## Report on the Medical Devices Fifth Amendment Rules, 2022
**1. Executive Summary:**
This report analyzes the Medical Devices Fifth Amendment Rules, 2022, as published in the Gazette of India, Extraordinary, Part II, Section 3, Subsection i, on September 30, 2022. This amendment to the Medical Devices Rules, 2017, introduces a new registration certificate for entities selling, stocking, exhibiting, or distributing medical devices as defined in clause zb of rule 3. The core purpose is to regulate the sale and distribution of medical devices by entities not previously requiring a license under the original rules. Key findings include the establishment of a registration process, associated fees, conditions for maintaining the registration, and procedures for suspension or cancellation.
**2. Introduction:**
This report provides an informative overview of the Medical Devices Fifth Amendment Rules, 2022, based solely on the provided policy text. The objective is to analyze the amendment's key provisions, intended audience, implementation aspects, and expected outcomes. This report is intended to provide clarity on this policy change for industry stakeholders.
**3. Policy Overview:**
* **Amendment to:** Medical Devices Rules, 2017.
* **Core Objective(s):** To regulate the sale, stock, exhibit, offer for sale, or distribution of medical devices, including in vitro diagnostic medical devices, by any person not holding licence under subrule 1 and intends to sell medical devices exclusively as referred to in clause zb of rule 3. This aims to establish a structured process for such entities to obtain a registration certificate.
**4. Background and Rationale:**
This amendment likely addresses a gap in the existing Medical Devices Rules, 2017. The introduction of the registration certificate (Form MD42) suggests that a segment of entities involved in the sale and distribution of medical devices, particularly those dealing with specific types of medical devices (as referenced in clause zb of rule 3), were not adequately covered under the existing licensing framework. This amendment seeks to bring these entities under regulatory oversight, ensuring compliance with quality and safety standards in the distribution chain.
**5. Key Provisions / Changes:**
The Medical Devices Fifth Amendment Rules, 2022, introduces the following changes to the Medical Devices Rules, 2017:
* **Rule 34 Amendment:** Inserts "or registration certificate in Form MD42" after "wholesale licence for sale or distribution" in subrule 1.
* **Rule 87 Amendment:** Inserts subrule 1A which mandates that any person not holding licence under subrule 1 and intends to sell medical devices exclusively as referred to in clause zb of rule 3, shall obtain registration certificate as provided in these rules.
* **New Rules 87A, 87B, 87C, and 87D:** These new rules detail the entire registration process:
* **Rule 87A:** Establishes the registration certificate process. An application in Form MD41 must be submitted to the State Licensing Authority, accompanied by fees (specified in the Second Schedule), a self-certificate of Good Distribution Compliance, details of the applicant, proof of premises ownership/occupancy, details of competent technical staff, a description of other activities carried out, and an undertaking to comply with storage requirements. The State Licensing Authority must grant or reject the application within ten days, with reasons for rejection recorded in writing. An appeal process to the State Government is provided for rejected applications.
* **Rule 87B:** Outlines the conditions of the registration certificate. This includes displaying the certificate prominently, providing adequate storage, maintaining requisite temperature and lighting, purchasing devices only from authorized sources (importer, licensed manufacturer, or registered/licensed entity), and maintaining detailed records of purchases and sales, which are subject to inspection by a Medical Device Officer.
* **Rule 87C:** Defines the validity of the registration certificate as perpetual, subject to a retention fee every five years. Late fees are applied for delayed payments, and non-payment leads to cancellation of the registration certificate.
* **Rule 87D:** Outlines the suspension and cancellation process. Contravention of the Act or Rules can lead to suspension or cancellation by the State Licensing Authority after providing an opportunity to show cause. An appeal process to the State Government is provided.
* **Second Schedule Amendment:** Adds fees for registration and retention (INR 3000 each). Specifically, adds entries related to Rules 87A3 and 87C1.
* **Fourth Schedule Amendment:** Modifies the Power of Attorney application form for import licenses to include "or registration certificate".
* **Appendix Amendment:** Inserts new Forms MD41, MD42, and MD43 related to the registration process. These forms relate to the application for the registration certificate, the registration certificate itself, and the inspection book to be maintained by the certificate holder.
* **Forms MD14, MD15, MD26 and MD28 Amendments:** Includes "or registration certificate" after "manufacturing licence".
The effect of these changes is the formal creation of a registration system and supporting guidelines for a defined group of medical device sellers and distributors, requiring them to adhere to specific standards and be subject to regulatory oversight.
**6. Target Audience and Stakeholders:**
The primary target audience of this amendment is any person not holding licence under subrule 1 and intends to sell medical devices exclusively as referred to in clause zb of rule 3, specifically those involved in selling, stocking, exhibiting, or distributing medical devices, including in vitro diagnostic medical devices, that do not currently require a license under the existing rules. Other stakeholders include:
* State Licensing Authorities: Responsible for implementing the registration process.
* Medical Device Officers: Responsible for inspecting premises and ensuring compliance.
* Manufacturers and Importers: As entities from whom registered distributors must purchase devices.
**7. Implementation Aspects (Inferred):**
* **Responsible Agency/Bodies:** State Licensing Authorities are primarily responsible for issuing and overseeing the registration certificates. Medical Device Officers are responsible for inspections.
* **Timelines/Procedures:** The State Licensing Authority has ten days to process applications. Appeals against rejections can be filed within forty-five days, with the State Government having sixty days to dispose of the appeal. The registration certificate is valid in perpetuity, subject to a five-year retention fee.
* **Specific Changes:** Implementation will require State Licensing Authorities to establish processes for receiving and processing applications in Form MD41, issuing registration certificates in Form MD42, and conducting inspections using Form MD43. Existing systems may need to be updated to accommodate the new registration category.
**8. Expected Outcomes / Impact of Changes:**
The likely intended outcome of these amendments is to improve the regulation and oversight of the medical device distribution chain. By requiring registration and adherence to specific conditions, the amendment aims to:
* Ensure that entities selling certain medical devices meet minimum quality and safety standards.
* Enhance traceability of medical devices through record-keeping requirements.
* Provide a mechanism for enforcement and accountability through inspections and potential suspension/cancellation of registration.
* Create a more level playing field by bringing previously unregulated entities under the purview of the Medical Devices Rules, 2017.
**9. Conclusion:**
The Medical Devices Fifth Amendment Rules, 2022, represent a significant update to the regulatory framework for medical devices in India. By introducing a registration certificate for previously unregulated entities involved in the sale and distribution of specific types of medical devices, the amendment aims to strengthen oversight and ensure compliance with quality and safety standards across the supply chain. This amendment is expected to have a positive impact on the safety and reliability of medical devices available to the public.
Key Entities Referenced
Medical Devices Rules, 2017: A set of rules pertaining to medical devices, which is being amended by this notification.
Drugs and Cosmetics Act, 1940: An act of the Indian Parliament related to drugs and cosmetics, under sections 12 and 33 of which the current notification is issued.
New Delhi: Location where the notification was issued.
Ministry of Health and Family Welfare: The government ministry responsible for issuing the notification.
Department of Health and Family Welfare: Department within the Ministry of Health and Family Welfare that is involved in the notification.
Medical Devices Fifth Amendment Rules, 2022: The short title of the rules introduced by this notification.
Drugs Technical Advisory Board: A board consulted by the Central Government before making the amendments to the Medical Devices Rules, 2017.
Form MD42: A form mentioned in the notification related to registration certificate for sale or distribution.
Form MD41: A form mentioned in the notification related to application for registration certificate for sale or distribution.
Form MD43: A form mentioned in the notification related to inspection book maintained by registration certificate holder.
State Licensing Authority: Authority responsible for issuing registration certificates.
State Government: The governmental body to which appeals can be made regarding decisions of the State Licensing Authority.
Good Distribution Compliance: Compliance standard referenced in the notification.
Medical Device Officer: Officer appointed under rule 18 responsible for inspection and making enquiries about medical devices.
रजजस्ट्री स.ं डी.एल.- 33004/99 REGD. No. D. L.-33004/99
xxxGIDHxxx
xxxGIDExxx
सी.जी.-डी.एल.-अ.-03102022-239316
CG-DL-E-03102022-239316
ऄसाधारण
EXTRAORDINARY
भाग II—खण् ड 3—ईप-खण्ड (i)
PART II—Section 3—Sub-section (i)
प्राजधकार स ेप्रकाजित
PUBLISHED BY AUTHORITY
स.ं 672] नइ दद्ली, िुक्रवार, जसतम्ब र 30, 2022/अजव न 8, 1944
No. 672] NEW DELHI, FRIDAY, SEPTEMBER 30, 2022/ASVINA 8, 1944
स्ट्व ास्ट्् य रर पिरवार क्य ाण मरालं ालय
(स्ट्व ास्ट्् य रर पिरवार क्य ाण जवभाग
ऄजधसचू ना
नइ दद्ल ी, 30 जसतम्ब र, 2022
सा.का.जन. 754 (ऄ).—जचदकत्सा युजि जनयम, 2017 का रर संिोधन करने 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) ऄधीन यथा-ऄपेजित, भारत सरकार के स्ट् वास्ट् ् य रर पिरवार क् याण मंरालालय (स्ट् वास्ट् ् य रर पिरवार क् याण
जवभाग) की ऄजधसूचना सं. सा.का.जन. 104(ऄ), तारीख 9 फ़रवरी, 2022 द्वारा भारत के राजपराल, ऄसाधारण, भाग II,
खंड 3, ईपखंड (i) में प्रकाजित दकया गया था, जजसमें ईन सभी व् यजियों स,े जजनके ईससे प्रभाजवत होने की संभावना ह ै
ईस तारीख स,े जजसको ईक्त ऄजधसूचना वाली राजपराल की प्रजतयां जनता को ईपलब् ध करा दी गइ थं, पैंतालीस ददनों की
ऄवजध के समाजि से पहले अिपे रर सुझाव अंमजरालत दकए गए थे;
रर, ईि राजपराल की प्रजतयां 10 फ़रवरी, 2022 को जनता को ईपलब् ध करा दी गइ थं;
रर केन्द रीय सरकार द्वारा ईक्त प्रारूप जनयमों पर जनता स े प्राि अिेप 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, ओषजध तकनीकी सलाहकार बोड ड से परामिड करन े के पश्चात,् जचदकत्सा
युजि जनयम, 2017 का रर सिं ोधन करने के जलए जनम्न जलजखत जनयम बनाती ह,ै ऄथाडत:् —
1. (1) आन जनयमों का संजिि नाम जचदकत्सा युजि (पांचवां संिोधन जनयम, 2022 ह।ै
(2 य ेराजपराल में ईनके प्रकािन की तारीख को प्रवृत होंगे।
6635 GI/2022 (1)2 THE GAZETTE OF INDIA : EXTRAORDINARY [PART II—SEC. 3(i)]
2. जचदकत् सा युजि जनयम, 2017 (जजसे आसम ें आसके पश्चात ् ईि जनयम कहा गया ह ै , जनयम 34 के ईपजनयम (1 म ें “थोक
रूप म ें जवक्रय या जवतरण करने की ऄनुज्ञजि’’ िब्दों के पश्चात “या प्ररूप एमडी-42 म ें रजजस्ट्रीकरण प्रमाण पराल’’ िब्द
रर ऄिर ऄंतःस्ट्थाजपत दकए जाएंगे।
3. ईि जनयमों म,ें जनयम 87 के ईपजनयम (1 के पश्चात,् जनम्नजलजखत ईपजनयम ऄंतःस्ट्थाजपत दकए जाएंग,े ऄथाडत्:—
"(1क कोइ भी व्यजि जो की ईपजनयम (1) के ऄधीन ऄनुज्ञजि नहं धारण करता ह ै रर जो जविेष रूप से जनयम
3 के खडं (य ख म ें जनर्ददष्ट जचदकत्सा युजि की जबक्री के जलए अिजयत ह,ै आन जनयमों में जनर्ददष्ट प्रावधान के
ऄनुसार रजजस्ट्रीकरण प्रमाण पराल प्राि करेगा।”
4. ईि जनयमों म,ें जनयम 87 के पश्चात्, जनम्नजलजखत जनयमों को ऄंतःस्ट्थाजपत दकया जाएगा, ऄथाडत्:—
"87क. आन जवरो नदै ाजनक जचदकत्सा यजु ि सजहत दकसी जचदकत्सा यजु ि की जबक्री, स्ट्टॉक, प्रदिनड या जबक्री के जलए
प्रस्ट्ततु करन ेया जवतिरत करन ेके जलए रजजस्ट्रीकरण प्रमाण पराल.—
(1 राज्य ऄनज्ञु ापन प्राजधकारी, आस भाग में यथा जवजनर्ददष्ट दकए गए िेरालों के जलए रजजस्ट्रीकरण प्रमाणपराल जारी
करने के प्रयोजन से ऄनज्ञु ापन प्राजधकारीयों की जनयुजि करेगा।
(2 कोइ भी व्यजि जो आन जवरो नैदाजनक जचदकत्सा युजि सजहत दकसी जचदकत्सा युजि की जबक्री, स्ट्टॉक, प्रदिडन
या जबक्री के जलए प्रस्ट्तुत करने या जवतिरत करने के जलए अिजयत ह,ै वह जबक्री, स्ट्टॉक, प्रदिडन या जबक्री या
जवतरण के जलए रजजस्ट्रीकरण प्रमाण पराल प्रदान करन े के जलए राज्य ऄनुज्ञापन प्राजधकरण को प्ररूप एमडी-
41 में अवेदन करेगा।
(3 ईपजनयम (2 के ऄधीन दकए गए अवेदन के साथ जनजम्नजलजखत प्रस्ट्ततु दकए जाएगं :े —
(i) जद्वतीय ऄनुसूची म ेंजनधाडिरत ि्ु क;
(ii) ऄच्छे जवतरण ऄनुपालन के संबंध में ऄनुपालन का स्ट्व-प्रमाण पराल;
(iii) पहचान प्रमाण ऄथाडत अधार काडड या पैन काडड के साथ साथ अवेदक/फम ड के गठन सजहत ईसका
जववरण,
(iv) पिरसर के दकराये पर होन े पर स्ट्वाजमत्व या ऄजधभोग के संबंध में दस्ट्तावेजी साक्ष्य;
(v) ईन सिम तकनीकी कमडचािरयों का जववरण जजनके जनदेिन रर पयडवेिण के ऄधीन जचदकत्सा
युजि की जबक्री गजतजवजध िरूु की जाएगी रर ऐस े कमचड ािरयों के पास जनम्नजलजखत िैजिक
योग्यता रर ऄनुभव होगा,—
(क दकसी मान्दयता प्राि जवश्वजवद्यालय/ संस्ट्थान का जडग्री धारक हो, या
(ख) रजजस्ट्रीकृत फामाडजसस्ट्ट हो; या
(ग दकसी मान्दयता प्राि बोडड से आंटरमीजडएट परीिा या आसके समकि परीिा ईत्तीणड की हो
रर जचदकत्सा युजि की जबक्री के संबंध में एक वषड का ऄनुभव रखते हों
(vi) अवेदक द्वारा की गइ ऄन्दय गजतजवजधयों के संबंध म ें संजिि जववरण, जैसे: दवाओं, जचदकत्सा
सामजग्रयों, खाद्य ईत्पादों, स्ट्टेिनरी अदद का भडं ारण या ईि पिरसर में अवेदक द्वारा की गइ कोइ
ऄन्दय गजतजवजध
(vii) आस अिय का वचनबंध दक जचदकत्सा युजि की जबक्री, स्ट्टॉक, प्रदिडन या जबक्री या जवतरण के जलए
भंडारण अवयकताओं का ऄनपु ालन दकया जाएगा।
(4 राज्य ऄनुज्ञापन प्राजधकरण, ईप-जनयम (2 के ऄधीन अवेदन करन े की तारीख स े दस ददनों के भीतर
दस्ट्तावेजों की जांच के बाद रर आस त्य से संतष्टु होन े पर दक आन जनयमों की ऄपेिाओं का ऄनुपालन दकया
गया ह,ै प्ररूप एमडी -42 में रजजस्ट्रीकरण प्रमाण पराल प्रदान करेगा, या यदद वह संतुष्ट नहं ह,ै तो जलजखत म ें
दजड दकए जाने वाले कारणों स ेअवेदन को ऄस्ट्वीकार कर दगे ा।
(5 यदद दकसी जचदकत्सा युजि की जबक्री, स्ट्टॉक, प्रदिडन ऄथवा जबक्री या जवतरण या प्रस्ट्तुत करने के जलए
रजजस्ट्रीकरण प्रमाण पराल प्रदान करने का अवेदन पराल ईप जनयम (4 के ऄंतगडत रद्द कर ददया जाता ह ै तो[भाग II—खण् ड 3(i)] भारत का राजपराल : ऄसाधारण 3
प्रभाजवत व्यजि, ऐसे रद्दकरण के प्राि होने की तारीख से 45 ददनों के ऄंदर राज्य सरकार को ऄपील कर
सकता ह,ै जो ऐसी पूछताछ के बाद रर ऄपीलकताड को सुनवाइ का एक ऄवसर देने के बाद ऐसी ऄपील प्राि
होने की तारीख स े60 ददनों के ऄवजध के ऄंदर ईसका जनपटान कर सकता ह।ै
87 ख. आन जवरो नदै ाजनक जचदकत्सा यजु ि सजहत दकसी जचदकत्सा यजु ि को बचे न,े स्ट्टॉक करन,े प्रदर्शित या जबक्री के जलए
प्रस्ट्ततु करन े या जवतिरत करन े के जलए रजजस्ट्रीकरण प्रमाण पराल की ित.ें — (1) जनयम 87 के ऄधीन प्रदान दकया गया
रजजस्ट्रीकरण प्रमाण पराल अम लोगों के जलए ददखाइ देन े वाल ेपिरसर म ें दकसी प्रमुख स्ट्थान पर प्रदर्शित दकया जाएगा।
(2) रजजस्ट्रीकरण प्रमाण पराल धारक जचदकत्सा युजि के भंडारण के जलए पयाडि स्ट्थान रर ईजचत भडं ारण की जस्ट्थजत
प्रदान करेगा।
(3) रजजस्ट्रीकरण प्रमाण पराल धारक ऐसे जचदकत्सा युजि की अवयकताओं के ऄनुसार ऄपेजित तापमान रर प्रकाि
व्यवस्ट्था बनाए रखेगा।
(4) जचदकत्सा युजि केवल अयातक या ऄनुज्ञजिधारी जवजनमाडता या रजजस्ट्रीकृत/ ऄनुज्ञजिधारी संस्ट्था से खरीद ेजाएंगे।
(5) ऐसे जचदकत्सा युजि के नाम रर माराला, जवजनमाडताओं/ अयातकों के नाम रर पते, बैच नबं र/लॉट नंबर, समाजि
तारीख को दिाडन े वाल े जचदकत्सा युजि की खरीद रर जबक्री का जववरण सॉफ्टवेयर सजहत आनवॉयस या रजजस्ट्टर
या आलेक्रॉजनक के रूप में पृथक िरकॉडड म ेंऄनुरजित दकया जाएगा।
(6) ईपजनयम (5) म ें जनर्ददष्ट िरकॉडड जनयम 18 के ईपजनयम (2 के ऄधीन जनयुि जचदकत्सा युजि ऄजधकारी द्वारा
जनरीिण के जलए खुले होंग,े जो यदद अवयक हो, जचदकत्सा युजि की खरीद रर जबक्री के बारे में जांच कर सकते ह ैं
रर परीिण के जलए नमून े भी ले सकत े ह।ैं
(7) आन जनयमों के ऄधीन ईज्लजखत सभी रजजस्ट्टरों रर िरकाडों को ऄंजतम प्रजवजष्ट से कम से कम दो वषड की ऄवजध के
जलए संरजित रखा जाएगा।
(8) रजजस्ट्रीकरण प्रमाण पराल धारक को प्ररूप एमडी -43 में एक जनरीिण पुजस्ट्तका बनाए रखनी होगी तादक जचदकत्सा
युजि ऄजधकारी ऄपनी िटप्पजणयों रर पाइ गइ खाजमयों को िरकॉडड कर सके।
87ग. रजजस्ट्रीकरण प्रमाण पराल की वधै ता.— (1 प्ररूप एमडी-42 में जारी दकया गया रजजस्ट्रीकरण प्रमाण पराल, जब तक
आसे राज्य ऄनुज्ञापन प्राजधकरण द्वारा जनलंजबत या रद्द नहं दकया जाता है, स्ट्थायी रूप से वैध रहगे ा, जो आसके जारी होने
की तारीख से पांच वषड की ऄवजध पूरी होन े से पहले दसू री ऄनुसूची में जवजनर्ददष्ट रजजस्ट्रीकरण प्रमाण पराल प्रजतधारण ि्ु क
के भुगतान के िताधड ीन ह:ै
परन्दत,ु यदद रजजस्ट्रीकरण प्रमाण पराल धारक जनयत तारीख को या ईससे पहले अवयक रजजस्ट्रीकरण प्रमाण पराल
प्रजतधारण ि्ु क का भगु तान करने म ें जवफल रहता ह,ै तो रजजस्ट्रीकरण प्रमाण पराल धारक, रजजस्ट्रीकरण प्रमाण पराल
प्रजतधारण ि्ु क के ऄजतिरि, छह महीने के भीतर हर महीने या ईसके दकसी जहस्ट्स े के जलए रजजस्ट्रीकरण प्रमाण पराल
प्रजतधारण ि्ु क के दो प्रजतित की दर स ेपिरकजलत दकए गए जवलंब ि्ु क का भगु तान करन ेके जलए ईत्तरदायी होगा। ।
परंतु यह भी दक, पहले ईपबंध म ें जवजनर्ददष्ट ईस ऄवजध के भीतर ऐसे िु्क का भुगतान न दकए जाने की जस्ट्थजत म,ें
रजजस्ट्रीकरण प्रमाण पराल को रद्द कर ददया गया समझा जाएगा।
87 (घ रजजस्ट्रीकरण प्रमाण पराल का जनलबं न रर रद्दकरण.—(1 जहा ं रजजस्ट्रीकरण प्रमाण पराल धारक, ऄजधजनयम या आन
जनयमों के दकसी भी प्रावधान का ई्लंघन करता ह,ै तो राज्य ऄनुज्ञापन प्राजधकरण, रजजस्ट्रीकरण प्रमाण पराल धारक को
कारण बताने का ऄवसर दने े के बाद दक ऐसा अदेि क्यों पािरत नहं दकया जाना चाजहए, एक अदेि द्वारा रर जलजखत
रूप म ें दज ड दकए जान े वाल े कारणों से, आसे ऐसी ऄवजध के जलए जनलंजबत कर दगे ा जो वह या तो पूरी तरह से या दकसी भी
जचदकत्सा युजि के संबंध म ेंअवयक समझता ह ैया रजजस्ट्रीकरण प्रमाण पराल रद्द करें।
(2 ऐसा रजजस्ट्रीकरण प्रमाण पराल धारक जजसका रजजस्ट्रीकरण प्रमाण पराल ईपजनयम (1 के ऄधीन राज्य ऄनज्ञु ापन
प्राजधकरण द्वारा जनलंजबत या रद्द कर ददया गया ह,ै ऐसे प्राजधकरण के अदेि की प्रजत प्राि होने के पैंतालीस ददनों के
भीतर, राज्य सरकार को ऄपील कर सकता ह ै रर राज्य सरकार रजजस्ट्रीकरण धारक को सनु वाइ का एक ऄवसर द े
कर, जलजखत रूप म ें दजड दकए जाने के कारणों के साथ, आस तरह के अदिे की पुजष्ट, ईसे बदल या संिोजधत कर
सकेगा ।” ।4 THE GAZETTE OF INDIA : EXTRAORDINARY [PART II—SEC. 3(i)]
5. ईि जनयमों म,ें जनयम 88 के ईपजनयम (1) म,ें “खुदरा या थोक” िब्दों के पश्चात,् "या प्ररूप एमडी-42 में
रजजस्ट्रीकरण प्रमाणपराल" िब्द िाजमल दकया जाएगा।
6. ईि जनयमों की दसू री ऄनुसूची म,ें—
(क) ईपबंध के सन्ददभ ड भाग म,ें "64(1 , 81(1 , 84" ऄंकों रर कोष्ठक के पश्चात् तथा ऄंक "91" से पहले जनम्नजलजखत
ऄंक, ऄिर रर कोष्ठक िाजमल दकए जाएंग,े ऄथाडत:्—
“87क(3), 87ग(1) रर”;
(ख) सारणी के क्रम संखयांक 51 रर ईससे संबंजधत प्रजवजष्टयों के पश्चात्, जनम्नजलजखत क्रम संखयांक रर प्रजवजष्टया ाँ
िाजमल की जाएंगी, ऄथाडत:्—
क्रमांक जनयम जवषय जहां डॉलर ($) म ें जनर्ददष्ट हो को छोड़कर,
रुपये म ें(₹)
(1) (2) (3) (4)
“52. 87क(3) जचदकत्सा युजि की जबक्री हते ु 3000
रजजस्ट्रीकरण प्रमाणपराल
53. 87ग(1) जचदकत्सा युजि की जबक्री के जलए 3000”
रजजस्ट्रीकरण प्रमाण पराल को
बनाए रखन े का ि्ु क
7. ईि जनयमों की चौथी ऄनुसूची म,ें भाग I म,ें अयात ऄनज्ञु जि जारी करने के जलए मुखतारनामा के अवेदन के प्रारूप के
पैरा 1 म ें "जवजनमाडण ऄनुज्ञजि" िब्दों के पश्चात,् "या रजजस्ट्रीकरण प्रमाणपराल" िब्द िाजमल दकया जाएगा।
8. ईि जनयमों के पिरजिष्ट म,ें —
(क) प्ररूप एमडी- 40 के पश्चात,् जनम्नजलजखत प्ररूप िाजमल दकए जाएंगे, ऄथाडत:्—
"प्ररूप एमडी -41
[जनयम 87क का ईपजनयम (2) देखें]
आन-जवरो डायग्नोजस्ट्टक जचदकत्सा यजु ि सजहत जचदकत्सा यजु ि को बचे न,े स्ट्टॉक करन,े प्रदर्शित करन ेया जबक्री या
जवतरण के जलए प्रस्ट्ताव हते ुरजजस्ट्रीकरण प्रमाण पराल प्रदान करन ेके जलए अवदे न
1. अवेदक का नाम:
2. रजजस्ट्रीकृत दकए जान े वाले पिरसर का पता:
3. टेलीफोन नंबर, मोबाआल नंबर, फैक्स नंबर रर इमले अइडी सजहत अवेदक का संपकड जववरण:
4. अवेदक की प्रकृजत रर गठन: (ऄथाडत ् स्ट्वाजमत्व, सीजमत देयता साझेदारी सजहत साझेदारी, जनजी या सावडजजनक
कंपनी, समाज, रस्ट्ट, ऄन्दय जवजनर्ददष्ट करें :
5. जनयुि दकए गए सिम व्यजि का नाम, योग्यता रर ऄनुभव:
6. िु्क भगु तान की तारीख___________ रुपये _____________ रसीद/चालान/लेनदेन अइडी ___________
7. मैंने जचदकत्सा युजि जनयम, 2017 के जनयम 87क के ईपजनयम (3) में जनर्ददष्ट दस्ट्तावेजों को संलग्न कर ददया ह।ै
स्ट्थान: __________
तारीख: ___________
जनदेिक/ स्ट्वत्वधारी /साझेदार का नाम, पदनाम रर हस्ट्तािर
प्ररूप एमडी-42
[जनयम 87क के ईपजनयम (4 रर जनयम 87ग के ईपजनयम (1) देख]ें[भाग II—खण् ड 3(i)] भारत का राजपराल : ऄसाधारण 5
आन-जवरो डायग्नोजस्ट्टक जचदकत्सा यजु ि सजहत जचदकत्सा यजु ि को बचे न,े स्ट्टॉक करन,े प्रदर्शित करन ेया जबक्री या जवतरण के
जलए प्रस्ट्ताव हते ु रजजस्ट्रीकरण प्रमाण पराल
रजजस्ट्रीकरण संखयांक: ………………
1. मैससड, …………………………………………………………(फमड का नाम , स्ट्थान …………
………………………………… (टेलीफोन रर इ-मेल सजहत पूरा पता को जचदकत्सा युजि जनयम, 2017 के ऄधीन
आन-जवरो डायग्नोजस्ट्टक मेजडकल युजि सजहत जचदकत्सा युजि को बेचने, स्ट्टॉक करन,े प्रदर्शित करने या जबक्री या जवतरण के
जलए प्रस्ट्ताव हते ु रजजस्ट्रीकृत दकया जाता ह।ै
2. सिम व्यजि का नाम रर योग्यता:
3. यह रजजस्ट्रीकरण रषजध रर प्रसाधन सामग्री ऄजधजनयम, 1940 (1940 का 23 रर जचदकत्सा युजि जनयम, 2017
में जनर्ददष्ट ितों के ऄध्यधीन ह।ै
स्ट्थान: __________
तारीख: ___________
राज्य ऄनुज्ञापन प्राजधकारी
प्ररूप एमडी-43
[जनयम 87ख का ईपजनयम (8) देखें]
प्ररूप जजसम ें जनरीिण पजु स्ट्तका रखी जाएगी
(क जनरीिण पुजस्ट्तका के कवर पर जनम्नजलजखत जववरण होगा, ऄथाडत्:—
1. रजजस्ट्रीकरण प्रमाणपराल धारक का नाम रर पता ______________________________
2. रजजस्ट्रीकरण प्रमाणपराल सखं या _____________________________________
(ख (i) जनरीिण पुजस्ट्तका के पृष्ठों को क्रमांदकत दकया जाएगा रर राज्य ऄनुज्ञापन प्राजधकारी द्वारा यथावत मुहर लगाइ
जाएगी। प्रथम रर ऄंजतम पष्ठृ के ऄलावा ऄन्दय पृष्ठों पर जनम्नजलजखत जववरण होंग:े-
पिरसर जनरीिण करन े वाले जचदकत्सा युजि ऄजधकारी का नाम रर पदनाम:
जनरीिण की तारीख ___________________________________________
जचदकत्सा युजि ऄजधकारी की िटप्पजणयां _______________
जचदकत्सा युजि ऄजधकारी के हस्ट्तािर
(ii) जनरीिण पुजस्ट्तका के प्रथम रर ऄंजतम पृष्ठ पर राज्य ऄनज्ञु ापन प्राजधकारी द्वारा जनम्नजलजखत िब्दों में पृष्ठांकन दकया
जाएगा, ऄथाडत:्—
जचदकत्सा युजि जनयम, 2017 के ऄधीन प्ररूप एमडी-43______________ में रजजस्ट्रीकरण संखया ______________
के जलए _______________________ पर जस्ट्थत मेससड _______ द्वारा जनरीिण पस्ट्ु तक रखी गइ ।
राज्य ऄनुज्ञापन प्राजधकारी
िटप्पजणयााँ:
(i) ऄनुज्ञजिधारी द्वारा जनरीिण पजु स्ट्तका की मुदरत प्रजत संबंजधत ऄनुज्ञापन प्राजधकारी द्वारा समय-समय पर जनर्ददष्ट
िु्क के भुगतान पर ऄनुज्ञजि प्राजधकारी से प्राि की जा सकती ह।ै
(ii) जनरीिण पुजस्ट्तका ऄनुज्ञजिधारी के पिरसर में रखी जाएगी।
(iii) जचदकत्सा युजि ऄजधकारी द्वारा की गइ िटप्पजणयों की मूल प्रजत ऄनुज्ञजिधारी के पिरसर म ें रखी जाएगी रर दसू री
प्रजत राज्य ऄनुज्ञापन प्राजधकारी को भेजी जाएगी। जचदकत्सा युजि ऄजधकारी द्वारा आस े तीन प्रजतयों को िरकॉड ड के
रूप म ेंजलया जाएगा।”;6 THE GAZETTE OF INDIA : EXTRAORDINARY [PART II—SEC. 3(i)]
(ख) प्ररूप एमडी-14 म,ें परै ा 3 के ईपपैरा (ii) में "जवजनमाडण ऄनज्ञु जि" िब्दों के पश्चात,् "या रजजस्ट्रीकरण
प्रमाणपराल" िब्द ऄंतःस्ट्थाजपत दकया जाएगा।
(ग) प्ररूप एमडी-15 के पैरा 1 म,ें "जवजनमाडण ऄनुज्ञजि" िब्दों के पश्चात,् "या रजजस्ट्रीकरण प्रमाणपराल" िब्द
ऄंतःस्ट्थाजपत दकया जाएगा।
(घ) प्ररूप एमडी-26 म,ें पैरा 3, ईपपैरा (ii) म ें "जवजनमाडण ऄनुज्ञजि" िब्दों के पश्चात,् "या रजजस्ट्रीकरण
प्रमाणपराल" िब्द ऄंतःस्ट्थाजपत दकया जाएगा।
(ङ) प्ररूप एमडी-28 म,ें पैरा 3, ईपपैरा (ii) म,ें "जवजनमाडण ऄनुज्ञजि" िब्दों के पश्चात,् "या रजजस्ट्रीकरण
प्रमाणपराल" िब्द ऄंतःस्ट्थाजपत दकया जाएगा।
[फा.सं. एक् स.11014/15/2021-डीअर]
डॉ. मनदीप के. भण्डारी, संयुक् त सजचव
िटप्पण: जचदकत्सा युजि जनयम, 2017, राजपराल म ें ऄजधसूचना सं. सा.का.जन. 78(ऄ), तारीख 31 जनवरी, 2017 द्वारा
प्रकाजित दकए गए थ े रर ऄजधसूचना स.ं सा.का.जन. 450(ऄ), तारीख 15 जून, 2022 द्वारा ऄंजतमतः संिोजधत
दकए गए थ े।
MINISTRY OF HEALTH AND FAMILY WELFARE
(Department of Health and Family Welfare)
NOTIFICATION
New Delhi, the 30th September, 2022
G.S.R.754(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. 104(E), dated the 9th February, 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 forty-five 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 the 10th February,
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), the Central Government, after consultation with the Drugs Technical Advisory Board, hereby
makes the following rules further to amend the Medical Devices Rules, 2017, namely:—
1. (i) These rules may be called the Medical Devices (Fifth Amendment) Rules, 2022.
(ii) 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 the said rules), in rule 34, in sub-rule (1), after the
words “wholesale licence for sale or distribution”, the words, letters and figure “or registration certificate in Form
MD-42” shall be inserted.
3. In the said rules, in rule 87, after sub-rule (1), the following sub-rule shall be inserted, namely:—
“(1A) Any person not holding licence under sub-rule (1) and intends to sell medical devices exclusively as referred
to in clause (zb) of rule 3, shall obtain registration certificate as provided in these rules.”.
4. In the said rules, after rule 87, the following rules shall be inserted, namely:—
“87A. Registration certificate to sell, stock, exhibit or offer for sale or distribute a medical device
including in vitro diagnostic medical device.— (1) The State Licencing Authority shall appoint[भाग II—खण् ड 3(i)] भारत का राजपराल : ऄसाधारण 7
Licensing Authorities for the purpose of issuing registration certificate under this Part for such areas
as may be specified.
(2) Any person who intends to sell, stock, exhibit or offer for sale or distribute a medical device
including in vitro diagnostic medical device, shall make an application in Form MD-41 to the State
Licensing Authority for grant of registration certificate to sell, stock, exhibit or offer for sale or
distribution.
(3) The application made under sub-rule (2) shall be accompanied with
(i) a fees specified in Second Schedule;
(ii) self certificate of compliance with respect to Good Distribution Compliance;
(iii) details of the applicant or firm including its constitution, along with identification proof,
such as, Aadhar card or PAN card;
(iv) documentary evidence in respect of ownership or occupancy on rental of the premises;
(v) details of competent technical staff, under whose direction and supervision the sales
activity of medical device shall be undertaken, who shall possess the following
educational qualification and experience, namely:—
(a) hold a degree from a recognized University/Institution; or
(b) is a registered pharmacist; or
(c) has passed intermediate examination or its equivalent examination from a
recognised Board with one-year experience in dealing with sale of medical
devices;
(vi) brief description on other activities carried out by applicant, namely, storage of drugs,
medical items, food products, stationeries, etc., or any other activities carried out by the
applicant in the said premises; and
(vii) an undertaking to the effect that the storage requirements to sell, stock, exhibit or offer for
sale or distribute a medical device will be complied with.
(4) The State Licensing Authority shall, after scrutiny of documents and on being satisfied that the
requirements of these rules have been complied with, grant a registration certificate in Form MD-
42, or if not satisfied, reject the application for reasons to be recorded in writing, within ten days
from the date the application is made under sub-rule (2).
(5) If the application for grant of registration certificate to sell, stock, exhibit or offer for sale or
distribute a medical device is rejected under sub-rule (4), the aggrieved person may prefer an
appeal before the State Government within forty-five days from the date of receipt of such
rejection, which may, after such enquiry and after giving an opportunity of being heard to the
appellant, dispose it within a period of sixty days from the date of receipt of such appeal.
87B. Conditions of registration certificate to sell, stock, exhibit or offer for sale or distribute a medical
device including in vitro diagnostic medical device.— (1) The registration certificate granted under
rule 87A shall be displayed at a prominent place in the premises visible to the public.
(2) The registration certificate holder shall provide adequate space and proper storage condition for
storage of the medical devices.
(3) The registration certificate holder shall maintain requisite temperature and lighting as per
requirements of such medical devices.
(4) The medical devices shall be purchased only from importer or licensed manufacturer or registered
or licensed entity.
(5) Separate records, in the form of invoice or register or electronic details including software of
purchases and sales of medical devices showing the names and quantities of such medical devices,
names and addresses of the manufacturers or importers, batch number or lot number and expiry
date (if applicable) shall be maintained.
(6) The records referred to in sub-rule (5) shall be open to inspection by a Medical Device Officer
appointed under the sub-rule (2) of rule 18, who may, if necessary, make enquiries about purchases
and sale of the medical devices and may also take samples for testing.8 THE GAZETTE OF INDIA : EXTRAORDINARY [PART II—SEC. 3(i)]
(7) All registers and records mentioned under these rules, shall be preserved for a period of not less
than two years from the last entry, therein.
(8) The registration certificate holder shall maintain an inspection book in Form MD-43 to enable the
Medical Devices Officer to record his observations and defects noticed.
87C. Validity of registration certificate.— (1) A registration certificate issued in Form MD-42, shall remain
valid in perpetuity, subject to payment of registration certificate retention fee as specified in the Second
Schedule, before completion of the period of five years from the date of its issue, unless, it is suspended
or cancelled by State Licensing Authority:
Provided that, if the registration certificate holder fails to pay the required registration
certificate retention fee on or before due date, the registration certificate holder shall, in addition to the
registration certificate retention fee, be liable to pay a late fee calculated at the rate of two per cent. of
the registration certificate retention fee for every month or part thereof within six months:
Provided further that in the event of non-payment of such fee within the period referred to in
the first proviso, the registration certificate shall be deemed to have been cancelled.
87D. Suspension and cancellation of Registration Certificate.— (1) Where the registration certificate holder
contravenes any provision of the Act or these rules, the State Licensing Authority, shall, after giving the
registration certificate holder an opportunity to show cause as to why such an order should not be
passed, by an order and for reasons to be recorded in writing, suspend it for such period as it considers
necessary either wholly or in respect of any of the medical device or, as the case may be, cancel the
registration certificate.
(2) A registration certificate holder whose registration certificate has been suspended or cancelled by the
State Licensing Authority under sub-rule (1), may within forty-five days of the receipt of a copy of
the order by such authority, prefer an appeal to the State Government and the State Government,
shall after giving the registration holder an opportunity of being heard, confirm, reverse or modify
such order, with reasons to be recorded in writing.”.
5. In the said rules, in rule 88, in sub-rule (1), after the words “retail or wholesale”, the words, letters and figures “or
registration certificate in Form MD-42” shall be inserted.
6. In the said rules, in the Second Schedule,—
(a) in the provisions reference portion, after the figures and brackets “64(1), 81(1), 84,” and before the figure
“91”, the following figures, letters and brackets shall be inserted, namely:—
“87A(3), 87C(1) and”;
(b) in the table, after serial number 51 and the entries relating thereto, the following serial numbers and entries
shall be inserted, namely:—
Sr. No. Rule Subject In rupees (INR) except where
specified in dollars ($)
(1) (2) (3) (4)
“52. 87A(3) Registration certificate for sale of 3000
medical devices
53. 87C(1) Retention fee for registration 3000”
certificate for sale of medical
devices
7. In the said rules, in the Fourth Schedule, in Part I, in the format of application of Power of Attorney for issuance of
import licence, in paragraph 1, after the words “or manufacturing licence”, the words “or registration certificate”
shall be inserted.
8. In the said rules, in the Appendix,—
(a) after Form MD-40, the following Forms shall be inserted, namely:—[भाग II—खण् ड 3(i)] भारत का राजपराल : ऄसाधारण 9
“Form MD-41
[See sub-rule (2) of rule 87A]
APPLICATION FOR GRANT OF REGISTRATION CERTIFICATE TO SELL, STOCK, EXHIBIT OR
OFFER FOR SALE OR DISTRIBUTE A MEDICAL DEVICE INCLUDING IN VITRO DIAGNOSTIC
MEDICAL DEVICE
1. Name of applicant:
2. Address of the premises to be registered:
3. Contact details of applicant including telephone number, mobile number, fax number and email id:
4. Nature and constitution of applicant: (i.e. proprietorship, partnership including Limited Liability Partnership,
private or public company, society, trust, other to be specified)
5. Name, qualification and experience of competent person appointed:
6. Fee paid on _______________ Rs____________________ receipt/challan/transaction Id___________.
7. I have enclosed the documents as specified in the sub-rule (3) of rule 87A of the Medical Devices Rules, 2017.
Place: __________
Date: ___________
Name, designation & signature of
Director/Proprietor/Partner
Form MD-42
[See sub-rule(4) of rule 87A and sub-rule (1) of rule 87C]
REGISTRATION CERTIFICATE TO SELL, STOCK, EXHIBIT OR OFFER FOR SALE OR DISTRIBUTE
A MEDICAL DEVICE INCLUDING IN VITRO DIAGNOSTIC MEDICAL DEVICE
Registration No.: ……………….
1. M/s, ……………………………………………………………………………(Name of the firm) situated at
………………...……………………………………………(full address with telephone and e-mail) has been
registered to sell, stock, exhibit or offer for sale or distribute a medical device including in vitro diagnostic medical
device under the Medical Devices Rules, 2017.
2. Name and qualification of competent person:
3. This registration is subject to the conditions as specified in the Drugs and Cosmetics Act, 1940 (23 of 1940) and the
Medical Devices Rules, 2017.
Place: __________
Date: ___________
State Licensing Authority
Form MD-43
[See sub-rule (8) of rule 87B]
Form in which the Inspection Book shall be maintained
(A) The cover of the inspection book shall contain the following particulars, namely:—
1. The name and address of the registration certificate holder __________
________________________________________.
2. Registration certificate number______________________________.
(B) (i) The pages of the inspection book shall be serially numbered and duly stamped by the State Licensing
Authority*. The pages, other than the first and the last pages, shall have the following particulars:—
Name and designation of the Medical Device Officer who inspected the premises:
Date of inspection ___________________________________________
Observations of the Medical Device Officer _______________________
Signature of the Medical Device Officer10 THE GAZETTE OF INDIA : EXTRAORDINARY [PART II—SEC. 3(i)]
(ii) The first and last pages of the inspection book shall be endorsed by the State Licensing Authority with the
following words, namely:—
Inspection book maintained by M/s _______________________situated at ______________ for Registration
number ______________ in Form MD-43______________ under the Medical Devices Rules, 2017.
State Licensing Authority
Notes:
(i) Printed copy of the inspection book may be obtained by the licencee from the Licensing Authority on
payment of fee as may be specified by the concerned Licensing Authority from time-to-time.
(ii) The inspection book shall be maintained at the premises of the licencee.
(iii) The original copy of observations made by the Medical Device Officer shall be maintained in the
premises of the licencee and duplicate copy shall be sent to the State Licensing Authority. The triplicate
copy shall be taken as record by the Medical Device Officer.”;
(b) in Form MD-14, in paragraph 3, in sub-para (ii), after the words “manufacturing licence”, the words
“or registration certificate” shall be inserted;
(c) in Form MD-15, in paragraph 1, after the words “manufacturing licence”, the words “or registration
certificate” shall be inserted;
(d) in Form MD-26, in paragraph 3, in sub-paragraph (ii), after the words “manufacturing licence”, the
words “or registration certificate” shall be inserted;
(e) in Form MD-28, in paragraph 3, sub-paragraph (ii), after the words “manufacturing licence”, the
words “or registration certificate” shall be inserted.”.
[F. No. X.11014/15/2021-DR]
DR. MANDEEP K. BHANDARI, Jt. Secy.
Note: The Medical Devices Rules, 2017 was published in the Gazette of India, Extraordinary, Part II, section 3, sub-
section (i) vide notification number G.S.R. 78(E), dated the 31st January, 2017 and last amended vide
notification number G.S.R. 450(E), dated the 15th June, 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.