## Policy Analysis Report: Amendment to Medical Devices Rules, 2017
**1. Executive Summary:**
This report analyzes a notification from the Ministry of Health and Family Welfare, Government of India, pertaining to an amendment to the Medical Devices Rules, 2017. The amendment introduces a registration certificate for entities selling medical devices exclusively as defined in rule 3(zb) of the original rules. This change aims to regulate the sale, stocking, exhibition, and distribution of medical devices, particularly in-vitro diagnostic medical devices, by requiring a registration process, adherence to good distribution practices, and ongoing compliance. The key findings relate to the new registration requirements, conditions for maintaining the registration, and the potential impact on businesses involved in the sale and distribution of medical devices.
**2. Introduction:**
The purpose of this report is to provide an informative analysis of the amendment to the Medical Devices Rules, 2017, as detailed in the provided government notification. This analysis focuses on the key changes introduced by the amendment and their potential implications for affected stakeholders. The report is based solely on the information contained within the provided text.
**3. Policy Overview:**
* The amendment modifies the existing Medical Devices Rules, 2017.
* The core objective of this amendment, as inferred from the text, is to expand the regulatory framework to include entities that exclusively sell certain medical devices (as per rule 3(zb)) by introducing a registration certificate requirement. This aims to ensure quality and safety standards are maintained throughout the distribution chain.
**4. Background and Rationale:**
The amendment introduces a registration requirement for persons intending to sell medical devices exclusively as referred to in clause zb of rule 3. This suggests a gap existed in the original rules, potentially leaving a segment of medical device distributors/sellers unregulated. The introduction of the registration certificate likely aims to address this gap by bringing these entities under the purview of the regulatory framework, ensuring adherence to quality standards and traceability.
**5. Key Provisions / Changes:**
The amendment introduces several new provisions centered around the concept of a "Registration Certificate" for entities selling medical devices exclusively as referred to in clause zb of rule 3. Key changes include:
* **New Rule 87A: Registration Certificate:** This introduces the requirement for a registration certificate to sell, stock, exhibit, or offer for sale or distribute a medical device, including in vitro diagnostic medical devices. The State Licensing Authority is responsible for issuing these certificates. Applicants must submit Form MD41 with prescribed fees, self-certification of Good Distribution Compliance, details of the firm, ownership evidence, details of competent technical staff, description of other activities, and an undertaking to comply with storage requirements. The Licensing Authority has ten days to grant or reject the application with reasons.
* **New Rule 87B: Conditions of Registration Certificate:** This outlines the conditions for maintaining the registration, including displaying the certificate, providing adequate storage, maintaining required temperature and lighting, purchasing devices only from licensed sources, maintaining records of purchases and sales (including batch numbers, expiry dates, etc.), preserving records for at least two years, and maintaining an inspection book (Form MD43).
* **New Rule 87C: Validity of Registration Certificate:** The registration certificate is valid in perpetuity, subject to a retention fee every five years. Failure to pay the fee results in a late fee, and ultimately, cancellation of the certificate.
* **New Rule 87D: Suspension and cancellation of Registration Certificate:** The State Licensing Authority can suspend or cancel the registration certificate for contravention of the Act or Rules, after providing an opportunity to show cause. An appeal process to the State Government is provided.
* **New Forms MD41, MD42, MD43:** These forms are introduced for the application, registration certificate, and inspection book, respectively.
* **Amendment to Rule 34:** Wholesale licenses now also apply to registration certificates in Form 42.
* **Amendment to Rule 88:** Subrule 1 now includes reference to Form 42.
* **Second Schedule Amendments:** Includes fee information for registration and retention of the certificate (Rule 87A3 and 87C1, INR 3000 each).
* **Fourth Schedule, Form MD14, MD15, MD26, MD28 Amendments:** The words "or registration certificate" are inserted into these forms.
**Effect of the Change:** The introduction of the registration certificate creates a new regulatory layer for businesses exclusively selling specific medical devices, requiring them to adhere to certain standards and undergo inspection. This places new obligations on these businesses but also potentially formalizes their operations and increases consumer confidence.
**6. Target Audience and Stakeholders:**
The primary target audience for this amendment is businesses or individuals intending to exclusively sell medical devices as defined in clause zb of rule 3 of the Medical Device Rules, 2017. Other stakeholders include:
* State Licensing Authorities responsible for issuing and overseeing the registration certificates.
* Medical Device Officers responsible for inspecting premises and enforcing compliance.
* The Ministry of Health and Family Welfare, responsible for overall policy and regulation.
* Manufacturers and importers of medical devices, who are identified as the legitimate sources from which registered entities can purchase devices.
**7. Implementation Aspects (Inferred):**
* **Responsible agency:** The State Licensing Authority is responsible for issuing and overseeing the registration certificates and for suspending or cancelling them.
* **Timelines:** The State Licensing Authority has ten days to process an application for a Registration Certificate (Rule 87A(4)). An aggrieved person can appeal a rejection within forty-five days, and the State Government has sixty days to dispose of the appeal. Retention fees are required every five years.
* **Procedures:** The text outlines the application process (Form MD41), the requirements for granting the certificate, the conditions of maintaining the certificate, and the process for suspension and cancellation.
**8. Expected Outcomes / Impact of Changes:**
The likely intended outcome of these amendments is improved regulation and oversight of the sale and distribution of specific medical devices. This could lead to:
* Increased compliance with quality standards and good distribution practices.
* Improved traceability of medical devices.
* Enhanced consumer protection through assurance of device quality and safety.
* Formalization of a previously unregulated segment of the medical device market.
**9. Conclusion:**
The amendment to the Medical Devices Rules, 2017, introduces a significant change by requiring registration for entities exclusively selling certain medical devices. This amendment introduces new requirements, timelines, and processes for businesses involved in the sale and distribution of these devices. This change is significant because it aims to close regulatory gaps and improve the overall quality and safety of medical devices available to the public. Affected stakeholders should carefully review the new rules and take necessary steps to comply with the registration requirements to avoid potential penalties.
Key Entities Referenced
Medical Device Rules, 2017: A set of rules pertaining to medical devices, which this notification proposes to amend.
Drugs and Cosmetics Act, 1940: An act of the Indian parliament related to drugs and cosmetics, cited as the source of authority for the proposed rules.
Drugs Technical Advisory Board: An advisory board consulted in the process of amending the Medical Device Rules, 2017.
Ministry of Health and Family Welfare: The Indian government ministry responsible for health and family welfare, specifically the Department of Health and Family Welfare.
Under Secretary Drugs: Position within the Ministry of Health and Family Welfare to whom objections and suggestions regarding the draft rules should be addressed.
Government of India: The governing authority of India.
Nirman Bhavan, New Delhi 110011: Location of the office of the Under Secretary Drugs, Ministry of Health and Family Welfare.
Medical Devices ......Amendment Rules, 2022: The name of the rules being amended in 2022.
Form42: A form related to registration certificates, referenced in the context of wholesale licenses for sale or distribution.
Form MD41: The form to be used when applying for a Registration Certificate to sell, stock, exhibit or offer for sale or distribute a medical device including in vitro diagnostic medical device
State Licensing Authority: Authority responsible for issuing Registration Certificates for medical devices.
Form MD42: The Registration Certificate to sell, stock, exhibit or offer for sale or distribute a medical device including in vitro diagnostic medical device.
State Government: The government of the state, which an appeal can be made to.
Form MD43: Form in which the Inspection Book shall be maintained
Medical Device Officer: Officer that can inspect the premises of the Registration Certificate holder to ensure compliance.
G.S.R. 78E: Notification number for the principal rules published in the Official Gazette, dated the 31st January, 2017.
Ring Road, Mayapuri, New Delhi110064: Address of the Dte. of Printing at Government of India Press
Delhi110054: Location of the Controller of Publications.
रजजस्ट्री स.ं डी.एल.- 33004/99 REGD. No. D. L.-33004/99
सी.जी.-डी.एल.-अ.-10022022-233279
xxxGIDHxxx
CG-DL-E-10022022-233279
xxxGIDExxx
ऄसाधारण
EXTRAORDINARY
भाग II—खण् ड 3—ईप-खण्ड (i)
PART II—Section 3—Sub-section (i)
प्राजधकार स ेप्रकाजित
PUBLISHED BY AUTHORITY
स.ं 102] नइ दद्ली, बुधवार, फरवरी 9, 2022/माघ 20, 1943
No. 102] NEW DELHI, WEDNESDAY, FEBRUARY 9, 2022/MAGHA 20, 1943
स्ट्व ास्ट्् य रर पिरवार क्य ाण मरं ालय
(स्ट्व ास्ट्् य रर पिरवार क्य ाण जवभाग)
ऄजधसचू ना
नइ दद्ली, 9 फरवरी, 2022
सा.का.जन. 104(ऄ).—जचदकत्सा युजि जनयम, 2017 का रर संिोधन करन े के जलए कजतपय जनयमों के
जनम्नजलजखत प्रारूप, जजसे केन्द्रीय सरकार रषजध तकनीकी सलाहकार बोडड के परामिड से रषजध रर प्रसाधन सामग्री
ऄजधजनयम, 1940 (23 के 1940) की धारा 12 की ईपधारा (1) रर धारा 33 की ईपधारा (1) द्वारा प्रदत्त िजियों का
प्रयोग करते हुए, आसके द्वारा प्रभाजवत होने की संभावना वाले सभी व्यजियों की जानकारी के जलए प्रकाजित दकया जाता ह ै
रर एतद द्वारा सूचना दी जाती ह ै दक ईक्त प्रारूप जनयमों पर ईस तारीख से पततालीस ददनों की ऄवजध समा् त होने पर
या ईसके बाद जवचार दकया जाएगा जजस तारीख को आन प्रारूप जनयमों वाल े भारत के राजपर की प्रजतया ं जनता को
ईपलब्ध कराइ जाएगी;
केन्द्रीय सरकार द्वारा ईपयुडि जवजनर्ददष्ट ऄवजध के भीतर दकसी भी व्यजि से प्राप्त होने वाली अपजत्तयों रर
सुझावों पर जवचार दकया जाएगा;
अपजत्तयां रर सुझाव, यदद कोइ हों, तो ऄवर सजचव, (रषजध), स्ट्वास्ट््य रर पिरवार क्याण मंरालय, भारत
सरकार, कमरा सं. 434, सी ववग, जनमाडण भवन, नइ दद्ली - 110011 को ऄग्रेजषत दकया जाए ऄथवा drugsdiv-
mohfw@gov.in पर इ-मेल की जाए।
879 GI/2022 (1)2 THE GAZETTE OF INDIA : EXTRAORDINARY [PART II—SEC. 3(i)]
प्रारूप जनयम
1. (i) आन जनयमों को जचदकत्सा युजि (….संिोधन) जनयम, 2022 कहा जाएगा।
(ii) ये जनयम, जब तक ऄन्द्यथा जवजनर्ददष्ट न हो, राजपर में आनके ऄंजतम प्रकािन की तारीख को प्रभावी होंगे।
2. जचदकत् सा युजि जनयम2 2017 (जजस े आसम ें आसके पश्चात ् ईि जनयम कहा गया ह)ै , जनयम 34 ईपजनयम (1)
‘’जवक्रय या जवतरण हते ु थोक ऄनुज्ञजप्त’’ िब्दों के पश्चात रर ‘’आन जनयमों के तहत’’ िब्दों से पूवड जनजम्नजलजखत
िब्द रर अंकडे िाजमल दकए जाएंगे, ऄथाडत:—
“या प्ररूप-42 में रजजस्ट्रीकरण प्रमाण पर’’
3. ईि जनयमों म,ें जनयम 87 म,ें ईपजनयम (1) के ऄंत म,ें जनम्नजलजखत ईपजनयम िाजमल दकया जाएगा, ऄथाडत्:—
"(1) (क) ईपजनयम (1) म ें ऄंतर्ववष्ट दकसी बात के होते हुए भी, जैसा दक जनयम 3 के खडं (य ख) में जनर्ददष्ट ह ै कोइ
भी व्यजि जो जविेष रूप स े जचदकत्सा युजि की जबक्री को मंिा रखता ह,ै आन जनयमों म ें आसके पश्चात दकए गए
प्रावधान के ऄनुसार रजजस्ट्रीकरण प्रमाण पर प्राप्त करेगा।”
4. ईि जनयमों म,ें जनयम 87 के बाद, जनम्नजलजखत जनयमों को िाजमल दकया जाएगा, ऄथाडत:्—
"87 (क) 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 पर
(1) राज्य ऄनज्ञु ापन प्राजधकारी, आस भाग में यथा जवजनर्ददष्ट दकए गए क्षेरों के जलए रजजस्ट्रीकरण प्रमाणपर 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 की मंिा रखता ह,ै वह जबक्री, स्ट्टॉक, प्रदिनड या जबक्री या
जवतरण के जलए रजजस्ट्रीकरण प्रमाण पर प्रदान करने के जलए राज्य ऄनज्ञु ापन प्राजधकरण को प्ररूप एमडी-
41 में अवेदन करेगा।
(3) ईप-जनयम (2) के तहत दकए गए अवेदन के साथ जनजम्नजलजखत प्रस्ट्ततु दकए जाएगं :े —
i. ईि जनयमों की जद्वतीय ऄनुसूची में जनधाडिरत ि्ु क;
ii. ऄच्छे जवतरण ऄनुपालन के संबंध में ऄनुपालन का स्ट्व-प्रमाण पर;
iii. पहचान प्रमाण ऄथाडत अधार काडड, पैन काड डके साथ साथ अवेदक/फमड के गठन सजहत ईसका जववरण,
iv. पिरसर के दकराये पर होन े पर स्ट्वाजमत्व या ऄजधभोग के संबंध में दस्ट्तावेजी साक्ष्य;
v. ईन सक्षम तकनीकी कमडचािरयों का जववरण जजनके जनदेिन रर पयडवेक्षण के तहत जचदकत्सा युजि की जबक्री
गजतजवजध िरूु की जाएगी रर ऐसे कमडचािरयों के पास जनम्नजलजखत िैजक्षक योग्यता रर ऄनुभव होगा,—
(क) दकसी मान्द्यता प्राप्त जवश्वजवद्यालय का जडग्री धारक हो, या
(ख) पंजीकृत फामाडजसस्ट्ट हो; या
(ग) दकसी मान्द्यता प्राप्त बोड ड से आंटरमीजडएट परीक्षा या आसके समकक्ष परीक्षा ईत्तीण ड की हो रर जचदकत्सा
युजि की जबक्री के संबंध म ें एक वषड का ऄनुभव रखत े हों
vi. अवेदक द्वारा की गइ ऄन्द्य गजतजवजधयों के संबंध में संजक्षप्त जववरण, जैसे: दवाओं, जचदकत्सा सामजग्रयों, खाद्य
ईत्पादों, स्ट्टेिनरी अदद का भडं ारण या ईि पिरसर म ेंअवेदक द्वारा की गइ कोइ ऄन्द्य गजतजवजध
vii. ईप-जनयम (2) के तहत दकए गए अवेदन के साथ आस अिय का बंधपर संलग्न दकया जाएगा दक जचदकत्सा
युजि की जबक्री, स्ट्टॉक, प्रदिडन या जबक्री या जवतरण के जलए भडं ारण अवश्यकताओं का ऄनपु ालन दकया जाएगा।[भाग II—खण् ड 3(i)] भारत का राजपर : ऄसाधारण 3
(4) राज्य ऄनुज्ञापन प्राजधकरण, ईप-जनयम (2) के तहत अवेदन करन े की तारीख स े दस ददनों के भीतर दस्ट्तावेजों
की जांच के बाद रर आस त्य से संतुष्ट होने पर दक आन जनयमों की ऄपेक्षाओं का ऄनुपालन दकया गया ह,ै प्ररूप
एमडी -42 में रजजस्ट्रीकरण प्रमाण पर प्रदान करेगा, या यदद वह संतुष्ट नहीं ह,ै तो जलजखत में दजड दकए जाने वाल े
कारणों स ेअवेदन को ऄस्ट्वीकार कर दगे ा।
(5) यदद दकसी जचदकत्सा युजि की जबक्री, स्ट्टॉक, प्रदिडन ऄथवा जबक्री या जवतरण या प्रस्ट्तुत करन े के जलए
रजजस्ट्रीकरण प्रमाण पर प्रदान करन े का अवेदन पर ईप जनयम (4) के ऄंतगडत रद्द कर ददया जाता ह ै तो प्रभाजवत
व्यजि, ऐसे रद्दकरण के प्राप्त होने की तारीख से 45 ददनों के ऄदं र राज्य सरकार को ऄपील कर सकता है, जो ऐसी
पूछताछ के बाद रर ऄपीलकताड को सुनवाइ का एक ऄवसर देने के बाद ऐसी ऄपील प्राप्त होने की तारीख से 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,े प्रदर्वित या जबक्री के जलए
प्रस्ट्ततु करन ेया जवतिरत करन ेके जलए रजजस्ट्रीकरण प्रमाण पर की ित-ें
i. रजजस्ट्रीकरण प्रमाण पर अम लोगों के जलए ददखाइ देन े वाले पिरसर में दकसी प्रमुख स्ट्थान पर प्रदर्वित दकया
जाएगा।
ii. रजजस्ट्रीकरण प्रमाण पर धारक जचदकत्सा युजि के भंडारण के जलए पयाडप्त स्ट्थान, ईजचत भंडारण की जस्ट्थजत प्रदान
करेगा।
iii. रजजस्ट्रीकरण प्रमाण पर धारक ऐसे जचदकत्सा युजि की अवश्यकताओं के ऄनुसार ऄपेजक्षत तापमान रर प्रकाि
व्यवस्ट्था बनाए रखेगा।
iv. ईि जनयमों के तहत जचदकत्सा युजि केवल अयातक या ऄनज्ञु जप्तधारी जवजनमाडता या रजजस्ट्रीकृत/ ऄनुज्ञजप्तधारी
संस्ट्था से खरीद ेजाएंगे।
v. ऐसे जचदकत्सा युजि के नाम रर मारा, जवजनमाडताओं/ अयातकों के नाम रर पते, बैच नंबर/लॉट नंबर, समाजप्त
जतजथ को दिाडने वाले जचदकत्सा युजि की खरीद रर जबक्री का जववरण सॉफ्टवेयर सजहत आनवॉयस या रजजस्ट्टर
या आलेक्रॉजनक के रूप म ें पृथक िरकॉडड में ऄनुरजक्षत दकया जाएगा। आस तरह के िरकॉडड ईि जनयम के जनयम 18
के ईपजनयम (2) के तहत जनयिु जचदकत्सा युजि ऄजधकारी द्वारा जनरीक्षण के जलए खुल े होंगे, जो यदद अवश्यक
हो, जचदकत्सा युजि की खरीद रर जबक्री के बारे म ेंजांच कर सकते ह तरर परीक्षण के जलए नमूने भी ले सकत े ह।त
vi. आन जनयमों के तहत ईज्लजखत सभी रजजस्ट्टरों रर िरकाडों को ऄंजतम प्रजवजष्ट स े कम स े कम दो वषड की ऄवजध के
जलए संरजक्षत रखा जाएगा।
vii. रजजस्ट्रीकरण प्रमाण पर धारक को प्ररूप एमडी -43 में एक जनरीक्षण पुजस्ट्तका बनाए रखनी होगी तादक
जचदकत्सा युजि ऄजधकारी ऄपनी िट्पजणयों रर पाइ गइ खाजमयों को िरकॉडड कर सके।
87 (ग) रजजस्ट्रीकरण प्रमाण पर की वधै ता
(1) प्ररूप एमडी-42 में जारी दकया गया रजजस्ट्रीकरण प्रमाण पर, जब तक आसे राज्य ऄनुज्ञापन प्राजधकरण द्वारा
जनलंजबत या रद्द नहीं दकया जाता है2 स्ट्थायी रूप से वैध रहगे ा, जो आसके जारी होने की तारीख से पांच वषड
की ऄवजध पूरी होने से पहल े दसू री ऄनुसूची में जवजनर्ददष्ट रजजस्ट्रीकरण प्रमाण पर प्रजतधारण िु्क के
भुगतान के िताधड ीन ह।ै
बिते दक, यदद रजजस्ट्रीकरण प्रमाण पर धारक ईपजनयम (1) म ें ईज्लजखत जनयत जतजथ को या ईससे
पहले अवश्यक रजजस्ट्रीकरण प्रमाण पर प्रजतधारण ि्ु क का भुगतान करने म ें जवफल रहता ह,ै तो
रजजस्ट्रीकरण प्रमाण पर धारक, रजजस्ट्रीकरण प्रमाण पर प्रजतधारण ि्ु क के ऄलावा, छह महीने के भीतर
हर महीने या ईसके दकसी जहस्ट्से के जलए रजजस्ट्रीकरण प्रमाण पर प्रजतधारण ि्ु क के दो प्रजतित की दर स े
पिरकजलत दकए गए जवलंब िु्क का भुगतान करने के जलए ईत्तरदायी होगा। ।4 THE GAZETTE OF INDIA : EXTRAORDINARY [PART II—SEC. 3(i)]
परंत ु यह भी दक, ईस ऄवजध के दौरान ऐस े ि्ु क का भगु तान न दकए जान े की जस्ट्थजत म,ें रजजस्ट्रीकरण
प्रमाण पर को रद्द कर ददया गया समझा जाएगा।
87 (घ) रजजस्ट्रीकरण प्रमाण पर का जनलबं न रर रद्दकरण।
(1) जहां रजजस्ट्रीकरण प्रमाण पर धारक, ऄजधजनयम रर ईि जनयमों के दकसी भी प्रावधान का ई्लघं न करता
ह,ै तो राज्य ऄनज्ञु ापन प्राजधकरण, रजजस्ट्रीकरण प्रमाण पर धारक को कारण बतान े का ऄवसर देन े के बाद
दक ऐसा अदेि क्यों पािरत नहीं दकया जाना चाजहए, एक अदेि द्वारा रर जलजखत रूप में दजड दकए जान े
वाले कारणों स,े आसे ऐसी ऄवजध के जलए जनलंजबत कर दगे ा जो वह या तो परू ी तरह से या दकसी भी
जचदकत्सा युजि के संबंध म ेंअवश्यक समझता ह ैया रजजस्ट्रीकरण प्रमाण पर रद्द करें।
(2) ऐसा रजजस्ट्रीकरण प्रमाण पर धारक जजसका रजजस्ट्रीकरण प्रमाण पर ईपजनयम (1) के तहत राज्य ऄनुज्ञापन
प्राजधकरण द्वारा जनलंजबत या रद्द कर ददया गया ह,ै ऐसे प्राजधकरण के अदिे की प्रजत प्राप्त होने के पततालीस
ददनों के भीतर, राज्य सरकार या राज्य सरकार द्वारा नाजमत प्राजधकारी को ऄपील कर सकता ह ै रर राज्य
सरकार या राज्य सरकार द्वारा नाजमत प्राजधकारी रजजस्ट्रीकरण धारक को सुनवाइ का एक ऄवसर द े कर2
जलजखत रूप म ें दज ड दकए जान े के कारणों के साथ, आस तरह के अदिे की पुजष्ट, ईसे बदल या संिोजधत कर
सकेगा।
5. ईि जनयमों म,ें पिरजिष्ट म,ें प्ररूप एमडी- 40 के पश्चात,् जनम्नजलजखत प्ररूप िाजमल दकए जाएंग,े ऄथाडत्:—
"प्ररूप एमडी -41
[जनयम 87(क) का ईप-जनयम (2) देखें]
आन-जवरो डायग्नोजस्ट्टक जचदकत्सा यजु ि सजहत जचदकत्सा यजु ि को बचे न,े स्ट्टॉक करन,े प्रदर्वित करन ेया जबक्री या
जवतरण के जलए प्रस्ट्ताव हते ुरजजस्ट्रीकरण प्रमाण पर प्रदान करन ेके जलए अवदे न
1. अवेदक का नाम:
2. पंजीकृत दकए जाने 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: (यानी स्ट्वाजमत्व, सीजमत देयता साझेदारी सजहत साझेदारी, जनजी या सावडजजनक
कंपनी, समाज, रस्ट्ट, ऄन्द्य जनर्ददष्ट करें):
5. जनयुि दकए गए सक्षम व्यजि का नाम, योग्यता रर ऄनुभव:
6. िु्क भगु तान की जतजथ___________ रुपये _____________ रसीद/चालान/लने देन अइडी ___________
7. मतने जचदकत्सा युजि जनयम, 2017 के जनयम 87(क)(3) में जनर्ददष्ट दस्ट्तावेजों को संलग्न कर ददया ह।ै
स्ट्थान: __________
ददनांक: ___________
जनदेिक/प्रॉपराआटर/साझेदार का नाम, पदनाम रर हस्ट्ताक्षर[भाग II—खण् ड 3(i)] भारत का राजपर : ऄसाधारण 5
प्ररूप एमडी-42
[जनयम 87(क) के ईपजनयम (4) रर जनयम 87(ग) देखें]
आन-जवरो डायग्नोजस्ट्टक जचदकत्सा यजु ि सजहत जचदकत्सा यजु ि को बचे न,े स्ट्टॉक करन,े प्रदर्वित करन ेया जबक्री या
जवतरण के जलए प्रस्ट्ताव हते ुरजजस्ट्रीकरण प्रमाण पर
रजजस्ट्रीकरण क्रमांक: ………………
1. मैसस,ड …………………………………………………………(फमड का नाम), स्ट्थान …………
………………………………… (टेलीफोन रर इ-मेल सजहत परू ा पता) को जचदकत्सा युजि जनयम, 2017 के तहत
आन-जवरो डायग्नोजस्ट्टक मेजडकल युजि सजहत जचदकत्सा युजि को बेचने, स्ट्टॉक करने, प्रदर्वित करने या जबक्री या जवतरण
के जलए प्रस्ट्ताव हते ु पंजीकृत दकया जाता ह।ै
2. सक्षम 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: __________
ददनांक: ___________
राज्य ऄनुज्ञापन प्राजधकारी
प्ररूप एमडी-43
[जनयम 87(ख) का खंड (vii) देखें]
प्ररूप जजसम ें जनरीक्षण पजु स्ट्तका रखी जाएगी
(क) जनरीक्षण पुजस्ट्तका के कवर पर जनम्नजलजखत जववरण होगा, नामतः-
1. रजजस्ट्रीकरण प्रमाणपर धारक का नाम रर पता ______________________________
2. रजजस्ट्रीकरण प्रमाणपर सख्ं या _____________________________________
(ख) (i) जनरीक्षण पुजस्ट्तका के पृष्ठों को क्रमांदकत दकया जाएगा रर राज्य ऄनज्ञु ापन प्राजधकारी द्वारा यथावत मुहर
लगाइ जाएगी। प्रथम रर ऄंजतम पृष्ठ के ऄलावा ऄन्द्य पृष्ठों पर जनम्नजलजखत जववरण होंगे:-
पिरसर जनरीक्षण करन े वाले जचदकत्सा युजि ऄजधकारी का नाम रर पदनाम:
जनरीक्षण की जतजथ ___________________________________________
जचदकत्सा युजि ऄजधकारी की िट्पजणयां _______________
जचदकत्सा युजि ऄजधकारी के हस्ट्ताक्षर6 THE GAZETTE OF INDIA : EXTRAORDINARY [PART II—SEC. 3(i)]
(ii) जनरीक्षण पुजस्ट्तका के प्रथम रर ऄंजतम पष्ठृ पर राज्य ऄनुज्ञापन प्राजधकारी द्वारा जनम्नजलजखत िब्दों म ें पष्ठृ ांकन
दकया जाएगा, नामतः-
जचदकत्सा युजि जनयम, 2017 के तहत प्ररूप एमडी-43______________ में रजजस्ट्रीकरण संख्या ______________
के जलए _______________________ पर जस्ट्थत मेससड _______ द्वारा जनरीक्षण पस्ट्ु तक रखी गइ ।
राज्य ऄनुज्ञापन प्राजधकारी
िट्पजणयााँ:
(i) ऄनुज्ञजप्तधारी द्वारा जनरीक्षण पुजस्ट्तका की मुदरत प्रजत सबं ंजधत ऄनुज्ञापन प्राजधकारी द्वारा समय-समय पर जनर्ददष्ट
िु्क के भुगतान पर ऄनुज्ञजप्त प्राजधकारी से प्राप्त की जा सकती ह।ै
(ii) जनरीक्षण पुजस्ट्तका ऄनुज्ञजप्तधारी के पिरसर म ेंरखी जाएगी।
(iii) जचदकत्सा युजि ऄजधकारी द्वारा की गइ िट्पजणयों की मलू प्रजत ऄनुज्ञजप्तधारी 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
में जलया जाएगा।”
6. ईि जनयमों म,ें —
(i) जनयम 88 के, ईपजनयम (1) म ें "या थोक" िब्दों के बाद तथा "अपूर्वत करेगा " िब्दों से पहल े जनम्नजलजखत िब्द रर
ऄंक ऄतं ःस्ट्थाजपत दकए जाएगं ,े ऄथाडत:् —
"या प्ररूप-42 में रजजस्ट्रीकरण प्रमाण पर"।
(ii) दसू री ऄनुसूची म ें "64(1), 81(1), 84" ऄंकों के बाद तथा ऄंक "91" से पहल े जनम्नजलजखत ऄंक रर ऄक्षर
ऄंतःस्ट्थाजपत दकए जाएगं ,े ऄथातड ्:—
"87 (क) (3) रर 87 (ग) (1)"।
(iii) दसू री ऄनुसूची म,ें ताजलका म,ें क्रमांक 51 रर ईसस े संबंजधत प्रजवजष्टयों के बाद, जनम्नजलजखत क्रम संख्या रर
प्रजवजष्टयााँ ऄंतःस्ट्थाजपत की जाएंगी, ऄथातड ्:—
"
क्रमांक जनयम जवषय जहां डॉलर ($) में जनर्ददष्ट हो को
छोडकर, रुपये म ें(₹)
(1) (2) (3) (4)
52. 87(क)(3) जचदकत्सा युजि की जबक्री हते ु 3000
रजजस्ट्रीकरण प्रमाणपर
53. 87(ग)(1) जचदकत्सा युजि की जबक्री के 3000
जलए रजजस्ट्रीकरण प्रमाण
पर को बनाए रखने का िु्क
”[भाग II—खण् ड 3(i)] भारत का राजपर : ऄसाधारण 7
(iv) चौथी ऄनुसूची म,ें भाग I म,ें "जवजनमाडण ऄनज्ञु जप्त" िब्दों के बाद रर "टेलीफोन के साथ" िब्दों से पहले "या
रजजस्ट्रीकरण प्रमाणपर" िब्द ऄंतःस्ट्थाजपत दकया जाएगा।
(v) पिरजिष्ट के तहत, प्ररूप एमडी-14 म,ें पैरा 3 ईपपैरा (ii) म ें "जवजनमाडण ऄनुज्ञजप्त" िब्दों के बाद "या रजजस्ट्रीकरण
प्रमाणपर" िब्द ऄंतःस्ट्थाजपत दकया जाएगा।
(vi) पिरजिष्ट के तहत, प्ररूप एमडी-15 म,ें पैरा 1 म,ें "जवजनमाडण ऄनुज्ञजप्त" िब्दों के बाद रर "ऄजधकृत एजेंट के" िब्दों
से पहल े "या रजजस्ट्रीकरण प्रमाणपर" िब्द ऄंतःस्ट्थाजपत दकया जाएगा।
(vii) पिरजिष्ट के तहत, प्ररूप एमडी-26 म,ें पैरा 3, ईपपैरा (ii) म ें "जवजनमाडण ऄनुज्ञजप्त" िब्दों के बाद "या रजजस्ट्रीकरण
प्रमाणपर" िब्द ऄंतःस्ट्थाजपत दकया जाएगा।
(viii) पिरजिष्ट के तहत, प्ररूप एमडी-28 म,ें पैरा 3, ईपपैरा (ii) म,ें "जवजनमाडण ऄनज्ञु जप्त" िब्दों के बाद "या
रजजस्ट्रीकरण प्रमाणपर" िब्द ऄंतःस्ट्थाजपत दकया जाएगा।
[फा. सं. एक् स.11014/15/2021-डीअर]
डॉ. मनदीप के भण्डारी, संयुक्त सजचव
िट्पण: 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. …….. (ऄ), तारीख ………… द्वारा ऄंजतमतः संिोजधत
दकए गए थ े।
MINISTRY OF HEALTH AND FAMILY WELFARE
(Department Of Health And Family Welfare)
NOTIFICATION
New Delhi, the 9th February, 2022
G.S.R. 104(E).—The following draft of certain rules further to amend 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 after consultation with
the Drugs Technical Advisory Board 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 forty-five 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 shall, unless specified otherwise, come into force on the date of their final publication in the Official
Gazette.
2. In the Medical Devices Rules, 2017(hereinafter to be referred as said rules), in rule 34, in sub-rule (1), after the
words “wholesale licence for sale or distribution” and before the words “under these rules”, the following words
and figure shall be inserted namely:—
“or registration certificate in Form-42”
3. In the said rules, in rule 87, at the end of sub-rule(1), the following sub-rule shall be inserted, namely: —
“(1)(A) Notwithstanding anything contained in sub-rule(1), any person intends to sale medical devices exclusively as
referred in clause (zb) of rule 3 shall obtain registration certificate as provided hereinafter in these rules.”8 THE GAZETTE OF INDIA : EXTRAORDINARY [PART II—SEC. 3(i)]
4. In the said rules, after rule 87, the following rules shall be inserted, namely:—
“87(A) 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 Licensing Authorities for the purpose of issuing Registration
Certificate in 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 for grant of Registration
Certificate to sell, stock, exhibit or offer for sale or distribution to the State Licensing Authority.
(3) The application made under sub-rule (2), shall be accompanied with
i. a fees prescribed in Second Schedule of the said rules;
ii. Self certificate of compliance with respect to Good Distribution Compliance;
iii. Details of the applicant/firm including its constitution, along with ID proof viz: Aadhar card, 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 and such staff shall possess the following educational qualification
and experience,—
(a) holds a degree of a recognized University; or
(b) is a registered Pharmacist; or
(c) has passed intermediate examination or its equivalent examination from a recognized Board
with the one-year experience in dealing with sale of Medical Devices.
vi. Brief description on other activities carried out by applicant, viz: storage of drugs, medical items, food
products, stationeries etc or any other activities carried out by applicant in the said premises.
vii. The application made under sub-rule (2), shall be accompanied with 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.
87(B) Conditions of registration certificate to sell, stock, exhibit or offer for sale or distribute a medical
device including in vitro diagnostic medical device.—
i. The Registration Certificate shall be displayed at a prominent place in the premises visible to the
public.
ii. The Registration Certificate holder shall provide adequate space, proper storage condition for
storage of the Medical Devices.
iii. The Registration Certificate holder shall maintain required temperature and lighting as per
requirements of such Medical Devices.
iv. The Medical Devices shall be purchased only from Importer or licensed manufacturer or
registered/licenced entity under said rules.
v. Separate records, in 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/importers, Batch Number/Lot Number, Expiry Date shall be[भाग II—खण् ड 3(i)] भारत का राजपर : ऄसाधारण 9
maintained. Such records shall be open to inspection by a Medical Device Officer appointed under
the sub-rule (2) of rule 18 of the said rules, who may, if necessary, make enquiries about purchases
and sale of the Medical devices and may also take samples for testing.
vi. 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.
vii. The Registration Certificate holder shall maintain an inspection book in Form MD-43 to enable the
Medical Devices Officer to record his/her observations and defects noticed.
87(C) 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 as referred to in sub-rule(1), 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 percent. 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 during that period, the Registration
Certificate shall be deemed to have been cancelled.
87(D) Suspension and cancellation of Registration Certificate.—
(1) Where the Registration Certificate holder, contravenes any provision of the Act and the said 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, shall 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 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 or Authority designated by the State
Government, and the State Government or Authority designated by 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 Appendix, after Form MD-40, the following Forms shall be inserted, namely:—
“Form MD-41
[See sub-rule (2) of rule 87(A)]
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___________.10 THE GAZETTE OF INDIA : EXTRAORDINARY [PART II—SEC. 3(i)]
7. I have enclosed the documents as specified in the rule 87(A)(3) of Medical Devices Rules, 2017.
Place: __________
Date: ___________
Name, Designation & Signature of Director/Proprietor/Partner
Form MD-42
[See sub-rule (4) of rule 87(A) and rule 87(C)]
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 clause (vii) of rule 87(B)]
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:—[भाग II—खण् ड 3(i)] भारत का राजपर : ऄसाधारण 11
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 officer
(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.
6. In the said rules,—
(i) in rule 88, in sub-rule (1), after the words “or wholesale” and before the words “may, supply”, the
following words and figure shall be inserted, namely:—
“or registration certificate in Form-42”.
(ii) In Second Schedule, after the figures “64(1), 81(1), 84,” and before the figure “91”, the following figures
and letters shall be inserted, namely:—
“87(A)(3) and 87(C)(1)”.
(iii) In Second Schedule, in the table, after serial number 51 and the entries relating thereto, the following
serial number and entries shall be inserted, namely:—
“
Sr.No. Rule Subject In rupees (INR) except where specified in
dollars ($)
(1) (2) (3) (4)
52. 87(A)(3) Registration Certificate for sale 3000
of Medical Devices
53. 87(C)(1) Retention fee for Registration 3000
certificate for sale of Medical
Devices
”
(iv) In Fourth Schedule, in Part I, after the words “manufacturing licence” and before the words “with
telephone”, the words “or registration certificate” shall be inserted.12 THE GAZETTE OF INDIA : EXTRAORDINARY [PART II—SEC. 3(i)]
(v) Under Appendix, in Form MD-14, in para 3, sub-para (ii), after the words “manufacturing licence” the words
“or registration certificate” shall be inserted.
(vi) Under Appendix, in Form MD-15, in para 1, after the words “manufacturing licence” and before the words
“of authorised agent” the words “or registration certificate” shall be inserted.
(vii) Under Appendix, in Form MD-26, in para 3, sub-para (ii), after the words “manufacturing licence” the words
“or registration certificate” shall be inserted.
(viii) Under Appendix, in Form MD-28, in para 3, sub-para (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 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. .......... (E), dated..............
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.