**Report on Amendment to the Medical Devices Rules, 2017**
**1. Executive Summary:**
This report analyzes an amendment to the Medical Devices Rules, 2017, as published in the Gazette of India on January 18, 2022. The amendment introduces a provisional registration pathway for medical device applicants who commit to obtaining ISO 13485 certification by May 31, 2022. This provision aims to provide temporary registration while applicants finalize their certification, with clear stipulations regarding the validity and potential cancellation of provisional registrations. The changes primarily affect medical device manufacturers and importers seeking registration.
**2. Introduction:**
This report provides an overview and analysis of the amendment to the Medical Devices Rules, 2017, as detailed in the provided government policy text. The report aims to inform stakeholders about the specific changes introduced by this amendment, their likely rationale, and potential impact, based solely on the information contained within the provided document.
**3. Policy Overview:**
* This document constitutes an *amendment* to the Medical Devices Rules, 2017.
* The core objective of this *amendment* is to introduce a mechanism for *provisional registration* of medical devices, contingent upon the applicant's commitment to obtain ISO 13485 certification within a specified timeframe.
**4. Background and Rationale:**
The amendment likely addresses a situation where medical device manufacturers and importers are in the process of obtaining ISO 13485 certification, a crucial requirement for registration. By allowing provisional registration based on an undertaking to obtain certification by May 31, 2022, the amendment facilitates the timely registration of medical devices without compromising the long-term requirement for full ISO 13485 compliance. This suggests a desire to balance regulatory rigor with the practical realities of certification processes. The reason for this specific amendment stems from wanting to provide leniency to those seeking registration to provide ISO 13485 certificate on or before May 31st, 2022.
**5. Key Provisions / Changes:**
The amendment introduces changes to Rules 19B, 19C, 19D and 19E of the Medical Devices Rules, 2017.
* **Rules 19B and 19D (related to registration):** These rules are amended by adding a *proviso* and *explanation* regarding provisional registration.
* **Original Policy (inferred):** Rules 19B and 19D likely required full compliance, including ISO 13485 certification, *prior* to registration.
* **New Rule (Amendment):**
* Applicants submitting an undertaking by February 28, 2022, to obtain ISO 13485 certification by May 31, 2022, can receive a provisional registration number.
* This provisional registration is valid until May 31, 2022, or the date ISO 13485 certification is obtained, whichever is earlier.
* The provisional registration is valid for all purposes.
* Failure to obtain ISO 13485 certification by May 31, 2022, results in automatic cancellation of the provisional registration without notice.
* **Effect of Change:** This allows manufacturers to begin the registration process and potentially market their devices *before* fully completing ISO 13485 certification, contingent on meeting the May 31, 2022 deadline.
* **Rules 19C and 19E (related to mentioning the registration number):** These rules are amended to account for the provisional registration number.
* **Original Policy (inferred):** Rules 19C and 19E required mentioning the registration number.
* **New Rule (Amendment):**
* Applicants may, if desired, mention the registration number or provisional registration number until May 31, 2022, after which mentioning the registration number is mandatory.
* **Effect of Change:** This change allows manufacturers to use the provisional registration number in cases where they haven't been fully registered yet.
**6. Target Audience and Stakeholders:**
The primary target audience and stakeholders are:
* Medical device manufacturers.
* Medical device importers.
* Applicants seeking registration under the Medical Devices Rules, 2017.
* Regulatory bodies involved in the registration process (inferred).
**7. Implementation Aspects (Inferred):**
* **Responsible Agency/Bodies:** The *Ministry of Health and Family Welfare*, specifically the *Department of Health and Family Welfare*, is responsible for implementing and overseeing these amendments (explicitly stated). The *Drugs Technical Advisory Board* is also mentioned regarding consultations, but the extent of its involvement with this amendment is unclear from this text.
* **Timelines/Procedures:**
* Applicants must submit an undertaking to obtain ISO 13485 certification by *February 28, 2022*, to be eligible for provisional registration.
* ISO 13485 certification must be obtained by *May 31, 2022*, for the provisional registration to remain valid.
* If ISO 13485 certification is not obtained by May 31, 2022, the provisional registration is automatically cancelled.
**8. Expected Outcomes / Impact of Changes:**
The likely intended outcome of these amendments is to:
* Facilitate the registration process for medical device manufacturers and importers who are in the process of obtaining ISO 13485 certification.
* Ensure that all registered medical devices ultimately meet the required quality standards by mandating ISO 13485 certification by May 31, 2022.
* Potentially accelerate the availability of medical devices in the market by allowing provisional registration.
* Provide a period of leniency for firms that were already in the process of seeking ISO 13485.
**9. Conclusion:**
The amendment to the Medical Devices Rules, 2017, introduces a provisional registration pathway contingent upon obtaining ISO 13485 certification by May 31, 2022. This change is significant because it provides flexibility for medical device manufacturers and importers while maintaining the overall requirement for quality standards. The amendment is temporary in nature, with a clear deadline for achieving full compliance, which is crucial for ensuring the safety and efficacy of medical devices.
Key Entities Referenced
NEW DELHI: Location of publication.
TUESDAY, JANUARY 18, 2022: Date of publication.
PAUSHA 28, 1943: Date in the Indian national calendar corresponding to the date of publication.
MINISTRY OF HEALTH AND FAMILY WELFARE: The government ministry responsible for the notification.
Department of Health and Family Welfare: Department within the Ministry of Health and Family Welfare.
NOTIFICATION: Indicates that this is an official government notification.
G.S.R. 19E: Notification number.
Medical Devices Rules, 2017: The rules being amended by this notification.
Drugs and Cosmetics Act, 1940: The principal act under which the rules are being amended. Referred to as '23 of 1940'.
G.S.R. 729E: Notification number for the draft rules that were published.
12th October, 2021: Date of the notification of the draft rules.
Gazette of India, Extraordinary, Part II, Section 3, Subsection i: The official publication in which the notification was published.
Central Government: The authority making the amendments to the rules.
Medical Devices Amendment Rules, 2022: Short title for the amended rules.
Official Gazette: The official publication where the rules will be published.
rule 19B: Rule number in the Medical Devices Rules, 2017 being amended.
28th February, 2022: Date before which an undertaking must be submitted for provisional registration.
ISO 13485: Standard for medical device quality management systems.
31st May, 2022: Date by which the ISO 13485 certificate must be obtained.
rule 19C: Rule number in the Medical Devices Rules, 2017 being amended.
rule 19D: Rule number in the Medical Devices Rules, 2017 being amended.
rule 19E: Rule number in the Medical Devices Rules, 2017 being amended.
F. No. X.11014122018DR: File number for the notification.
Dr. MANDEEP K BHANDARI: Name of the Joint Secretary issuing the notification.
Jt. Secy.: Title of Dr. MANDEEP K BHANDARI.
G.S.R. 78E: Notification number for the original Medical Devices Rules, 2017 publication.
31st January, 2017: Date of the original Medical Devices Rules, 2017 publication.
G.S.R. 918E: Notification number of the last amendment to the Medical Devices Rules, 2017.
31st, December, 2021: Date of the last amendment to the Medical Devices Rules, 2017.
रजिस्ट्री स.ं डी.एल.- 33004/99 REGD. No. D. L.-33004/99
xxxGIDHxxx
सी.जी.-डी.एxलx.x-GअID.-E1x9xx0 12022-232729
CG-DL-E-19012022-232729
ऄसाधारण
EXTRAORDINARY
भाग II—खण् ड 3—ईप-खण्ड (i)
PART II—Section 3—Sub-section (i)
प्राजधकार स ेप्रकाजित
PUBLISHED BY AUTHORITY
स.ं 19] नइ दद्ली, मगं लवार, िनवरी 18, 2022/पौष 28, 1943
No. 19] 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 दद् ली, 18 िनवरी, 2022
सा.का.जन. 19(ऄ).—जचदकत्सा युजि जनयम, 2017 का रर संिोधन करन े के जलए कजतपय जनयमों का प्रारूप,
रषजध रर प्रसाधन सामग्री ऄजधजनयम, 1940 (1940 का 23) की धारा 12 की ईप-धारा (1) रर धारा 33 की
ईप-धारा (1) ऄधीन यथा ऄपेजित, भारत सरकार के स्ट् वास्ट् ् य रर पिरवार क् याण मरालं ालय (स्ट् वास्ट् ् य रर पिरवार
क् याण जवभाग) की ऄजधसूचना स.ं सा.का.जन. 729(ऄ), तारीख 12 ऄक् तूबर, 2021 द्वारा भारत के रािपराल,
ऄसाधारण, भाग II, खंड 3, ईपखंड (i) में प्रकाजित दकया गया था, जिसमें ईन सभी व् यजियों से, जिनके ईसस े प्रभाजवत
होने की संभावना ह ै ईस तारीख से, जिसको ईक्त ऄजधसूचना ऄ्त्वष्ट क करने वाली रािपराल की प्रजतयां िनता को ईपल ध
करा दी गइ थी, सात ददनों की ऄवजध के ऄवसान से पहले अिेप रर सुझाव अंमजरालत दकए गए थे;
रर, ईि रािपराल की प्रजतया ं12 ऄक्टूबर, 2021 को िनता को ईपल ध करा दी गइ थी;
रर, ईक्त जनयमों पर िनता स ेप्रा्त अिेप रर सुझावों पर के् रीय सरकार द्वारा जवचार कर जलया गया ह;ै
ऄत: ऄब, के् रीय सरकार, रषजध रर प्रसाधन सामग्री ऄजधजनयम, 1940 (1940 का 23 की धारा 12 रर
धारा 33 द्वारा प्रदत् त िजियों का प्रयोग करते ुए, आस जवचार के साथ दक रषजध तकनीकी सलाहकार बोडड से परामि ड
ईपबंधों के ऄनुसार दकया िाएगा, जचदकत्सा युजि जनयम, 2017 का संिोधन करन े के जलए जनम्न जलजखत जनयम बनाती ह,ै
ऄथाडत:् —
333 GI/2022 (1)2 THE GAZETTE OF INDIA : EXTRAORDINARY [PART II—SEC. 3(i)]
1. (1) सजं ि्त नाम रर प्रारंभ.—आन जनयमों का संजि्त नाम जचदकत्सा युजि (संिोधन जनयम, 2022 ह।ै
(2 य ेरािपराल में ईनके प्रकािन की तारीख को प्रवृत होंगे। ।
2. जचदकत्सा युजि जनयम, 2017(जिसे आसमें आसके पश्चात् ईि जनयम कहा गया ह)ै में, जनयम 19ख के ईपजनयम (2 म,ें
मद (iii) के ऄंत में, जनम्नजलजखत पर्तुक रर ईसका स्ट्पष्ट कीकरण ऄंतःस्ट्थाजपत दकया िाएगा, ऄथाडत:् —
“पर्तु दक अवेदक 28 फ़रवरी, 2022 को या से पहले एक पिरवचन प्रस्ट्त ुत करता ह ै दक अवेदक 31 मइ, 2022 को
या से पहल े जनयम 19ख के ईपजनयम (2 के खडं (iii) में यथा संद्भत ऄनपु ालन प्रमाण पराल के स्ट्थ ान पर अइएस
13485 प्रमाण पराल प्राप् त कर लेगा तो एक ऄनंजतम रजिस्ट्रीकरण संख् या सृजित की िाएगी िो 31 मइ, 2022 तक
ऄथवा ईम् मीदवार द्वारा ासा अइएस प्रमाण पराल प्राप् त करने की तारीख, िो भी पहले हो तक के जलए वैध रहगे ा।
ईक्त सृजित ऄनंजतम रजिस्ट्रीकरण सख्ं या सभी ईदेशे यों के जलए वैध रहगे ी।
स्ट्प ष्ट ीकरण.— संदेह के समाधान के जलए, एतद्द्वारा घोजषत दकया िाता ह ै दक ासा अइएस 13485 प्रमाण पराल
ईम् मीद्वार द्वारा परंतुक म ेंसंद्भत पिरवचन के ऄनुसार 31 मइ, 2022 से पहले प्राप् त नह दकया िाता ह ैतो ऄनंजतम
पंिीकरण कोइ सूचना ददए जबना सभी ईदेशे यों के जलए रदेश समझा िाएगा।”
3. ईि जनयम के जनयम 19ग म,ें "रजिस्ट्रीकरण संख्या का ई्लखे करेगा" िदों के स्ट्थान पर जनम्नजलजखत िद, ऄिर
रर ऄंक रख े िाएंग,े ऄथाडत:् —
“यदद ासा वांजित हो, 31 मइ, 2022 तक की ऄवजध के जलए रजिस्ट्रीकरण संख् या ऄथवा ऄनंजतम रजिस्ट्रीकरण
संख् या, िो भी मामला हो, का ई् लेख करें, ईसके बाद यह सभी रजिस्ट्रीकरण धािरयों के जलए ऄजनवायड होगा” ।
4. ईि जनयम के जनयम 19घ में, ईपजनयम (2 के मद (iii) के ऄंत म,ें जनम्नजलजखत पर्तुक रर ईसका स्ट्पष्ट कीकरण
ऄंतःस्ट्थाजपत दकया िाएगा, ऄथाडत:् —
“पर्तु दक अवेदक 28 फ़रवरी, 2022 को या से पहल े एक पिरवचन प्रस्ट् तुत करता ह ै दक अवेदक 31 मइ, 2022 को
या से पहल े जनयम 19घ के ईपजनयम (2 के खडं (iii) में यथा संद्भत ऄनुपालन प्रमाण पराल के स्ट् थान पर अइएस
13485 प्रमाण पराल प्राप् त कर लेगा तो एक ऄनंजतम रजिस्ट्रीकरण संख् या सृजित की िाएगी िो 31 मइ, 2022 तक
ऄथवा ईम् मीदवार द्वारा ासा अइएस प्रमाण पराल प्राप् त करने की तारीख, िो भी पहले हो तक के जलए वैध रहगे ा।
ईक्त सृजित ऄनंजतम रजिस्ट्रीकरण सख्ं या सभी ईदेशे यों के जलए वैध रहगे ी।
स्ट्प ष्ट ीकरण.— संदेह के समाधान के जलए, एतद्द्वारा घोजषत दकया िाता ह ै दक ासा अइएस 13485 प्रमाण पराल
ईम म् ीद्वार द्वारा परंतुक म ें संद्भत पिरवचन के ऄनुसार 31 मइ, 2022 से पहल े प्राप् त नह दकया िाता ह ै तो
ऄनंजतम रजिस्ट्रीकरण कोइ सूचना ददए जबना सभी ईदेशे यों के जलए रदेश समझा िाएगा।”
5. ईि जनयम के जनयम 19ड़ म,ें "रजिस्ट्रीकरण संख्या का ई्लखे करेगा" िदों के स्ट्थान पर जनम्नजलजखत िद, ऄिर
रर ऄंक रख े िाएंग,े ऄथाडत:् —
“यदद ासा वांजित हो, 31 मइ, 2022 तक की ऄवजध के जलए रजिस्ट्रीकरण संख् या ऄथवा ऄनंजतम रजिस्ट्रीकरण
संख् या, िो भी मामला हो, का ई् लेख करें, ईसके बाद यह सभी रजिस्ट्रीकरण धािरयों के जलए ऄजनवायड होगा” ।
[फा. सं. एक् स.11014/12/2018-डीअर]
डॉ. मनदीप के भण्डारी, संयुि सजचव
िटप्पण : जचदकत्सा युजि जनयम, 2017, रािपराल म ें ऄजधसूचना स.ं सा.का.जन. 78(ऄ), तारीख 31 िनवरी, 2017 द्वारा
प्रकाजित दकए गए थ े रर ऄजधसूचना सं. सा.का.जन. 918(ऄ), तारीख 31 ददसम् बर, 2021 द्वारा ऄंजतम बार
संिोजधत दकए गए थ े ।[भाग II—खण् ड 3(i)] भारत का रािपराल : ऄसाधारण 3
MINISTRY OF HEALTH AND FAMILY WELFARE
(Department of Health and Family Welfare)
NOTIFICATION
New Delhi the 18th January, 2022
G.S.R. 19(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. 729(E), dated the
12th October, 2021, 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 seven
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
12th October, 2021;
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), with consideration that consultation with Drugs Technical Advisory
Board shall be held as per the provisions, the Central Government hereby makes the following rules further
to amend the Medical Devices Rules, 2017, namely:―
1. (1) These rules may be called the Medical Devices (….. Amendment) Rules, 2022.
(2) These rules shall come into force on the date of their 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 28th February, 2022, 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:—
“Provided that in case the applicant submits, on or before the 28th February, 2022, 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.4 THE GAZETTE OF INDIA : EXTRAORDINARY [PART II—SEC. 3(i)]
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. 918(E), dated the 31st, December, 2021.
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.