**Report on the Medical Devices Sixth Amendment Rules, 2022**
**1. Executive Summary:**
This report analyzes the Medical Devices Sixth Amendment Rules, 2022, based solely on the official gazette notification provided. This amendment primarily focuses on Class A medical devices, specifically excluding non-sterile and non-measuring devices from certain regulatory requirements and introducing a new registration process for them. The core purpose is to streamline the regulatory pathway for this specific subset of Class A medical devices. Key findings include the establishment of an online registration system, self-certification requirements for manufacturers and importers, and exemptions from certain chapters of the existing Medical Devices Rules, 2017.
**2. Introduction:**
This report aims to provide an informative overview of the Medical Devices Sixth Amendment Rules, 2022, using only the information contained within the provided government policy text. It outlines the changes introduced, their potential impact, and relevant implementation aspects. This report is intended for those in the medical device industry affected by these rules.
**3. Policy Overview:**
* This document amends the Medical Devices Rules, 2017.
* **Core Objective:** The core objective, as inferred from the provided text, is to establish a simplified registration process and tailored regulatory requirements for Class A non-sterile and non-measuring medical devices.
**4. Background and Rationale:**
This amendment appears designed to address the perceived over-regulation or undue burden on manufacturers and importers of Class A non-sterile and non-measuring medical devices under the original Medical Devices Rules, 2017. By creating a separate registration pathway and exempting these devices from specific chapters of the original rules (IV, V, VII, VIII, and XI), the amendment suggests a desire to reduce compliance costs and administrative complexities for this lower-risk category of medical devices.
**5. Key Provisions / Changes:**
The Medical Devices Sixth Amendment Rules, 2022, introduce the following key changes:
* **Amendment of Rule 13, 14, 20, 31, 36:** These rules have been amended to exclude "non-sterile and non-measuring" devices from certain requirements that apply to Class A devices generally.
* **Chapter IIIB: Registration of Class A Non-Sterile and Non-Measuring Medical Devices:** This new chapter introduces a registration system specifically for these devices. This includes:
* **Applicability:** The chapter applies to all non-sterile and non-measuring devices classified as Class A.
* **Online Portal:** Registration must occur through an identified online portal for medical devices.
* **Information Upload:** Manufacturers and importers must upload specified information, including the name and address of the manufacturing site, device details (generic name, brand name, model number, intended use, material of construction, dimensions, shelf life), and undertakings regarding device classification and compliance.
* **Self-Certification:** Manufacturers and importers must self-certify that their products conform to the essential principles checklist of safety and performance and comply with the standards specified in the rules.
* **Registration Number Generation:** A registration number will be generated upon successful submission of the required information.
* **Import Requirements:** Importers must provide additional documentation, including a self-attested copy of the overseas manufacturing site registration or a Free Sale Certificate issued by the National Regulatory Authority.
* **Record Maintenance:** Manufacturers and importers must maintain records related to manufacturing or importing, along with sales and distribution records. These records, along with labels and instructions for use, must be produced upon request by Licensing Authorities.
* **Cancellation or Suspension of Registration:** The State Licensing Authority or the Central Licensing Authority can cancel or suspend the registration number if the registrant fails to comply with the provisions of Chapter IIIB. An appeal process is available.
* **Amendment of the Second, Third and Fourth Schedule:** Excludes "non-sterile and non-measuring" devices from certain requirements that apply to Class A devices generally.
* **Amendment of the Eighth Schedule:** Adds exemptions from Chapters IV, V, VII, VIII, and XI of the rules for manufacturing and import of Class A nonsterile and nonmeasuring medical devices, conditional upon registration under Chapter IIIB.
* **Amendment of the Appendix:** Forms MD2, MD3, MD4, MD5, MD6 are amended to exclude "non-sterile and non-measuring" devices from certain requirements that apply to Class A devices generally.
* **Difference/Effect:** The primary effect is to create a streamlined registration process and reduce the regulatory burden for Class A non-sterile and non-measuring medical devices, separating them from the stricter requirements applied to other Class A devices.
**6. Target Audience and Stakeholders:**
The primary target audience and stakeholders are:
* Manufacturers of Class A non-sterile and non-measuring medical devices.
* Importers of Class A non-sterile and non-measuring medical devices.
* State Licensing Authorities.
* Central Licensing Authority.
**7. Implementation Aspects (Inferred):**
* **Responsible Agency/Bodies:** The Central Government, Ministry of Health and Family Welfare, State Licensing Authorities, and the Central Licensing Authority are the responsible bodies.
* **Timelines/Procedures:**
* The rules came into force on the date of their publication in the Official Gazette (October 14, 2022).
* Manufacturers and importers of Class A non-sterile and non-measuring devices are required to register through the identified online portal.
* An appeal against cancellation or suspension of registration can be preferred within forty-five days of the receipt of a copy of such order.
* The Licensing Authorities may verify the records and documents and investigate quality or safety related failures or complaints at any point of time.
**8. Expected Outcomes / Impact of Changes:**
The likely intended outcomes of these changes are:
* Reduced compliance costs and administrative burden for manufacturers and importers of Class A non-sterile and non-measuring medical devices.
* A more efficient registration process for these devices.
* Potentially increased availability and affordability of these essential medical devices.
* Focus of resources on devices presenting greater risk.
**9. Conclusion:**
The Medical Devices Sixth Amendment Rules, 2022, represent a significant step toward streamlining the regulatory framework for Class A non-sterile and non-measuring medical devices. By establishing a separate registration pathway and exempting these devices from certain provisions of the Medical Devices Rules, 2017, the amendment seeks to reduce compliance costs, promote efficiency, and improve the accessibility of these essential medical devices. Manufacturers and importers of these devices should familiarize themselves with the new requirements and procedures outlined in this amendment.
Key Entities Referenced
NEW DELHI: The location where the notification was issued.
Medical Devices Rules, 2017: A set of rules being amended by this notification.
Drugs and Cosmetics Act, 1940: The act under which the rules are being amended; specifically, sections 12 and 33.
Ministry of Health and Family Welfare: The ministry responsible for the notification.
Department of Health and Family Welfare: The department within the Ministry of Health and Family Welfare issuing the notification.
Central Government: The governing body enacting the rules.
Medical Devices Sixth Amendment Rules, 2022: The name of the amended rules.
Class A nonsterile and nonmeasuring medical device: Category of medical devices affected by the amendments.
Online System for Medical Devices: The platform for registration of Class A nonsterile and nonmeasuring medical devices.
Trade Marks Act, 1999: Act referenced for registration details related to medical devices.
First Schedule: Reference to the schedule defining Class A medical devices
State Licensing Authority: Authority involved in cancellation or suspension of registration.
Central Licensing Authority: Authority involved in cancellation or suspension of registration.
State Government: The appellate body for orders passed by the State Licensing Authority.
Drugs Technical Advisory Board: Body consulted regarding the amendments.
Central Government: The appellate body for orders passed by the Central Licensing Authority.
Ring Road, Mayapuri, New Delhi: Location of the Government of India Press.
Delhi: Location of the Controller of Publications.
रजजस्ट्री स.ं डी.एल.- 33004/99 REGD. No. D. L.-33004/99
सी.जी.-डी.एल.-अ.-15102022-239681
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CG-DL-E-15102022-239681
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ऄसाधारण
EXTRAORDINARY
भाग II—खण् ड 3—ईप-खण्ड (i)
PART II—Section 3—Sub-section (i)
प्राजधकार स ेप्रकाजित
PUBLISHED BY AUTHORITY
स.ं 691] नइ दद्ली, िुक्रवार, ऄक्त बू र 14, 2022/अजव न 22, 1944
No. 691] NEW DELHI, FRIDAY, OCTOBER 14, 2022/ASVINA 22, 1944
स्ट्व ास्ट्् य रर पिरवार क्य ाण मरं ालय
(स्ट्व ास्ट्् य रर पिरवार क्य ाण जवभाग)
ऄजधसचू ना
नइ दद् ली, 14 ऄक् तूबर, 2022
सा.का.जन. 777(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 ईपधारा (1) रर धारा 33 की
ईपधारा (1) के ऄधीन यथा ऄपेजित, भारत सरकार के स्ट् वास्ट् ् य रर पिरवार क् याण मरं ालय (स्ट् वास्ट् ् य रर पिरवार
क् याण जवभाग) की ऄजधसूचना सं. सा.का.जन. 710(ऄ), तारीख 20 जसतंबर, 2022 द्वारा भारत के राजपर, ऄसाधारण,
भाग II, खंड 3, ईपखंड (i) में प्रकाजित दकया गया था, जजसमें ईन सभी व् यजियों से, जजनके ईससे प्रभाजवत होने की
संभावना है, ईस तारीख से, जजसको ईक्त ऄजधसूचना वाली राजपर की प्रजतयां जनता को ईपलब् ध करा दी गइ थी, सात
ददनों की ऄवजध के समाजि से पहले अिेप रर सुझाव अंमजरत दकए गए थे;
रर, ईि राजपर की प्रजतयां 20 जसतंबर, 2022 को जनता को ईपलब् ध करा दी गइ थी;
रर केन्द रीय सरकार द्वारा ईक्त जनयमों पर जनता से प्राि अिपे रर सुझावों पर जवचार कर जलया गया ह;ै
ऄत: ऄब, केन्द रीय सरकार, रषजध रर प्रसाधन सामग्री ऄजधजनयम, 1940 (1940 का 23) की धारा 12 रर
धारा 33 द्वारा प्रदत् त िजियों का प्रयोग करत े ुए, रर रषजध तकनीकी सलाहकार बोड ड के साथ पूव ड कायोत्तर परामि ड
रर ईि धाराओं के प्रावधानों के ऄनुसार बोड ड के सुझावों पर जवचार के ऄधीन, जचदकत्सा युजि जनयम, 2017 का रर
संिोधन करने के जलए जनम्न जलजखत जनयम बनाती ह,ै ऄथाडत:्—
1. (1) आन जनयमों का संजिि नाम जचदकत्सा युजि (छठा संिोधन) जनयम, 2022 ह।ै
(2) ये राजपर में ईनके प्रकािन की तारीख को प्रवृत होंगे।
6971 GI/2022 (1)2 THE GAZETTE OF INDIA : EXTRAORDINARY [PART II—SEC. 3(i)]
2. जचदकत् सा युजि जनयम, 2017 (जजसे आसमें आसके पश्चात ्ईि जनयम कहा गया ह)ै के जनयम 13 म,ें—
(क) ईपजनयम (2) म,ें “श्रेणी क” िब्द रर ऄिर के पश्चात,् “(गैर-स्ट्टेराआल रर गरै -मापन के ऄजतिरि)” िब्द रर
कोष्ठक ऄंतःस्ट्थाजपत दकए जाएगँ ;े
(ख) ईपजनयम (3) म,ें “श्रेणी क” िब्द रर ऄिर के पश्चात,् “(गैर-स्ट्टेराआल रर गरै -मापन के ऄजतिरि)” िब्द रर
कोष्ठक ऄंतःस्ट्थाजपत दकए जाएगँ े ।
3. ईि जनयमों म,ें जनयम 14 म,ें “श्रेणी क” िब्द रर ऄिर के पश्चात्, “(गरै -स्ट्टेराआल रर गैर-मापन के ऄजतिरि)” िब्द
रर कोष्ठक ऄंतःस्ट्थाजपत दकए जाएँगे ।
4. ईि जनयमों म,ें जनयम 19 च के पश्चात,् जनम्नजलजखत ऄतं ःस्ट्थाजपत दकए जाएगँ ,े ऄथाडत्:—
"ऄध्याय III ख
श्रणे ी क (गरै -स्ट्टेराआल रर गरै -मापन वाल)े जचदकत्सा यजु ियों का रजजस्ट्रीकरण
19 छ. आस ऄध्याय का ऄनप्रु योग.— (1) यह ऄध्याय, ईि जनयमों की पहली ऄनुसूची के ऄनुसार, श्रेणी क जचदकत्सा
युजियों के रूप म ें वगीकृत सभी गरै -स्ट्टेराआल रर गरै -मापन वाले युजियों पर लाग ू होगा (यहां से आस ऄध्याय म ें
गैर-स्ट्टेराआल रर गैर-मापन वाले श्रेणी क जचदकत्सा युजि के रूप में संदर्भभत दकया गया ह)ै ।
(2) ईपजनयम (1) में जनर्ददष्ट जचदकत्सा युजियों को आस प्रयोजन के जलए स्ट्थाजपत एक जनधािड रत ऑनलाआन पोटलड
के माध्यम से रजजस्ट्रीकृत दकया जाएगा।
19 ज. रजजस्ट्रीकरण के जलए जानकारी ऄपलोड करना.— (1) दकसी गैर-स्ट्टेराआल रर गैर-मापन वाल े श्रणे ी क जचदकत्सा
युजियों का जवजनमाडता जचदकत्सा युजियों के जलए ऑनलाआन प्रणाली पर रजजस्ट्रीकरण के जलए ईस जचदकत्सा युजि
से संबंजधत ईपजनयम (2) में जवजनर्ददष्ट जानकारी ऄपलोड करेगा।
(2) जवजनमाडता जचदकत्सा युजियों के जलए ऑनलाआन प्रणाली में जनम्नजलजखत ऄपलोड करेगा, ऄथाडत्:—
(i) जवजनमाडण स्ट्थल का नाम रर पता;
(ii) गैर-स्ट्टेराआल रर गरै -मापन वाल ेश्रेणी क जचदकत्सा युजियों का प्रदान दकए जान े वाल ेब्योरे:
जेनेिरक ब्ांड का नाम(यदद व्यापार मॉडल सख्ं य ा अिजयत जनमाडण की अयाम (यदद जनधानी अय ु
नाम जचह्न ऄजधजनयम, 1999 के (यदद कोइ हो) ईपयोग सामग्री लाग ूहो) (यदद लागू हो)
ऄधीन रजजस्ट्रीकृत ह)ै
(1) (2) (3) (4) (5) (6) (7)
(iii) जवजनमाडता यह बतात े ुए वचनबंध दगे ा दक प्रस्ट्ताजवत युजि, प्रथम ऄनुसूची के ऄनुसार, गैर- स्ट्टेराआल
रर गरै -मापन वाल ेश्रेणी क जचदकत्सा युजि ह;ै
(iv) जवजनमाडता स्ट्व-प्रमाजणत करेगा दक यह ईत्पाद ऐसे युजियों की सुरिा रर जनष्पादन के ऄजनवायड
जसद्ांतों की जांचसूची के ऄनुरूप ह;ै
(v) जवजनमाडता आन जनयमों में जवजनर्ददष्ट मानकों के ऄनुपालन को स्ट्व-प्रमाजणत करेगा; रर
(vi) जवजनमाडता द्वारा जवजधवत् हस्ट्त ाििरत आस ई्ल ेख का वचनबंध दक अवेदक द्वारा दी गइ जानकारी सत् य
रर प्रामाजणक ह।ै[भाग II—खण् ड 3(i)] भारत का राजपर : ऄसाधारण 3
19झ. रजजस्ट्रीकरण सख्ं याकं .— आस प्रयोजन के जलए स्ट् थाजपत ऑनलाआन जचदकत् सा युजि प्रणाली पर जनयम 19ज के
ऄनुसार सूचना ददए जान े के पश्चात,् गैर-स्ट्टेराआल रर गैर-मापन वाल े श्रेणी क जचदकत्सा युजि के जलए
रजजस्ट्रीकरण सख्ं या सृजजत हो जाएगी।
19 অ. गरै -स्ट्टेराआल रर गरै -मापन वाल े श्रणे ी क जचदकत्सा यजु ि का अयात.— (1) कोइ भी व्यजि जो दकसी गरै -
स्ट्टेराआल रर गरै -मापन वाल े श्रेणी क जचदकत्सा युजि को अयात करना चाहता है, वह जचदकत्सा युजियों की
ऑनलाआन प्रणाली पर रजजस्ट्रीकरण के जलए ईस जचदकत्सा युजि से संबंजधत ईपजनयम (2) में जानकारी ऄपलोड
करेगा।
(2) अयातक जचदकत्सा युजियों के जलए ऑनलाआन प्रणाली में जनम्नजलजखत ऄपलोड करेगा, ऄथाडत्:—
(i) अयातक का नाम रर पता तथा जवजनमाडण स्ट्थल का नाम रर पता;
(ii) गैर-स्ट्टेराआल रर गरै -मापन वाल ेश्रेणी क जचदकत्सा युजियों का प्रदान दकए जान े वाल ेब्योरे:
जेनेिरक ब्ांड का नाम मॉडल अिजयत जनमाडण की अयाम जनधानी
नाम संख् या (यदद ईपयोग सामग्री (यदद अयु (यदद
(यदद व्यापार जचन्दह
कोइ हो) लाग ूहो) लाग ूहो)
ऄजधजनयम, 1999 के
ऄधीन रजजस्ट्रीकृत ह)ै
(1) (2) (3) (4) (5) (6) (7)
(iii) अयातक यह ई्लेख करते ुए एक वचनबंध देगा दक प्रस्ट्ताजवत युजि, प्रथम ऄनुसूची के ऄनुसार गरै -
स्ट्टेराआल रर गरै -मापन वाल ेश्रेणी क जचदकत्सा युजि ह;ै
(iv) अयातक स्ट्व-प्रमाजणत करेगा दक ईत्पाद ऐसे युजियों की सुरिा रर जनष्पादन के ऄजनवायड जसद्ांतों की
जांचसूची के ऄनुरूप ह;ै
(v) अयातक आन जनयमों में जवजनर्ददष्ट मानकों के ऄनुपालन को स्ट्व-प्रमाजणत करेगा;
(vi) सिम प्राजधकारी द्वारा जारी दकए गए मलू देि में जवदेिी जवजनमाडण स्ट्थल या प्रजतष्ठान या संयरं
रजजस्ट्रीकरण, जजस नाम से भी कहा जाए, की स्ट्व-सत्याजपत प्रजत या राष्ट्रीय जवजनयामक प्राजधकरण द्वारा
जारी जन:ि्ु क जबक्री प्रमाण पर; रर
(vii) अयातक द्वारा जवजधवत ् हस्ट्त ाििरत आस ई् लेख का वचनबंध दक अवेदक द्वारा दी गइ जानकारी सत् य रर
प्रामाजणक ह।ै ।
19 ट. अयात के जलए रजजस्ट्रीकरण सख्ं याकं .— आस प्रयोजन के जलए स्ट्थाजपत जचदकत्सा युजियों की ऑनलाआन प्रणाली पर
जनयम 19 ञ के ऄनुसार सूचना प्रस्ट्ततु करने के बाद, गैर-स्ट्टेराआल रर गरै -मापन वाल े श्रणे ी क जचदकत्सा युजि के
जलए रजजस्ट्रीकरण संख् या सृजजत हो जाएगी।
19 ठ. ऄजभलखे ों का रखरखाव.— (1) जवजनमाडता या अयातक, जैसी भी जस्ट्थजत हो, ऄपनी जबक्री या जवतरण के साथ
जवजनमाडण या अयात से संबंजधत िरकॉड डरखगे ा।
(2) जवजनमाडता या अयातक, जो भी मामलो हो, ऄनुज्ञापन प्राजधकािरयों के ऄनुरोध पर िरकॉडड, लेबल, ईपयोग के
ऄनुदेि प्रस्ट्तुत करेंगे।
(3) ऄनुज्ञापन प्राजधकारी दकसी भी समय ईपजनयम (2) में जवजनर्ददष्ट िरकोडों रर दस्ट्तावजे ों को सत्याजपत कर
सकते ह ैंरर गणु वत्ता या सुरिा संबंधी ऄसफलताओं या जिकायतों की जांच कर सकते ह।ैं
19 ड. रजजस्ट्रीकरण का जनलबं न या जनरसन.— (1) राज्य ऄनुज्ञापन प्राजधकरण या केंरीय ऄनुज्ञापन प्राजधकरण, जैसी भी
जस्ट्थजत हो, यदद ईसकी राय म ें रजजस्ट्रीकृत व्यजि पूण ड रूप स े या दकसी भी जचदकत्सा युजि के संबंध म ें आस ऄध्याय
के जनयमों के दकसी प्रावधान का पालन नहीं कर पाया है, तो रजजस्ट्रीकृत दकए गए व्यजि को आस ऄिय का कारण
बताओ नोिटस का ईत्तर दने े का ऄवसर प्रदान करन े के बाद, दक क्यों न आस प्रकार का अदेि पािरत कर ददया4 THE GAZETTE OF INDIA : EXTRAORDINARY [PART II—SEC. 3(i)]
जाए, जलजखत में कारण बताते ुए अदिे द्वारा जनयम 19- অ या जनयम 19 ठ के ईपबंधों के ऄधीन सृजजत
रजजस्ट्रीकरण सख्ं या रद्द करने या ईस ऄवजध के जलए जजसे वह ईजचत समझे, जनलंजबत कर सकता ह।ै
(2) कोइ व्यजि, राज्य ऄनुज्ञापन प्राजधकरण या केन्दरीय ऄनज्ञु ापन प्राजधकरण, जो भी मामला हो, द्वारा पािरत
अदेि से व्यजथत ह,ै तो वह ऐसे प्राजधकरण के अदिे की प्रजत प्राि होन े के पैंतालीस ददनों के भीतर, राज्य सरकार
या केन्दरीय सरकार, जो भी मामला हो, को ऄपील कर सकता ह,ै रर राज्य सरकार या केन्दरीय सरकार, ईि
ऄपीलकता डको सुनन,े के बाद अदेि की आसे पष्टु करेगी या बदलगे ी या संिोजधत करेगी।”।
5. ईि जनयमों म,ें जनयम 20 म,ें—
(क) सीमांत िीषडक म,ें “श्रेणी क” िब्द रर ऄिर के पश्चात्, “(गैर-स्ट्टेराआल रर गरै -मापन के ऄजतिरि)” िब्द
रर कोष्ठक ऄंतःस्ट्थाजपत दकए जाएँगे ;
(ख) “श्रेणी क” िब्द रर ऄिर, जहां भी यह हो, के पश्चात,् “(गैर-स्ट्टेराआल रर गरै -मापन के ऄजतिरि)” िब्द रर
कोष्ठक ऄंतःस्ट्थाजपत दकए जाएगँ े ।
6. ईि जनयमों म,ें जनयम 31 के ईपजनयम (1) म,ें “श्रेणी क” िब्द रर ऄिर के पश्चात,् “(गैर-स्ट्टेराआल रर गरै -मापन के
ऄजतिरि)” िब्द रर कोष्ठक ऄतं ःस्ट्थाजपत दकए जाएँग े ।
7. ईि जनयमों म,ें जनयम 36 के ईपजनयम (5) म,ें “श्रेणी क” िब्द रर ऄिर के पश्चात,् “(गरै -स्ट्टेराआल रर गरै -मापन के
ऄजतिरि)” िब्द रर कोष्ठक ऄतं ःस्ट्थाजपत दकए जाएँग े ।
8. ईि जनयमों म,ें दसू री ऄनुसूची में, सारणी म,ें “श्रेणी क” िब्द रर ऄिर, जहां भी यह हो, के स्ट्थान पर “श्रणे ी क (गरै -
स्ट्टेराआल रर गरै -मापन के ऄजतिरि)” िब्द रर कोष्ठक ऄतं ःस्ट्थाजपत दकए जाएगँ े ।
9. ईि जनयमों म,ें तीसरी ऄनुसूची में, भाग 2 के ऄधीन, पैरा 1, खंड (1) के ऄंतगतड , “श्रेणी क” िब्द रर ऄिर के पश्चात,्
“(गैर-स्ट्टेराआल रर गैर-मापन के ऄजतिरि)” िब्द रर कोष्ठक ऄंतःस्ट्थाजपत दकए जाएँग े ।
10. ईि जनयमों में, चौथी ऄनुसूची में, भाग 2 के ऄंतगतड , पैरा (i) म,ें “श्रेणी क” िब्द रर ऄिर के पश्चात,् “(गैर-स्ट्टेराआल
रर गरै -मापन के ऄजतिरि)” िब्द रर कोष्ठक ऄंतःस्ट्थाजपत दकए जाएँगे ।
11. ईि जनयमों की अठवीं ऄनुसचू ी की सारणी में, क्रम संख्यांक 7 रर आससे संबंजधत प्रजवजष्टयों के पश्चात्, जनम्नजलजखत
ऄंतःस्ट्थाजपत की जाएगी, ऄथाडत:—
क्रम सं. जचदकत् सा युजियों का वग ड छूट का जवस्ट्तार रर ित ें
"8. श्रेणी क गैर-स्ट्टेराआल रर गैर- आन जनयमों के ऄध्याय IV, VII, VIII रर XI के सभी
मापने वाल े जचदकत्सा युजियों का प्रावधान, आस ितड के ऄधीन दक जवजनमाडता आन जनयमों
जवजनमाडण के ऄध्याय III ख के ऄनसु ार ऐसे युजियों का
रजजस्ट्रीकरण कराएगा।
9. श्रेणी क गैर-स्ट्टेराआल रर गैर- आन जनयमों के ऄध्याय V, VII, VIII रर XI के सभी
मापने वाल े जचदकत्सा युजियों का प्रावधान, आस ितड के ऄधीन दक अयातक आन जनयमों के
अयात ऄध्याय III ख के ऄनुसार ऐसे युजियों का रजजस्ट्रीकरण
कराएगा।” ।
12. ईि जनयमों के पिरजिष्ट म,ें —
(क) प्ररूप एमडी-2 म,ें “श्रेणी क” िब्द रर ऄिर के पश्चात,् “(गैर-स्ट्टेराआल रर गरै -मापन के ऄजतिरि)” िब्द
रर कोष्ठक ऄंतःस्ट्थाजपत दकए जाएँगे ;
(ख) प्ररूप एमडी-3 म,ें “श्रेणी क” िब्द रर ऄिर के पश्चात,् “(गैर-स्ट्टेराआल रर गरै -मापन के ऄजतिरि)” िब्द
रर कोष्ठक ऄंतःस्ट्थाजपत दकए जाएँगे ;
(ग) प्ररूप एमडी-4 म,ें “श्रेणी क” िब्द रर ऄिर के पश्चात,् “(गैर-स्ट्टेराआल रर गरै -मापन के ऄजतिरि)” िब्द
रर कोष्ठक ऄंतःस्ट्थाजपत दकए जाएँगे ;[भाग II—खण् ड 3(i)] भारत का राजपर : ऄसाधारण 5
(घ) प्ररूप एमडी-5 म,ें “श्रेणी क” िब्द रर ऄिर के पश्चात,् “(गैर-स्ट्टेराआल रर गरै -मापन के ऄजतिरि)” िब्द
रर कोष्ठक ऄंतःस्ट्थाजपत दकए जाएँगे ;
(ङ) प्ररूप एमडी-6 म,ें “श्रेणी क” िब्द रर ऄिर के पश्चात,् “(गैर-स्ट्टेराआल रर गरै -मापन के ऄजतिरि)” िब्द
रर कोष्ठक ऄंतःस्ट्थाजपत दकए जाएँगे ।
[फा. सं. एक् स.11014/10/2022-डीअर]
डॉ. मनदीप के भण्डारी, संयुक् त सजचव
िटप्पण : जचदकत्सा युजि जनयम, 2017, राजपर म ें ऄजधसूचना सं. सा.का.जन. 78(ऄ), तारीख 31 जनवरी, 2017 द्वारा
प्रकाजित दकए गए थ े रर ऄजधसूचना सं. सा.का.जन. 754(ऄ), तारीख 30 जसतंबर, 2022 द्वारा ऄंजतम बार
संिोजधत दकए गए थ े।
MINISTRY OF HEALTH AND FAMILY WELFARE
(Department of Health and Family Welfare)
NOTIFICATION
New Delhi, the 14th October, 2022
G.S.R. 777(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. 710(E), dated
the 20th September, 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 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
20th September, 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), and subject to ex post consultation with the Drugs Technical Advisory
Board and consideration of suggestions of the Board in accordance with the provisions of the said sections,
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 (Sixth 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 referred to as the said rules), in rule 13,―
(a) in sub-rule (2), after the word and letter “Class A”, the brackets and words “(other than non-
sterile and non-measuring)” shall be inserted;
(b) in sub-rule (3), after the word and letter “Class A”, the brackets and words “(other than non-
sterile and non-measuring)” shall be inserted.
3. In the said rules, in rule 14, after the word and letter “Class A”, the brackets and words “(other than
non-sterile and non-measuring)” shall be inserted.
4. In the said rules, after rule 19F, the following shall be inserted, namely:―
“CHAPTER IIIB
REGISTRATION OF CLASS A (NON-STERILE AND NON-MEASURING) MEDICAL DEVICES
19G. Application of this Chapter.― (1) This Chapter shall be applicable to all non-sterile and non-
measuring devices classified as Class A medical devices as per the First Schedule (herein in this
chapter referred to as Class A non-sterile and non-measuring medical device).6 THE GAZETTE OF INDIA : EXTRAORDINARY [PART II—SEC. 3(i)]
(2) The medical devices referred to in sub-rule (1) shall be registered through an identified online
portal established for the purpose.
19H. Uploading of information for registration.― (1) The manufacturer of a Class A non-sterile
and non-measuring medical device shall upload the information specified in sub-rule (2) relating
to that medical device for registration on the Online System for Medical Devices.
(2) The manufacturer shall upload the following in the Online System for Medical Devices,
namely:―
(i) name and address of the manufacturing site;
(ii) details of Class A non-sterile and non-measuring medical devices to be provided:
Generic Brand Model No Intended Material of Dimension Shelf life
name Name (if any) use construction (if (if
applicable) applicable)
(if
registered
under the
Trade
Marks
Act,
1999)
(1) (2) (3) (4) (5) (6) (7)
(iii) an undertaking from the manufacturer stating that the proposed device is a Class A
non-sterile and non-measuring medical device, as per the First Schedule;
(iv) the manufacturer shall self-certify that the product is conforming to the essential
principles checklist of safety and performance of such devices;
(v) the manufacturer shall self-certify to comply with the standards specified in these
rules; and
(vi) an undertaking duly signed by the manufacturer stating that the information furnished
by the applicant is true and authentic.
19-I. Registration number.― The registration number for a Class A non-sterile and non-measuring
medical device shall be generated after furnishing of the information in accordance with rule 19H
on the Online System for Medical Devices established for this purpose.
19J. Import of Class A non-sterile and non-measuring medical device.― (1) Any person who
intends to import any Class A non-sterile and non-measuring medical device shall upload the
information in sub-rule (2) relating to that medical device for registration on the Online System
for Medical Devices.
(2) The importer shall upload the following in the Online System for Medical Devices, namely:―
(i) name and address of importer and the name and address of the manufacturing site;
(ii) details of Class A non-sterile and non-measuring medical devices to be provided:
Generic Brand Name Model Intended Material of Dimension (if Shelf life (if
name No (if use construction applicable) applicable)
(if registered
any)
under the
Trade Marks
Act, 1999)
(1) (2) (3) (4) (5) (6) (7)[भाग II—खण् ड 3(i)] भारत का राजपर : ऄसाधारण 7
(iii) an undertaking from the importer stating that the proposed device is Class A non-sterile
and non-measuring medical device, as per the First Schedule;
(iv) the importer shall self-certify that the product is conforming to the essential principles
checklist of safety and performance of such devices;
(v) the importer shall self-certify to comply with the standards specified in these rules;
(vi) self-attested copy of the overseas manufacturing site or establishment or plant registration,
by whatever name called, in the country of origin issued by the competent authority or Free
Sale Certificate issued by the National Regulatory Authority; and
(vii) an undertaking duly signed by the importer stating that the information furnished by the
applicant is true and authentic.
19K. Registration number for import.― The registration number for import of a class A non-sterile
and non-measuring medical device shall be generated after furnishing of the information in
accordance with rule 19J on the Online System for Medical Devices established for this purpose.
19L. Maintainance of records.― (1) The manufacturer or, as the case may be, importer shall maintain
the records relating to manufacturing or importing along with its sales or distribution.
(2) The manufacturer or, as the case may be, importer shall produce the records, labels,
instructions for use, on request by Licensing Authorities.
(3) The Licensing Authorities may verify the records and documents referred to in sub-rule (2) at
any point of time and investigate quality or safety related failures or complaints.
19M. Cancellation or suspension of registration.― (1) The State Licensing Authority or the Central
Licensing Authority, as the case may be, may, after giving the registrant an opportunity to show
cause as to why such an order should not be passed, by an order in writing stating the reasons
thereof, cancel the registration number generated under the provisions of rule 19-I or rule 19K, or
suspend it for such period as the Licensing Authority thinks fit, either wholly or in respect of any
of the medical devices to which it relates, if in its opinion, the registrant has failed to comply
with any of the provisions of the rules under this Chapter;
(2) Any person who is aggrieved by an order passed by the State Licensing Authority or the
Central Licensing Authority, as the case may be, may, within forty-five days of the receipt of a
copy of such order, prefer an appeal to the State Government or the Central Government, as the
case may be, and the State Government or the Central Government, shall after giving the said
appellant an opportunity of being heard, confirm, reverse or modify such order.”.
5. In the said rules, in rule 20,―
(a) in the marginal heading, after the word and letter “Class A”, the brackets and words “(other
than non-sterile and non-measuring)” shall be inserted;
(b) after the word and letter “Class A”, wherever they occur, the brackets and words “(other than
non-sterile and non-measuring)” shall be inserted.
6. In the said rules, in rule 31, in sub-rule (1), after the word and letter “Class A”, the brackets and words
“(other than non-sterile and non-measuring)” shall be inserted.
7. In the said rules, in rule 36, in sub-rule (5), after the word and letter “Class A”, the brackets and words
“(other than non-sterile and non-measuring)” shall be inserted.
8. In the said rules, in the Second Schedule, in the table, for the word and letter “Class A”, wherever they
occur, the words and brackets “Class A (other than non-sterile and non-measuring)” shall be
substituted.
9. In the said rules, in the Third Schedule, in Part II, in paragraph 1, in clause (1), after the word and
letter “Class A”, the brackets and words “(other than non-sterile and non-measuring)” shall be
inserted.
10. In the said rules, in the Fourth Schedule, in Part II, in paragraph (i), after the word and letter “Class
A”, the brackets and words “(other than non-sterile and non-measuring)” shall be inserted.8 THE GAZETTE OF INDIA : EXTRAORDINARY [PART II—SEC. 3(i)]
11. In the said rules, in the Eighth Schedule, in the table, after serial number 7 and the entries relating
thereto, the following shall be inserted, namely:―
S.No. Class of medical devices Extent and conditions of exemptions
“8. Manufacturing of Class A All provisions of Chapter IV, VII, VIII and XI
non-sterile and non-measuring of these rules, subject to the condition that the
medical devices manufacturer shall make registration of such
devices, under the provisions of Chapter IIIB of
these rules.
9. Import of Class A non-sterile All provisions of Chapter V, VII, VIII and XI of
and non-measuring medical these rules, subject to the condition that the
devices importer shall make registration of such devices,
under the provisions of Chapter IIIB of these
rules.”.
12. In the said rules, in the Appendix,―
(a) in Form MD-2, after the word and letter “Class A”, the brackets and words “(other than non-
sterile and non-measuring)” shall be inserted;
(b) in Form MD-3, after the word and letter “Class A”, the brackets and words “(other than non-
sterile and non-measuring)” shall be inserted;
(c) in Form MD-4, after the word and letter “Class A”, the brackets and words “(other than non-
sterile and non-measuring)” shall be inserted;
(d) in Form MD-5, after the word and letter “Class A”, the brackets and words “(other than non-
sterile and non-measuring)” shall be inserted;
(e) in Form MD-6, after the word and letter “Class A”, the brackets and words “(other than non-
sterile and non-measuring)” shall be inserted.
[F. No. X.11014/10/2022-DR]
Dr. MANDEEP K BHANDARI, Jt. Secy.
Note : The principal rules were 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. 754(E), dated the
30th September, 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.