Executive Summary:
This notification announces draft amendments to the Medical Devices Rules, 2017. It addresses registration requirements and the provision for provisional registration based on an undertaking to obtain ISO 13485 certification by May 31, 2022. Stakeholders are invited to submit objections or suggestions within seven days of the draft rules being made available.
Key Points / Main Content:
Provisional Registration Based on Undertaking:
* Applicants can submit an undertaking by November 30, 2021, to obtain ISO 13485 certification by May 31, 2022, in lieu of a compliance certificate.
* Upon submission of the undertaking, a provisional registration number will be generated, valid until May 31, 2022, or the date the ISO certificate is obtained, whichever is earlier.
* Failure to obtain the ISO 13485 certificate by May 31, 2022, will result in the automatic cancellation of the provisional registration without notice.
Mentioning Registration Number:
* Registration holders may optionally mention their registration number or provisional registration number until May 31, 2022.
* Mentioning the registration number will be mandatory for all registration holders after May 31, 2022.
Impact Analysis:
Applicants for Medical Device Registration:
* Impact: Can obtain provisional registration by undertaking to acquire ISO 13485 certification by May 31, 2022.
* Action Required: Submit the undertaking by November 30, 2021, and obtain ISO 13485 certification by May 31, 2022, to maintain valid registration.
Current Registration Holders:
* Impact: Flexibility in mentioning registration numbers until May 31, 2022, after which it becomes mandatory.
* Action Required: Ensure systems are updated to mandatorily include the registration number after May 31, 2022.
Central Government (Ministry of Health and Family Welfare):
* Impact: Must consider objections and suggestions to the draft rules.
* Action Required: Review and address any objections/suggestions received within the specified timeframe.
Key Entities Referenced
Medical Device Rules, 2017: A set of rules pertaining to medical devices, which this notification seeks to amend.
Drugs and Cosmetics Act, 1940: The principal act governing drugs and cosmetics in India, under which the Medical Device Rules are framed.
Drugs Technical Advisory Board: A board consulted during the amendment process of the Medical Device Rules.
Ministry of Health and Family Welfare: The government ministry responsible for health and family welfare policies and regulations.
New Delhi: The location where the notification was issued and where the Ministry of Health and Family Welfare is located, Delhi.
ISO 13485: An international standard for quality management systems specific to the medical device industry. Compliance with this standard is referenced in the context of provisional registration.
Dr. Mandeep K. Bhandari: The Joint Secretary who signed the notification.
Nirman Bhavan: Building in New Delhi, where the Ministry of Health and Family Welfare is located.
रजिस्ट्री स.ं डी.एल.- 33004/99 REGD. No. D. L.-33004/99
सी.जी.-डी.एल.-अ.-12102021-230365
xxxGIDHxxx
CG-DL-E-12102021-230365
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.ं 587] नई दिल्ली, मगं लवार, अक्त बू र 12, 2021/आजव न 20, 1943
No. 587] NEW DELHI, TUESDAY, OCTOBER 12, 2021/ASVINA 20, 1943
स्ट्वास्ट््य और पररवार कल्याण मत्रं ालय
(स्ट्वास्ट््य और पररवार कल्याण जवभाग)
अजधसचू ना
नई दिल्ली, 12 अक् तूबर, 2021
सा.का.जन. 729(अ).—जचदकत्सा युजि जनयम, 2017 का और संिोधन करन े के जलए कजतपय जनयमों के
जनम्नजलजखत प्रारूप, जिसे केन्द्रीय सरकार औषजध तकनीकी सलाहकार बोडड के परामिड से औषजध और प्रसाधन सामग्री
अजधजनयम, 1940 (23 के 1940) की धारा 12 की उपधारा (1) और धारा 33 की उपधारा (1) द्वारा प्रित्त िजियों का
प्रयोग करते हुए, इसके द्वारा प्रभाजवत होने की संभावना वाले सभी व्यजियों की िानकारी के जलए प्रकाजित दकया िाता ह ै
और एतिद्व् ारा सूचना िी िाती ह ै दक उक्त प्रारूप जनयमों पर उस तारीख से सात दिनों की अवजध समा् त होन े पर या
उसके बाि जवचार दकया िाएगा जिस तारीख को इन प्रारूप जनयमों वाल े भारत के रािपत्र की प्रजतया ं िनता को उपलधध
कराई िाएगी।
केन्द्रीय सरकार द्वारा उपयुडि जवजनर्िष्टड अवजध के भीतर दकसी भी व्यजि से प्राप्त होने वाली आपजत्तयों और
सुझावों पर जवचार दकया िाएगा।
आपजत्तयां और सुझाव, यदि कोई हों, तो अवर सजचव, (औषजध), स्ट्वास्ट््य और पररवार कल्याण मंत्रालय, भारत
सरकार, कमरा सं. 434, सी ववंग, जनमाडण भवन, नई दिल्ली - 110011 को अग्रेजषत दकया िाए अथवा drugsdiv-
mohfw@gov.in पर ई-मेल की िाए।
5819GI/2021 (1)2 THE GAZETTE OF INDIA : EXTRAORDINARY [PART II—SEC. 3(i)]
प्रारूप जनयम
(1) (1) इन जनयमों को जचदकत्सा युजि (….संिोधन) जनयम, 2021 कहा िाएगा।
(2) य ेजनयम, िब तक अन्द्यथा जवजनर्िष्टड न हो, रािपत्र में इनके अंजतम प्रकािन की तारीख को प्रभावी होंगे।
(2) जचदकत्सा युजि जनयम, 2017(जिसे इसमें इसके पश्चात् उि जनयम कहा गया है) में, जनयम 19ख के उपजनयम (2)
में, मि (iii) के अंत में, जनम्नजलजखत परन्द्तुक और उसका स्ट्पष्टीकरण िाजमल दकया िाएगा, अथाडत:—
“बिते दक आवेिक 30 नवंबर, 2021 से पहले एक िपथपत्र प्रस्ट् तुत करता ह ै दक आवेिक 22 मई, 2022 से पहल े
जनयम 19ख के उपजनयम (2) के खंड (iii) में यथा संिर्भडत अनुपालन प्रमाण पत्र के स्ट्थ ान पर आईएस1 134
प्रमाण पत्र प्रा् त कर लगे ा तो एक अनंजतम पंिीकरण सं् या सिजित की िाएगी िो 31 मई, 2022 तक अथवा
उम् मीिवार द्वारा ासा आईएस1 प्रमाण पत्र प्रा् त करने की तारीख, िो भी पहले हो तक के जलए वैध रहगे ा।
उक्त सिजित अनंजतम पंिीकरण सं् या सभी उदेशे यों के जलए वधै रहगे ी।
स्ट्प ष्ट ीकरण- संिेह के समाधान के जलए, एतद्द्वारा घोजषत दकया िाता ह ै दक ासा आईएस1 134 प्रमाण पत्र
उम् मीद्वार द्वारा परंतुक में संिर्भडत िपथ पत्र के अनुसार 31 मई, 2022 से पहले प्रा् त नह दकया िाता ह ै तो
अनंजतम पंिीकरण कोई सूचना दिए जबना सभी उदेशे यों के जलए रदेश समझा िाएगा।”
(3) उि जनयम के जनयम 19ग म,ें "रजिस्ट्रीकरण सं्या का उल्लेख करेगा" िधिों के स्ट्थान पर जनम्नजलजखत िधि,
अक्षर और अंक रखे िाएंगे, अथाडत:—
“यदि ासा वांजित हो, 31 मई, 2022 तक की अवजध के जलए पंिीकरण सं् या अथवा अनंजतम पंिीकरण सं् या,
िो भी मामला हो, का उल्ल ेख करें। उसके बाि यह सभी पंिीकरण धाररयों के जलए अजनवायड होगा” ।
(4) उि जनयम के जनयम 19घ में, उपजनयम (2) के मि (iii) के अतं म,ें जनम्नजलजखत परन्द्तुक और उसका स्ट्पष्टीकरण
िाजमल दकया िाएगा, अथाडत:—
“बिते दक आवेिक 30 नवंबर, 2021 से पहले एक िपथपत्र प्रस्ट् तुत करता ह ै दक आवेिक 22 मई, 2022 से पहल े
जनयम 19घ के उपजनयम (2) के खंड (iii) म ें यथा संिर्भडत अनुपालन प्रमाण पत्र के स्ट्थ ान पर आईएस1 134
प्रमाण पत्र प्रा् त कर लगे ा तो एक अनंजतम पंिीकरण सं् या सिजित की िाएगी िो 31 मई, 2022 तक अथवा
उम् मीिवार द्वारा ासा आईएस1 प्रमाण पत्र प्रा् त करने की तारीख, िो भी पहले हो तक के जलए वैध रहगे ा।
उक्त सिजित अनंजतम पंिीकरण सं् या सभी उदेशे यों के जलए वधै रहगे ी।
स्ट्प ष्ट ीकरण- संिेह के समाधान के जलए, एतद्द्वारा घोजषत दकया िाता ह ै दक ासा आईएस1 134 प्रमाण पत्र
उम् मीद्वार द्वारा परंतुक में संिर्भडत िपथ पत्र के अनुसार 31 मई, 2022 से पहले प्रा् त नह दकया िाता ह ै तो
अनंजतम पंिीकरण कोई सूचना दिए जबना सभी उदेशे यों के जलए रदेश समझा िाएगा।”
(5) उि जनयम के जनयम 19ड़ म,ें "रजिस्ट्रीकरण सं्या का उल्लेख करेगा" िधिों के स्ट्थान पर जनम्नजलजखत िधि,
अक्षर और अंक रखे िाएंगे, अथाडत:—
“यदि ासा वांजित हो, 31 मई, 2022 तक की अवजध के जलए पंिीकरण सं् या अथवा अनंजतम पंिीकरण सं् या,
िो भी मामला हो, का उल्ल ेख करें। उसके बाि यह सभी पंिीकरण धाररयों के जलए अजनवायड होगा” ।
[फा.सं. एक् स.11014/12/2018-डीआर]
डॉ. मनिीप के भण्डारी, संयक्ु त सजचव
रट्पण: जचदकत्सा युजि जनयम, 2017, रािपत्र म ें अजधसूचना सं. सा.का.जन. 78(अ), तारीख 31 िनवरी, 2017 द्वारा
प्रकाजित दकए गए थ े और अजधसूचना सं. सा.का.जन. …….. (अ), तारीख ………… द्वारा अंजतमतः सिं ोजधत
दकए गए थ े।[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 12th October, 2021
G.S.R. 729(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 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 on or after the expiry of a period of seven 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 Regulation),
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) (i) These rules may be called the Medical Devices (......Amendment) Rules, 2021.
(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(hereinafter to be referred as said rules), in rule 19B, in sub-
rule(2), in item (iii), at the end, the following Proviso and Explanation thereto shall be inserted,
namely:—
“Provided that in case the applicant submits, on or before the 30th November, 2021, an undertaking
that applicant shall obtain the ISO 13485 certificate on or before the 31st May, 2022 in lieu of
certificate of compliance as referred in clause (iii) of sub-rule (2) of rule 19B, a provisional
registration number shall be generated which will remain valid up to the 31st May, 2022 or the date
on which the applicant obtained such ISO certificate whichever is earlier. The said generated
provisional registration number shall be valid for all purposes.
Explanation.— For the removal of doubt, it is hereby declared that in case of such ISO 13485
certificate not obtained before the 31st May, 2022 as per undertaking referred in the Proviso by the
applicant the provisional registration shall be deemed to have been cancelled for all purposes
without any notice.”
(3) In the said rules, in rule 19C, for the words “shall mention the registration number” the following
words, letters and figures shall be substituted, namely:—
“may, if so desired, mention the registration number or provisional registration number, as the case
may be, for a period up to the 31st May, 2022, thereafter it shall be mandatory for all registration
holders”.
(4) In the said rules, in rule 19D, in sub-rule(2), in item (iii), at the end, the following Proviso and
Explanation thereto shall be inserted, namely:—4 THE GAZETTE OF INDIA : EXTRAORDINARY [PART II—SEC. 3(i)]
“Provided that in case the applicant submits, on or before the 30th November, 2021, an undertaking
that applicant shall obtain the ISO 13485 certificate on or before the 31st May, 2022 in lieu of
certificate of compliance as referred in clause (iii) of sub-rule (2) of rule 19D, a provisional
registration number shall be generated which will remain valid up to the 31st May, 2022 or the date
on which the applicant obtained such ISO certificate whichever is earlier. The said generated
provisional registration number shall be valid for all purposes.
Explanation.— For the removal of doubt , it is hereby declared that in case of such ISO 13485
certificate not obtained before the 31st May, 2022 as per undertaking referred in the Proviso by the
applicant the provisional registration shall be deemed to have been cancelled for all purposes
without any notice.”
(5) In the said rules, in rule 19E, for the words “shall mention the registration number” the following
words, letters and figures shall be substituted, namely:—
“may, if so desired, mention the registration number or provisional registration number, as the case
may be, for a period up to the 31st May, 2022, thereafter it shall be mandatory for all registration
holders”.
[F.No. X.11014/12/2018-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. …
(E), dated the …………
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.