## Report on Amendment to the Medical Devices Rules, 2017
**1. Executive Summary:**
This report analyzes a proposed amendment to the Medical Devices Rules, 2017, as outlined in the provided notification G.S.R. 23(E) dated January 18, 2022. The amendment introduces Rule 43A, focusing on the suspension and cancellation of licenses for manufacturers and licensees who fail to comply with import license conditions, provisions of the Drugs and Cosmetics Act, 1940, or the Medical Devices Rules, 2017. The key finding is the strengthening of the Central Licensing Authority's power to ensure compliance and impose penalties for non-compliance, including suspension or cancellation of licenses and potential destruction of medical device stocks.
**2. Introduction:**
This report aims to provide an informative overview of the proposed amendment to the Medical Devices Rules, 2017, based solely on the provided government notification. It analyzes the key provisions of the amendment and its potential impact on manufacturers and licensees of medical devices.
**3. Policy Overview:**
* This report concerns an *amendment* to the existing Medical Devices Rules, 2017.
* The core objective of this amendment, as inferred from the text, is to strengthen the regulatory framework governing medical devices by introducing clear provisions and consequences for non-compliance with licensing conditions and other applicable regulations.
**4. Background and Rationale:**
This amendment likely addresses potential issues related to non-compliance with existing regulations within the medical device industry. The amendment suggests that there may have been instances of manufacturers or licensees failing to adhere to the conditions of their import licenses or the provisions of the Drugs and Cosmetics Act, 1940, and the Medical Devices Rules, 2017. The introduction of Rule 43A seems designed to provide a clear enforcement mechanism and deter future non-compliance by explicitly outlining the circumstances under which licenses can be suspended or cancelled.
**5. Key Provisions / Changes:**
This amendment introduces Rule 43A, "Suspension and cancellation of license," to the Medical Devices Rules, 2017. The key changes and provisions are as follows:
* **Specific Part of Original Policy Changed:** The amendment adds a new rule, Rule 43A, after existing Rule 43 in the Medical Devices Rules, 2017.
* **New Rule/Provision:** Rule 43A empowers the Central Licensing Authority to:
* Suspend or cancel a license issued under the rules if a manufacturer or licensee fails to comply with the conditions of an import license or any provision of the Drugs and Cosmetics Act, 1940, or the Medical Devices Rules, 2017.
* Direct the licensee to stop import, sale, or distribution of the said medical device.
* Order the destruction of the medical device and the stock thereof in the presence of an authorized officer.
* **Effect of Change:** This amendment strengthens the Central Licensing Authority's enforcement power. It provides a mechanism for dealing with non-compliant manufacturers and licensees by allowing for the suspension or cancellation of licenses, cessation of import, sale or distribution and destruction of medical devices. This change introduces a stricter enforcement regime than before. A licensee now faces potentially severe penalties for non-compliance. The amendment also introduces a formal process for appeal to the Central Government.
**6. Target Audience and Stakeholders:**
Based on the provided text, the target audience and stakeholders directly affected by this amendment are:
* Manufacturers of medical devices.
* Licensees involved in the import, sale, and distribution of medical devices.
* The Central Licensing Authority.
* The Central Government (in relation to appeals).
**7. Implementation Aspects (Inferred):**
* **Responsible Agency/Bodies:** The Central Licensing Authority is primarily responsible for implementing this amendment, specifically for monitoring compliance, issuing show-cause notices, and making decisions regarding suspension or cancellation of licenses. The Central Government is responsible for hearing appeals against the Central Licensing Authority's orders.
* **Timelines/Procedures:**
* The amendment will come into force on the date of its final publication in the Official Gazette.
* Before suspending or cancelling a license, the Central Licensing Authority must provide the manufacturer or licensee an opportunity to show cause why such an order should not be passed.
* An aggrieved person can file an appeal to the Central Government within thirty days of the serving of the order.
**8. Expected Outcomes / Impact of Changes:**
The likely intended outcomes of this amendment are:
* Increased compliance with the Medical Devices Rules, 2017, and the Drugs and Cosmetics Act, 1940, by manufacturers and licensees.
* Reduced instances of substandard or non-compliant medical devices being imported, sold, or distributed.
* Enhanced public safety through stricter regulation and enforcement within the medical device industry.
* A more robust and transparent regulatory framework for medical devices.
**9. Conclusion:**
The amendment to the Medical Devices Rules, 2017, through the introduction of Rule 43A, represents a significant step towards strengthening the regulatory oversight of the medical device industry. By empowering the Central Licensing Authority to suspend or cancel licenses for non-compliance, the amendment aims to improve adherence to existing regulations, protect public safety, and ensure the quality and safety of medical devices available in the market. This change requires medical device manufacturers and licensees to be even more diligent in maintaining compliance with all applicable regulations.
Key Entities Referenced
India: Country, publishing the Gazette.
NEW DELHI: Location of publication: Gazette of India, Ministry of Health and Family Welfare notification.
TUESDAY, JANUARY 18, 2022: Date of the Gazette of India publication.
PAUSHA 28, 1943: Date in the Indian national calendar corresponding to the date of publication.
THE GAZETTE OF INDIA: Official journal of the Government of India.
MINISTRY OF HEALTH AND FAMILY WELFARE: The ministry responsible for the notification related to amending the Medical Device Rules.
Department of Health and Family Welfare: Department within the Ministry of Health and Family Welfare.
NOTIFICATION: Indicates that the document is an official notification.
G.S.R. 23E: Notification number related to the draft of rules to amend the Medical Device Rules, 2017.
Medical Device Rules, 2017: The set of rules being amended by the notification.
Central Government: The governing body proposing to make changes to the Medical Device Rules, 2017.
subsection 1 of section 12: Legal provision granting power to the Central Government.
subsection 1 of section 33: Legal provision granting power to the Central Government.
Drugs and Cosmetics Act, 1940: The primary legislation under which the rules are being amended.
Drugs Technical Advisory Board: Advisory board consulted for the draft rules.
Gazette of India: Official publication where the draft rules are made available to the public.
Central Government: The governing body that will consider objections and suggestions to the draft rules.
Under Secretary Drugs, Ministry of Health and Family Welfare, Government of India: The designated authority to whom objections and suggestions should be addressed.
Government of India: The governing body of India.
Room No. 434, C Wing, Nirman Bhavan, New Delhi 110011: Address for submitting objections and suggestions.
Medical Devices ......Amendment Rules, 2021: Title of the amendment rules.
Official Gazette: The official publication where the final amendment rules will be published.
Medical Devices Rules, 2017: The rules which are being amended.
Central Licensing Authority: Authority responsible for issuing licenses and taking action on non-compliance.
Central Government: The appellate authority for orders passed by the Central Licensing Authority.
F.No.X. 1101442019 DR: File number of the notification.
Dr. MANDEEP K BHANDARI: Joint Secretary (Jt. Secy.) signing the notification.
G.S.R. 78E: Notification number of the original Medical Devices Rules, 2017 publication.
31st January, 2017: Date of publication of the original Medical Devices Rules, 2017.
Government of India Press, Ring Road, Mayapuri, New Delhi110064: Location of the printing press.
Controller of Publications, Delhi110054: The publishing authority.
रजिस्ट्री स.ं डी.एल.- 33004/99 REGD. No. D. L.-33004/99
xxxGIDHxxx
सी.जी.-डी.एxलx.x-GअID.-E1x9xx0 12022-232769
CG-DL-E-19012022-232769
ऄसाधारण
EXTRAORDINARY
भाग II—खण् ड 3—ईप-खण्ड (i)
PART II—Section 3—Sub-section (i)
प्राजधकार स ेप्रकाजित
PUBLISHED BY AUTHORITY
स.ं 23] नइ दद्ली, मगं लवार, िनवरी 18, 2022/पौष 28, 1943
No. 23] NEW DELHI, TUESDAY, JANUARY 18, 2022/PAUSHA 28, 1943
स्ट्व ास्ट्् य रर पिरवार क्य ाण मरालं ालय
(स्ट्व ास्ट्् य रर पिरवार क्य ाण जवभाग)
ऄजधसचू ना
नइ दद्ली, 18 िनवरी, 2022
सा.का.जन. 23(ऄ).—जचदकत्सा युजि जनयम, 2017 का रर संिोधन करने के जलए कजतपय जनयमों के
जनम्नजलजखत प्रारूप, जिसे केन्द्रीय सरकार रषजध तकनीकी सलाहकार बोड ड के परामि ड स े रषजध रर प्रसाधन सामग्री
ऄजधजनयम, 1940 (23 के 1940) की धारा 12 की ईपधारा (1) रर धारा 33 की ईपधारा (1) द्वारा प्रदत्त िजियों का
प्रयोग करत े हुए, आसके द्वारा प्रभाजवत होने की संभावना वाल े सभी व्यजियों की िानकारी के जलए प्रकाजित दकया िाता ह ै
रर एतद द्वारा सूचना दी िाती ह ै दक ईक्त प्रारूप जनयमों पर ईस तारीख से पतत ालीस ददनों की ऄवजध समा् त होन े पर या
ईसके बाद जवचार दकया िाएगा जिस तारीख को आन प्रारूप जनयमों वाल े भारत के रािपराल की प्रजतया ं िनता को ईपलधध
कराइ िाएगी;
केन्द्रीय सरकार द्वारा ईपयिुड जवजनर्ददष्ट ऄवजध के भीतर दकसी भी व्यजि स े प्राप्त होन े वाली अपजत्तयों रर
सुझावों पर जवचार दकया िाएगा;
अपजत्तयां रर सुझाव, यदद कोइ हों, तो ऄवर सजचव, (रषजध), स्ट्वास्ट््य रर पिरवार क्याण मंरालालय, भारत
सरकार, कमरा सं. 434, सी ववग, जनमाडण भवन, नइ दद्ली - 110011 को ऄग्रेजषत दकया िाए ऄथवा drugsdiv-
mohfw@gov.in पर इ-मेल की िाए।
374 GI/2022 (1)2 THE GAZETTE OF INDIA : EXTRAORDINARY [PART II—SEC. 3(i)]
प्रारूप जनयम
1. (1) आन जनयमों को जचदकत्सा युजि (….संिोधन) जनयम, 2022 कहा िाएगा।
(2) य ेजनयम, िब तक ऄन्द्यथा जवजनर्ददष्ट न हो, रािपराल में आनके ऄंजतम प्रकािन की तारीख को प्रभावी होंगे।
2. जचदकत्सा युजि जनयम, 2017 में, जनयम 43 के पश्चात,् जनम्नजलजखत जनयम ऄतं :स्ट्थाजपत दकया िाएगा,
ऄथाडत:्—
“43क. ऄनज्ञु जप्त का जवलबं न तथा जनरसन— (1) यदद जवजनमाडता ऄथवा ऄनुज्ञजप्तधारी अयात ऄनज्ञु जप्त की दकसी
ितड ऄथवा ऄजधजनयम के दकसी ईपबंध ऄथवा आन जनयमों का पालन नहीं करता ह ै तो केंरीय ऄनुज्ञापन
प्राजधकारी जवजनमाडता ऄथवा ऄनुज्ञजप्तधारी को ‘कारण बताओ’ का एक ऄवसर देत े हुए एक अदिे द्वारा जलजखत
रूप से कारणों का ई्लेख करत े हुए दक ऐसा अदेि पािरत क्यों न कर ददया िाए, जनयमों के तहत िारी दकए गय े
ऄनुज्ञजप्त को, ऐसी ऄवजध के जलए िैसा दक वह ईपयुि समझे या तो पूणड रूप से ऄथवा जचदकत्सा ईपकरण के
दकसी भाग के संबंध में जिससे वह संबंजधत हो, जनरस्ट्त कर सकता ह ै ऄथवा ऄनज्ञु जप्तधारी को ईि जचदकत्सा युजि
के अयात, जबक्री ऄथवा जवतरण को रोकन े के जनदेि द े सकता ह ै रर तत्पश्चात ् केंरीय ऄनुज्ञापन प्राजधकरण द्वारा
प्राजधकृत दकए गए एक ऄजधकारी की ईपजस्ट्थजत में, यदद ईसकी राय म,ें ऄनुज्ञजप्तधारी ऄनज्ञु जप्त की दकसी ित ड
ऄथवा ऄजधजनयम के दकसी ईपबंध ऄथवा ईसके ऄधीन बनाए गए जनयमों का पालन करने म ें ऄसमथ ड रहा है, तो
जचदकत्सा युजि रर तत्संबंधी स्ट्टॉक को नष्ट करन े का अदेि दे सकता ह।ै
परंत ु दक कोइ व्यजि िो केंरीय ऄनुज्ञापन प्राजधकरण द्वारा पािरत दकए गए अदेि से ऄसंतष्टु ह ै तो वह
अदेि तामील दकए िाने के तीस ददन के ऄंदर केंरीय सरकार के पास ऄपील दायर कर सकता है, रर केंरीय
सरकार आस मामल े म ें ऐसी िाचं करन े के बाद, जिसे वह ऄजनवायड समझती ह ैरर ईसके बाद ईि ऄपीलकता ड को
सुनवाइ का ऄवसर दने े के बाद, ऐसा अदेि पािरत कर सकती ह ैजिसे वह ईजचत समझती ह।ै
[फा.सं. एक् स. 11014/4/2019-डीअर]
डॉ. मनदीप के भण्डारी, संयुक् त सजचव
िट्पण: जचदकत्सा युजि जनयम, 2017, रािपराल म ें ऄजधसूचना सं. सा.का.जन. 78(ऄ), तारीख 31 िनवरी, 2017 द्वारा
प्रकाजित दकए गए थ े रर ऄजधसूचना सं. सा.का.जन. …….. (ऄ), तारीख ………… द्वारा ऄंजतमतः संिोजधत
दकए गए थ े।
MINISTRY OF HEALTH AND FAMILY WELFARE
(Department of Health and Family Welfare)
NOTIFICATION
New Delhi, the 18th January, 2022
G.S.R. 23(E).—The following draft of certain rules further to amend the 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) and in consultation after
publication with the Drugs Technical Advisory Board, is hereby published 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 or after the expiry
of a period of forty-five days from the date on which the copies of the Gazette of India 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;[भाग II—खण् ड 3(i)] भारत का रािपराल : ऄसाधारण 3
Objections and suggestions, if any, may be addressed to the Under Secretary (Drugs), Ministry of Health and
Family Welfare, Government of India, Room No. 434, C Wing, Nirman Bhavan, New Delhi - 110011 or emailed at
drugsdiv-mohfw@gov.in.
DRAFT RULES
1. (1) These rules may be called the Medical Devices (......Amendment) Rules, 2021.
(2) These rules shall, unless specified otherwise, come into force on the date of its final publication in the
Official Gazette.
2. In the Medical Devices Rules, 2017, after rule 43, the following rule shall be inserted, namely:—
“43A. Suspension and cancellation of license.— (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 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 presence of officer authorized by
Central Licensing Authority, if in its opinion, the licensee has failed to comply with any of the conditions of
the license or with any provisions of the Act or 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, may file 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 for hearing, 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 No. G.S.R. 78(E),
dated 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.