Executive Summary:
This document is a notification containing a draft of amendments to the Medical Device Rules, 2017, as proposed by the Central Government. It includes an opportunity for the public to submit objections and suggestions regarding the proposed changes within thirty days of the draft rules being made available. The notification specifies contact information for submitting feedback.
Key Points / Main Content:
Proposed Amendments to Medical Device Rules, 2017:
* The draft rules are called the Medical Devices Amendment Rules, 2018.
* The rules will come into force on the date of their final publication in the Official Gazette.
Amendment Details:
* In the Medical Devices Rules, 2017, Fourth Schedule, Part II, item ii, sub-item h is to be substituted.
* The substituted sub-item relates to performance evaluation reports for in vitro diagnostic medical devices.
* The manufacturer must submit a performance evaluation report.
* State Licensing Authority (for Class B) or the Central License Authority (for Class C and D) may require a report from a certified laboratory.
* Acceptable laboratories include the Central Medical Devices Testing Laboratory, a Medical Device Laboratory registered under rule 83, or a laboratory accredited by the National Accreditation Board for Testing and Calibration Laboratories.
Public Consultation:
* The draft rules are published for public information, allowing those affected to provide feedback.
* Objections and suggestions must be submitted within thirty days of the draft rules being made available.
* Feedback can be sent to the Under Secretary Drugs, Ministry of Health and Family Welfare, or via email.
Impact Analysis:
Public and Stakeholders:
Impact: The public and stakeholders in the medical device industry have the opportunity to influence the final rules by providing feedback on the proposed amendments.
Action Required: Review the draft rules and submit any objections or suggestions to the Ministry of Health and Family Welfare within the specified timeframe.
Medical Device Manufacturers:
Impact: Manufacturers of in vitro diagnostic medical devices will need to comply with the new requirements for performance evaluation reports.
Action Required: Ensure that performance evaluation reports are prepared and submitted as required and be prepared to provide reports from certified laboratories if requested by the State or Central Licensing Authority.
State Licensing Authority and Central License Authority:
Impact: These authorities are given the power to request further testing reports for certain classes of in vitro diagnostic medical devices.
Action Required: Determine when the additional reports will be required.
Medical Device Testing Laboratories:
Impact: The central medical device testing laboratory and other accredited labs are now required as acceptable testing entities for performance evaluation reports.
Action Required: Ensure they are able to perform the required testing and provide the necessary reports.
Key Entities Referenced
Medical Device Rules, 2017: A set of rules pertaining to medical devices, which are being amended by the current notification.
Drugs and Cosmetics Act, 1940: An act of the Indian Parliament that regulates the import, manufacture, distribution and sale of drugs and cosmetics.
Drugs Technical Advisory Board: A statutory body constituted by the Government of India to advise on technical matters related to drugs and cosmetics.
Ministry of Health and Family Welfare: The Indian government ministry responsible for health policy in India.
New Delhi: The capital city of India.
Central Government: The Union Government of India.
State Licensing Authority: Licensing authority at state level. Required for Class B in vitro diagnostic medical devices.
Central License Authority: Licensing authority at central level. Required for Class C and Class D in vitro diagnostic medical devices
jftLVªh laö Mhö ,yö&33004@99 REGD. No. D. L.-33004/99
vlk/kj.k
EXTRAORDINARY
Hkkx II—[k.M 3—mi&[k.M (i)
PART II—Section 3—Sub-section (i)
izkf/dkj ls izdkf'kr
PUBLISHED BY AUTHORITY
la- 280] ubZ fnYyh] शशशश(cid:3)(cid:3)ुु(cid:3)(cid:3)ुु okj] vizSy 27] 2018@ववववैशैशैशैशााााखखखख 7] 1940
No. 280] NEW DELHI, FRIDAY, APRIL 27, 2018/VAISAKHA 7, 1940
(cid:1)(cid:1)(cid:1)(cid:1)ववववाााा(cid:1)(cid:1)(cid:1)(cid:1)(cid:4)(cid:4)(cid:4)(cid:4)यययय औऔऔऔरररर पपपप(cid:10)(cid:10)(cid:10)(cid:10)ररररववववाााारररर कककक(cid:12)(cid:12)(cid:12)(cid:12)ययययााााणणणण ममममं(cid:16)ं(cid:16)ं(cid:16)ं(cid:16)ााााललललयययय
((cid:1)(cid:1)(cid:1)(cid:1)ववववाााा(cid:1)(cid:1)(cid:1)(cid:1)(cid:4)(cid:4)(cid:4)(cid:4)यययय औऔऔऔरररर पपपप(cid:10)(cid:10)(cid:10)(cid:10)ररररववववाााारररर कककक(cid:12)(cid:12)(cid:12)(cid:12)ययययााााणणणण ििििववववभभभभाााागगगग))))
अअअअििििधधधधससससचचूूचचूू ननननाााा
नई (cid:4)द(cid:6) ली, 27 अ(cid:10)ैल, 2018
lk-dk-fu- 412¼v½-&िच(cid:4)क(cid:15)सा उपकरण िनयम, 2017 को आगे संशोिधत करने के िलए कुछ िनयम( का िन)िलिखत
मसौदा, िजस े बनान े के िलए के./ सरकार इनके (cid:10)काशन के बाद औषिध तकनीक3 सलाहकार बोड 6के परामश6 स े औषिध और
(cid:10)साधन साम7ी अिधिनयम, 1940 (1940 का 23) क3 धारा 12 और धारा 33 =ारा (cid:10)द> शि?य( का (cid:10)योग करते @ए
(cid:10)Aताव करती ह,ै उस ेइसके =ारा (cid:10)भािवत होन ेक3 सभं ावना वाल ेसभी Dि?य( क3 जानकारी के िलए (cid:10)कािशत (cid:4)कया जाता
ह ैऔर एतद्=ारा सूचना दी जाती ह ै(cid:4)क उFत (cid:10)ाGप िनयम( पर उस तारीख स ेतीस (cid:4)दन( क3 अविध समाH होने पर या उसके
बाद िवचार (cid:4)कया जाएगा िजस तारीख को इन (cid:10)ाGप िनयम( वाल े भारत के राजपI क3 (cid:10)ितयां जनता को उपलJध कराई
जाएगी।
उपयु6? िनKदL6 अविध के भीतर (cid:4)कसी भी Dि? स े (cid:10)ाH होने वाली आपि>य( और सझु ाव( पर के./ सरकार =ारा
िवचार (cid:4)कया जाएगा;
आपि> और सझु ाव, य(cid:4)द कोई हो, तो अवर सिचव (औषिध), AवाANय और पOरवार क(cid:6)याण मंIालय, भारत
सरकार, कमरा स.ं 414ए, डी Qवंग, िनमा6ण भवन, नई (cid:4)द(cid:6)ली-110011 को अ7ेिषत (cid:4)कया जाए अथवा drugsdiv-
mohfw@gov.in पर ई-मेल (cid:4)कया जाए।
(cid:17)(cid:17)(cid:17)(cid:17)ाााा(cid:18)(cid:18)(cid:18)(cid:18)पपपप ििििननननययययमममम
1. (i) इन िनयम( को िच(cid:4)क(cid:15)सा उपकरण (...... संशोधन) िनयम, 2018 कहा जाएगा।
(ii) ये सरकारी राजपI म Tइनके अंितम (cid:10)काशन क3 तारीख को लाग ूह(गे।
2. िच(cid:4)क(cid:15)सा उपकरण िनयम, 2017 क3 चौथी अनुसूची के भाग II के उप-भाग (ii) के खंड (ज) म T िन)ानुसार खंड
(cid:10)ितAथािपत (cid:4)कया जाएगा, नामतः-
2430 GI/2018 (1)2 THE GAZETTE OF INDIA : EXTRAORDINARY [PART II—SEC. 3(i)]
“(ज) इन िवVो नैदािनक िच(cid:4)क(cid:15)सा उपकरण( के मामले मT, िविनमा6ता =ारा दी गई िनWपादन मू(cid:6)याकं न Oरपोट6 आवेदक
=ारा (cid:10)Aतुत क3 जाएगी:
बशतY, इन िवVो नदै ािनक िच(cid:4)क(cid:15)सा उपकरण( क3 Zेणी ख के िलए रा[य लाइसQT संग (cid:10)ािधकरण या Zेणी ग और Zेणी घ
के िलए के./ीय लाइसQT संग (cid:10)ािधकरण, जैसा भी मामला हो, =ारा िविशL तौर पर मांगे जाने पर, आवदे क के./ीय
िच(cid:4)क(cid:15)सा उपकरण परी]ण (cid:10)योगशाला या िनयम 83 के तहत पंजीकृत (cid:4)कसी िच(cid:4)क(cid:15)सा उपकरण (cid:10)योगशाला या रा‘ीय
परी]ण और अंशाकन (कैलीaशे न) (cid:10)योगशाला (cid:10)(cid:15)यायन बोड 6 =ारा (cid:10)(cid:15)याियत (cid:4)कसी (cid:10)योगशाला =ारा जारी क3 गई
Oरपोट6 (cid:10)Aतुत करेगा।”
[फा. स.ं एF स.11014/5/2018-डीआरएस]
सुधीर कुमार, संयु? सिचव
MINISTRY OF HEALTH AND FAMILY WELFARE
(Department of Health and Family Welfare)
NOTIFICATION
New Delhi, the 27th April, 2018
G.S.R. 412(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 sections 12 and 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 thirty 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;
Objections and suggestions, if any, may be addressed to the Under Secretary (Drugs), Ministry of Health and
Family Welfare, Government of India, Room No. 414 A, D 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, 2018.
(ii) They shall come into force on the date of their final publication in the Official Gazette.
2. In the Medical Devices Rules, 2017, in Fourth Schedule, in Part II, in item (ii), for sub-item (h), the following
sub-item shall be substituted, namely:—
“(h) In case of in vitro diagnostic medical devices, performance evaluation report by the manufacturer shall
be submitted by the applicant:
Provided that, when specifically required by State Licensing Authority for Class B or the Central
License Authority for Class C and Class D in vitro diagnostic medical devices, as the case may be,
applicant shall submit the report issued by the Central Medical Devices Testing Laboratory or a Medical
Device Laboratory registered under rule 83 or by any Laboratory accredited by National Accreditation
Board for Testing and Calibration Laboratories.”.
[F.No. X.11014/5/2018-DRS]
SUDHIR KUMAR, Jt. Secy.
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.