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REGD. No. D. L.-33004/99
The Gazette of India
CG-DL-E-10042026-271705
EXTRAORDINARY
PART II-Section 3-Sub-section (i)
PUBLISHED BY AUTHORITY
No. 250]
NEW DELHI, FRIDAY, APRIL 10, 2026/CHAITRA 20, 1948
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-
[email protected].
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]
+--------+-----------------------------------------------------+---------------------------------+
| Sr. No. | Type of Test/Evaluation | Cost 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 | 2000 |
| | sets etc., | |
+--------+-----------------------------------------------------+---------------------------------+
| 6. | Surgical Sutures | 3000 |
+--------+-----------------------------------------------------+---------------------------------+
| 7. | Optical Rotation, Specific Gravity, Refractive | 250 each |
| | Index, weight per ml, Fluorescence etc. | |
+--------+-----------------------------------------------------+---------------------------------+
| 8. | Absorbency, Weight per unit area (Surgical), | 150 each |
| | Foreign matter, Extractive 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. (E), dated
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