**Executive Summary**
This notification, issued by the Ministry of Health and Family Welfare on April 10, 2026, proposes the Medical Devices (Amendment) Rules, 2026, to further amend the Medical Devices Rules, 2017. It introduces a standardized fee schedule for testing and evaluation, specific labeling requirements for outsourced sterilization, and a mandatory 30-day window for public objections or suggestions before the rules are finalized.
**Key Points / Main Content**
**Definitions and Administrative Changes**
* **Registration Certificate:** A new definition is inserted, specifying it as a certificate granted by State or Central Licensing Authorities in Forms MD-2, MD-40, or MD-42.
* **Omission of Terms:** The phrase “of a licencee” is removed from Rule 3, clause (j).
**Labeling for Outsourced Sterilization**
* Manufacturers who outsource sterilization must now mention the sterilization site’s license number on the medical device label.
* The license number must be preceded by specific phrases: “Sterilization sites Manufacturing License Number,” “Ster. Mfg. Lic. No.,” or “S.M. L.”
**The Ninth Schedule (Fee Structure)**
* A new schedule is established to define fees for various tests and evaluations, including:
* **Implantation test:** INR 5,000
* **Sterility test:** INR 2,000
* **Surgical Dressings / Syringes & needles:** INR 1,000
* **Condoms / Intrauterine Devices:** INR 2,500
* **Bacterial endotoxin test:** INR 3,000 (Qualitative) to INR 4,500 (Quantitative)
* **Annual Escalation:** The cost of tests and analyses will automatically increase by 5% every year.
* **Unspecified Tests:** Fees for tests not listed in the table will be determined by the Director or Medical Device Testing Officer of the relevant laboratory/institute.
**Impact Analysis**
**Medical Device Manufacturers**
**Impact**
Manufacturers are affected by new labeling mandates for outsourced processes and a formalized, escalating fee structure for product testing.
**Action Required**
Must update product labels to include sterilization site license numbers where applicable and ensure the correct fees from the Ninth Schedule accompany applications in Form MD-33.
**Central and State Licensing Authorities**
**Impact**
The rules provide clearer definitions for registration certificates and a standardized fee framework for the evaluation of devices.
**Action Required**
Authorities must ensure that license applications and renewals comply with the new labeling standards and the updated fee requirements.
**Medical Device Testing Laboratories and Officers**
**Impact**
Directors and Testing Officers are granted the authority to determine fees for specialized tests not explicitly listed in the Ninth Schedule.
**Action Required**
Laboratories must update their billing systems to reflect the new schedule and implement the automatic 5% annual fee increase.
**General Public / Stakeholders**
**Impact**
The public has a defined period to influence the proposed regulatory changes.
**Action Required**
Any person wishing to object or provide suggestions must submit them in writing to the Under Secretary (Drugs), Ministry of Health and Family Welfare, or via email to drugsdiv-mohfw@gov.in within 30 days of the notification's publication.
Key Entities Referenced
Medical Devices Rules, 2017: The principal regulatory framework being amended to introduce new fee structures for testing and evaluation and to clarify labeling requirements for medical devices.
Drugs and Cosmetics Act, 1940: The primary legislation under which the Central Government exercises its power to formulate and amend rules for the regulation of medical devices.
Ministry of Health and Family Welfare: The central government ministry responsible for issuing this notification and overseeing the administration of health policies and medical device regulations.
Drugs Technical Advisory Board: The statutory advisory body consulted by the Central Government to provide technical expertise regarding the proposed amendments to the medical device regulations.
रजिस्ट्री स.ं डी.एल.- 33004/99 REGD. No. D. L.-33004/99
सी.जी.-डी.एल.-अ.-10042026-271705
xxxGIDHxxx
CG-DLxx-ExG-I1D0E0x4x2x0 26-271705
असाधारण
EXTRAORDINARY
भाग II—खण् ड 3—उप-खण्ड (i)
PART II—Section 3—Sub-section (i)
प्राजधकार स ेप्रकाजित
PUBLISHED BY AUTHORITY
स.ं 250] नई दिल्ली, िुक्रवार, अप्रलै 10, 2026/चत्रै 20, 1948
No. 250] NEW DELHI, FRIDAY, APRIL 10, 2026/CHAITRA 20, 1948
स्ट्वास्ट््य और पररवार कल्याण मत्रं ालय
(स्ट्वास्ट््य और पररवार कल्याण जवभाग)
अजधसचू ना
नई दिल्ली, 10 अप्रलै , 2026
सा.का.जन. 270(अ).— जचदकत्सा उपकरण जनयम, 2017 म ें और संिोधन करन े के जलए कुछ जनयमों का
जनम्नजलजखत प्रारूप, जिसे केंद्र सरकार औषजध और प्रसाधन सामग्री अजधजनयम, 1940 (1940 का 23) की धारा 12 की
उप-धारा (1) और धारा 33 की उप-धारा (1) द्वारा प्रित्त िजियों का प्रयोग करत े हुए बनाना प्रस्ट्ताजवत करती ह,ै औषजध
तकनीकी सलाहकार बोड ड के परामि ड के पश्चात ् एतद्द्वारा उन सभी व्यजियों की िानकारी के जलए प्रकाजित दकया िाता ह ै
जिनके इसस े प्रभाजवत होने की संभावना ह ै और एतद्द्वारा नोरिस दिया िाता ह ै दक उि प्रारूप जनयमों पर उस तारीख स े
तीस दिन की अवजध समाप्त होने पर या उसके पश्चात ् जवचार दकया िाएगा जिस तारीख को इन प्रारूप जनयमों वाले भारत
के रािपत्र की प्रजतया ं िनता के जलए उपलब्ध कराई िाती ह;ैं
आपजत्तयां और सुझाव िो ऊपर जनर्िडष्ट अवजध के भीतर दकसी भी व्यजि स े प्राप्त हो सकत े ह,ैं उन पर केंद्र सरकार
द्वारा जवचार दकया िाएगा;
2598 GI/2026 (1)2 THE GAZETTE OF INDIA : EXTRAORDINARY [PART II—SEC. 3(i)]
आपजत्तयां और सुझाव, यदि कोई हों, अवर सजचव (औषजध), स्ट्वास्ट््य और पररवार कल्याण मत्रं ालय, भारत सरकार,
सी ववंग, कतडव्य भवन, नई दिल्ली - 110001 को संबोजधत दकए िा सकत े ह ैं या drugsdiv-mohfw@gov.in पर ईमले
दकए िा सकते ह।ैं
प्रारूप जनयम
1. (i) इन जनयमों को जचदकत्सा उपकरण (.........संिोधन) जनयम, 2026 कहा िा सकता ह।ै
(ii) ये जनयम, िब तक अन्यथा जनर्िडष्ट न हो, रािपत्र म ेंउनके अंजतम प्रकािन की तारीख स े प्रवृत्त होंगे।
2. उि जनयमों म,ें जनयम 3 के खंड (j) म,ें िब्ि “दकसी लाइसेंसधारी का” हिा दिया िाएगा।
3. उि जनयमों म,ें जनयम 3 के खंड (y) के पश्चात,् जनम्नजलजखत खडं अंतःस्ट्थाजपत दकया िाएगा।
(ya) “पंिीकरण प्रमाणपत्र” का अथड ह ैराज्य लाइसेंवसंग प्राजधकारी या केंद्रीय लाइसेंवसंग प्राजधकारी द्वारा प्ररूप एमडी-
2, प्ररूप एमडी-40 और प्ररूप एमडी-42 म,ें यथाजस्ट्थजत, प्रिान दकया गया पंिीकरण प्रमाणपत्र;
4. उि जनयमों म,ें जनयम 44 के खडं (o) के पश्चात,् जनम्नजलजखत खंड अतं ःस्ट्थाजपत दकया िाएगा।
(प) जचदकत्सा उपकरण जनमाडता के मामल ेम ेंजिसने नसबंिी गजतजवजध को दकसी अन्य सुजवधा के स्ट्थल पर आउिसोसड
दकया ह ैजिसके पास जचदकत्सा उपकरणों की नसबंिी प्रदक्रया को पूरा करन ेके जलए वैध लाइसेंस ह,ै वास्ट्तजवक नसबंिी
स्ट्थल का लाइसेंस नंबर उपकरण के लेबल पर उल्लेख दकया िाना चाजहए। नसबंिी स्ट्थल लाइससें नंबर िब्िों “नसबंिी
स्ट्थल जवजनमाडण लाइसेंस संख्या” या “नसबंिी जव.ला.स.ं” या “न.जव.ला.स.ं” स ेपहल े होगा;
5. उि जनयमों म,ें जनयम 44 के खंड (o) म,ें िब्ि “और (m)” के पश्चात,् िब्िों, “(एम) और (पी)” द्वारा प्रजतस्ट्थाजपत
दकया िाएगा।
6. जचदकत्सा उपकरण जनयम, 2017 (जिन्ह ेंइसम ेंइसके बाि उि जनयम कहा िाएगा) म,ें आठवीं अनुसूची के पश्चात्,
नौवीं अनुसूची अतं ःस्ट्थाजपत की िाएगी, अथाडत्: -
नौवीं अनसु चू ी
“परीक्षण या मल्ू यांकन के जलए िुल्क
[जनयम 19, 69 िेख]ें
क्रम परीक्षण/मल्ू याकं न का प्रकार परीक्षण/मल्ू याकं न की लागत
स.ं
रुपय ेम ें(INR)
(1) (2) (3)
1. प्रत्यारोपण परीक्षण 5000
2. बंध्यता परीक्षण 2000
3. िल्य जचदकत्सा ड्रेवसंग 1000
4. जसररंि और सुई 1000[भाग II—खण् ड 3(i)] भारत का रािपत्र : असाधारण 3
5. परफ्यूिन सेि आदि के जलए भौजतक परीक्षण / भौजतक-रासायजनक परीक्षण 2000
6. िल्य जचदकत्सा िांके 3000
7. ऑजटिकल रोिेिन, जवजिष्ट गरुु त्व, अपवतडनांक, प्रजत जमलीलीिर विन, प्रजतिीजप्त 250 प्रत्येक
आदि।
8. अविोषण क्षमता, प्रजत इकाई क्षत्रे विन (िल्य जचदकत्सा), जविेिी पिाथ,ड जनष्कषडण 150 प्रत्येक
मूल्य, धाग े की सख्ं या, लंबाई और चौडाई (िल्य जचदकत्सा), सतह सदक्रय पिाथ,ड
अम्लता या क्षारीयता, नेटस, सेरिंग समय आदि।
9. कंडोम 2500
10. अंतगडभाडियी उपकरण 2500
11. िीवाणु एंडोिॉजससन परीक्षण ----
क. गुणात्मक 3000
ख. मात्रात्मक 4500
रिटपणी: -
(1) ऊपर िी गई ताजलका म ें जनर्िडष्ट न दकए गए परीक्षणों/मल्ू यांकनों के जलए, िुल्क प्रयोगिाला/संस्ट्थान के जनिेिक या
जचदकत्सा उपकरण परीक्षण अजधकारी द्वारा, यथाजस्ट्थजत, जनधाडररत दकए िाएंगे।
(2) परीक्षण/जवश्लेषण की जनधाडररत लागत प्रजतवष ड 5% स्ट्वतः बढ़ िाएगी।
7. उि जनयमों म,ें अध्याय III म,ें जनयम 19 म,ें उप-जनयम (2) के पश्चात,् जनम्नजलजखत उप-जनयम अतं ःस्ट्थाजपत दकया िाएगा,
अथाडत:् -
“(3) परीक्षण या मूल्यांकन के जलए िुल्क नौवीं अनुसूची म ें जनर्िडष्ट होंगे।”
8. उि जनयमों म,ें अध्याय IX म,ें जनयम 69 म,ें िब्ि “प्ररूप एमडी-33 म”ें के पश्चात,् िब्ि “नौवीं अनुसूची म ें जनर्िडष्ट िुल्क
के साथ” अंतःस्ट्थाजपत दकए िाएंगे।
[फा. स.ं X.11035/112/2024-डीआर]
हष ड मंगला, संयुस त सजचव
रिटपणी: जचदकत्सा उपकरण जनयम, 2017 रािपत्र म ेंअजधसूचना संख्या 78 (ई), दिनांक 31 िनवरी, 2017 द्वारा प्रकाजित
दकए गए थ े और अंजतम बार अजधसूचना संख्या सा.का.जन. ………… (अ), दिनांक ………… द्वारा संिोजधत
दकए गए थे।4 THE GAZETTE OF INDIA : EXTRAORDINARY [PART II—SEC. 3(i)]
MINISTRY OF HEALTH AND FAMILY WELFARE
(Department of Health and Family Welfare)
NOTIFICATION
New Delhi, the 10th April, 2026
G.S.R. 270(E).— The following draft of certain rules further to amend Medical Devices 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 thirty 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, C Wing, Kartavya Bhavan, New Delhi - 110001 or emailed at drugsdiv-
mohfw@gov.in.
DRAFT RULES
1. (i) These rules may be called the Medical Devices (.........Amendment) Rules, 2026.
(ii) These rules unless specified otherwise, come into force on the date of their final publication in the Official
Gazette.
2. In the said rules, in clause (j) of rule 3, the word “of a licencee” shall be omitted.
3. In the said rules, after the clause (y)of rule 3, the following clause shall be inserted.
(ya) “Certificate of Registration” means a registration certificate granted by the State Licensing Authority or
the Central Licensing Authority in Form MD-2, Form MD-40 and Form MD-42 as the case may be;
4. In the said rules, after clause (o) of Rule 44, the following clause shall be inserted.
(p) In case of medical device manufacturer who outsourced the sterilization activity at the site of another facility
having valid license to carry out sterilization process of medical devices, the license number of the sterilization
site should be mentioned on label of the device. The sterilization site license number by preceding the words
“Sterilization sites Manufacturing License Number” or “Ster. Mfg. Lic. No.” or “S.M. L”;
5. In the said rules, in the clause (o) of Rule 44, after the words “and (m)”, shall be substituted by the words, “(m)
and (p)”.
6. In the Medical Devices Rules, 2017, (hereinafter referred to as the said rules), after Eighth Schedule, the Ninth
Schedule shall be inserted namely: -
Ninth Schedule
“Fee for test or evaluation
[See rules 19, 69]
Cost of Test/Evaluation
Sr. No. Type of Test/Evaluation in rupees (INR)
(1) (2) (3)
1. Implantation test 5000
2. Sterility test 2000
3. Surgical Dressings 1000
4. Syringes & needles 1000
5. Physical test / Physiochemical test for perfusion sets etc., 2000
6. Surgical Sutures 3000[भाग II—खण् ड 3(i)] भारत का रािपत्र : असाधारण 5
7. Optical Rotation, Specific Gravity, Refractive Index, weight per ml, 250 each
Fluorescence etc.
8. Absorbency, Weight per unit area (Surgical), Foreign matter, Extractive value, 150 each
Threads count, Length & Width (Surgical), Surface active substances, Acidity
or alkalinity, Neps, Setting time etc.
9. Condoms 2500
10. Intrauterine Devices 2500
11. Bacterial endotoxin test ----
a. Qualitative 3000
b. Quantitative 4500
Note: -
1. For test/evaluations not specified in the above table, charges shall be determined by the Director or Medical
Device Testing Officer of the Laboratory/Institute as the case may be.
2. The prescribed cost of the test/analysis shall automatically increase by 5% annually.
7. In the said rules, in Chapter III, in rule 19, after sub-rule (2), the following sub-rule shall be inserted namely: -
“(3) The fees for test or evaluation shall be those specified in ninth Schedule.”
8. In the said rules, in Chapter IX, in rule 69, after the words “in Form MD-33”, the words “accompanied with a fee
specified in the Ninth Schedule” shall be inserted.
[F. No. X.11035/112/2024-DR]
HARSH MANGLA, Jt. Secy.
Note: The Medical Devices Rules, 2017 was published in the Official Gazette vide notification number 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.