारा 33 द्वारा प्रदत् त िजियों का प्रयोग करत े ुए, रषजध तकनीकी सलाहकार बोड ड से परामिड करन े के पश्चात्, जचदकत्सा
युजि जनयम, 2017 का रर सिं ोधन करने के जलए जनम्न जलजखत जनयम बनाती ह,ै अथाडत्:—
1. (1) इन जनयमों का संजिि नाम जचदकत्सा युजि (तीसरा संिोधन) जनयम, 2022 ह।ै
(2) ये रािपर में उनके प्रकािन की तारीख को प्रवृत होंगे।
3347 GI/2022 (1)2 THE GAZETTE OF INDIA : EXTRAORDINARY [PART II—SEC. 3(i)]
2. जचदकत्सा युजि जनयम, 2017 म,ें जनयम 43 के पश्चात,् “जनम्नजलजखत जनयम अतं :स्ट्थाजपत दकया िाएगा, अथाडत:्—
“43क. अनुज्ञजि का जनलंबन तथा जनरसन— (1) यदद जवजनमाडता अथवा अनज्ञु जिधारी आयात अनुज्ञजि की दकसी
ितड अथवा अजधजनयम के दकसी उपबंध अथवा इन जनयमों का पालन नहीं करता ह ै तो केंरीय अनुज्ञापन
प्राजधकारी जवजनमाडता अथवा अनुज्ञजिधारी को ‘कारण बताओ’ का एक अवसर देत े ुए एक आदिे द्वारा जलजखत
रूप से कारणों का उ्लेख करत े ुए दक ऐसा आदेि पािरत क्यों न कर ददया िाए, जनयमों के अधीन िारी की गई
अनुज्ञजि को, ऐसी अवजध के जलए िैसा दक वह उपयुि समझे या तो पणू ड रूप से अथवा जचदकत्सा उपकरण के
दकसी भाग के संबंध म ें जिससे वह संबंजधत हो, जनरस्ट्त कर सकेगी अथवा अनुज्ञजिधारी को उि जचदकत्सा युजि के
आयात, जबक्री अथवा जवतरण को रोकने के जनदिे द े सकेगा रर तत्पश्चात्, केंरीय अनुज्ञापन प्राजधकरण द्वारा
प्राजधकृत दकए गए एक अजधकारी की उपजस्ट्थजत में, यदद उसकी राय म,ें अनुज्ञजिधारी अनज्ञु जि की दकसी ित ड
अथवा अजधजनयम के दकसी उपबंध अथवा उसके अधीन बनाए गए जनयमों का पालन करने म ें असमथ ड रहा है, तो
जचदकत्सा युजि रर तत्संबंधी स्ट्टॉक को नष्ट करन े का आदेि दे सकेगा ।
परंतु कोई व्यजि िो केंरीय अनुज्ञापन प्राजधकरण द्वारा पािरत दकए गए आदेि से असंतष्टु ह ै तो वह
आदेि तामील दकए िाने के तीस ददन के अंदर केंरीय सरकार के पास अपील दायर कर सकेगा, रर केंरीय
सरकार इस मामले में ऐसी िाचं करने के पश्चात्, जिसे वह आवश्यक समझे रर उसके पश्चात ् उि अपीलकताड को
सुनवाई का अवसर दने े के पश्चात्, ऐसा आदेि पािरत कर सकेगी जिसे वह उजचत समझ े ।
[फा. सं. एक् स.11014/4/2019-डीआर]
डॉ. मनदीप के भण्डारी, संयुि सजचव
िटप्पण : जचदकत्सा युजि जनयम, 2017, रािपर म ें अजधसूचना सं. सा.का.जन. 78(अ), तारीख 31 िनवरी, 2017 द्वारा
प्रकाजित दकए गए थे रर अजधसूचना सं. सा.का.जन. 174(अ), तारीख 4 माचड, 2022 द्वारा अंजतम बार
संिोजधत दकए गए थे ।
MINISTRY OF HEALTH AND FAMILY WELFARE
(Department of Health and Family Welfare)
NOTIFICATION
New Delhi, the 18th May, 2022
G.S.R. 356(E).—Whereas a draft of certain rules further to amend the Medical Devices Rules,
2017, was published as required under sub-section (1) of section 12 and sub-section (1) of section 33 of the
Drugs and Cosmetics Act, 1940 (23 of 1940) vide notification of the Government of India in the Ministry
of Health and Family Welfare (Department of Health and Family Welfare) number G.S.R. 23(E), dated the
18th January, 2022, in the Gazette of India, Extraordinary, Part II, Section 3, Sub-section (i), inviting
objections and suggestions from persons likely to be affected thereby, before the expiry of a period of forty-
five days from the date on which the copies of the Official Gazette containing the said notification were
made available to the public;
And whereas, copies of the said Official Gazette were made available to the public on the 19th
January, 2022;
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 sections 12 and 33 of the Drugs and
Cosmetics Act, 1940 (23 of 1940), the Central Government, after consultation with the 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 (Third Amendment) Rules, 2022.
(2) They shall come into force on the date of their publication in the Official Gazette.[भाग II—खण् ड 3(i)] भारत का रािपर : असाधारण 3
2. In the Medical Devices Rules, 2017, after rule 43, the following rule shall be inserted, namely:—
“43A. Suspension and cancellation of licence.— (1) If the manufacturer or licensee fails to comply
with any of the conditions of an import license, or any provisions of the Act and these rules, the
Central Licensing Authority may after giving the manufacturer or licensee an opportunity to show
cause why such an order should not be passed, by an order in writing stating the reasons therefor,
cancel a license issued under rules, or suspend it for such period as it may thinks fit either wholly
or in respect of any of the part of medical device to which it relates or direct the licensee to stop
import, sale or distribution of the said medical device and, thereupon, order the destruction of
medical device and the stock thereof in the presence of an officer authorised by the Central
Licensing Authority, if in its opinion, the licensee has failed to comply with any of the conditions
of the licence or with any provisions of the Act or the rules made thereunder:
Provided that a person who is aggrieved by the order passed by the Central Licensing
Authority under this rule may, within thirty days of the serving of the order, file an appeal to the
Central Government, and the Central Government may, after such enquiry into the matter, as it
considers necessary and after giving the said appellant an opportunity of being heard, pass such
order as it thinks fit.”.
[F. No. X.11014/4/2019-DR]
Dr. MANDEEP K. BHANDARI, Jt. Secy.
Note : The Medical Devices Rules, 2017 was 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.
174(E), dated the 4th March, 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.