Second Amendment in Medical Device Rules, 2017
Issued by Ministry of Health and Family Welfare · Department of Health and Family Welfare
Read or download the official PDF of this gazette notification issued by the Ministry of Health and Family Welfare on 19th August 2026. Classified under Extra Ordinary.
Executive Summary & Key Takeaways
Executive Summary The Medical Devices (Second Amendment) Rules, 2026, issued by the Ministry of Health and Family Welfare on August 14, 2026, amends the Medical Devices Rules, 2017. The document introduces new definitions for registration certificates, establishes specific labeling requirements for outsourced sterilization, and implements a standardized fee schedule for device testing and evaluation. Compliance with the new labeling provisions is mandatory within six months of the notification date.
Key Points / Main Content
Definitions and General Amendments
- The term "of a licencee" is omitted from Rule 3, clause (j).
- "Certificate of Registration" is now explicitly defined as a certificate granted by State or Central Licensing Authorities in Forms MD-2, MD-40, or MD-42.
Labeling Requirements for Sterilization
- Manufacturers who outsource sterilization to a third-party facility must include the license number of the sterilization site on the medical device label.
- The sterilization license number must be preceded by specific phrases: “Sterilization sites Manufacturing License Number”, “Ster. Mfg. Lic. No.”, or “S.M. L.”
- Compliance with these labeling requirements becomes mandatory six months from the date of this notification.
Testing and Evaluation Fees (Ninth Schedule)
- A new "Ninth Schedule" is inserted to standardize fees for various medical device tests.
- Sample fees include: Implantation test (₹5,000), Sterility test (₹2,000), Surgical Sutures (₹3,000), and Condoms/Intrauterine Devices (₹2,500).
- Fees for tests not specified in the schedule will be determined by the Director or Medical Device Testing Officer of the respective Laboratory or Institute.
- All prescribed testing fees will automatically increase by 5% annually.
Impact Analysis
Medical Device Manufacturers Impact: Manufacturers must adjust their supply chain documentation and product labeling for devices undergoing outsourced sterilization. They are also subject to a new standardized fee structure for device evaluations. Action Required: Update device labels to include outsourced sterilization site license numbers within the six-month grace period. Budget for testing costs according to the Ninth Schedule, accounting for the 5% annual fee increase.
Licensing Authorities (State and Central) Impact: Authorities are formally recognized as the issuers of "Certificates of Registration" under specific forms (MD-2, MD-40, MD-42). Action Required: Ensure the issuance of registration certificates aligns with the newly inserted definitions and monitor manufacturer compliance with the updated labeling rules.
Testing Laboratories and Institutes Impact: Laboratories must implement the standardized fee schedule for all specified medical device tests and evaluations. Action Required: Apply the Ninth Schedule fees for all incoming tests. The Director or Testing Officer must determine and set charges for any specialized tests not explicitly listed in the schedule.
Key Entities Referenced
Medical Devices (Second Amendment) Rules, 2026: The primary policy document that introduces amendments to medical device regulations, specifically regarding outsourced sterilization labeling and testing fees.
Medical Devices Rules, 2017: The principal regulatory framework governing medical devices in India, which is being updated and expanded by this notification.
Drugs and Cosmetics Act, 1940: The parent legislation that provides the legal authority for the Central Government to frame and amend rules related to medical devices.
Drugs Technical Advisory Board: The statutory advisory body consulted by the Central Government to provide expert technical guidance on these regulatory amendments.
Ministry of Health and Family Welfare: The nodal ministry responsible for the oversight, formulation, and notification of medical device safety and quality standards in India.
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रजिस्ट्री स.ं डी.एल.- 33004/99 REGD. No. D. L.-33004/99
सी.जी.-डी.एल.-अ.-21082026-275637
xxxGIDHxxx
CG-DLxx-ExG-I2D1E0x8x2x0 26-275637
असाधारण
EXTRAORDINARY
भाग II—खण् ड 3—उप-खण्ड (i)
PART II—Section 3—Sub-section (i)
प्राजधकार स ेप्रकाजित
PUBLISHED BY AUTHORITY
स.ं 677] नई दिल्ली, बुधवार, अगस्ट्त 19, 2026/श्रावण 28, 1948
No. 677] NEW DELHI, WEDNESDAY, AUGUST 19, 2026/SHRAVAN 28, 1948
स्ट्वास्ट््य और पररवार कल्याण मत्रं ालय
(स्ट्वास्ट््य और पररवार कल्याण जवभाग)
अजधसचू ना
नई दिल्ली, 14 अगस्ट् त, 2026
lk.का.fu. 743(अ) .— ओषजध और प्रसाधन सामग्री अजधजनयम, 1940 (1940 का 23) की धारा 12 की उपधारा
(1) तथा धारा 33 की उपधारा (1) द्वारा यथा अपेजित जचदकत्सा युजि जनयम, 2017 का और संिोधन करन ेके जलए प्रारूप
जनयम, भारत के रािपत्र, असाधारण, भाग 2, खडं 3, उप-खडं (i) द्वारा संखयांक सा.का.जन. 270(अ), तारीख 10 अप्रैल,
2026 द्वारा प्रकाजित दकया गया थ,े जिसम ेउि अजधसूचना को अंतर्विष्ट करने वाली रािपत्र की प्रजतयां िनता को उपलब्ध
कराए िान े की तारीख से तीस दिन की अवजध के अवसान से पवू ि उससे प्रभाजवत होन े वाल ेसभी संभाव्य व्यजियों स ेआपेि
और सुझाव आमंजत्रत दकए गए थ;े
और उि आजधकाररक रािपत्र की प्रजतयां 10 अप्रलै , 2026 को िनता को उपलब्ध करा िी गईं थी;
और उि प्रारूप जनयमों के संबधं म ें िनता स े प्राप्त आपेिों और सुझावों पर केंद्रीय सरकार द्वारा जवचार दकया
गया ह;ै
6409 GI/2026 (1)2 THE GAZETTE OF INDIA : EXTRAORDINARY [PART II—SEC. 3(i)]
अतः, अब केंद्रीय सरकार ओषजध और प्रसाधन सामग्री अजधजनयम, 1940 (1940 का 23) की धारा 12 तथा धारा 33
द्वारा प्रित्त िजियों का प्रयोग करते हुए, ओषजध तकनीकी सलाहकार बोडि स ेपरामि िकरन ेके पश्चात, जचदकत्सा युजि जनयम,
2017 का और संिोधन करने के जलए जनम्नजलजखत जनयम बनाती ह,ै अथाित:् ⸻
1. संजिप्त नाम और प्रारंभ .-(1) इन जनयमों का संजिप् त नाम जचदकत्सा युजत (िसू रा संिोधन) जनयम, 2026 ह।ै
(2) य ेजनयम, िब तक अन्यथा जवजनर्ििष्ट न हो, रािपत्र म ें इनके अंजतम प्रकािन की तारीख को प्रवृत्त होंगे।
2. उि जनयमों म,ें जनयम 3 के खंड (ञ) म,ें "अनज्ञु जप्तधारक के " िब्िों का लोप दकया िाएगा।
3. उि जनयमों म,ें जनयम 3 के खंड (म) के पश्चात,् जनम्नजलजखत खंड अंतःस्ट्थाजपत दकया िाएगा:
(मक) "रजिस्ट्रीकरण प्रमाणपत्र” स े यथाजस्ट्थजत राज्य अनुज्ञापन प्राजधकारी या केंद्रीय अनज्ञु ापन
प्राजधकारी द्वारा प्ररूप एमडी-2, प्ररूप एमडी-40 तथा प्ररूप एमडी-42 म,ें अनुित्त दकया गया रजिस्ट्रीकरण
प्रमाणपत्र अजभप्रते ह।ै
4. उि जनयमों म,ें जनयम 44 के खडं (ण) के पश्चात,् जनम्नजलजखत खंड अतं ःस्ट्थाजपत दकया िाएगा, अथाित:्
(त) जचदकत्सा युजि जवजनमािता की ििा म,ें
िो जचदकत्सा युजि के जवसंक्रमण प्रदक्रया को करने के जलए जवजधमान्य अनुज्ञजप्त रखने वाले दकसी अन्य सुजवधा स्ट्थल
पर जवसंक्रमण दक्रयाकलाप को बाहरी स्रोत स े ठेके पर करवाता ह,ै
जवसंक्रमण स्ट्थल की अनज्ञु जप्त संखया युजि के लेबल पर उजल्लजखत होनी चाजहए। जवसंक्रमण स्ट्थल अनज्ञु जप्त संखया
िब्िों का उपयोग "जवसंक्रमण स्ट्थल जवजनमािण अनुज्ञजप्त संखया" या "जवसं.जवजनमाि. अन.ुस.ं " या "जव.जव.अ. स े पहल े
होगा"।
5. उि जनयमों म,ें जनयम 44 के खडं (ण) म,ें "और (ड)" िब्िों के स्ट्थान पर "(ड) और (त) । " िब्ि रखे िाएगं े।
बित,े खंड (त) का अनुपालन इस अजधसूचना की तारीख स े छह महीन े स ेलाग ू होगा।
6. जचदकत्सा उपकरण जनयम, 2017 (जिसे इसम ें इसके पश्चात ् उि जनयम कहा गया ह)ै म,ें आठवीं अनुसूची के
पश्चात,् नौवीं अनुसूची अंतःस्ट्थाजपत की िाएगी, अथाित:् -
नौवीं अनसु चू ी
“परीिण या मल्ू यांकन के जलए िुल्क
[जनयम 19, 69 िेजखए]
क्रम स.ं परीिण/मल्ू याकं न का प्रकार परीिण/मल्ू याकं न की लागत रुपय ेम ें (भा.रू)
(1) (2) (3)
1. प्रत्यारोपण परीिण 5000
2. िीवाणुरजहणता परीिण 2000[भाग II—खण् ड 3(i)] भारत का रािपत्र : असाधारण 3
3. िल्य जचदकत्सा ड्रेससंग 1000
4. सररंि और सूई 1000
5. परफ्यूिन के जलए भौजतक परीिण/ भौजतक रासायजनक परीिण 2000
6. िल्य जचदकत्सा टांके 3000
7. प्रकािीय घूणिन, जवजनर्ििष्ट गरुु त्वाकषिण, अपवतिक सूचक, भार 250
प्रजत जम.ली., प्रजतदिजप्त
8. अविोषण िमता, ित्रे (िल्य जचदकत्सा) प्रजत यूजनट भार जविेिी 150
पिाथि, जनष्कषिण मल्ू य, धाग े की मात्रा, लंबाई और चौडाई(िल्य
जचदकत्सा),सतह सक्रीय पिाथि, अम्लता या िारीयता, नेप्स, सेरटंग
समय आदि
9. कंडोम 2500
10. अंतगिभािियी युजि 2500
11. िीवाणु अंतराजवष परीिण ----
क. गुणात्मक 3000
ख. मात्रात्मक 4500
रटप्पण: -
(1)
उपरोि सारणी म ें जवजनर्ििष्ट न दकए गए परीिण/मल्ू यांकनों के जलए प्रभार, प्रयोगिाला/संस्ट्थान के यथाजस्ट्थजत जनिेिक या
जचदकत्सा युजि परीिण अजधकारी द्वारा अवधाररत दकए िाएंगे।।
(2) परीिण/मल्ू यांकन की जवजहत लागत स्ट्वतः पांच प्रजतित वार्षिक द्वारा बढ़ िाएगी।
7. उि जनयमों म,ें अध्याय 3 के जनयम 19 म,ें उप-जनयम (2) के पश्चात,् जनम्नजलजखत उप-जनयम अंतःस्ट्थाजपत दकया िाएगा,
अथाित:् -
“(3) परीिण या मूल्यांकन के जलए फीस वह होगी िो नौवीं अनुसूची म ें जवजनर्ििष्ट ह।ै "
8. उि जनयमों म,ें अध्याय 9 के जनयम 69 म ें"प्ररुप एमडी-33" िब्िों के पश्चात,् “नौवीं अनुसचू ी म ें जवजनर्ििष्ट फीस के साथ”
िब्ि अंतःस्ट्थाजपत दकए िाएंगे।
[फा. सं. एस.11035/112/2024-डीआर]
हष ि मंगला, संयुि सजचव
रटप्पण: जचदकत्सा युजि जनयम, 2017 रािपत्र म ें अजधसूचना संखया 78 (अ), दिनांक 31 िनवरी, 2017 द्वारा प्रकाजित
दकए गए थ ेतथा अंजतम बार अजधसूचना संखयांक सा.का.जन. 165(अ), दिनांक 02 माचि, 2026 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 14th August, 2026
G.S.R. 743(E).— Whereas a draft of certain rules further to amend Medical Device Rules, 2017,
were published in the Gazette of India, Extraordinary, Part II, Section 3, Sub-section (i) vide number G.S.R.
270(E), dated the 10th April, 2026 as required by Sub-section (1) of section 12 and Sub-section (1) of section
33 of the Drugs and Cosmetics Act, 1940 (23 of 1940), inviting objections and suggestions from all person
likely to be affected thereby before the expiry of a period of thirty days from the date which on the copies of
the Official Gazette containing the said notification was published were made available to public;
And whereas, copies of the said Official Gazette were made available to the public on 10th April,
2026;
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 section 12 and section 33 of the Drugs and
Cosmetics Act, 1940 (23 of 1940), the Central Government, after consultation with 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 (Second 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).”
Provided, the compliance with clause (p) shall be mandatory with effect from six months from the date
of this notification.
6. In the Medical Devices Rules, 2017, (hereinafter referred to as the said rules), after Eighth
Schedule, the Ninth Schedule shall be inserted namely: -[भाग II—खण् ड 3(i)] भारत का रािपत्र : असाधारण 5
Ninth Schedule
Fee for test or evaluation
[See rules 19, 69]
Cost of Test/
Sr. No. Type of Test/Evaluation 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
7. Optical Rotation, Specific Gravity, Refractive Index, weight per ml, 250 each
Fluorescence etc.
8. Absorbency, Weight per unit area (Surgical), Foreign matter, Extractive 150 each
value, 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. 165(E), dated 2nd
March, 2026.
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.