## Report on Amendment to the Medical Devices Rules, 2017
**1. Executive Summary:**
This report analyzes a notification amending the Medical Devices Rules, 2017, specifically focusing on the introduction of Chapter IIIB regarding the registration of Class A non-sterile and/or non-measuring medical devices. The core purpose of this amendment is to establish a registration process for these specific types of medical devices through an online portal. Key findings indicate a shift towards increased regulatory oversight of Class A non-sterile and/or non-measuring medical devices, requiring manufacturers and importers to register these devices and self-certify their compliance with safety and performance standards.
**2. Introduction:**
This report aims to provide an informative overview of the amendment to the Medical Devices Rules, 2017, as detailed in the provided notification. The analysis is based solely on the provided text and focuses on the implications of these amendments.
**3. Policy Overview:**
* **Original Policy:** Medical Devices Rules, 2017.
* **Core Objective(s) (inferred):** The amendment's objective, inferred from the text, is to establish a registration system for Class A non-sterile and/or non-measuring medical devices, ensuring their compliance with established safety and performance standards.
**4. Background and Rationale:**
* **Amendment Rationale (inferred):** The amendment appears to address a gap in the existing regulatory framework by explicitly including Class A non-sterile and/or non-measuring medical devices under a mandatory registration process. This suggests a need for increased oversight and quality assurance for these types of devices, potentially due to concerns regarding their safety, performance, or market compliance.
**5. Key Provisions / Changes:**
This amendment introduces Chapter IIIB to the Medical Devices Rules, 2017, specifically targeting Class A non-sterile and/or non-measuring medical devices. Key changes include:
* **Establishment of Online Registration (Rule 19G):** Requires registration of Class A non-sterile and/or non-measuring medical devices through an identified online portal. This shifts the regulatory landscape by requiring pre-market registration for these devices.
* **Manufacturer Responsibilities (Rule 19H):** Manufacturers must upload specific information, including manufacturing site details, device details (generic name, brand, model, intended use, etc.), an undertaking confirming the device's classification, and self-certification of compliance with safety and performance standards. This places a new burden of documentation and self-assessment on manufacturers.
* **Importer Responsibilities (Rule 19J):** Importers must upload similar information as manufacturers, including details of both the importer and manufacturing site, device specifics, an undertaking regarding device classification, self-certification of compliance, and a self-attested copy of the overseas manufacturing site registration or Free Sale Certificate. This extends the registration requirement to importers, ensuring accountability for imported devices.
* **Registration Number Generation (Rules 19I, 19K):** Upon furnishing the required information, a registration number will be generated, signifying completion of the registration process.
* **Record Keeping and Inspection (Rule 19L):** Manufacturers and importers must maintain records of manufacturing/import, sales, and distribution, and produce them upon request by Licensing Authorities. Licensing Authorities may verify records and investigate quality or safety related failures. This allows for post-market surveillance and enforcement.
* **Cancellation or Suspension of Registration (Rule 19M):** The State or Central Licensing Authority can cancel or suspend a registration number if the registrant fails to comply with the rules. An appeal process is provided. This creates a mechanism for enforcement and ensures compliance.
* **Exemption Conditions (Amendment to Eighth Schedule):** Manufacturing and import of Class A non-sterile and/or non-measuring medical devices are now subject to registration as per Chapter IIIB.
* **Amendments to Rules 13, 14, 20, 31, and 36**: These rules are amended to explicitly exclude non-sterile and/or non-measuring Class A medical devices, indicating that the new Chapter IIIB now governs these devices separately.
**6. Target Audience and Stakeholders:**
The primary target audience includes:
* Manufacturers of Class A non-sterile and/or non-measuring medical devices.
* Importers of Class A non-sterile and/or non-measuring medical devices.
* State Licensing Authorities.
* Central Licensing Authority.
**7. Implementation Aspects (Inferred):**
* **Responsible Agency/Bodies:** State Licensing Authority and Central Licensing Authority are responsible for overseeing the registration process and enforcing compliance.
* **Timelines/Procedures:** The rules come into force upon final publication in the Official Gazette. Manufacturers and importers must register their devices through an identified online portal. An appeal process is available within forty-five days of an order from the Licensing Authority. The online portal will play a central role.
**8. Expected Outcomes / Impact of Changes:**
The intended outcome of these amendments is likely to:
* Enhance the quality and safety of Class A non-sterile and/or non-measuring medical devices available in the market.
* Improve traceability and accountability of manufacturers and importers of these devices.
* Streamline the regulatory process through the use of an online registration portal.
* Provide Licensing Authorities with greater oversight and enforcement capabilities.
* Increase compliance to standards by manufacturers/importers through self-certification requirements.
**9. Conclusion:**
The amendment to the Medical Devices Rules, 2017, introducing Chapter IIIB, marks a significant step towards regulating Class A non-sterile and/or non-measuring medical devices. By establishing a registration process and outlining specific responsibilities for manufacturers and importers, the amendment aims to improve the quality, safety, and traceability of these devices, contributing to enhanced patient safety and regulatory oversight within the medical device sector.
Key Entities Referenced
NEW DELHI: The city where the notification was issued.
Medical Device Rules, 2017: A set of rules pertaining to medical devices, which this notification seeks to amend.
Drugs and Cosmetics Act, 1940: The act under which the powers are conferred to make the amendments to the Medical Device Rules, 2017.
Central Government: The governing body responsible for considering objections and suggestions to the draft rules.
Ministry of Health and Family Welfare: The ministry to which objections and suggestions should be addressed.
Government of India: The government to which objections and suggestions should be addressed.
Nirman Bhavan, New Delhi 110011: The address of the Ministry of Health and Family Welfare.
Medical Devices .........Amendment Rules, 2022: The name of the rules being introduced to amend the existing Medical Device Rules.
Online System for Medical Devices: The online portal established for the registration of medical devices.
Class A Medical Device: A category of medical devices subject to the rules outlined in the notification, specifically nonsterile and/or nonmeasuring devices.
Trade Marks Act, 1999: Act related to trade marks under which medical devices may be registered.
First Schedule: Schedule of the said rules that defines Class A medical devices.
State Licensing Authority: Authority that may cancel or suspend the registration number of a medical device.
Central Licensing Authority: Authority that may cancel or suspend the registration number of a medical device.
State Government: The government to which an appeal can be made against an order passed by the State Licensing Authority.
Central Government: The government to which an appeal can be made against an order passed by the Central Licensing Authority.
Chapter IV: Chapter of Medical Devices Rules, 2017 related to manufacturing of Class A nonsterile andor nonmeasuring medical devices
Chapter IIIB: Chapter of the amendment rules regarding registration of Class A nonsterile and/or nonmeasuring medical devices.
Chapter V: Chapter of Medical Devices Rules, 2017 related to import of Class A nonsterile andor nonmeasuring medical devices
रजिस्ट्री स.ं डी.एल.- 33004/99 REGD. No. D. L.-33004/99
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असाधारण
EXTRAORDINARY
भाग II—खण् ड 3—उप-खण्ड (i)
PART II—Section 3—Sub-section (i)
प्राजधकार स ेप्रकाजित
PUBLISHED BY AUTHORITY
स.ं 629] नई दि्ली, तगं लवार, जसतम्ब र 20, 2022/भार 29, 1944
No. 629] NEW DELHI, TUESDAY, SEPTEMBER 20, 2022/BHADRA 29, 1944
स्ट्व ास्ट्् य रर पिरवार क्य ाण तरं ालय
(स्ट्व ास्ट्् य रर पिरवार क्य ाण जवभाग)
अजधसचू ना
नई दि्ली, 20 जसतम्ब र, 2022
सा.का.जन. 710(अ).—जचदकत्सा युजि जनयत, 2017 त ें रर संिोधन करन े के जलए कजतपय जनयतों का प्रारूप,
जिसे केन्द्रीय सरकार, रषजध रर प्रसाधन सातग्री अजधजनयत, 1940 (23 के 1940) की धारा 12 की उपधारा (1) रर
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 ै रर एतिद्वारा सूचना िी िाती ह ै दक उक्त प्रारूप जनयतों पर उस
तारीख से सात दिनों की अवजध सताप्त होन े पर या उसके बाि जवचार दकया िाएगा जिस तारीख को इन प्रारूप जनयतों
वाले भारत के रािपर की प्रजतयां िनता को उपलब्ध कराई िाएगी;
केन्द्रीय सरकार द्वारा उपयुुि जवजनर्िष्टु अवजध के भीतर दकसी भी व्यजि से प्राप्त होने वाली आपजत्तयों रर
सुझावों पर जवचार दकया िाएगा;
आपजत्तयां रर सुझाव, यदि कोई हों, तो अवर सजचव, (रषजध), स्ट्वास्ट््य रर पिरवार क्याण तंरालय, भारत
सरकार, कतरा सं. 434, सी ववंग, जनताुण भवन, नई दि्ली - 110011 को अग्रेजषत दकया िाए अथवा drugsdiv-
mohfw@gov.in पर ई-तेल की िाए।
प्रारूप जनयत
1. (1) इन जनयतों को जचदकत्सा युजि (….संिोधन) जनयत, 2022 कहा िाएगा।
(2) य ेजनयत, िब तक अन्द्यथा जवजनर्िष्टु न हो, रािपर तें इनके अंजतत प्रकािन की तारीख को प्रभावी होंगे।
6249 GI/2022 (1)2 THE GAZETTE OF INDIA : EXTRAORDINARY [PART II—SEC. 3(i)]
2. जचदकत्सा युजि जनयत, 2017 (जिसे इसतें इसके पश्चात् उि जनयत कहा गया ह)ै तें, अध्याय IIIक के पश्चात,्
जनम्नजलजखत अध्याय IIIख अंतःस्ट्थाजपत दकया िाएगा, अथाुत:—
"अध्याय III ख
श्रणे ी क (गरै - स्ट्टेराइल रर / या गरै -तापन वाल)े जचदकत्सा यजु ियों का पिं ीकरण
19 छ(1) यह अध्याय, उि जनयतों की पहली अनसु चू ी के अनसु ार, श्रणे ी क जचदकत्सा उपकरणों के रूप त ें वगीकृत
सभी गरै - स्ट्टेराइल रर / या गरै -तापन वाल ेयजु ियों पर लाग ूहोगा।
(2) उप-जनयत (1) तें जनर्िष्टु जचदकत्सा युजियों को इस उद्देश्य के जलए स्ट्थाजपत एक जनधाुिरत ऑनलाइन पोटलु के
ताध्यत से रजिस्ट्रीकृत दकया िाएगा।
19 ि(1) दकसी जचदकत्सा यजु ियों का जवजनतातु ा "जचदकत्सा यजु ियों के जलए ऑनलाइन प्रणाली" पर रजिस्ट्रीकरन के
जलए उस जचदकत्सा यजु ि स ेसबं जं धत उप-जनयत (2) त ेंजवजनर्िष्टु िानकारी अपलोड करेगा।
(2) जवजनताुता जनम्नजलजखत िानकारी अपलोड करेगा:
(i) जवजनताुण स्ट्थल का नात रर पता
(ii) जचदकत्सा युजियों का ब्यौरा
िेनेिरक ब्ांड का नात(यदि व्यापार तॉडल सख्ं या आिजयत जनताुण की आयात जनधानी आयु
नात जचह्न अजधजनयत, 1999 के (यदि कोई उपयोग सातग्री (यदि लाग ू (यदि लागू हो)
तहत रजिस्ट्रीकृत ह)ै हो) हो)
(iii) जवजनताुता यह बतात े हुए वचनबंध िगे ा दक प्रस्ट्ताजवत युजि उि जनयतों की प्रथत अनुसूची के अनुसार, श्रेणी क
जचदकत्सा युजि (गैर- स्ट्टेराइल रर/या गरै -तापन वाल)े ह।ै
(iv) जवजनताुता स्ट्व-प्रताजणत करेगा दक यह उत्पाि ऐसे युजियों की सुरक्षा रर जनष्पािन के अजनवायु जसद्ांतों की
िांचसूची के अनुरूप ह।ै
(v) जवजनताुता जचदकत्सा युजि जनयत, 2017 तें जनधाुिरत तानकों के अनुपालन को स्ट्व-प्रताजणत करेगा।
(vi) जवजनताुता द्वारा जवजधवत् हस्ट्त ाक्षिरत इस उ् लेख का वचनबंध दक आवेिक द्वारा िी गई िानकारी सत् य रर
प्राताजणक ह।ै
19झ इस प्रयोिन के जलए स्ट् थाजपत ‘ऑनलाइन जचदकत् सा युजि प्रणाली’ पर जनयत 19ि के अनुसार उपयुुक् त सूचना दिए
िाने के बाि रजिस्ट्रीकरण संख् या सृजित हो िाएगी।
19 অ (1) कोई भी व्यजि िो जनयत 19 छ(1) के तहत दकसी भी जचदकत्सा यजु ि को आयात करना चाहता ह,ै वह
"जचदकत्सा युजियों की ऑनलाइन प्रणाली" पर रजिस्ट्रीकरण के जलए उस जचदकत्सा यजु ि स े सबं जं धत उप-जनयत (2) त ें
िानकारी अपलोड करेगा।
(2) आयातक अपलोड करेगा,—
(i) आयातक का नात रर पता तथा जवजनताुण स्ट्थल का नात रर पता।
(ii) जचदकत्सा युजियों का ब्यौरा
िेनेिरक ब्ांड का नात तॉडल सख्ं य ा आिजयत जनताुण की आयात (यदि जनधानी आय ु
नात (यदि कोई हो) उपयोग सातग्री लाग ूहो) (यदि लागू हो)
(यदि व्यापार
जचन्द्ह
अजधजनयत,
1999 के
तहत पंिीकृत
ह)ै[भाग II—खण् ड 3(i)] भारत का रािपर : असाधारण 3
(iii) आयातक यह उ्लेख करते हुए एक वचनबंध िेगा दक प्रस्ट्ताजवत युजि उि जनयतों की प्रथत अनुसूची के
अनुसार श्रेणी क जचदकत्सा युजि (गरै - स्ट्टेराइल रर/या गैर-तापन वाला) ह।ै
(iv) आयातक स्ट्व-प्रताजणत करेगा दक उत्पाि ऐसे युजियों की सुरक्षा रर जनष्पािन के अजनवायु जसद्ांतों की
िांचसूची के अनुरूप ह।ै
(v) आयातक जचदकत्सा युजि जनयत, 2017 तें जनधाुिरत तानकों के अनपु ालन को स्ट्व-प्रताजणत करेगा।
(vi) सक्षत प्राजधकारी द्वारा िारी दकए गए तलू िेि तें जविेिी जवजनताुण स्ट्थल या प्रजतष्ठान या संयंर पंिीकरण,
जिस नात स े भी कहा िाए, की स्ट्व-स्ट्त्याजपत प्रजत या राष्ट्रीय जवजनयातक प्राजधकरण द्वारा िारी जन:िु्क
जबक्री प्रताण पर।
(vii) आयातक द्वारा जवजधवत ् हस्ट्त ाक्षिरत इस उ् लेख का वचनबंध दक आवेिक द्वारा िी गई िानकारी सत् य रर
प्राताजणक ह।ै ।
19 ट. इस प्रयोिन के जलए स्ट्थाजपत "जचदकत्सा युजियों की ऑनलाइन प्रणाली" पर जनयत 19 ञ के अनुसार सूचना प्रस्ट्ततु
करने के बाि, रजिस्ट्रीकरण संख्य ा सृजित हो िाएगी।
19 ठ. जवजनतातु ा/आयातक अपनी जबक्री या जवतरण के साथ जवजनताणु /आयात का िरकॉड ुरखगे ा। जवजनताुता रर आयातक
अनज्ञु ापन प्राजधकािरयों के अनरु ोध पर िरकॉडु, लबे ल, उपयोग के अनिु ेि प्रस्ट्ततु करेंग।े अनज्ञु ापन प्राजधकारी दकसी भी
सतय िरकोडों, िस्ट्ताविे ों को सत्याजपत कर सकत े ह ैं रर गणु वत्ता या सरु क्षा सबं धं ी असफलताओं या जिकायतों की िाचं
कर सकत ेह।ैं
19ड. राज्य अनज्ञु ापन प्राजधकरण या केंरीय अनज्ञु ापन प्राजधकरण, िसै ा भी तातला हो, यदि उसकी राय त ें रजिस्ट्रीकृत
व्यजि पणू ु रूप स े या दकसी भी जचदकत्सा यजु ि के सबं धं त ें इस अध्याय के जनयतों के दकसी प्रावधान का पालन नहीं कर
पाया ह,ै तो रजिस्ट्रीकृत दकए गए व्यजि को इस अिय का कारण बताओ नोिटस का उत्तर िेन े का अवसर प्रिान करन े के
बाि, दक क्यों न इस प्रकार का आििे पािरत कर दिया िाए, जलजखत त ें कारण बतात े हुए आिेि द्वारा रजिस्ट्रीकरण
सख्ं या रद्द करन ेया उस अवजध के जलए जिस ेवह उजचत सतझे, जनलजं बत कर सकता ह।ै
परन्द्तु कोई व्यजि, राज्य अनज्ञु ापन प्राजधकरण या केन्द्रीय अनुज्ञापन प्राजधकरण, िो भी तातला हो, द्वारा पािरत
आिेि स े व्यजथत ह,ै तो वह ऐसे प्राजधकरण के आिेि की प्रजत प्राप्त होन े के पैंतालीस दिनों के भीतर, राज्य सरकार या
केन्द्रीय सरकार, िो भी तातला हो, को अपील कर सकता ह,ै रर राज्य सरकार या केन्द्रीय सरकार, उि अपीलकताु को
सुनने, के बाि आिेि की इसे पष्टु करेगी या बिलगे ी या संिोजधत करेगी।”
3. उि जनयतों की आठवीं अनुसूची तें, "छूट की सीता रर ितें" िीषुक के तहत सारणी तें, क्र. सं. 7 के पश्चात,
जनम्नजलजखत प्रजवजष्ट अंतःस्ट्थाजपत की िाएगी, अथाुत:—
"8. श्रेणी क (गैर- स्ट्टेराइल रर / या गैर- जचदकत्सा युजि जनयत, 2017 के अध्याय IV के सभी प्रावधान,
तापने वाले) जचदकत्सा युजियों का इस ितु के अधीन दक जवजनताुता इन जनयतों के अध्याय IIIख के
जवजनताुण अनुसार ऐस े युजियों का रजिस्ट्रीकरण कराएगा।
9. श्रेणी क (गैर- स्ट्टेराइल रर / या गैर- जचदकत्सा युजि जनयत, 2017 के अध्याय V के सभी प्रावधान,
तापने वाले) जचदकत्सा युजियों का आयात इस ितु के अधीन ख दक आयातक इन जनयतों के अध्याय IIIखके
अनुसार ऐस े युजियों का रजिस्ट्रीकरण कराएगा।”
4. उि जनयतों त,ें—
(i) जनयत 13 त,ें —
(क) उपजनयत (2) त,ें “श्रेणी क” िब्िों के पश्चात् रर "रर श्रणे ी ख” िब्िों से पहल े जनम्नजलजखत िब्ि,
अंक रर कोष्ठक अतं ःस्ट्थाजपत दकए िाएँगे, अथाुत:—
"(गैर- स्ट्टेराइल रर / या गरै -तापन के अलावा)"
(ख) उपजनयत (3) त,ें "श्रेणी क" िब्िों के पश्चात ् रर "या श्रणे ी ख" िब्िों से पहल े जनम्नजलजखत िब्ि,
अंक रर कोष्ठक अतं ःस्ट्थाजपत दकए िाएँगे, अथाुत:—4 THE GAZETTE OF INDIA : EXTRAORDINARY [PART II—SEC. 3(i)]
"(गैर- स्ट्टेराइल रर / या गरै -तापनवाले के अलावा)"
(ii) जनयत 14 त,ें "श्रेणी क" िब्िों के पश्चात रर "या श्रणे ी ख" िब्िों स े पहल े जनम्नजलजखत िब्ि, अंक रर
कोष्ठक अंतःस्ट्थाजपत दकए िाएगं ,े अथाुत:—
"(गैर- स्ट्टेराइल रर / या गरै -तापन वाले)"
(iii) जनयत 20 त,ें
(क) िीषुक त,ें "श्रेणी क" िब्िों के पश्चात् रर "अथवा श्रणे ी ख" िब्िों के पहले जनम्नजलजखत िब्ि, अंक
रर कोष्ठक अंतः स्ट्थाजपत दकए िाएँगे, अथाुत:—
"(गरै - स्ट्टेराइल रर/ अथवा गरै -तापन वाल ेके अलावा)"
(ख) उपजनयत (1) त,ें "श्रेणी क" िब्िों के पश्चात ् रर "या श्रेणी ख" िब्िों स े पहले जनम्नजलजखत िब्ि,
अंक रर कोष्ठक अतं ःस्ट्थाजपत दकए िाएँगे, अथाुत:—
"(गरै - स्ट्टेराइल रर / या गरै -तापन वाल ेके अलावा)"
(ग) उपजनयत (4) त,ें "श्रेणी क" िब्िों के पश्चात ् रर िब्िों रर अंक "प्ररूप एतडी-5 त ें जचदकत्सा
युजि" से पहल,े जनम्नजलजखत िब्ि, अंक रर कोष्ठक अंतःस्ट्थाजपत दकए िाएँगे, अथाुत:—
"(गैर- स्ट्टेराइल रर / या गरै -तापन वाले के अलावा)"
(घ) उपजनयत (4) के परंतुक (i) त,ें "श्रेणी क" िब्िों के पश्चात ् रर "जचदकत्सा युजियों; रर", िब्िों स े
पहले जनम्नजलजखत िब्ि, आंकडे रर कोष्ठक अंतःस्ट्थाजपत दकए िाएंगे, अथाुत:—
"(गैर- स्ट्टेराइल रर/ या गैर-तापन वाल ेके अलावा)"
(iv) जनयत 31 त,ें उपजनयत (1) त,ें "श्रेणी क" िब्िों के पश्चात् रर "या श्रणे ी ख" िब्िों से पहल े जनम्नजलजखत
िब्ि, अंक रर कोष्ठक अतं ःस्ट्थाजपत दकए िाएँगे, अथाुत:—
"(गैर- स्ट्टराइल रर / या गरै -तापन वाले के अलावा)"
(v) जनयत 36 त,ें उपजनयत (5) त,ें "श्रेणी क" िब्िों के पश्चात् रर "या श्रणे ी ख" िब्िों के पहले जनम्नजलजखत
िब्ि, अंक रर कोष्ठक अतं ःस्ट्थाजपत दकए िाएँगे, अथाुत:—
"(गैर- स्ट्टेराइल रर / या गरै -तापन वाले के अलावा)"
(vi) िसू री अनुसूची त,ें ताजलका त,ें "श्रेणी क" िब्िों िहां भी यह हो को "श्रेणी क (गरै - स्ट्टेराइल रर / या गैर-
तापन वाले के अलावा)" िब्िों, अंकों रर कोष्ठकों के साथ प्रजतस्ट्थाजपत दकया िाएगा।
(vii) तीसरी अनुसूची तें, भाग II के अतं गतु , पैरा 1, खंड (1) के अंतगुत, "श्रेणी क" िब्िों के पश्चात् रर "या श्रेणी
ख" िब्िों से पहले जनम्नजलजखत िब्ि, अंक रर कोष्ठक अतं ःस्ट्थाजपत दकए िाएँगे, अथाुत:—
"(गैर- स्ट्टेराइल रर / या गरै -तापन वाले के अलावा)"
(viii) चौथी अनुसूची त,ें भाग II के अंतगतु , पैरा (i) के अंतगतु िीषुक त,ें “श्रेणी क” िब्िों के पश्चात् रर
“जचदकत्सा युजि” िब्िों से पहल ेजनम्नजलजखत िब्ि, अंक रर कोष्ठक अंतःस्ट्थाजपत दकए िाएंगे, अथाुत:—
"(गरै - स्ट्टेराइल रर/ या गरै -तापन वाल ेके अलावा)"
(ix) पिरजिष्ट त,ें
(क) प्ररूप एतडी -2 त,ें पैरा (1) त,ें "श्रेणी क" िब्िों के पश्चात ् रर "रर/ अथवा श्रेणी ख" िब्िों से
पहल,े जनम्नजलजखत िब्ि, आंकडे रर कोष्ठक अंतःस्ट्थाजपत दकए िाएंगे, अथाुत:—
"(गैर- स्ट्टेराइल रर / या गरै -तापन वाले के अलावा)"
(ख) प्ररूप एतडी-3 त,ें िीषुक त,ें "श्रेणी क" िब्िों के पश्चात ् रर "रर/ अथवा श्रेणी ख" िब्िों स े
पहले जनम्नजलजखत िब्ि, अंक रर कोष्ठक अंतःस्ट्थाजपत दकए िाएँगे, अथाुत:—
"(गरै - स्ट्टेराइल रर / या गरै -तापन वाल ेके अलावा)"[भाग II—खण् ड 3(i)] भारत का रािपर : असाधारण 5
(ग) प्ररूप एतडी-4 त,ें िीषुक त,ें "श्रेणी क" िब्िों के पश्चात ् रर "रर/अथवा श्रेणी ख" िब्िों से
पहले जनम्नजलजखत िब्ि, अंक रर कोष्ठक अंतःस्ट्थाजपत दकए िाएंगे, अथाुत:—
"(गरै - स्ट्टेराइल रर / या गरै -तापन वाल ेके अलावा)"
(घ) प्ररूप एतडी-5 त,ें िीषुक त,ें "श्रेणी क" िब्िों के पश्चात ् रर "रर/अथवा श्रेणी ख" िब्िों स े
पहले जनम्नजलजखत िब्ि, अंक रर कोष्ठक अंतःस्ट्थाजपत दकए िाएंगे, अथाुत:—
"(गरै - स्ट्टेराइल रर / या गरै -तापन वाल ेके अलावा)"
(ङ) प्ररूप एतडी-6 त,ें िीषुक त,ें "श्रेणी क" िब्िों के पश्चात ् रर "रर/अथवा श्रणे ी ख" िब्िों स े
पहले जनम्नजलजखत िब्ि, अंक रर कोष्ठक अंतःस्ट्थाजपत दकए िाएंगे, अथाुत:—
"(गरै - स्ट्टेराइल रर / या गरै -तापन वाल ेके अलावा)"
[फा. सं. एक्स.11014/10/2022-डीआर]
डॉ. तनिीप के. भण्डारी, संयुि सजचव
िटप्पण: जचदकत्सा युजि जनयत, 2017, रािपर त ें अजधसूचना सं. सा.का.जन. 78(अ), तारीख 31 िनवरी, 2017 द्वारा
प्रकाजित दकए गए थे रर अजधसूचना सं. सा.का.जन. ……(अ), तारीख ……….. द्वारा अंजतततः संिोजधत दकए
गए थे ।
MINISTRY OF HEALTH AND FAMILY WELFARE
(Department of Health and Family Welfare)
NOTIFICATION
New Delhi, the 20th September, 2022
G.S.R. 710(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), 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), 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, 2022.
(ii) These rules, 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), after CHAPER IIIA, the following
CHAPTER IIIB shall be inserted, namely:―
“CHAPTER IIIB
REGISTRATION OF CLASS A (NON-STERILE AND/OR NON-MEASURING) MEDICAL DEVICES
19G (1) This Chapter shall be applicable to all non-sterile and/or non-measuring devices classified as Class A
medical devices, as per First Schedule of said rules.
(2) The medical devices referred in sub-rule (1) shall be registered through an identified online portal established
for the purpose.
19H (1).The manufacturer of a 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 manufacture shall upload:6 THE GAZETTE OF INDIA : EXTRAORDINARY [PART II—SEC. 3(i)]
(i) The name and address of the manufacturing site.
(ii) Details of Medical devices
Generic Brand Model No (if Intended use Material of Dimension (if Shelf life (if
name Name any) construction applicable) applicable)
(if
registered
under the
Trade
Marks Act,
1999)
(iii) An undertaking from the manufacturer stating that the proposed device is Class A Medical Device
(non-sterile and/or non-measuring), as per First Schedule of said rules.
(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 prescribed in the Medical Devices
Rules, 2017.
(vi) Undertaking duly signed by the manufacturer stating that the information furnished by the applicant
is true and authentic
19I. After furnishing of the information as per rule 19H, on the “Online System for Medical Devices” established
for this purpose, registration number will be generated.
19J (1) Any person who intends to import any medical device under rule 19G(1) 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,—
(i) The name and address of importer and the name and address of the manufacturing site.
(ii) Details of medical devices
Generic Brand Model No (if Intended use Material of Dimension (if Shelf life (if
name Name any) construction applicable) applicable)
(if
registered
under the
Trade
Marks Act,
1999)
(iii) An undertaking from the importer stating that the proposed device is Class A Medical Device (non-
sterile and/or non-measuring), as per First Schedule of said rules.
(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 prescribed in the Medical Devices
Rules, 2017.
(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.
(vii) Undertaking duly signed by the importer stating that the information furnished by the applicant is
true and authentic.
19K. After furnishing of the information as per rule 19J on the “Online System for Medical Devices” established
for this purpose, registration number will be generated.
19L.The manufacturer/ importer shall maintain the records of manufacturing/ import along with its sales or
distribution. The manufacturer and importer shall produce the records, labels, Instructions for Use, on
request by Licensing Authorities. The Licensing Authorities may verify the records, documents at any
point of time and investigate quality or safety related failures or complaints.[भाग II—खण् ड 3(i)] भारत का रािपर : असाधारण 7
19M. State Licensing Authority or 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 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 provision of rules under this chapter.
Provided that a person who is aggrieved by the 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 the
order by such authority, 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.”
3. In the said rules, in the Eighth Schedule, in the table under heading “Extent and conditions of exemption”,
after S.N. 7, the following entry shall be inserted, namely:―
“8. Manufacturing of Class A (non-sterile All provisions of Chapter IV of Medical Devices Rules, 2017,
and/or non-measuring) medical devices subject to the condition that the manufacturer shall make
registration of such devices, as per Chapter IIIB of these rules.
9. Import of Class A (non-sterile and/or All provisions of Chapter V of Medical Devices Rules, 2017,
non-measuring) medical devices subject to the condition that the importer shall make
registration of such devices, as per Chapter IIIB of these rules.”
4. In the said rules,―
(i) in rule 13,―
(a) in sub-rule (2), after the words “Class A” and before the words “and Class B” the following
words, figures and brackets shall be inserted, namely:―
“(other than non-sterile and/or non-measuring)”
(b) in sub-rule (3), after the words “Class A” and before the words “or Class B”, the following
words, figures and brackets shall be inserted, namely:―
“(other than non-sterile and/or non-measuring)”
(ii) in rule 14, after the words “Class A” and before the words “or Class B” the following words,
figures and brackets shall be inserted, namely:―
“(other than non-sterile and/or non-measuring)”
(iii) in rule 20,―
(a) in the heading, after the words “Class A” and before the words “or Class B” the following
words, figures and brackets shall be inserted, namely:―
“(other than non-sterile and/or non-measuring)”
(b) in sub-rule (1), after the words “Class A” and before the words “or Class B” the following
words, figures and brackets shall be inserted, namely:―
“(other than non-sterile and/or non-measuring)”
(c) in sub-rule (4), after the words “Class A” and before the words and figures, “medical devices
in Form MD-5”, the following words, figures and brackets shall be inserted, namely:―
“(other than non-sterile and/or non-measuring)”
(d) in proviso (i) of sub-rule (4), after the words “Class A” and before the words “medical devices;
and”, the following words, figures and brackets shall be inserted, namely:―
“(other than non-sterile and/or non-measuring)”
(iv) in rule 31, in sub-rule (1), after the words “Class A” and before the words “or Class B” the
following words, figures and brackets shall be inserted, namely:―
“(other than non-sterile and/or non-measuring)”
(v) in rule 36, in sub-rule(5), after the words “Class A” and before the words “or Class B” the
following words, figures and brackets shall be inserted, namely:―
“(other than non-sterile and/or non-measuring)”8 THE GAZETTE OF INDIA : EXTRAORDINARY [PART II—SEC. 3(i)]
(vi) in SECOND SCHEDULE, in the table, the words, “Class A” shall be substituted with the words,
figures and brackets “Class A (other than non-sterile and/or non-measuring)”, wherever it occurs.
(vii) in THIRD SCHEDULE, under Part II, under para 1, clause (1), after the words “Class A” and
before the words “or Class B”, the following words, figures and brackets shall be inserted,
namely:―
“(other than non-sterile and/or non-measuring)”
(viii) in FOURTH SCHEDULE, under Part II, in the heading under para (i), after the words “Class A”
and before the words “medical device-”, the following words, figures and brackets shall be inserted,
namely:―
“(other than non-sterile and/or non-measuring)”
(ix) in Appendix,―
(a) in Form MD-2, in para (1), after the words “Class A” and before the words “and/or Class
B”, the following words, figures and brackets shall be inserted, namely:―
“(other than non-sterile and/or non-measuring)”
(b) in Form MD-3, in the heading, after the words “Class A” and before the words “and/or
Class B” the following words, figures and brackets shall be inserted, namely:―
“(other than non-sterile and/or non-measuring)”
(c) in Form MD-4, in the heading, after the words “Class A” and before the words “and/or
Class B” the following words, figures and brackets shall be inserted, namely:―
“(other than non-sterile and/or non-measuring)”
(d) in Form MD-5, in the heading, after the words “Class A” and before the words “and/or
Class B” the following words, figures and brackets shall be inserted, namely:―
“(other than non-sterile and/or non-measuring)”
(e) in Form MD-6, in the heading, after the words “Class A” and before the words “and/or
Class B” the following words, figures and brackets shall be inserted, namely:―
“(other than non-sterile and/or non-measuring)”
[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
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.